Linaclotide

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Experience 2.0

Guanylate cyclase-C agonist peptide

Linaclotide is a guanylate cyclase-C agonist peptide studied for gastrointestinal symptoms. Constipation-related conditions, age groups, and bowel-preparation studies are distinct settings and should be interpreted separately.

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Traceability partial

Last meaningful update: 9/26/2026

Evidence searched through:: Not recorded
Assessment updated:: 9/26/2026
Documented human review:: No documented human review recorded
Automated scientific assessment:: None recorded
AI source check:: 9/26/2026

Published source links and profile text pass separate gates. Only a documented human review is labelled as human review; an automated scientific assessment applies deterministic checks, and an AI source check confirms only that a source exists and matches its identifiers. A source count alone does not establish a review.

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500

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167

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Corpus generated 2026-09-18. Counts remain separately labeled so screening is not represented as completed review.

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500

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167

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6 published domain syntheses connected to 0 featured studies

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Inspect the published evidence record167 governed records · titles, provenance, and original-source linksOpen records ↓

2014Phase 3 human evidence

Impact of linaclotide treatment on work productivity and activity impairment in adults with irritable bowel syndrome with constipation: results from 2 randomized, double-blind, placebo-controlled phase 3 trials.

Content-verified record concerning Linaclotide: "Impact of linaclotide treatment on work productivity and activity impairment in adults with irritable bowel syndrome with constipation: results from 2 randomized, double-blind, placebo-controlled phase 3 trials." Abstract excerpt: Irritable bowel syndrome with constipation (IBS-C), a chronic functional gastrointestinal disorder, has been shown to negatively affect work productivity and impair daily activity, resulting in a substantial burden for patients and employers. Linaclotide is a first-in-class guanylate cyclase-C agonist approved for the treatment of adults with IBS-C and chronic idiopathic constipation in the United

Source: peer_reviewed_research
PubMed: 25237424

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2019Phase 3 human evidence

High-dose linaclotide is effective and safe in patients with chronic constipation: A phase III randomized, double-blind, placebo-controlled study with a long-term open-label extension study in Japan.

Content-verified record concerning Linaclotide: "High-dose linaclotide is effective and safe in patients with chronic constipation: A phase III randomized, double-blind, placebo-controlled study with a long-term open-label extension study in Japan." Abstract excerpt: A previous phase II dose-ranging study of linaclotide in a Japanese chronic constipation (CC) population showed that 0.5 mg was the most effective dose. This study aimed to verify the hypothesis that 0.5 mg of linaclotide is effective and safe in Japanese CC patients. This was a Japanese phase III randomized, double-blind, placebo-controlled (part 1), and long-term, open-label extension

Source: peer_reviewed_research
DOI: 10.1111/nmo.13487
PubMed: 30353619

Open original source

2024Phase 3 human evidence

Linaclotide for functional constipation in paediatric patients: phase III results.

Content-verified record concerning Linaclotide: "Linaclotide for functional constipation in paediatric patients: phase III results." (identity confirmed; no abstract text available to excerpt.)

Source: peer_reviewed_research
DOI: 10.1038/s41575-024-00903-6
PubMed: 38347080

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2014Phase 3 human evidence

The impact of abdominal pain on global measures in patients with chronic idiopathic constipation, before and after treatment with linaclotide: a pooled analysis of two randomised, double-blind, placebo-controlled, phase 3 trials.

Content-verified record concerning Linaclotide: "The impact of abdominal pain on global measures in patients with chronic idiopathic constipation, before and after treatment with linaclotide: a pooled analysis of two randomised, double-blind, placebo-controlled, phase 3 trials." Abstract excerpt: Few clinical trials in chronic idiopathic constipation (CIC) patients have evaluated abdominal symptom severity and whether CIC patients with abdominal symptoms respond similarly to patients with limited abdominal symptoms. To examine abdominal symptom severity and relationships between symptoms and global measures at baseline; compare linaclotide's effect on symptoms in subpopulations with more o

Source: peer_reviewed_research
DOI: 10.1111/apt.12985
PubMed: 25312449

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2014Phase 3 human evidence

Responders vs clinical response: a critical analysis of data from linaclotide phase 3 clinical trials in IBS-C.

Content-verified record concerning Linaclotide: "Responders vs clinical response: a critical analysis of data from linaclotide phase 3 clinical trials in IBS-C." Abstract excerpt: US Food and Drug Administration (FDA) set a rigorous standard for defining patient responders in irritable bowel syndrome-C (IBS-C; i.e., FDA's Responder Endpoint) for regulatory approval. However, this endpoint's utility for health-care practitioners to assess clinical response has not been determined. We analyzed pooled IBS-C linaclotide trial data to evaluate clinically significant responses in

Source: peer_reviewed_research
DOI: 10.1111/nmo.12264
PubMed: 24382134

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2018Phase 3 human evidence

Linaclotide in irritable bowel syndrome with constipation: A Phase 3 randomized trial in China and other regions.

Content-verified record concerning Linaclotide: "Linaclotide in irritable bowel syndrome with constipation: A Phase 3 randomized trial in China and other regions." Abstract excerpt: Linaclotide is a guanylate cyclase-C agonist approved in multiple countries to treat irritable bowel syndrome with constipation (IBS-C). China has unmet need for well-tolerated therapy that is effective in treating both bowel and abdominal symptoms of IBS-C. This trial evaluated linaclotide's efficacy and safety in IBS-C patients in China and other regions. This Phase 3, double-blind trial randomi

Source: peer_reviewed_research
DOI: 10.1111/jgh.14086
PubMed: 29319191

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2013Phase 3 human evidence

Randomised clinical trials: linaclotide phase 3 studies in IBS-C - a prespecified further analysis based on European Medicines Agency-specified endpoints.

Content-verified record concerning Linaclotide: "Randomised clinical trials: linaclotide phase 3 studies in IBS-C - a prespecified further analysis based on European Medicines Agency-specified endpoints." Abstract excerpt: Treatment options that improve overall symptoms of irritable bowel syndrome with constipation (IBS-C) are lacking. A prespecified further analysis to evaluate the efficacy and safety of linaclotide, a guanylate cyclase C agonist, in patients with IBS-C, based on efficacy parameters prespecified for European Medicines Agency (EMA) submission. Two randomised, double-blind, multicentre Phase 3 trials

Source: peer_reviewed_research
DOI: 10.1111/apt.12123
PubMed: 23116208

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2019Phase 3 human evidence

Safety and tolerability of linaclotide for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation: pooled Phase 3 analysis.

Content-verified record concerning Linaclotide: "Safety and tolerability of linaclotide for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation: pooled Phase 3 analysis." Abstract excerpt: Linaclotide is approved for treating irritable bowel syndrome with constipation (IBS-C; 290 µg QD) and chronic idiopathic constipation (CIC; 145 µg or 72 µg QD). These analyses aimed to assess linaclotide safety in a large, pooled Phase 3 population. In six randomized controlled trials (RCTs), patients received linaclotide (72 µg, 145 µg, 290 

Source: peer_reviewed_research
DOI: 10.1080/17474124.2019.1575203
PubMed: 30791771

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2013Phase 3 human evidence

An evaluation of the FDA responder endpoint for IBS-C clinical trials: analysis of data from linaclotide Phase 3 clinical trials.

Content-verified record concerning Linaclotide: "An evaluation of the FDA responder endpoint for IBS-C clinical trials: analysis of data from linaclotide Phase 3 clinical trials." Abstract excerpt: Our objective was to evaluate the performance of the Food and Drug Administration (FDA) Responder Endpoint for clinical trials in IBS-C, using data from two large Phase 3 clinical trials of linaclotide. The FDA interim endpoint requires that, for 50% of trial weeks, patients report ≥30% decrease in Abdominal Pain at its worst and (in the same week) an increase in Complete Spontaneous Bowel

Source: peer_reviewed_research
DOI: 10.1111/nmo.12089
PubMed: 23384406

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2022Phase 3 human evidence

Efficacy and safety of linaclotide in patients with irritable bowel syndrome with constipation: Chinese sub-cohort analysis of a phase III, randomized, double-blind, placebo-controlled trial.

Content-verified record concerning Linaclotide: "Efficacy and safety of linaclotide in patients with irritable bowel syndrome with constipation: Chinese sub-cohort analysis of a phase III, randomized, double-blind, placebo-controlled trial." Abstract excerpt: To conduct a sub-cohort analysis to evaluate the efficacy and safety of linaclotide in Chinese patients with constipation-predominant irritable bowel syndrome (IBS-C) using data from a completed trial (NCT01880424). In this phase III, double-blind, placebo-controlled trial, IBS-C patients were randomized to receive linaclotide (290 μg/d) or placebo for 12 weeks. Efficacy was assessed with tw

Source: peer_reviewed_research
DOI: 10.1111/1751-2980.13081
PubMed: 35019221

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2024Phase 3 human evidence

Efficacy and safety of linaclotide in treating functional constipation in paediatric patients: a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial.

Content-verified record concerning Linaclotide: "Efficacy and safety of linaclotide in treating functional constipation in paediatric patients: a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial." Abstract excerpt: Linaclotide, a guanylate cyclase C agonist, has been approved in the USA for the treatment of chronic idiopathic constipation and irritable bowel syndrome with predominant constipation in adults. We aimed to assess the efficacy and safety of linaclotide in paediatric patients aged 6-17 years with functional constipation. This randomised, double-blind, placebo-controlled, multicentre, phase 3 study

Source: peer_reviewed_research
DOI: 10.1016/s2468-1253(23)00398-9
PubMed: 38211604

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2021Phase 1–2 human evidence

Polyethylene glycol combined with linaclotide is an effective and well-tolerated bowel preparation regimen for colonoscopy: an endoscopist-blinded, randomized, controlled trial.

Content-verified record concerning Linaclotide: "Polyethylene glycol combined with linaclotide is an effective and well-tolerated bowel preparation regimen for colonoscopy: an endoscopist-blinded, randomized, controlled trial." Abstract excerpt: Bowel preparation is an important determinant of the quality of colonoscopy. The traditional split-dose regimen of 4 L polyethylene glycol (PEG) solutions for bowel preparation is effective but poorly tolerated. The aim of this was to study the efficacy and tolerability of using linaclotide as an adjunctive agent with low-volume PEG for bowel preparation. This was an endoscopist-blinded, randomize

Source: peer_reviewed_research
DOI: 10.1097/meg.0000000000002184
PubMed: 34034273

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2018Phase 1–2 human evidence

Determining an optimal dose of linaclotide for use in Japanese patients with irritable bowel syndrome with constipation: A phase II randomized, double-blind, placebo-controlled study.

Content-verified record concerning Linaclotide: "Determining an optimal dose of linaclotide for use in Japanese patients with irritable bowel syndrome with constipation: A phase II randomized, double-blind, placebo-controlled study." Abstract excerpt: Clinical testing to determine a suitable dose of linaclotide for Japanese patients with irritable bowel syndrome with constipation (IBS-C) was needed. This was a randomized, double-blind, placebo-controlled, dose-finding trial. Japanese patients with IBS-C diagnosed using Rome III criteria (n = 559, men/women: 49/510) were randomly assigned to 1 of 4 linaclotide doses (0.0625, 0.125, 0.2

Source: peer_reviewed_research
DOI: 10.1111/nmo.13275
PubMed: 29278278

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2024Phase 1–2 human evidence

Randomized controlled trial of linaclotide in children aged 6-17 years with functional constipation.

Content-verified record concerning Linaclotide: "Randomized controlled trial of linaclotide in children aged 6-17 years with functional constipation." Abstract excerpt: Linaclotide, a guanylate cyclase-C agonist, was recently approved in the United States for treatment of children 6-17 years old with functional constipation (FC). This study evaluated the safety and efficacy of several linaclotide doses in children 6-17 years old with FC. In this multicenter, randomized, double-blind, placebo-controlled phase 2 study, 173 children with FC (based on Rome III c

Source: peer_reviewed_research
DOI: 10.1002/jpn3.12184
PubMed: 38533633

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2025Phase 1–2 human evidence

Effects of the combined use of linaclotide and oral sulfate solution in bowel preparation for patients with chronic constipation undergoing colonoscopy: protocol of a prospective, randomised, controlled, single-blind clinical trial from a single centre in China.

Content-verified record concerning Linaclotide: "Effects of the combined use of linaclotide and oral sulfate solution in bowel preparation for patients with chronic constipation undergoing colonoscopy: protocol of a prospective, randomised, controlled, single-blind clinical trial from a single centre in China." Abstract excerpt: Chronic constipation is an independent risk factor for inadequate bowel preparation. The objective of this study is to evaluate the effectiveness and safety of the combined use of linaclotide and oral sulfate solution (OSS) in patients with chronic constipation undergoing colonoscopy. This is a prospective, randomised, controlled, single-blind (endoscopist) clinical trial that compares three bowel

Source: peer_reviewed_research
DOI: 10.1136/bmjopen-2025-099687
PubMed: 40335135

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2020Phase 1–2 human evidence

Randomised clinical trial: linaclotide vs placebo-a study of bi-directional gut and brain axis.

Content-verified record concerning Linaclotide: "Randomised clinical trial: linaclotide vs placebo-a study of bi-directional gut and brain axis." Abstract excerpt: Linaclotide, a guanylate cyclase C agonist relieves irritable bowel syndrome with predominant constipation (IBS-C) symptoms, but how it improves pain in humans is unknown. To investigate the effects of linaclotide and placebo on the afferent and efferent gut-brain-gut signalling in IBS-C patients, in a randomised clinical trial. Patients with IBS-C (Rome III) and rectal hypersensitivity were rando

Source: peer_reviewed_research
DOI: 10.1111/apt.15772
PubMed: 32406112

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2020Phase 1–2 human evidence

Efficacy and safety of linaclotide for opioid-induced constipation in patients with chronic noncancer pain syndromes from a phase 2 randomized study.

Content-verified record concerning Linaclotide: "Efficacy and safety of linaclotide for opioid-induced constipation in patients with chronic noncancer pain syndromes from a phase 2 randomized study." Abstract excerpt: Constipation is the most common adverse event (AE) of opioid therapy. This multicenter, phase 2 study evaluated the efficacy and safety of linaclotide in treating opioid-induced constipation (OIC) in patients with chronic noncancer pain syndromes (NCT02270983). Adults with OIC (<3 spontaneous bowel movements [SBMs]/week) related to chronic noncancer pain were randomized 1:1:1 to receive linaclo

Source: peer_reviewed_research
DOI: 10.1097/j.pain.0000000000001754
PubMed: 32310620

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2026Phase 1–2 human evidence

Short-term linaclotide plus polyethylene glycol in patients at increased risk of inadequate bowel preparation: A randomized, double-blind, multicenter trial.

Content-verified record concerning Linaclotide: "Short-term linaclotide plus polyethylene glycol in patients at increased risk of inadequate bowel preparation: A randomized, double-blind, multicenter trial." Abstract excerpt: The benefit of combining linaclotide with polyethylene glycol (PEG) for improving bowel preparation quality and adenoma detection in patients at risk for inadequate bowel preparation remains uncertain. This study aimed to evaluate its efficacy and safety. From August 2022 to July 2023, a multicenter, randomized trial assigned participants to a 2-day linaclotide or placebo plus PEG regimen. The pri

Source: peer_reviewed_research
DOI: 10.1016/j.dld.2026.01.229
PubMed: 41692643

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2024Phase 1–2 human evidence

Evaluation of the efficacy of polyethylene glycol in combination with different doses of linaclotide in a fractionated bowel preparation for colonoscopy: a prospective randomized controlled study.

Content-verified record concerning Linaclotide: "Evaluation of the efficacy of polyethylene glycol in combination with different doses of linaclotide in a fractionated bowel preparation for colonoscopy: a prospective randomized controlled study." Abstract excerpt: The ideal bowel cleansing program still needs to be explored. The aim was to compare the bowel cleansing effect and patient tolerance of low-dose polyethylene glycol (PEG) combined with different doses of linaclotide in fractionated bowel preparation. The subjects were randomly assigned to the 3LPEG group, 2LPEG + 2L group, or 2LPEG + L group. The primary outcome was to use the Ottawa Bowel Prepar

Source: peer_reviewed_research
DOI: 10.1007/s00384-024-04718-4
PubMed: 39289199

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2026Phase 1–2 human evidence

Linaclotide in combination with compound polyethylene glycol powder enhances bowel preparation for colonoscopy in patients aged over 60 years: a multi-center, endoscopist-blind, randomized controlled trial.

Content-verified record concerning Linaclotide: "Linaclotide in combination with compound polyethylene glycol powder enhances bowel preparation for colonoscopy in patients aged over 60 years: a multi-center, endoscopist-blind, randomized controlled trial." Abstract excerpt: This study aimed to investigate the efficacy and safety of bowel preparation by linaclotide (Lina) combined with compound polyethylene glycol (PEG) in patients aged over 60 years. A multi-center, endoscopist-blind, randomized controlled trial involved 527 patients aged over 60 years scheduled for colonoscopy at two hospitals in Chongqing from January 2022 to December 2023. Participants were random

Source: peer_reviewed_research
DOI: 10.1080/00365521.2025.2588230
PubMed: 41222080

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2018Phase 1–2 human evidence

Randomized, double-blind, placebo-controlled study vs data in the daily practice using linaclotide in patients with irritable bowel syndrome with constipation.

Content-verified record concerning Linaclotide: "Randomized, double-blind, placebo-controlled study vs data in the daily practice using linaclotide in patients with irritable bowel syndrome with constipation." (identity confirmed; no abstract text available to excerpt.)

Source: peer_reviewed_research
DOI: 10.1111/nmo.13363
PubMed: 29700962

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2023Phase 1–2 human evidence

A novel ultra-low-volume regimen combining 1 L polyethylene glycol and linaclotide versus 2 L polyethylene glycol for colonoscopy cleansing in low-risk individuals: a randomized controlled trial.

Content-verified record concerning Linaclotide: "A novel ultra-low-volume regimen combining 1 L polyethylene glycol and linaclotide versus 2 L polyethylene glycol for colonoscopy cleansing in low-risk individuals: a randomized controlled trial." Abstract excerpt: The single dose of 2 L polyethylene glycol (PEG) has shown high cleaning efficacy and tolerability in low-risk patients. However, the dosage of this regimen is still challenging for many patients. We investigated the efficacy and tolerability of a novel ultra-low-volume regimen using 1 L PEG and linaclotide (1 L PEG+L) versus a single dose of 2 L PEG in low-risk patients. In this prospective,

Source: peer_reviewed_research
DOI: 10.1016/j.gie.2022.12.015
PubMed: 36572127

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2018Phase 1–2 human evidence

Low-Dose Linaclotide (72 μg) for Chronic Idiopathic Constipation: A 12-Week, Randomized, Double-Blind, Placebo-Controlled Trial.

Content-verified record concerning Linaclotide: "Low-Dose Linaclotide (72 μg) for Chronic Idiopathic Constipation: A 12-Week, Randomized, Double-Blind, Placebo-Controlled Trial." Abstract excerpt: Linaclotide is a guanylate cyclase-C agonist approved in the United States, Canada, and Mexico at a once-daily 145-μg dose for the treatment of chronic idiopathic constipation (CIC); a once-daily 72-μg dose for CIC recently received FDA approval. The trial objective was to evaluate the efficacy and safety of a 72-μg linaclotide dose in CIC patients. This double-blind, placebo-con

Source: peer_reviewed_research
DOI: 10.1038/ajg.2017.230
PubMed: 29091082

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2026Phase 1–2 human evidence

Effect of Linaclotide on Colonic Motility Assessed With Intraluminal Colonic High-Resolution Manometry in Healthy Subjects. An Acute, Open Label, Randomized, Crossover, Reader-Blinded Study.

Content-verified record concerning Linaclotide: "Effect of Linaclotide on Colonic Motility Assessed With Intraluminal Colonic High-Resolution Manometry in Healthy Subjects. An Acute, Open Label, Randomized, Crossover, Reader-Blinded Study." Abstract excerpt: Polyethilenglicole (PEG), bisacodyl, prucalopride, and linaclotide were demonstrated to be superior to placebo for the treatment of chronic constipation. In a recent study, we reported the actions of PEG, bisacodyl, and prucalopride on colonic motor patterns. The aim of the present study was to evaluate the effect of linaclotide as compared to placebo on colonic motility assessed with high-resolut

Source: peer_reviewed_research
DOI: 10.1111/nmo.70222
PubMed: 41413756

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2024Phase 1–2 human evidence

Efficacy of Polyethylene Glycol Electrolyte Powder Combined With Linaclotide for Colon Cleansing in Patients With Chronic Constipation Undergoing Colonoscopy: A Multicenter, Single-Blinded, Randomized Controlled Trial.

Content-verified record concerning Linaclotide: "Efficacy of Polyethylene Glycol Electrolyte Powder Combined With Linaclotide for Colon Cleansing in Patients With Chronic Constipation Undergoing Colonoscopy: A Multicenter, Single-Blinded, Randomized Controlled Trial." Abstract excerpt: Constipation is an independent risk factor for poor bowel preparation. This study aimed to evaluate the bowel cleansing efficacy and safety of polyethylene glycol (PEG) combined with linaclotide (lin) for colonoscopy in patients with chronic constipation (CC). This single-blinded, randomized, controlled, and multicenter study was conducted from July 2021 to December 2022 at 7 hospitals. Patients w

Source: peer_reviewed_research
DOI: 10.14309/ctg.0000000000000708
PubMed: 38713137

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2025Phase 1–2 human evidence

Efficacy of 1 L Polyethylene Glycol Plus Ascorbic Acid With Linaclotide Versus Senna for Bowel Preparation: A Multicenter, Endoscopist-Blinded, Randomized Controlled Trial (Apple Trial).

Content-verified record concerning Linaclotide: "Efficacy of 1 L Polyethylene Glycol Plus Ascorbic Acid With Linaclotide Versus Senna for Bowel Preparation: A Multicenter, Endoscopist-Blinded, Randomized Controlled Trial (Apple Trial)." Abstract excerpt: No bowel preparation (BP) for colonoscopy achieves optimal efficacy and tolerability. Combining polyethylene glycol plus ascorbic acid (PEG-Asc) with adjuvants has been explored to enhance cleansing efficacy and reduce the required volume. The aim of this study was to evaluate whether adding 0.5 mg linaclotide to 1 L PEG-Asc (1 L-PEG/AL) improves superior cleansing compared with adding 24 mg senna

Source: peer_reviewed_research
DOI: 10.14309/ajg.0000000000003370
PubMed: 39996602

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2021Phase 1–2 human evidence

Randomized Trial of 2 Delayed-Release Formulations of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation.

Content-verified record concerning Linaclotide: "Randomized Trial of 2 Delayed-Release Formulations of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation." Abstract excerpt: Immediate-release (IR) formulation of linaclotide 290 μg improves abdominal pain and constipation (APC) in patients with irritable bowel syndrome (IBS) with constipation. Delayed-release (DR) formulations were developed on the premise that targeting the ileum (delayed-release formulation 1 [DR1]) or ileocecal junction and cecum (MD-7246, formerly DR2) would modulate linaclotide's secretory e

Source: peer_reviewed_research
DOI: 10.14309/ajg.0000000000000967
PubMed: 33065589

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2018Phase 1–2 human evidence

A randomized controlled and long-term linaclotide study of irritable bowel syndrome with constipation patients in Japan.

Content-verified record concerning Linaclotide: "A randomized controlled and long-term linaclotide study of irritable bowel syndrome with constipation patients in Japan." Abstract excerpt: Clinical testing was required to verify the effect of linaclotide 0.5 mg/d in patients with irritable bowel syndrome with constipation (IBS-C) in Japan. This was a randomized, double-blind, placebo-controlled (Part 1) and long-term, open-label extension (Part 2) study of linaclotide at 60 hospitals and clinics in Japan. Patients with IBS-C diagnosed using Rome III criteria (n = 500)

Source: peer_reviewed_research
DOI: 10.1111/nmo.13444
PubMed: 30136447

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2024Phase 1–2 human evidence

Application of linaclotide in bowel preparation for colonoscopy in patients with constipation: A prospective randomized controlled study.

Content-verified record concerning Linaclotide: "Application of linaclotide in bowel preparation for colonoscopy in patients with constipation: A prospective randomized controlled study." Abstract excerpt: Colonoscopy plays a crucial role in the early diagnosis and treatment of colorectal cancer. Adequate bowel preparation is essential for clear visualization of the colonic mucosa and lesion detection. However, inadequate bowel preparation is common in patients with constipation, and there is no standardized preparation protocol for these patients. This study aimed to explore the effectiveness and t

Source: peer_reviewed_research
DOI: 10.1111/jgh.16734
PubMed: 39252470

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2015Phase 1–2 human evidence

Linaclotide in Chronic Idiopathic Constipation Patients with Moderate to Severe Abdominal Bloating: A Randomized, Controlled Trial.

Content-verified record concerning Linaclotide: "Linaclotide in Chronic Idiopathic Constipation Patients with Moderate to Severe Abdominal Bloating: A Randomized, Controlled Trial." Abstract excerpt: Abdominal bloating is a common and bothersome symptom of chronic idiopathic constipation. The objective of this trial was to evaluate the efficacy and safety of linaclotide in patients with chronic idiopathic constipation and concomitant moderate-to-severe abdominal bloating. This Phase 3b, randomized, double-blind, placebo-controlled clinical trial randomized patients to oral linaclotide (145 or

Source: peer_reviewed_research
DOI: 10.1371/journal.pone.0134349
PubMed: 26222318

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2024Phase 1–2 human evidence

Efficacy of linaclotide in combination with polyethylene glycol for bowel preparation in Chinese patients undergoing colonoscopy polypectomy: protocol for a randomised controlled trial.

Content-verified record concerning Linaclotide: "Efficacy of linaclotide in combination with polyethylene glycol for bowel preparation in Chinese patients undergoing colonoscopy polypectomy: protocol for a randomised controlled trial." Abstract excerpt: Adequate bowel preparation is essential for successful colonoscopy and polypectomy procedures. However, a significant proportion of patients still exhibit suboptimal bowel preparation, ranging from 18% to 35%. The effectiveness of bowel preparation agents can be hampered by volume and taste, adversely affecting patient compliance and tolerance. Therefore, exploring strategies to minimise laxative

Source: peer_reviewed_research
DOI: 10.1136/bmjopen-2023-080723
PubMed: 39043596

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2024Phase 1–2 human evidence

Safety and efficacy of linaclotide in children aged 2-5 years with functional constipation: Phase 2, randomized study.

Content-verified record concerning Linaclotide: "Safety and efficacy of linaclotide in children aged 2-5 years with functional constipation: Phase 2, randomized study." Abstract excerpt: Linaclotide, a guanylate cyclase-C agonist, was recently approved in the United States for the treatment of children 6-17 years of age with functional constipation (FC). This study evaluated the dose-response, safety, and efficacy of 4 weeks of linaclotide compared with placebo in children 2-5 years of age with FC. In this phase 2, randomized, double-blind, placebo-controlled, multidose study, 35

Source: peer_reviewed_research
DOI: 10.1002/jpn3.12306
PubMed: 38962910

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2026Phase 1–2 human evidence

Efficacy and Safety of Linaclotide in Pediatric Patients of Functional Constipation: A Meta-analysis of Randomized Controlled Trials.

Content-verified record concerning Linaclotide: "Efficacy and Safety of Linaclotide in Pediatric Patients of Functional Constipation: A Meta-analysis of Randomized Controlled Trials." Abstract excerpt: To evaluate the efficacy and safety of linaclotide in children with functional constipation (FC) by synthesizing evidence from randomized controlled trials (RCTs). A systematic search of PubMed, Scopus, Cochrane Central Register of Controlled Trials, and Google Scholar was conducted from inception through December 2024. The protocol was registered in PROSPERO (CRD420251018285), and the review was

Source: peer_reviewed_research
DOI: 10.1177/10600280261479335
PubMed: 42695347

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2018Phase 1–2 human evidence

Dose-finding study of linaclotide in Japanese patients with chronic constipation: A phase II randomized, double-blind, and placebo-controlled study.

Content-verified record concerning Linaclotide: "Dose-finding study of linaclotide in Japanese patients with chronic constipation: A phase II randomized, double-blind, and placebo-controlled study." Abstract excerpt: Based on the previous phase II/III studies of irritable bowel syndrome with constipation (IBS-C) in Japan that demonstrated the efficacy and safety of linaclotide 0.5 mg/d, we evaluated linaclotide at doses of 0.5 mg/d and lower in the treatment of Japanese patients with chronic constipation (CC). This was a phase II randomized, double-blind, placebo-controlled, dose-finding study of lin

Source: peer_reviewed_research
DOI: 10.1111/nmo.13442
PubMed: 30084233

Open original source

2012Phase 1–2 human evidence

Linaclotide for irritable bowel syndrome with constipation: a 26-week, randomized, double-blind, placebo-controlled trial to evaluate efficacy and safety.

Content-verified record concerning Linaclotide: "Linaclotide for irritable bowel syndrome with constipation: a 26-week, randomized, double-blind, placebo-controlled trial to evaluate efficacy and safety." Abstract excerpt: Linaclotide is a minimally absorbed peptide guanylate cyclase-C agonist. The objective of this trial was to determine the efficacy and safety of linaclotide treatment in patients with irritable bowel syndrome with constipation (IBS-C) over 26 weeks. This phase 3, double-blind, parallel-group, placebo-controlled trial randomized IBS-C patients to placebo or 290 μg of oral linaclotide once dai

Source: peer_reviewed_research
DOI: 10.1038/ajg.2012.254
PubMed: 22986437

Open original source

2026Phase 1–2 human evidence

Effect of 3-Day Linaclotide Administration to Reduce the Polyethylene Glycol Volume for Colonoscopy Bowel Preparation: A Multicenter, Noninferiority, Randomized Controlled Trial.

Content-verified record concerning Linaclotide: "Effect of 3-Day Linaclotide Administration to Reduce the Polyethylene Glycol Volume for Colonoscopy Bowel Preparation: A Multicenter, Noninferiority, Randomized Controlled Trial." Abstract excerpt: Several studies have investigated the role of linaclotide in bowel preparation; however, dosage and timing still warrant further exploration. This noninferiority randomized controlled study was performed in 16 medical centers. The eligible subjects were randomly assigned to 3 groups: the Lct + 3 L polyethylene glycol (PEG) group (group A), the 3 L PEG group (group B), or the Lct + 2 L PEG group (g

Source: peer_reviewed_research
DOI: 10.14309/ajg.0000000000003557
PubMed: 40423516

Open original source

2025Phase 1–2 human evidence

Efficacy of Linaclotide in Functional Dyspepsia and Constipation-Predominant Irritable Bowel Syndrome Overlap: A Randomized Trial.

Content-verified record concerning Linaclotide: "Efficacy of Linaclotide in Functional Dyspepsia and Constipation-Predominant Irritable Bowel Syndrome Overlap: A Randomized Trial." Abstract excerpt: Linaclotide is effective in relieving constipation-predominant irritable bowel syndrome symptoms. However, few studies focus on the efficacy of linaclotide for overlapping symptoms of functional dyspepsia among irritable bowel syndrome patients. This study aimed to assess the efficacy of linaclotide compared with lactulose in patients with functional dyspepsia and constipation-predominant irritabl

Source: peer_reviewed_research
DOI: 10.1111/jgh.16925
PubMed: 40079184

Open original source

2012Phase 1–2 human evidence

A 12-week, randomized, controlled trial with a 4-week randomized withdrawal period to evaluate the efficacy and safety of linaclotide in irritable bowel syndrome with constipation.

Content-verified record concerning Linaclotide: "A 12-week, randomized, controlled trial with a 4-week randomized withdrawal period to evaluate the efficacy and safety of linaclotide in irritable bowel syndrome with constipation." Abstract excerpt: Linaclotide is a minimally absorbed guanylate cyclase-C agonist. The objective of this trial was to determine the efficacy and safety of linaclotide in patients with irritable bowel syndrome with constipation (IBS-C). This phase 3, double-blind, parallel-group, placebo-controlled trial randomized IBS-C patients to placebo or 290 μ g oral linaclotide once daily in a 12-week treatment period,

Source: peer_reviewed_research
DOI: 10.1038/ajg.2012.255
PubMed: 22986440

Open original source

2011Phase 1–2 human evidence

Two randomized trials of linaclotide for chronic constipation.

Content-verified record concerning Linaclotide: "Two randomized trials of linaclotide for chronic constipation." Abstract excerpt: Linaclotide is a minimally absorbed peptide agonist of the guanylate cyclase C receptor. In two trials, we aimed to determine the efficacy and safety of linaclotide in patients with chronic constipation. We conducted two randomized, 12-week, multicenter, double-blind, parallel-group, placebo-controlled, dual-dose trials (Trials 303 and 01) involving 1276 patients with chronic constipation. Patient

Source: peer_reviewed_research
DOI: 10.1056/nejmoa1010863
PubMed: 21830967

Open original source

2023Phase 1–2 human evidence

Linaclotide Reduced Response Time for Irritable Bowel Syndrome With Constipation Symptoms: Analysis of 4 Randomized Controlled Trials.

Content-verified record concerning Linaclotide: "Linaclotide Reduced Response Time for Irritable Bowel Syndrome With Constipation Symptoms: Analysis of 4 Randomized Controlled Trials." Abstract excerpt: These post hoc analyses provide clinically relevant data concerning time to response for individual irritable bowel syndrome with constipation (IBS-C) symptoms after linaclotide use. Time-to-response data were pooled from 4 randomized controlled trials. Response time for abdominal symptoms (pain, discomfort, and bloating) and complete spontaneous bowel movements (CSBMs) were analyzed using the Kap

Source: peer_reviewed_research
DOI: 10.14309/ajg.0000000000002064
PubMed: 36227782

Open original source

2024Observational human evidence

Bowel preparation with linaclotide and 1 L polyethylene glycol plus ascorbic acid prior to colonoscopy in chronic constipated patients.

Content-verified record concerning Linaclotide: "Bowel preparation with linaclotide and 1 L polyethylene glycol plus ascorbic acid prior to colonoscopy in chronic constipated patients." Abstract excerpt: Information on effective bowel preparation (BP) methods for patients with constipation is limited. We recently reported the efficacy of 1 L polyethylene glycol plus ascorbic acid (PEG-Asc) combined with senna for BP; however, this regimen was insufficient in patients with constipation. We hypothesized that the addition of linaclotide, which is approved for the treatment of chronic constipation, to

Source: peer_reviewed_research
DOI: 10.1080/00365521.2024.2398094
PubMed: 39219191

Open original source

2025Observational human evidence

Real-world safety of linaclotide in Chinese patients with irritable bowel syndrome with constipation: a multicenter, single-arm, prospective observational study.

Content-verified record concerning Linaclotide: "Real-world safety of linaclotide in Chinese patients with irritable bowel syndrome with constipation: a multicenter, single-arm, prospective observational study." Abstract excerpt: Linaclotide, a guanylate cyclase-C agonist, is indicated for irritable bowel syndrome with constipation (IBS-C). However, real-world data on the safety and patient-reported outcomes (PROs) of linaclotide are scarce in Chinese patients with IBS-C. To assess the real-world safety and PROs of linaclotide in the Chinese IBS-C population. Multicenter, prospective observational study. Adults with IBS-C

Source: peer_reviewed_research
DOI: 10.1177/17562848251314819
PubMed: 39917729

Open original source

2024Observational human evidence

Ten years of successful linaclotide treatment in a patient with intestinal pseudo-obstruction due to Ehlers-Danlos syndrome.

Content-verified record concerning Linaclotide: "Ten years of successful linaclotide treatment in a patient with intestinal pseudo-obstruction due to Ehlers-Danlos syndrome." (identity confirmed; no abstract text available to excerpt.)

Source: peer_reviewed_research
DOI: 10.1007/s11739-023-03522-2
PubMed: 38159221

Open original source

2022Observational human evidence

Linaclotide for treating patients with irritable bowel syndrome with predominant constipation: a multicentre study of real-world data in China.

Content-verified record concerning Linaclotide: "Linaclotide for treating patients with irritable bowel syndrome with predominant constipation: a multicentre study of real-world data in China." Abstract excerpt: Linaclotide, a guanylate cyclase C agonist that improves the symptoms of irritable bowel syndrome with predominant constipation (IBS-C), has been recently approved for IBS-C treatment. This study aimed to report real-world data on linaclotide treatment in China. This was a prospective multicentre study of the effectiveness of linaclotide treatment in patients with IBS-C from 10 primary medical ins

Source: peer_reviewed_research
DOI: 10.1177/17562848221092596
PubMed: 35509427

Open original source

2018Observational human evidence

Health Care Resource Use and Costs Pre- and Post-Treatment Initiation With Linaclotide: Retrospective Analyses of a U.S. Insured Population.

Content-verified record concerning Linaclotide: "Health Care Resource Use and Costs Pre- and Post-Treatment Initiation With Linaclotide: Retrospective Analyses of a U.S. Insured Population." Abstract excerpt: As expected, pharmacy costs increased with the introduction of this new treatment in a market dominated by over-the-counter and generic treatments. On the other hand, outpatient GI-related and irritable bowel disease health care resource use and costs substantially decreased among commercial and Medicare patients following linaclotide treatment initiation.

Source: peer_reviewed_research
PubMed: 29451468

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2022Observational human evidence

Linaclotide utilization and potential for off-label use and misuse in three European countries.

Content-verified record concerning Linaclotide: "Linaclotide utilization and potential for off-label use and misuse in three European countries." Abstract excerpt: Linaclotide is approved for adults with moderate-to-severe irritable bowel syndrome (IBS) with constipation (IBS-C). Linaclotide is not indicated for weight loss or for patients with inflammatory bowel disease (IBD); it is contraindicated in patients with mechanical bowel obstruction (MBO). Some patients with obesity or eating disorders (ED) may use linaclotide off-label for weight loss or as a la

Source: peer_reviewed_research
DOI: 10.1177/17562848221100946
PubMed: 35706826

Open original source

2018Observational human evidence

Linaclotide inhibits colonic and urinary bladder hypersensitivity in adult female rats following unpredictable neonatal stress.

Content-verified record concerning Linaclotide: "Linaclotide inhibits colonic and urinary bladder hypersensitivity in adult female rats following unpredictable neonatal stress." Abstract excerpt: Irritable bowel syndrome (IBS) and bladder pain syndrome (BPS) are female-predominant, chronic functional pain disorders that are associated with early life stress (ELS) and therapeutic options for such patients remain limited. Linaclotide, a guanylate cyclase-C (GC-C) agonist, relieves abdominal pain and bowel symptoms in adult patients suffering from IBS with constipation. Here, we test the hypo

Source: peer_reviewed_research
DOI: 10.1111/nmo.13375
PubMed: 29797376

Open original source

2021Observational human evidence

The Use of Linaclotide in Children with Functional Constipation or Irritable Bowel Syndrome: A Retrospective Chart Review.

Content-verified record concerning Linaclotide: "The Use of Linaclotide in Children with Functional Constipation or Irritable Bowel Syndrome: A Retrospective Chart Review." Abstract excerpt: Linaclotide is a well-tolerated and effective agent for adults with functional constipation (FC) or irritable bowel syndrome with constipation (IBS-C). However, data in children are lacking. The aim of this study is to examine the efficacy and safety of linaclotide in children. We performed a retrospective review of children < 18 years old who started linaclotide at our institution (N

Source: peer_reviewed_research
DOI: 10.1007/s40272-021-00444-4
PubMed: 33876403

Open original source

2021Observational human evidence

[Efficacy and Safety of Linaclotide in Elderly Patients].

Content-verified record concerning Linaclotide: "[Efficacy and Safety of Linaclotide in Elderly Patients]." Abstract excerpt: The efficacy and safety of linaclotide in elderly patients are poorly understood. Herein, we aimed to assess the efficacy and safety of linaclotide in elderly patients in real-world setting. We retrospectively enrolled consecutive patients who started linaclotide therapy at Sapporo Medical University Hospital from October 1, 2017 to December 31, 2019. The efficacy and safety of linaclotide were ex

Source: peer_reviewed_research
DOI: 10.1248/yakushi.20-00176
PubMed: 33518646

Open original source

2025Observational human evidence

Linaclotide Use for the Treatment of Constipation and Gastrointestinal Symptoms in People With Cystic Fibrosis.

Content-verified record concerning Linaclotide: "Linaclotide Use for the Treatment of Constipation and Gastrointestinal Symptoms in People With Cystic Fibrosis." Abstract excerpt: Cystic Fibrosis (CF) is a multisystem autosomal recessive disease characterized by thick, sticky mucus which causes lung disease, pancreatic insufficiency, and many other manifestations. Constipation is a common complication in CF and few advances in treatment have been made until recent years. Linaclotide is a treatment approved for chronic idiopathic constipation and irritable bowel syndrome wit

Source: peer_reviewed_research
DOI: 10.1002/ppul.27431
PubMed: 39620387

Open original source

2018Observational human evidence

Long-term results of linaclotide in the treatment of constipation-type irritable bowel syndrome.

Content-verified record concerning Linaclotide: "Long-term results of linaclotide in the treatment of constipation-type irritable bowel syndrome." Abstract excerpt: constipation-predominant irritable bowel syndrome (C-IBS) is a prevalent, complex and multifactorial disorder that represents a challenge in terms of diagnosis and therapeutic management. to evaluate the effectiveness, safety and treatment satisfaction of linaclotide in C-IBS patients. prospective, single-center and observational study conducted in patients diagnosed with C-IBS. The patients were

Source: peer_reviewed_research
DOI: 10.17235/reed.2018.5268/2017
PubMed: 29685047

Open original source

2013Animal research

Pharmacologic properties, metabolism, and disposition of linaclotide, a novel therapeutic peptide approved for the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation.

Content-verified record concerning Linaclotide: "Pharmacologic properties, metabolism, and disposition of linaclotide, a novel therapeutic peptide approved for the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation." Abstract excerpt: Linaclotide, a potent guanylate cyclase C agonist, is a therapeutic peptide approved in the United States for the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation. We present for the first time the metabolism, degradation, and disposition of linaclotide in animals and humans. We examined the metabolic stability of linaclotide in conditions that mimic the

Source: peer_reviewed_research
DOI: 10.1124/jpet.112.199430
PubMed: 23090647

Open original source

2013Animal research

Linaclotide for constipation-predominant IBS.

Content-verified record concerning Linaclotide: "Linaclotide for constipation-predominant IBS." Abstract excerpt: Irritable bowel syndrome is a chronic relapsing disorder characterised by abdominal pain or discomfort associated with defaecation, abdominal bloating and a change in bowel habit. IBS may be classified by the change in bowel function as 'diarrhoea predominant' (IBS-D), 'constipation predominant' (IBS-C) or mixed, or may be unclassified. Although it is not thought to be associated with the developm

Source: peer_reviewed_research
DOI: 10.1136/dtb.2013.11.0218
PubMed: 24227771

Open original source

2021Animal research

Linaclotide for the treatment of refractory lower bowel manifestations of systemic sclerosis.

Content-verified record concerning Linaclotide: "Linaclotide for the treatment of refractory lower bowel manifestations of systemic sclerosis." Abstract excerpt: Lower gastrointestinal (GI) tract involvement can affect up to 50% of systemic sclerosis (SSc) patients, and may result in malabsorption, pseudo-obstruction, hospitalization, and death. We report our experience with linaclotide, a selective agonist of guanylate cyclase C (GC-C), for SSc patients with refractory lower GI disease. We performed an analysis of patients seen at the Johns Hopkins Sclero

Source: peer_reviewed_research
DOI: 10.1186/s12876-021-01738-0
PubMed: 33858329

Open original source

2019Animal research

Linaclotide treatment reduces endometriosis-associated vaginal hyperalgesia and mechanical allodynia through viscerovisceral cross-talk.

Content-verified record concerning Linaclotide: "Linaclotide treatment reduces endometriosis-associated vaginal hyperalgesia and mechanical allodynia through viscerovisceral cross-talk." Abstract excerpt: Endometriosis, an estrogen-dependent chronic inflammatory disease, is the most common cause of chronic pelvic pain. Here, we investigated the effects of linaclotide, a Food and Drug Administration-approved treatment for IBS-C, in a rat model of endometriosis. Eight weeks after endometrium transplantation into the intestinal mesentery, rats developed endometrial lesions as well as vaginal hyperalge

Source: peer_reviewed_research
DOI: 10.1097/j.pain.0000000000001657
PubMed: 31335750

Open original source

2018Animal research

Linaclotide Attenuates Visceral Organ Crosstalk: Role of Guanylate Cyclase-C Activation in Reversing Bladder-Colon Cross-Sensitization.

Content-verified record concerning Linaclotide: "Linaclotide Attenuates Visceral Organ Crosstalk: Role of Guanylate Cyclase-C Activation in Reversing Bladder-Colon Cross-Sensitization." Abstract excerpt: Bladder pain syndrome (BPS) is poorly understood; however, there is a female predominance and comorbidity with irritable bowel syndrome (IBS). Here we test the hypothesis that linaclotide, a guanylate cyclase-C (GC-C) agonist approved for the treatment of IBS with constipation (IBS-C), may represent a novel therapeutic for BPS acting through a mechanism involving an inhibition of visceral organ cr

Source: peer_reviewed_research
DOI: 10.1124/jpet.118.248567
PubMed: 29784661

Open original source

2018Animal research

Linaclotide improves gastrointestinal transit in cystic fibrosis mice by inhibiting sodium/hydrogen exchanger 3.

Content-verified record concerning Linaclotide: "Linaclotide improves gastrointestinal transit in cystic fibrosis mice by inhibiting sodium/hydrogen exchanger 3." Abstract excerpt: Gastrointestinal dysfunction in cystic fibrosis (CF) is a prominent source of pain among patients with CF. Linaclotide, a guanylate cyclase C (GCC) receptor agonist, is a US Food and Drug Administration-approved drug prescribed for chronic constipation but has not been widely used in CF, as the cystic fibrosis transmembrane conductance regulator (CFTR) is the main mechanism of action. However, ane

Source: peer_reviewed_research
DOI: 10.1152/ajpgi.00261.2017
PubMed: 30118317

Open original source

2017Animal research

Linaclotide activates guanylate cyclase-C/cGMP/protein kinase-II-dependent trafficking of CFTR in the intestine.

Content-verified record concerning Linaclotide: "Linaclotide activates guanylate cyclase-C/cGMP/protein kinase-II-dependent trafficking of CFTR in the intestine." Abstract excerpt: The transmembrane receptor guanylyl cyclase-C (GC-C), expressed on enterocytes along the intestine, is the molecular target of the GC-C agonist peptide linaclotide, an FDA-approved drug for treatment of adult patients with Irritable Bowel Syndrome with Constipation and Chronic Idiopathic Constipation. Polarized human colonic intestinal cells (T84, CaCo-2BBe) rat and human intestinal tissues were e

Source: peer_reviewed_research
DOI: 10.14814/phy2.13299
PubMed: 28592587

Open original source

2014Animal research

Linaclotide. A bacterial enterotoxin derivative with a laxative action, nothing more.

Content-verified record concerning Linaclotide: "Linaclotide. A bacterial enterotoxin derivative with a laxative action, nothing more." Abstract excerpt: When patients complain of recurrent functional bowel disorders consisting of alterations in intestinal transit with abdominal pain or discomfort, treatment is purely symptomatic. Increased intake of dietary fibre or use of a bulk-forming or osmotic laxative is used when constipation is the main complaint. Linaclotide, a small peptide closely related to certain toxins secreted by diarrhoea-causing

Source: peer_reviewed_research
PubMed: 25629140

Open original source

2013Animal research

Linaclotide in the treatment of patients with irritable bowel syndrome and constipation - analysis of an opportunity.

Content-verified record concerning Linaclotide: "Linaclotide in the treatment of patients with irritable bowel syndrome and constipation - analysis of an opportunity." Abstract excerpt: Linaclotide is a secretagogue that provides a combined effect on visceral pain. The European Medicines Agency has authorized its indication for the symptomatic treatment of moderate to severe irritable bowel syndrome with constipation in adults. The purpose of this review is to discuss the clinical framework for linaclotide use in our setting, the drug´s characteristics and pre-clinical devel

Source: peer_reviewed_research
DOI: 10.4321/s1130-01082013000600006
PubMed: 24090017

Open original source

2012Animal research

Linaclotide: first global approval.

Content-verified record concerning Linaclotide: "Linaclotide: first global approval." Abstract excerpt: Linaclotide is a once-daily, orally administered, first-in-class agonist of guanylate cyclase-C that is minimally absorbed. It is being developed to treat gastrointestinal disorders by Ironwood Pharmaceuticals and its partners, Forest Laboratories (North America), Almirall (Europe) and Astellas Pharma (Asia-Pacific). Linaclotide has received its first global approval in the US for the treatment of

Source: peer_reviewed_research
DOI: 10.2165/11470590-000000000-00000
PubMed: 23083112

Open original source

2010Animal research

Linaclotide, through activation of guanylate cyclase C, acts locally in the gastrointestinal tract to elicit enhanced intestinal secretion and transit.

Content-verified record concerning Linaclotide: "Linaclotide, through activation of guanylate cyclase C, acts locally in the gastrointestinal tract to elicit enhanced intestinal secretion and transit." Abstract excerpt: Linaclotide is a first-in-class, orally administered 14-amino acid peptide that is in development for the treatment of irritable bowel syndrome with constipation and chronic constipation. We have characterized the solution structure of linaclotide, the in vitro binding and agonist activity to guanylate cyclase C receptors, the stability of linaclotide under conditions mimicking the gastric environ

Source: peer_reviewed_research
DOI: 10.1016/j.ejphar.2010.09.019
PubMed: 20863829

Open original source

2010Animal research

Linaclotide is a potent and selective guanylate cyclase C agonist that elicits pharmacological effects locally in the gastrointestinal tract.

Content-verified record concerning Linaclotide: "Linaclotide is a potent and selective guanylate cyclase C agonist that elicits pharmacological effects locally in the gastrointestinal tract." Abstract excerpt: Linaclotide is an orally administered 14-amino acid peptide being developed for the treatment of constipation-predominant irritable bowel syndrome (IBS-C) and chronic constipation. We determined the stability of linaclotide in the intestine, measured the oral bioavailability, and investigated whether the pharmacodynamic effects elicited in rodent models of gastrointestinal function are mechanistic

Source: peer_reviewed_research
DOI: 10.1016/j.lfs.2010.03.015
PubMed: 20307554

Open original source

2006Animal research

Linaclotide

Content-verified record concerning Linaclotide: "Linaclotide" Abstract excerpt: Linaclotide is minimally absorbed from the gastrointestinal tract and the drug and its active metabolite are not measurable in milk following administration of doses up to 290 mcg daily. Linaclotide appears to be acceptable in nursing mothers and no special precautions are required.

Source: other
PubMed: 29999932

Open original source

2024Animal research

Examining linaclotide for the treatment of chronic idiopathic constipation.

Content-verified record concerning Linaclotide: "Examining linaclotide for the treatment of chronic idiopathic constipation." Abstract excerpt: Chronic idiopathic constipation (CIC) is characterized by infrequent bowel movements and hard stools lasting for at least three months or longer. This disease affects 8-12% of the US population and 10-17% of the world population. Treatment and management involve identifying the primary cause, changing dietary habits, and adequate physical activity. Linaclotide is a guanylate cyclase-agonist acting

Source: peer_reviewed_research
DOI: 10.1080/14656566.2024.2386160
PubMed: 39058326

Open original source

2015Animal research

A comparison of linaclotide and lubiprostone dosing regimens on ion transport responses in human colonic mucosa.

Content-verified record concerning Linaclotide: "A comparison of linaclotide and lubiprostone dosing regimens on ion transport responses in human colonic mucosa." Abstract excerpt: Linaclotide, a synthetic guanylyl cyclase C (GC-C) agonist, and the prostone analog, Lubiprostone, are approved to manage chronic idiopathic constipation and constipation-predominant irritable bowel syndrome. Lubiprostone also protects intestinal mucosal barrier function in ischemia. GC-C signaling regulates local fluid balance and other components of intestinal mucosal homeostasis including epith

Source: peer_reviewed_research
DOI: 10.1002/prp2.128
PubMed: 26038704

Open original source

2020Animal research

Tadalafil versus linaclotide in gastrointestinal dysfunction and depressive behavior in constipation-predominant irritable bowel syndrome.

Content-verified record concerning Linaclotide: "Tadalafil versus linaclotide in gastrointestinal dysfunction and depressive behavior in constipation-predominant irritable bowel syndrome." Abstract excerpt: Intestinal GC-C/cGMP pathway may be involved in visceral hypersensitivity and fluid secretion in irritable bowel syndrome (IBS). The guanylcyclase C agonist linaclotide, approved for IBS- constipation, is contraindicated in children as it may cause severe diarrhea. In contrast, drugs increasing cGMP by inhibiting phosphodiesterase 5 (PDE-5) are well tolerated in children with pulmonary hypertensio

Source: peer_reviewed_research
DOI: 10.1016/j.lfs.2020.117960
PubMed: 32534033

Open original source

2024Animal research

DRA involvement in linaclotide-stimulated bicarbonate secretion during loss of CFTR function.

Content-verified record concerning Linaclotide: "DRA involvement in linaclotide-stimulated bicarbonate secretion during loss of CFTR function." Abstract excerpt: Duodenal bicarbonate secretion is critical to epithelial protection, as well as nutrient digestion and absorption, and is impaired in cystic fibrosis (CF). We examined if linaclotide, typically used to treat constipation, may also stimulate duodenal bicarbonate secretion. Bicarbonate secretion was measured in vivo and in vitro using mouse and human duodenum (biopsies and enteroids). Ion transporte

Source: peer_reviewed_research
DOI: 10.1172/jci.insight.172364
PubMed: 38869953

Open original source

2019Animal research

Clinical response to linaclotide at week 4 predicts sustained response in irritable bowel syndrome with constipation and improvements in digestive and extra-digestive symptoms.

Content-verified record concerning Linaclotide: "Clinical response to linaclotide at week 4 predicts sustained response in irritable bowel syndrome with constipation and improvements in digestive and extra-digestive symptoms." Abstract excerpt: Linaclotide is approved for the treatment of moderate-to-severe irritable bowel syndrome (IBS) with constipation (IBS-C) in adults. This study aimed to assess factors predictive of a clinical response and improvements in non-IBS symptoms with linaclotide treatment in a Spanish patient population. In this open-label phase IIIb study, patients with moderate-to-severe IBS-C received linaclotide 290 &

Source: peer_reviewed_research
DOI: 10.1177/1756284819857358
PubMed: 31428193

Open original source

2022Animal research

Cost-Effectiveness of Linaclotide Compared to Osmotic Laxatives in the Treatment of Irritable Bowel Syndrome with Constipation in China.

Content-verified record concerning Linaclotide: "Cost-Effectiveness of Linaclotide Compared to Osmotic Laxatives in the Treatment of Irritable Bowel Syndrome with Constipation in China." Abstract excerpt: Linaclotide, a selective agonist of guanylate cyclase C, was highly recommended for the treatment of irritable bowel syndrome with constipation (IBS-C). However, the cost-effectiveness of linaclotide in Chinese is not known, and this study aimed to assess the cost-effectiveness of linaclotide for patients with IBS-C. An economic evaluation was conducted with a Markov model from a societal perspect

Source: peer_reviewed_research
DOI: 10.1007/s12325-022-02161-x
PubMed: 35488140

Open original source

2017Animal research

Optimizing the Use of Linaclotide in Patients with Constipation-Predominant Irritable Bowel Syndrome: An Expert Consensus Report.

Content-verified record concerning Linaclotide: "Optimizing the Use of Linaclotide in Patients with Constipation-Predominant Irritable Bowel Syndrome: An Expert Consensus Report." Abstract excerpt: Irritable bowel syndrome (IBS) is a functional bowel disorder characterized by chronic or recurrent abdominal pain in association with defecation or a change in bowel habits. A predominant disorder of bowel habits, IBS is classified into three main subtypes: constipation-predominant IBS (IBS-C), diarrhea-predominant IBS (IBS-D) and IBS alternating between constipation and diarrhea (IBS-M). Linaclo

Source: peer_reviewed_research
DOI: 10.1007/s12325-016-0473-8
PubMed: 28083815

Open original source

2016Animal research

Cost-effectiveness of linaclotide compared to antidepressants in the treatment of irritable bowel syndrome with constipation in Scotland.

Content-verified record concerning Linaclotide: "Cost-effectiveness of linaclotide compared to antidepressants in the treatment of irritable bowel syndrome with constipation in Scotland." Abstract excerpt: Presently, linaclotide is the only EMA-approved therapy indicated for the treatment of irritable bowel syndrome with constipation (IBS-C). This study sought to determine the cost-effectiveness of linaclotide compared to antidepressants for the treatment of adults with moderate to severe IBS-C who have previously received antispasmodics and/or laxatives. A Markov model was created to estimate costs

Source: peer_reviewed_research
DOI: 10.1007/s10198-015-0747-0
PubMed: 26728984

Open original source

2012Animal research

Linaclotide in the management of gastrointestinal tract disorders.

Content-verified record concerning Linaclotide: "Linaclotide in the management of gastrointestinal tract disorders." Abstract excerpt: Chronic constipation is a highly prevalent, heterogeneous disorder that significantly affects patients' lives. Nearly 15% of the U.S. population meets diagnostic criteria for chronic constipation (1). Chronic constipation reduces patients' quality of life and imposes a significant economic burden to the healthcare system (2, 3). A number of therapeutic options are currently available to treat symp

Source: peer_reviewed_research
DOI: 10.1358/dot.2012.48.3.1745228
PubMed: 22462039

Open original source

2011Animal research

Linaclotide, a synthetic guanylate cyclase C agonist, for the treatment of functional gastrointestinal disorders associated with constipation.

Content-verified record concerning Linaclotide: "Linaclotide, a synthetic guanylate cyclase C agonist, for the treatment of functional gastrointestinal disorders associated with constipation." Abstract excerpt: Chronic constipation (CC) and irritable bowel syndrome with constipation (IBS-C) are two functional gastrointestinal disorders that are associated with constipation. CC and IBS-C affect approximately 20% of the general population including the elderly, impairing quality of life. Patients not responding to over-the-counter treatments require effective and safe long-term therapies. Some treatments i

Source: peer_reviewed_research
DOI: 10.1586/egh.11.30
PubMed: 21651347

Open original source

2018Animal research

Chronic linaclotide treatment reduces colitis-induced neuroplasticity and reverses persistent bladder dysfunction.

Content-verified record concerning Linaclotide: "Chronic linaclotide treatment reduces colitis-induced neuroplasticity and reverses persistent bladder dysfunction." Abstract excerpt: Irritable bowel syndrome (IBS) patients suffer from chronic abdominal pain and extraintestinal comorbidities, including overactive bladder (OAB) and interstitial cystitis/painful bladder syndrome (IC-PBS). Mechanistic understanding of the cause and time course of these comorbid symptoms is lacking, as are clinical treatments. Here, we report that colitis triggers hypersensitivity of colonic affere

Source: peer_reviewed_research
DOI: 10.1172/jci.insight.121841
PubMed: 30282832

Open original source

2023Animal research

Cost impact of incorporating linaclotide into low-volume colonoscopy preparation.

Content-verified record concerning Linaclotide: "Cost impact of incorporating linaclotide into low-volume colonoscopy preparation." (identity confirmed; no abstract text available to excerpt.)

Source: peer_reviewed_research
DOI: 10.1016/j.gie.2023.05.054
PubMed: 37863578

Open original source

2024Animal research

The Effects of Combined Use of Linaclotide and Polyethylene Glycol Electrolyte Powder in Colonoscopy Preparation for Patients With Chronic Constipation.

Content-verified record concerning Linaclotide: "The Effects of Combined Use of Linaclotide and Polyethylene Glycol Electrolyte Powder in Colonoscopy Preparation for Patients With Chronic Constipation." Abstract excerpt: The purpose of this study is to evaluate the safety and efficacy of linaclotide and polyethylene glycol (PEG) electrolyte powder in patients with chronic constipation undergoing colonoscopy preparation. We included 260 patients with chronic constipation who were scheduled to undergo a colonoscopy. They were equally divided into 4 groups using a random number table: 4L PEG, 3L PEG, 3L PEG+L, and 2L

Source: peer_reviewed_research
DOI: 10.1097/sle.0000000000001273
PubMed: 38444073

Open original source

2020Animal research

The guanylate cyclase C agonist linaclotide ameliorates the gut-cardio-renal axis in an adenine-induced mouse model of chronic kidney disease.

Content-verified record concerning Linaclotide: "The guanylate cyclase C agonist linaclotide ameliorates the gut-cardio-renal axis in an adenine-induced mouse model of chronic kidney disease." Abstract excerpt: Cardiorenal syndrome is a major cause of mortality in patients with chronic kidney disease (CKD). However, the involvement of detrimental humoral mediators in the pathogenesis of cardiorenal syndrome is still controversial. Trimethylamine-N-oxide (TMAO), a hepatic metabolic product of trimethylamine generated from dietary phosphatidylcholine or carnitine derived by the gut microbiota, has been lin

Source: peer_reviewed_research
DOI: 10.1093/ndt/gfz126
PubMed: 31411705

Open original source

2024Animal research

Renoprotective effects of laxative linaclotide: Inhibition of acute kidney injury and fibrosis in a rat model of renal ischemia-reperfusion.

Content-verified record concerning Linaclotide: "Renoprotective effects of laxative linaclotide: Inhibition of acute kidney injury and fibrosis in a rat model of renal ischemia-reperfusion." Abstract excerpt: Ischemia-reperfusion (I/R) leads to tissue damage in transplanted kidneys, resulting in acute kidney injury (AKI) and chronic graft dysfunction, which critically compromises transplant outcomes, such as graft loss. Linaclotide, a guanylate cyclase C agonist clinically approved as a laxative, has recently been identified to exhibit renoprotective effects in a chronic kidney disease (CKD) model. Thi

Source: peer_reviewed_research
DOI: 10.1016/j.bbrc.2024.149709
PubMed: 38554603

Open original source

2023Animal research

Microbiota-derived butyrate dampens linaclotide stimulation of the guanylate cyclase C pathway in patient-derived colonoids.

Content-verified record concerning Linaclotide: "Microbiota-derived butyrate dampens linaclotide stimulation of the guanylate cyclase C pathway in patient-derived colonoids." Abstract excerpt: Disorders of gut-brain interaction (DGBI) are complex conditions that result in decreased quality of life and a significant cost burden. Linaclotide, a guanylin cyclase C (GCC) receptor agonist, is approved as a DGBI treatment. However, its efficacy has been limited and variable across DGBI patients. Microbiota and metabolomic alterations are noted in DGBI patients, provoking the hypothesis that t

Source: peer_reviewed_research
DOI: 10.1111/nmo.14681
PubMed: 37736865

Open original source

2025Animal research

Cost-Effectiveness of Vibrant System vs. Linaclotide in Chronic Idiopathic Constipation.

Content-verified record concerning Linaclotide: "Cost-Effectiveness of Vibrant System vs. Linaclotide in Chronic Idiopathic Constipation." Abstract excerpt: Chronic idiopathic constipation (CIC) is a common disorder that has a large unmet clinical need, affecting 8.0-12.0% of the US population and disproportionately affecting female individuals more than male individuals. Patients and physicians are equally dissatisfied with over-the-counter and prescription treatments. Physician dissatisfaction is at 78%. CIC has a significant negative impact on qual

Source: peer_reviewed_research
DOI: 10.1007/s12325-024-03035-0
PubMed: 39527338

Open original source

2019Animal research

[Pharmacological and clinical profile of linaclotide (Linzess®), a novel therapeutic agent for irritable bowel syndrome with constipation and chronic constipation].

Content-verified record concerning Linaclotide: "[Pharmacological and clinical profile of linaclotide (Linzess®), a novel therapeutic agent for irritable bowel syndrome with constipation and chronic constipation]." Abstract excerpt: Linaclotide (Linzess ® tablets 0.25 mg) is a guanylate cyclase-C (GC-C) agonist with high selectivity and binding affinity to GC-C. In Japan, linaclotide was approved for 〝irritable bowel syndrome with constipation (IBS-C)〟 in December 2016 and 〝chronic constipation (CC) (excluding constipation due to organic disease)〟 in August 2018. Non-clinical studies de

Source: peer_reviewed_research
DOI: 10.1254/fpj.153.289
PubMed: 31178535

Open original source

2021Animal research

Improving the Gastrointestinal Stability of Linaclotide.

Content-verified record concerning Linaclotide: "Improving the Gastrointestinal Stability of Linaclotide." Abstract excerpt: High susceptibility to proteolytic degradation in the gastrointestinal tract limits the therapeutic application of peptide drugs in gastrointestinal disorders. Linaclotide is an orally administered peptide drug for the treatment of irritable bowel syndrome with constipation (IBS-C) and abdominal pain. Linaclotide is however degraded in the intestinal environment within 1 h, and improvements in gas

Source: peer_reviewed_research
DOI: 10.1021/acs.jmedchem.1c00380
PubMed: 33979161

Open original source

2010Animal research

Guanylate cyclase C-mediated antinociceptive effects of linaclotide in rodent models of visceral pain.

Content-verified record concerning Linaclotide: "Guanylate cyclase C-mediated antinociceptive effects of linaclotide in rodent models of visceral pain." Abstract excerpt: BACKGROUND Linaclotide is a novel, orally administered investigational drug currently in clinical development for the treatment of constipation-predominant irritable bowel syndrome (IBS-C) and chronic idiopathic constipation. Visceral hyperalgesia is a major pathophysiological mechanism in IBS-C. Therefore, we investigated the anti-nociceptive properties of linaclotide in rodent models of inflamma

Source: peer_reviewed_research
DOI: 10.1111/j.1365-2982.2009.01385.x
PubMed: 19706070

Open original source

2023Animal research

A New Regioselective Synthesis of the Cysteine-Rich Peptide Linaclotide.

Content-verified record concerning Linaclotide: "A New Regioselective Synthesis of the Cysteine-Rich Peptide Linaclotide." Abstract excerpt: Linaclotide is a 14-amino acid residue peptide approved by the FDA for the treatment of irritable bowel syndrome with constipation (IBS-C), which activates guanylate cyclase C to accelerate intestinal transit. Here we show a new method for the synthesis of linaclotide through the completely selective formation of three disulfide bonds in satisfactory overall yields via mild oxidation reactions of

Source: peer_reviewed_research
DOI: 10.3390/molecules28031007
PubMed: 36770675

Open original source

2025Animal research

Characterization of disulfide bridges containing cyclic peptide Linaclotide and its degradation products by using LC-HRMS/MS.

Content-verified record concerning Linaclotide: "Characterization of disulfide bridges containing cyclic peptide Linaclotide and its degradation products by using LC-HRMS/MS." Abstract excerpt: Linaclotide (LINA) is a first-in-class guanylate cyclase agonist used for treating irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation. Stress degradation studies were performed to examine LINA's intrinsic stability, adhering to International Council for Harmonisation of Technical ICH) guidelines Q1A (R2). The current study endeavours to elucidate the stability b

Source: peer_reviewed_research
DOI: 10.1016/j.jpba.2024.116533
PubMed: 39427438

Open original source

2015Animal research

MRP4 Modulation of the Guanylate Cyclase-C/cGMP Pathway: Effects on Linaclotide-Induced Electrolyte Secretion and cGMP Efflux.

Content-verified record concerning Linaclotide: "MRP4 Modulation of the Guanylate Cyclase-C/cGMP Pathway: Effects on Linaclotide-Induced Electrolyte Secretion and cGMP Efflux." Abstract excerpt: MRP4 mediates the efflux of cGMP and cAMP and acts as an important regulator of these secondary messengers, thereby affecting signaling events mediated by cGMP and cAMP. Immunofluorescence staining showed high MRP4 expression localized predominantly in the apical membrane of rat colonic epithelium. In vitro studies were performed using a rat colonic mucosal layer mounted in an Ussing chamber. Lina

Source: peer_reviewed_research
DOI: 10.1124/jpet.115.224329
PubMed: 26216942

Open original source

2026Animal research

Identification and Quantification of Structurally Related Peptide Impurity in Linaclotide by Liquid Chromatography-High Resolution Mass Spectrometry.

Content-verified record concerning Linaclotide: "Identification and Quantification of Structurally Related Peptide Impurity in Linaclotide by Liquid Chromatography-High Resolution Mass Spectrometry." Abstract excerpt: Linaclotide is an important peptide drug used to treat irritable bowel syndrome with constipation (IBS-C). However, structurally related impurities in peptide drugs can be generated during synthesis, storage, or transport, which compromise the quality and safety. Therefore, developing a highly sensitive analytical method for impurity detection is of great significance. A liquid chromatography-high

Source: peer_reviewed_research
DOI: 10.1002/rcm.70030
PubMed: 41539984

Open original source

2019Animal research

The Impact of Stool Consistency on Bowel Movement Satisfaction in Patients With IBS-C or CIC Treated With Linaclotide or Other Medications: Real-World Evidence From the CONTOR Study.

Content-verified record concerning Linaclotide: "The Impact of Stool Consistency on Bowel Movement Satisfaction in Patients With IBS-C or CIC Treated With Linaclotide or Other Medications: Real-World Evidence From the CONTOR Study." Abstract excerpt: This study aimed to characterize the impact of stool consistency on patient-reported bowel movement (BM) satisfaction in patients with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation, with a focus on linaclotide. As new medications for constipation become available, understanding patients' perceptions of treatment effects may help clinicians manage patient exp

Source: peer_reviewed_research
DOI: 10.1097/mcg.0000000000001245
PubMed: 31361710

Open original source

2013Insufficient evidence

Linaclotide-a novel secretagogue in the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation.

Content-verified record concerning Linaclotide: "Linaclotide-a novel secretagogue in the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation." Abstract excerpt: Irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) are highly prevalent gastrointestinal disorders. Traditional symptoms based therapies had somewhat limited success and efficacy in addressing the disorders. Recently, linaclotide emerged as novel peptide capable of improving abdominal symptoms in patients suffering from IBS-C and CIC. Guanylate cyclase C (

Source: peer_reviewed_research
DOI: 10.2174/1389557511313110011
PubMed: 24001336

Open original source

2013Insufficient evidence

Linaclotide: a novel compound for the treatment of irritable bowel syndrome with constipation.

Content-verified record concerning Linaclotide: "Linaclotide: a novel compound for the treatment of irritable bowel syndrome with constipation." Abstract excerpt: Irritable Bowel Syndrome with constipation (IBS-C) is associated with abdominal pain and infrequent spontaneous bowel movements. Patients with Chronic Idiopathic Constipation do not have abdominal pain as a predominant symptom. Linaclotide represents a new class of medication approved in the USA for both of these common conditions. Linaclotide is approved for IBS-C only in the EU. The only other m

Source: peer_reviewed_research
DOI: 10.1517/14656566.2013.833605
PubMed: 24007408

Open original source

2013Insufficient evidence

Linaclotide inhibits colonic nociceptors and relieves abdominal pain via guanylate cyclase-C and extracellular cyclic guanosine 3',5'-monophosphate.

Content-verified record concerning Linaclotide: "Linaclotide inhibits colonic nociceptors and relieves abdominal pain via guanylate cyclase-C and extracellular cyclic guanosine 3',5'-monophosphate." Abstract excerpt: Linaclotide is a minimally absorbed agonist of guanylate cyclase-C (GUCY2C or GC-C) that reduces symptoms associated with irritable bowel syndrome with constipation (IBS-C). Little is known about the mechanism by which linaclotide reduces abdominal pain in patients with IBS-C. We determined the effects of linaclotide on colonic sensory afferents in healthy mice and those with chronic visceral hype

Source: peer_reviewed_research
DOI: 10.1053/j.gastro.2013.08.017
PubMed: 23958540

Open original source

Insufficient evidence

Application of oral sulfate solution combined with linaclotide in bowel preparation for colonoscopy.

Source reference associated with Linaclotide. Source identity and peptide connection confirmed; scientific conclusions and evidence strength have not been assessed in this source-linking step.

Source: other
DOI: 10.3389/fmed.2026.1696298
PubMed: 41889509

Open original source

2014Insufficient evidence

Clarification of linaclotide pharmacology presented in a recent clinical study of plecanatide.

Content-verified record concerning Linaclotide: "Clarification of linaclotide pharmacology presented in a recent clinical study of plecanatide." (identity confirmed; no abstract text available to excerpt.)

Source: peer_reviewed_research
DOI: 10.1007/s10620-013-2953-x
PubMed: 24652108

Open original source

2013Insufficient evidence

[Joint Statement of the German Society for Digestive and Metabolic Diseases (DGVS), the German Society for Neurogastroenterology and motility (DGNM) and the German Society for Internal Medicine (DGIM) for linaclotide-benefit assessment of the Institute for Quality and Efficiency in Health Care (IQWiG) in accordance with § 35a SGB V (dossier evaluation)].

Content-verified record concerning Linaclotide: "[Joint Statement of the German Society for Digestive and Metabolic Diseases (DGVS), the German Society for Neurogastroenterology and motility (DGNM) and the German Society for Internal Medicine (DGIM) for linaclotide-benefit assessment of the Institute for Quality and Efficiency in Health Care (IQWiG) in accordance with § 35a SGB V (dossier evaluation)]." (identity confirmed; no abstract text available to excerpt.)

Source: systematic_review_or_meta_analysis
DOI: 10.1055/s-0033-1357025
PubMed: 24266047

Open original source

2026Insufficient evidence

A post hoc analysis of linaclotide in pediatric patients with functional constipation and neurodevelopmental disorders.

Content-verified record concerning Linaclotide: "A post hoc analysis of linaclotide in pediatric patients with functional constipation and neurodevelopmental disorders." Abstract excerpt: Functional constipation (FC) is common in children with comorbid neurodevelopmental disorders (NDD) and its optimal treatment may be challenged by adherence and medication tolerability issues in this population. We assessed the efficacy and safety of linaclotide in pediatric patients with FC and NDD. This post hoc analysis of a Phase 3, randomized, placebo-controlled study assessed oral linaclotid

Source: peer_reviewed_research
DOI: 10.1002/jpn3.70424
PubMed: 41913506

Open original source

2013Insufficient evidence

Linaclotide, novel therapy for the treatment of chronic idiopathic constipation and constipation-predominant irritable bowel syndrome.

Content-verified record concerning Linaclotide: "Linaclotide, novel therapy for the treatment of chronic idiopathic constipation and constipation-predominant irritable bowel syndrome." Abstract excerpt: Chronic constipation (CC) and irritable bowel syndrome with constipation (IBS-C) are common gastrointestinal (GI) disorders. Current treatment options, either prescription or nonprescription medications, have limited efficacy in a subset of patients. There is significant demand for more efficacious medications for the treatment of CC and IBS-C. Linaclotide, a secretagogue, has a novel mechanism of

Source: peer_reviewed_research
DOI: 10.1007/s12325-013-0012-9
PubMed: 23436110

Open original source

2025Insufficient evidence

Efficacy and Safety of Linaclotide as an Adjunct to Polyethylene Glycol in Bowel Preparation: A Meta-Analysis.

Content-verified record concerning Linaclotide: "Efficacy and Safety of Linaclotide as an Adjunct to Polyethylene Glycol in Bowel Preparation: A Meta-Analysis." Abstract excerpt: Linaclotide, a guanylyl cyclase-C agonist, may enhance efficacy and tolerability when combined with polyethylene glycol (PEG) for bowel preparation. This meta-analysis evaluated linaclotide plus PEG versus PEG alone for bowel preparation prior to colonoscopy. Randomized controlled trials (RCTs) including adults undergoing colonoscopy that compared linaclotide plus PEG with PEG alone for bowel prep

Source: peer_reviewed_research
DOI: 10.1111/1751-2980.70008
PubMed: 40955723

Open original source

2024Insufficient evidence

Safety and efficacy of linaclotide in children aged 7-17 years with irritable bowel syndrome with constipation.

Content-verified record concerning Linaclotide: "Safety and efficacy of linaclotide in children aged 7-17 years with irritable bowel syndrome with constipation." Abstract excerpt: Linaclotide, a guanylate cyclase-C agonist, was recently approved in the United States for the treatment of children 6-17 years old with functional constipation. This study evaluated the safety and efficacy of various linaclotide doses in children 7-17 years old with irritable bowel syndrome with constipation (IBS-C). In this 4-week, randomized, double-blind, placebo-controlled, parallel-group, Ph

Source: peer_reviewed_research
DOI: 10.1002/jpn3.12103
PubMed: 38504394

Open original source

2014Insufficient evidence

Linaclotide: a novel agent for chronic constipation and irritable bowel syndrome.

Content-verified record concerning Linaclotide: "Linaclotide: a novel agent for chronic constipation and irritable bowel syndrome." Abstract excerpt: The pharmacology, pharmaco-kinetics, and clinical efficacy and safety of linaclotide in the management of chronic constipation (CC) and constipation-predominant irritable bowel syndrome (IBS-C) are reviewed. Linaclotide (Linzess, Forest Pharmaceuticals) is a 14-amino acid peptide indicated for the treatment of adults with CC and IBS-C. Linaclotide acts on guanylate cyclase-C receptors on the lumin

Source: peer_reviewed_research
DOI: 10.2146/ajhp130575
PubMed: 24939497

Open original source

2010Insufficient evidence

Molecule of the month. Linaclotide acetate.

Content-verified record concerning Linaclotide: "Molecule of the month. Linaclotide acetate." (identity confirmed; no abstract text available to excerpt.)

Source: peer_reviewed_research
DOI: 10.1358/dnp.2010.23.8.1538348
PubMed: 21031167

Open original source

2012Insufficient evidence

Linaclotide (Linzess) for constipation.

Content-verified record concerning Linaclotide: "Linaclotide (Linzess) for constipation." (identity confirmed; no abstract text available to excerpt.)

Source: peer_reviewed_research
PubMed: 23183319

Open original source

2024Insufficient evidence

Linaclotide for paediatric functional constipation.

Content-verified record concerning Linaclotide: "Linaclotide for paediatric functional constipation." (identity confirmed; no abstract text available to excerpt.)

Source: peer_reviewed_research
DOI: 10.1016/s2468-1253(23)00440-5
PubMed: 38211605

Open original source

2011Insufficient evidence

Optimized Fmoc solid-phase synthesis of the cysteine-rich peptide linaclotide.

Content-verified record concerning Linaclotide: "Optimized Fmoc solid-phase synthesis of the cysteine-rich peptide linaclotide." Abstract excerpt: Linaclotide, a small 14-mer peptide highly rich in cysteines, is currently in phase III clinical trials for the treatment of gastrointestinal disorders. The challenge in the assembly of linaclotide consists of achieving the correct and clean folding of its three disulfide bridges. For this purpose, a number of regioselective, semiregioselective, and random strategies have been studied. In addition

Source: peer_reviewed_research
DOI: 10.1002/bip.21480
PubMed: 20560145

Open original source

2025Insufficient evidence

Combined linaclotide and polyethylene glycol electrolyte for colonoscopy preparation: a network meta-analysis of 14 randomized controlled trials.

Content-verified record concerning Linaclotide: "Combined linaclotide and polyethylene glycol electrolyte for colonoscopy preparation: a network meta-analysis of 14 randomized controlled trials." Abstract excerpt: Recent evidence supports linaclotide (Lin) for colonoscopy preparation. This network meta-analysis evaluates the combination of different pill numbers of Lin with polyethylene glycol (PEG) (high and low volumes in liters (L)) for bowel cleansing. This systematic review and frequentist network meta-analysis, conducted in October 2024, assessed randomized controlled trials (RCTs) from Scopus, PubMed

Source: systematic_review_or_meta_analysis
DOI: 10.1007/s00384-025-04931-9
PubMed: 40528061

Open original source

2026Insufficient evidence

Evaluating linaclotide for the treatment of functional constipation in children and adolescents.

Content-verified record concerning Linaclotide: "Evaluating linaclotide for the treatment of functional constipation in children and adolescents." Abstract excerpt: Pediatric functional constipation is a highly prevalent disorder associated with significant morbidity and impaired quality of life. Despite widespread use of osmotic and stimulant laxatives, a substantial proportion of children remain symptomatic, highlighting an unmet need for novel therapies. This review provides an overview of the mechanism of action, pharmacokinetics, safety, and clinical eff

Source: peer_reviewed_research
DOI: 10.1080/14656566.2026.2669339
PubMed: 42083746

Open original source

2014Insufficient evidence

Linaclotide: a review of its use in the treatment of irritable bowel syndrome with constipation.

Content-verified record concerning Linaclotide: "Linaclotide: a review of its use in the treatment of irritable bowel syndrome with constipation." Abstract excerpt: Linaclotide (Constella®) is a synthetic 14-amino acid peptide, structurally related to guanylin and uroguanylin, that acts as a potent guanylate cyclase C receptor agonist. It is a first-in-class agent recently approved in the EU for the treatment of adult patients with moderate to severe irritable bowel syndrome with constipation (IBS-C). Linaclotide has very low oral bioavailability and act

Source: peer_reviewed_research
DOI: 10.1007/s40265-013-0157-5
PubMed: 24293117

Open original source

2018Insufficient evidence

Efficacy of linaclotide in irritable bowel syndrome with constipation: Real-world data.

Content-verified record concerning Linaclotide: "Efficacy of linaclotide in irritable bowel syndrome with constipation: Real-world data." (identity confirmed; no abstract text available to excerpt.)

Source: peer_reviewed_research
DOI: 10.1111/nmo.13328
PubMed: 29700960

Open original source

2010Insufficient evidence

Constipation: Linaclotide--a stimulating new drug for chronic constipation.

Content-verified record concerning Linaclotide: "Constipation: Linaclotide--a stimulating new drug for chronic constipation." (identity confirmed; no abstract text available to excerpt.)

Source: peer_reviewed_research
DOI: 10.1038/nrgastro.2010.84
PubMed: 20606631

Open original source

2018Insufficient evidence

Linaclotide for the treatment of chronic constipation.

Content-verified record concerning Linaclotide: "Linaclotide for the treatment of chronic constipation." Abstract excerpt: Chronic constipation (CC) is a common gastrointestinal disorder with limited treatment options. Linaclotide is a potent peptide agonist of the guanylate cyclase-C receptor. This action activates intracellular conversion of guanosine 5-triphosphate to cyclic guanosine monophosphate resulting in the stimulation of intestinal fluid secretion. Linaclotide is a promising new agent for refractory consti

Source: peer_reviewed_research
DOI: 10.1080/14656566.2018.1494728
PubMed: 29985664

Open original source

2019Insufficient evidence

Linaclotide increases cecal pH, accelerates colonic transit, and increases colonic motility in irritable bowel syndrome with constipation.

Content-verified record concerning Linaclotide: "Linaclotide increases cecal pH, accelerates colonic transit, and increases colonic motility in irritable bowel syndrome with constipation." Abstract excerpt: Linaclotide is efficacious in the management of irritable bowel syndrome with constipation (IBS-C), yet relatively little is known regarding its effect on human gastrointestinal physiology. The primary aim of the study was to examine the effect of linaclotide on change in pH across the ileocecal junction (ICJ), a proposed measure of cecal fermentation, and its relationship to symptoms and quality

Source: peer_reviewed_research
DOI: 10.1111/nmo.13492
PubMed: 30353623

Open original source

2024Insufficient evidence

Efficacy and safety of linaclotide in treatment-resistant chronic constipation: A multicenter, open-label study.

Content-verified record concerning Linaclotide: "Efficacy and safety of linaclotide in treatment-resistant chronic constipation: A multicenter, open-label study." Abstract excerpt: This study aimed to evaluate the efficacy and safety of linaclotide in patients with chronic constipation (CC) or irritable bowel syndrome with constipation (IBS-C) who did not respond to treatment with magnesium oxide (MgO). This study was designed as a multicenter, open-label, single-arm, exploratory study. Patients with CC or IBS-C who took MgO and those meeting the medication initiation criter

Source: peer_reviewed_research
DOI: 10.1111/nmo.14938
PubMed: 39370607

Open original source

2026Insufficient evidence

Linaclotide for irritable bowel syndrome with constipation: integrating realworld evidence into the therapeutic puzzle.

Content-verified record concerning Linaclotide: "Linaclotide for irritable bowel syndrome with constipation: integrating realworld evidence into the therapeutic puzzle." Abstract excerpt: Irritable bowel syndrome with constipation (IBS-C) is a common subtype of functional bowel disorder associated with substantial symptom burden and reduced quality of life. Management typically begins with dietary and lifestyle modification, laxatives, and antispasmodics; however, many patients experience inadequate relief, underscoring the need for more effective therapies. Linaclotide, a syntheti

Source: peer_reviewed_research
DOI: 10.51821/89.1.14529
PubMed: 41745639

Open original source

2012Insufficient evidence

Linaclotide

Content-verified record concerning Linaclotide: "Linaclotide" Abstract excerpt: Linaclotide is small peptide agonist of guanylate cyclase C receptors in the intestine and is used orally as treatment of chronic constipation and irritable bowel syndrome. Linaclotide has not been linked to serum enzyme elevations during treatment or to episodes of clinically apparent liver injury.

Source: other
PubMed: 31643353

Open original source

2016Insufficient evidence

Economic Evaluation of Linaclotide for the Treatment of Adult Patients With Chronic Idiopathic Constipation in the United States.

Content-verified record concerning Linaclotide: "Economic Evaluation of Linaclotide for the Treatment of Adult Patients With Chronic Idiopathic Constipation in the United States." Abstract excerpt: To evaluate the effectiveness and costs of linaclotide (Linzess) versus lubiprostone (Amitiza) in the treatment of adult patients with chronic idiopathic constipation (CIC). A decision-tree model using model inputs derived from published literature, linaclotide phase 3 trial data, and a physician survey. Measures of treatment efficacy were selected based on comparability between trial data, with p

Source: peer_reviewed_research
PubMed: 27008836

Open original source

2015Insufficient evidence

Economic evaluation of linaclotide for the treatment of adult patients with irritable bowel syndrome with constipation in the United States.

Content-verified record concerning Linaclotide: "Economic evaluation of linaclotide for the treatment of adult patients with irritable bowel syndrome with constipation in the United States." Abstract excerpt: To use techniques of decision-analytic modeling to evaluate the effectiveness and costs of linaclotide vs lubiprostone in the treatment of adult patients with irritable bowel syndrome with constipation (IBS-C). Using model inputs derived from published literature, linaclotide Phase III trial data and a physician survey, a decision-tree model was constructed. Response to therapy was defined as (1)

Source: peer_reviewed_research
DOI: 10.3111/13696998.2014.979291
PubMed: 25333331

Open original source

Insufficient evidence

Linaclotide for Bowel Preparation: Is "Afterload Reduction" Not Just for Heart Failure Anymore?

Source reference associated with Linaclotide. Source identity and peptide connection confirmed; scientific conclusions and evidence strength have not been assessed in this source-linking step.

Source: other
DOI: 10.14309/ajg.0000000000003375
PubMed: 40110861

Open original source

2025Insufficient evidence

Safety and efficacy of linaclotide as an adjuvant for bowel preparation: A systematic review and meta-analysis.

Content-verified record concerning Linaclotide: "Safety and efficacy of linaclotide as an adjuvant for bowel preparation: A systematic review and meta-analysis." Abstract excerpt: High-volume polyethylene glycol (PEG) is widely used for bowel preparation, but its large volume and unpleasant taste are common drawbacks. These factors frequently lead to reduced patient adherence. Linaclotide, an FDA-approved drug for constipation, appears to offer a potential solution by lowering the amount of PEG needed. Our search included MEDLINE through PubMed, Scopus, Web of Science (WOS)

Source: systematic_review_or_meta_analysis
DOI: 10.1016/j.ajg.2025.09.017
PubMed: 41203453

Open original source

2012Insufficient evidence

Contrasting effects of linaclotide and lubiprostone on restitution of epithelial cell barrier properties and cellular homeostasis after exposure to cell stressors.

Content-verified record concerning Linaclotide: "Contrasting effects of linaclotide and lubiprostone on restitution of epithelial cell barrier properties and cellular homeostasis after exposure to cell stressors." Abstract excerpt: Linaclotide has been proposed as a treatment for the same gastrointestinal indications for which lubiprostone has been approved, chronic idiopathic constipation and irritable bowel syndrome with constipation. Stressors damage the epithelial cell barrier and cellular homeostasis leading to loss of these functions. Effects of active linaclotide on repair of barrier and cell function in pig jejunum a

Source: peer_reviewed_research
DOI: 10.1186/1471-2210-12-3
PubMed: 22553939

Open original source

Insufficient evidence

Partially differentiated enterocytes in ileal and distal-colonic human F508del-CF-enteroids secrete fluid in response to forskolin and linaclotide

Source reference associated with Linaclotide. Source identity and peptide connection confirmed; scientific conclusions and evidence strength have not been assessed in this source-linking step.

Source: other
DOI: 10.1101/2025.02.03.636268

Open original source

Insufficient evidence

A pharmacovigilance study of the association between linaclotide/plecanatide and muscle spasms based on food and drug administration adverse event reporting system.

Source reference associated with Linaclotide. Source identity and peptide connection confirmed; scientific conclusions and evidence strength have not been assessed in this source-linking step.

Source: other
DOI: 10.3389/fphar.2025.1635792
PubMed: 40843382

Open original source

Insufficient evidence

Constipation-predominant irritable bowel syndrome treatment options Linaclotide, Lubiprostone, Plecanatide, and Tenapanor: analysis of the FDA Adverse Event Reporting System (FAERS) database.

Source reference associated with Linaclotide. Source identity and peptide connection confirmed; scientific conclusions and evidence strength have not been assessed in this source-linking step.

Source: other
DOI: 10.1080/14740338.2025.2519833
PubMed: 40503810

Open original source

2026Insufficient evidence

The Efficacy of Single Dose Linaclotide in Polyethylene Glycol-Based Bowel Preparation: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Content-verified record concerning Linaclotide: "The Efficacy of Single Dose Linaclotide in Polyethylene Glycol-Based Bowel Preparation: A Systematic Review and Meta-Analysis of Randomized Controlled Trials." Abstract excerpt: Adjunct agents in bowel preparation for colonoscopy have the potential to improve procedure outcomes. We performed a systematic review and meta-analysis to investigate the effects of adjunct single-dose linaclotide with bowel prep on colonoscopy outcomes. We conducted a comprehensive search in PubMed, Embase, Cochrane, and Web of Science from inception until April 2025 for randomized controlled tr

Source: systematic_review_or_meta_analysis
DOI: 10.1097/mcg.0000000000002267
PubMed: 41123247

Open original source

2018Insufficient evidence

Efficacy and tolerability of linaclotide in the treatment of irritable bowel syndrome with constipation in a real‑world setting - results from a German noninterventional study.

Content-verified record concerning Linaclotide: "Efficacy and tolerability of linaclotide in the treatment of irritable bowel syndrome with constipation in a real‑world setting - results from a German noninterventional study." Abstract excerpt: Linaclotide is a minimally absorbed peptide guanylate cyclase-C agonist approved for the treatment of irritable bowel syndrome with constipation (IBS-C). This study assessed the efficacy and tolerability of linaclotide in IBS-C in routine clinical practice in Germany. This was a 52-week, noninterventional study of linaclotide in patients aged ≥ 18 years with moderate to severe IBS-C.

Source: peer_reviewed_research
DOI: 10.1055/s-0043-124875
PubMed: 29742779

Open original source

2009Insufficient evidence

Pilot study on the effect of linaclotide in patients with chronic constipation.

Content-verified record concerning Linaclotide: "Pilot study on the effect of linaclotide in patients with chronic constipation." Abstract excerpt: Chronic constipation is a common gastrointestinal disorder with limited treatment options. Oral administration of linaclotide, a novel peptide agonist of guanylate cyclase-C receptors, has been shown in animal studies to stimulate intestinal fluid secretion and transit. In Phase 1 studies in healthy human volunteers, linaclotide was well-tolerated, increased bowel movement frequency, and loosened

Source: peer_reviewed_research
DOI: 10.1038/ajg.2008.59
PubMed: 19098860

Open original source

2007Insufficient evidence

Linaclotide, a new direction in the treatment of irritable bowel syndrome and chronic constipation.

Content-verified record concerning Linaclotide: "Linaclotide, a new direction in the treatment of irritable bowel syndrome and chronic constipation." Abstract excerpt: Microbia Inc is developing the oral guanylate cyclase C agonist linaclotide, a 14mer peptide for the potential treatment of constipation-predominant irritable bowel syndrome and chronic idiopathic constipation. Phase II clinical trials are underway for both indications.

Source: peer_reviewed_research
PubMed: 17694454

Open original source

Insufficient evidence

Clinical Study on the Application of Low-Dose 2L Lactulose Combined with Linaclotide in Bowel Preparation Before Colonoscopy

Source reference associated with Linaclotide. Source identity and peptide connection confirmed; scientific conclusions and evidence strength have not been assessed in this source-linking step.

Source: other
DOI: 10.21203/rs.3.rs-7391900/v1

Open original source

Insufficient evidence

Efficacy of linaclotide as adjunct for bowel preparation in patients with chronic constipation: a pre-specified analysis of the APPLE trial.

Source reference associated with Linaclotide. Source identity and peptide connection confirmed; scientific conclusions and evidence strength have not been assessed in this source-linking step.

Source: other
DOI: 10.5946/ce.2026.214
PubMed: 42681900

Open original source

2013Insufficient evidence

Challenges of managing pain in constipation-predominant IBS: clinical perspectives on antinociceptive actions of linaclotide.

Content-verified record concerning Linaclotide: "Challenges of managing pain in constipation-predominant IBS: clinical perspectives on antinociceptive actions of linaclotide." (identity confirmed; no abstract text available to excerpt.)

Source: peer_reviewed_research
DOI: 10.1053/j.gastro.2013.10.039
PubMed: 24409483

Open original source

2013Insufficient evidence

Linaclotide for treatment of irritable bowel syndrome--the view of European regulators.

Content-verified record concerning Linaclotide: "Linaclotide for treatment of irritable bowel syndrome--the view of European regulators." (identity confirmed; no abstract text available to excerpt.)

Source: peer_reviewed_research
DOI: 10.1016/j.dld.2013.03.017
PubMed: 23701993

Open original source

2019Insufficient evidence

Multicentre, non-interventional study of the efficacy and tolerability of linaclotide in the treatment of irritable bowel syndrome with constipation in primary, secondary and tertiary centres: the Alpine study.

Content-verified record concerning Linaclotide: "Multicentre, non-interventional study of the efficacy and tolerability of linaclotide in the treatment of irritable bowel syndrome with constipation in primary, secondary and tertiary centres: the Alpine study." Abstract excerpt: We evaluated the effectiveness and tolerability of linaclotide, a minimally absorbed guanylate cyclase-C agonist, in patients with irritable bowel syndrome with constipation (IBS-C) in routine clinical practice. A multicentre, non-interventional study conducted between December 2013 and November 2015 across 31 primary, secondary and tertiary centres in Austria and Switzerland. The study enrolled 1

Source: peer_reviewed_research
DOI: 10.1136/bmjopen-2018-025627
PubMed: 31892640

Open original source

Insufficient evidence

Efficacy and safety of Guanylyl cyclase C agonists (linaclotide and plecanatide) in patients with irritable bowel syndrome with constipation: a systematic review and meta-analysis of randomized controlled trials.

Source reference associated with Linaclotide. Source identity and peptide connection confirmed; scientific conclusions and evidence strength have not been assessed in this source-linking step.

Source: other
DOI: 10.3389/fphar.2026.1761301
PubMed: 42038325

Open original source

2019Insufficient evidence

Effectiveness and tolerability of linaclotide in the treatment of IBS-C in a "real-life" setting: Results from a Portuguese single-center study.

Content-verified record concerning Linaclotide: "Effectiveness and tolerability of linaclotide in the treatment of IBS-C in a "real-life" setting: Results from a Portuguese single-center study." Abstract excerpt: Although linaclotide has been approved to treat moderate to severe IBS-C, no data are available on its effectiveness and tolerability in patients in a real-life setting. A prospective single-center study of the effectiveness and tolerability of linaclotide was carried out on patients (n = 40) with moderate to severe IBS-C, all fulfilling the Rome IV criteria. Clinical information was rec

Source: peer_reviewed_research
DOI: 10.1111/nmo.13508
PubMed: 30569519

Open original source

2023Insufficient evidence

Linaclotide (Linzess) for functional constipation.

Content-verified record concerning Linaclotide: "Linaclotide (Linzess) for functional constipation." (identity confirmed; no abstract text available to excerpt.)

Source: peer_reviewed_research
DOI: 10.58347/tml.2023.1683d
PubMed: 37651297

Open original source

2019Insufficient evidence

Long-term treatment with linaclotide of intestinal pseudo-obstruction secondary to Ehlers-Danlos syndrome.

Content-verified record concerning Linaclotide: "Long-term treatment with linaclotide of intestinal pseudo-obstruction secondary to Ehlers-Danlos syndrome." (identity confirmed; no abstract text available to excerpt.)

Source: peer_reviewed_research
DOI: 10.1016/j.dld.2018.10.012
PubMed: 30470553

Open original source

2013Insufficient evidence

A review of the clinical efficacy of linaclotide in irritable bowel syndrome with constipation.

Content-verified record concerning Linaclotide: "A review of the clinical efficacy of linaclotide in irritable bowel syndrome with constipation." Abstract excerpt: The aims were: firstly, to review the definition and diagnosis of irritable bowel syndrome with constipation (IBS-C, a subtype of IBS); secondly, to critically assess current therapies for IBS-C with a focus on effectiveness for abdominal pain; and thirdly, to review clinical studies evaluating the efficacy of linaclotide, a therapy recently approved by the US Food and Drug Administration for the

Source: peer_reviewed_research
DOI: 10.1185/03007995.2012.754743
PubMed: 23198977

Open original source

Insufficient evidence

Efficacy and safety of linaclotide plus polyethylene glycol for bowel preparation before colonoscopy in elderly Chinese patients: a systematic review and meta-analysis.

Source reference associated with Linaclotide. Source identity and peptide connection confirmed; scientific conclusions and evidence strength have not been assessed in this source-linking step.

Source: other
DOI: 10.3389/fmed.2026.1833539
PubMed: 42482900

Open original source

2024Insufficient evidence

Comparative profiles of lubiprostone, linaclotide, and elobixibat for chronic constipation: a systematic literature review with meta-analysis and number needed to treat/harm.

Content-verified record concerning Linaclotide: "Comparative profiles of lubiprostone, linaclotide, and elobixibat for chronic constipation: a systematic literature review with meta-analysis and number needed to treat/harm." Abstract excerpt: To comprehensively evaluate the efficacy, safety, patient symptoms, and quality-of-life (QoL) of lubiprostone, linaclotide, and elobixibat as treatment for chronic constipation (CC). Systematic literature review (SLR) and meta-analysis (MA). Literature searches were conducted on PubMed and Embase using the Ovid platform. SLR including randomized controlled trials (RCTs) and observational studies w

Source: systematic_review_or_meta_analysis
DOI: 10.1186/s12876-023-03104-8
PubMed: 38166671

Open original source

2013Insufficient evidence

Constella™(EU)-Linzess™(USA): the last milestone in the long journey of the peptide linaclotide and its implications for the future of peptide drugs.

Content-verified record concerning Linaclotide: "Constella™(EU)-Linzess™(USA): the last milestone in the long journey of the peptide linaclotide and its implications for the future of peptide drugs." Abstract excerpt: Irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) are highly prevalent gastrointestinal disorders associated with health, economical and social problems. Recently, after a long journey of preclinical studies and clinical trials, linaclotide, a first-in-class GC-C receptor peptide agonist, has received the approval in the USA and Europe for the treatment o

Source: peer_reviewed_research
DOI: 10.4155/fmc.13.5
PubMed: 23464519

Open original source

2011Insufficient evidence

The pharmacokinetics, pharmacodynamics, clinical efficacy, safety and tolerability of linaclotide.

Content-verified record concerning Linaclotide: "The pharmacokinetics, pharmacodynamics, clinical efficacy, safety and tolerability of linaclotide." Abstract excerpt: Linaclotide is a novel intestinal secretagogue that is in the advanced stages of development for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation. These functional gastrointestinal disorders are highly prevalent in adults and children and often do not respond satisfactorily to available treatments. Linaclotide appears to be a promising new agent for pati

Source: peer_reviewed_research
DOI: 10.1517/17425255.2011.572875
PubMed: 21446888

Open original source

2012Insufficient evidence

Elvitegravir/cobicistat, mirabegron, and linaclotide.

Content-verified record concerning Linaclotide: "Elvitegravir/cobicistat, mirabegron, and linaclotide." (identity confirmed; no abstract text available to excerpt.)

Source: peer_reviewed_research
DOI: 10.1331/japha.2012.12544
PubMed: 23229974

Open original source

2024Insufficient evidence

Linaclotide

Content-verified record concerning Linaclotide: "Linaclotide" Abstract excerpt: Linaclotide is an FDA-approved medication indicated for adults suffering from irritable bowel syndrome with predominant constipation (IBS-C) and chronic idiopathic constipation (CIC). Linaclotide, administered daily, is a potent and highly selective agonist of guanylate cyclase-C (GC-C) receptors in the intestine, offering a novel therapeutic approach with a favorable safety profile. Beyond its FD

Source: other
PubMed: 35201736

Open original source

2026Insufficient evidence

Effect of linaclotide combined with polyethylene glycol on bowel preparation before colonoscopy in patients with constipation.

Content-verified record concerning Linaclotide: "Effect of linaclotide combined with polyethylene glycol on bowel preparation before colonoscopy in patients with constipation." Abstract excerpt: Linaclotide, a promising medication for treating irritable bowel syndrome with predominant constipation, has the potential to enhance bowel preparation for colonoscopy. This study aims to evaluate the efficacy and tolerability of linaclotide combined with low-volume polyethylene glycol (PEG) in constipated patients. In this randomized, single-blind controlled trial, 210 constipated patients were a

Source: peer_reviewed_research
DOI: 10.3389/fmed.2026.1686654
PubMed: 41658593

Open original source

2013Insufficient evidence

Linaclotide: A new drug for the treatment of chronic constipation and irritable bowel syndrome with constipation.

Content-verified record concerning Linaclotide: "Linaclotide: A new drug for the treatment of chronic constipation and irritable bowel syndrome with constipation." Abstract excerpt: Linaclotide is the first member of a novel class of drugs to be extensively evaluated for the treatment of chronic constipation (CC) and irritable bowel syndrome with constipation (IBS-C). To provide a comprehensive overview of the current state of knowledge on linaclotide, its pharmacological properties, mode of action and efficacy in clinical trials to date. We conducted a systematic review of t

Source: systematic_review_or_meta_analysis
DOI: 10.1177/2050640612474446
PubMed: 24917937

Open original source

2014Insufficient evidence

Effect of linaclotide on severe abdominal symptoms in patients with irritable bowel syndrome with constipation.

Content-verified record concerning Linaclotide: "Effect of linaclotide on severe abdominal symptoms in patients with irritable bowel syndrome with constipation." Abstract excerpt: Patients with irritable bowel syndrome with constipation (IBS-C) have abdominal symptoms that vary in severity. Linaclotide, a guanylate cyclase-C agonist, improves abdominal and bowel symptoms in these patients. We examined the prevalence of severe abdominal symptoms in patients with IBS-C and assessed the effects of linaclotide on abdominal symptoms, global measures, and quality of life (QOL). I

Source: peer_reviewed_research
DOI: 10.1016/j.cgh.2013.09.022
PubMed: 24075889

Open original source

2026Insufficient evidence

Linaclotide combined with polyethylene glycol for bowel preparation in colonoscopy: a systematic review and meta-analysis of randomized controlled trials.

Content-verified record concerning Linaclotide: "Linaclotide combined with polyethylene glycol for bowel preparation in colonoscopy: a systematic review and meta-analysis of randomized controlled trials." Abstract excerpt: Polyethylene glycol (PEG) is the standard agent for bowel preparation in colonoscopy. However, its combination with linaclotide may enhance bowel cleansing. This systematic review and meta-analysis compared the efficacy and safety of linaclotide combined with PEG versus PEG alone in patients undergoing colonoscopy. We searched PubMed, Embase, and Cochrane Library databases. We calculated pooled ri

Source: systematic_review_or_meta_analysis
DOI: 10.1007/s00464-025-12288-x
PubMed: 41168471

Open original source

2024Insufficient evidence

The gut microbiota participates in the effect of linaclotide in patients with irritable bowel syndrome with constipation (IBS-C): a multicenter, prospective, pre-post study.

Content-verified record concerning Linaclotide: "The gut microbiota participates in the effect of linaclotide in patients with irritable bowel syndrome with constipation (IBS-C): a multicenter, prospective, pre-post study." Abstract excerpt: Interindividual variation characterizes the relief experienced by constipation-predominant irritable bowel syndrome (IBS-C) patients following linaclotide treatment. Complex bidirectional interactions occur between the gut microbiota and various clinical drugs. To date, no established evidence has elucidated the interactions between the gut microbiota and linaclotide. We aimed to explore the impac

Source: peer_reviewed_research
DOI: 10.1186/s12967-024-04898-1
PubMed: 38263117

Open original source

2014Insufficient evidence

Effect of linaclotide in irritable bowel syndrome with constipation (IBS-C): a systematic review and meta-analysis.

Content-verified record concerning Linaclotide: "Effect of linaclotide in irritable bowel syndrome with constipation (IBS-C): a systematic review and meta-analysis." Abstract excerpt: Treatment options for constipation-predominant irritable bowel syndrome (IBS-C) are limited. While linaclotide improved IBS-C symptoms in randomized controlled trials (RCTs), results vary among studies and the magnitude of benefit is unclear. Two investigators independently extracted data on study participants, methods and outcomes (i.e., symptoms, quality of life, and adverse events) from eligibl

Source: systematic_review_or_meta_analysis
DOI: 10.1111/nmo.12292
PubMed: 24351035

Open original source

2010Insufficient evidence

Linaclotide - a secretagogue and antihyperalgesic agent - what next?

Content-verified record concerning Linaclotide: "Linaclotide - a secretagogue and antihyperalgesic agent - what next?" Abstract excerpt: Ongoing clinical trials suggest that linaclotide, a first-in-class, 14-amino acid peptide guanylate cyclase-C (GC-C) receptor agonist and intestinal secretagogue is an effective treatment for chronic constipation. A study in this issue of the Journal suggests that linaclotide also has antihyperalgesic effects in three common rat models of inflammation- and stress-induced hypersensitivity (i.e., ac

Source: peer_reviewed_research
DOI: 10.1111/j.1365-2982.2009.01465.x
PubMed: 20377786

Open original source

2026Insufficient evidence

Adjunctive linaclotide improves bowel cleansing and patient experience in polyethylene glycol-based bowel preparation.

Content-verified record concerning Linaclotide: "Adjunctive linaclotide improves bowel cleansing and patient experience in polyethylene glycol-based bowel preparation." Abstract excerpt: Adequate bowel preparation is critical for successful colonoscopy but is often compromised by the large volume and poor palatability of polyethylene glycol (PEG) solutions, leading to poor patient adherence. Linaclotide, a secretagogue, may enhance the efficacy and tolerability of PEG-based regimens. We systematically searched PubMed, Web of Science, Embase, and the Cochrane Library for randomized

Source: peer_reviewed_research
DOI: 10.1038/s41598-026-49852-x
PubMed: 42009975

Open original source

2026Insufficient evidence

Evaluating linaclotide for the treatment of irritable bowel syndrome with constipation in children and adolescents.

Content-verified record concerning Linaclotide: "Evaluating linaclotide for the treatment of irritable bowel syndrome with constipation in children and adolescents." Abstract excerpt: Irritable bowel syndrome with constipation (IBS-C) is a common pediatric disorder of gut - brain interaction (DGBI) characterized by constipation-related bowel dysfunction and recurrent abdominal pain. Despite multimodal management, pharmacologic options specifically evaluated for pediatric IBS-C have historically been absent. Linaclotide, a guanylate cyclase-C agonist with local intestinal activi

Source: peer_reviewed_research
DOI: 10.1080/14656566.2026.2702388
PubMed: 42425925

Open original source

2022Insufficient evidence

Effects of linaclotide in the treatment of chronic constipation and irritable bowel syndrome with constipation: a meta-analysis.

Content-verified record concerning Linaclotide: "Effects of linaclotide in the treatment of chronic constipation and irritable bowel syndrome with constipation: a meta-analysis." Abstract excerpt: Linaclotide is a guanylate cyclase-C (GCC) agonist that is found in intestinal epithelial cells and is used when treating chronic constipation (CC) and irritable bowel syndrome with constipation (IBS-C). Several randomized controlled trials (RCTs) were conducted for evaluating its efficacy and safety. The PubMed, EMBASE, and Cochrane databases and the Web of Science were searched to find multiple

Source: peer_reviewed_research
DOI: 10.1055/a-1491-1784
PubMed: 34215016

Open original source

2010Insufficient evidence

Linaclotide improves abdominal pain and bowel habits in a phase IIb study of patients with irritable bowel syndrome with constipation.

Content-verified record concerning Linaclotide: "Linaclotide improves abdominal pain and bowel habits in a phase IIb study of patients with irritable bowel syndrome with constipation." Abstract excerpt: Linaclotide, a minimally absorbed, 14-amino acid peptide agonist of guanylate cyclase-C, has shown benefit in a proof-of-concept study for the treatment of patients with irritable bowel syndrome (IBS) with constipation (IBS-C). We assessed the efficacy and safety of linaclotide at a daily dose range of 75-600 μg in IBS-C. We performed a randomized, double-blind, multicenter, placebo-controll

Source: peer_reviewed_research
DOI: 10.1053/j.gastro.2010.08.041
PubMed: 20801122

Open original source

2013Insufficient evidence

Effects of linaclotide in patients with irritable bowel syndrome with constipation or chronic constipation: a meta-analysis.

Content-verified record concerning Linaclotide: "Effects of linaclotide in patients with irritable bowel syndrome with constipation or chronic constipation: a meta-analysis." Abstract excerpt: Linaclotide is a minimally absorbed, 14-amino acid peptide used to treat patients with irritable bowel syndrome with constipation (IBS-C) or chronic constipation (CC). We performed a meta-analysis to determine the efficacy of linaclotide, compared with placebo, for patients with IBS-C or CC. MEDLINE, EMBASE, and the Cochrane central register of controlled trials were searched for randomized, place

Source: systematic_review_or_meta_analysis
DOI: 10.1016/j.cgh.2013.04.032
PubMed: 23644388

Open original source

2011Insufficient evidence

Linaclotide: a novel approach to the treatment of irritable bowel syndrome.

Content-verified record concerning Linaclotide: "Linaclotide: a novel approach to the treatment of irritable bowel syndrome." Abstract excerpt: To review the pharmacology, pharmacokinetics, efficacy, and safety of linaclotide for irritable bowel syndrome (IBS). A literature search using PubMed (1966-August 2011) and International Pharmaceutical Abstracts (1970-July 2011) was conducted using the terms linaclotide and MD-1100. Additional publications were identified by reviewing bibliographies. Abstracts were included in the absence of publ

Source: peer_reviewed_research
DOI: 10.1345/aph.1q428
PubMed: 22045908

Open original source

2021Insufficient evidence

Efficacy of Linaclotide in Reducing Abdominal Symptoms of Bloating, Discomfort, and Pain: A Phase 3B Trial Using a Novel Abdominal Scoring System.

Content-verified record concerning Linaclotide: "Efficacy of Linaclotide in Reducing Abdominal Symptoms of Bloating, Discomfort, and Pain: A Phase 3B Trial Using a Novel Abdominal Scoring System." Abstract excerpt: Linaclotide improves abdominal pain and constipation in patients with constipation-predominant irritable bowel syndrome (IBS-C). Patients report additional bothersome abdominal symptoms of bloating and discomfort. The intention of this study was to evaluate linaclotide's efficacy in relieving IBS-C-related abdominal symptoms (bloating, discomfort, and pain) using a novel multi-item Abdominal Score

Source: peer_reviewed_research
DOI: 10.14309/ajg.0000000000001334
PubMed: 34465695

Open original source

2019Insufficient evidence

Single-Dose Linaclotide Is Equal in Efficacy to Polyethylene Glycol for Bowel Preparation Prior to Capsule Endoscopy.

Content-verified record concerning Linaclotide: "Single-Dose Linaclotide Is Equal in Efficacy to Polyethylene Glycol for Bowel Preparation Prior to Capsule Endoscopy." Abstract excerpt: Video capsule endoscopy provides noninvasive visualization of the small bowel, but yield is often limited by debris. At our institution, preparation with polyethylene glycol (PEG) and simethicone is used to improve visualization. We hypothesized that linaclotide and simethicone would yield equal to better results. We enrolled 29 subjects for the experimental regimen of linaclotide and simethicone.

Source: peer_reviewed_research
DOI: 10.1159/000496350
PubMed: 30731474

Open original source

2010Insufficient evidence

Efficacy of linaclotide for patients with chronic constipation.

Content-verified record concerning Linaclotide: "Efficacy of linaclotide for patients with chronic constipation." Abstract excerpt: Linaclotide is a minimally absorbed peptide agonist of the guanylate cyclase-C receptor that stimulates intestinal fluid secretion and transit and reduces pain in animal models. We assessed the safety and efficacy of a range of linaclotide doses in patients with chronic constipation. We performed a multicenter, double-blind, placebo-controlled, parallel-group study of 310 patients with chronic con

Source: peer_reviewed_research
DOI: 10.1053/j.gastro.2009.12.050
PubMed: 20045700

Open original source

2012Insufficient evidence

Linaclotide: promising IBS-C efficacy in an era of provisional study endpoints.

Content-verified record concerning Linaclotide: "Linaclotide: promising IBS-C efficacy in an era of provisional study endpoints." Abstract excerpt: Recent disappointing developments in the pharmacotherapy of irritable bowel syndrome (IBS) have not dampened the enthusiasm surrounding linaclotide, a novel guanylate cyclase-C agonist for the management of constipation-predominant IBS (IBS-C). Two recent phase 3 studies reporting on a single, daily dose of linaclotide are presented in this issue of the American Journal of Gastroenterology. Import

Source: peer_reviewed_research
DOI: 10.1038/ajg.2012.325
PubMed: 23160292

Open original source

2014Insufficient evidence

Review article: Linaclotide for the management of irritable bowel syndrome with constipation.

Content-verified record concerning Linaclotide: "Review article: Linaclotide for the management of irritable bowel syndrome with constipation." Abstract excerpt: Irritable bowel syndrome with constipation (IBS-C) represents a significant burden to patients and healthcare systems due to its prevalence and lack of successful symptomatic resolution with established treatment options. Linaclotide 290 μg has recently been approved by the European Medicines Agency (EMA) for moderate-to-severe IBS-C and by the US Food and Drug Administration for IBS-C (290

Source: peer_reviewed_research
DOI: 10.1111/apt.12604
PubMed: 24433216

Open original source

2026Insufficient evidence

Effect of Age and Age-Defined Menopausal Status on Linaclotide Efficacy and Safety in Adults With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation: Post Hoc Analyses of Phase 2b/3 Studies.

Content-verified record concerning Linaclotide: "Effect of Age and Age-Defined Menopausal Status on Linaclotide Efficacy and Safety in Adults With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation: Post Hoc Analyses of Phase 2b/3 Studies." Abstract excerpt: This post hoc study explored the effect of age and age-defined menopausal status on linaclotide efficacy and safety in adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). Data were pooled from eight randomized, placebo-controlled studies of linaclotide 72 μg (CIC), 145 μg (CIC), or 290 μg (IBS-C). Patients were stratified by ag

Source: peer_reviewed_research
DOI: 10.1111/nmo.70429
PubMed: 42702764

Open original source

2007Insufficient evidence

Effect of 5 days linaclotide on transit and bowel function in females with constipation-predominant irritable bowel syndrome.

Content-verified record concerning Linaclotide: "Effect of 5 days linaclotide on transit and bowel function in females with constipation-predominant irritable bowel syndrome." Abstract excerpt: Oral linaclotide, a novel agonist of guanylate cylase-C, stimulates intestinal fluid secretion and transit, and decreases visceral hypersensitivity in animal studies. In healthy volunteers, linaclotide was safe, well tolerated, increased stool frequency, and decreased stool consistency and time to first bowel movement. This randomized, double-blind, placebo-controlled study evaluated the effects o

Source: peer_reviewed_research
DOI: 10.1053/j.gastro.2007.06.067
PubMed: 17854590

Open original source

Insufficient evidence

Efficacy of Polyethylene Glycol Electrolyte Powder Combined with Linaclotide for Bowel Preparation for Colonoscopy in Children with Functional Constipation.

Source reference associated with Linaclotide. Source identity and peptide connection confirmed; scientific conclusions and evidence strength have not been assessed in this source-linking step.

Source: other
DOI: 10.1620/tjem.2026.j007
PubMed: 41780967

Open original source

2023Insufficient evidence

Editorial: repurposed linaclotide and the quest for abdominal pain management in irritable bowel syndrome.

Content-verified record concerning Linaclotide: "Editorial: repurposed linaclotide and the quest for abdominal pain management in irritable bowel syndrome." (identity confirmed; no abstract text available to excerpt.)

Source: peer_reviewed_research
DOI: 10.1111/apt.17304
PubMed: 36565004

Open original source

2026Insufficient evidence

Efficacy safety of linaclotide combined with polyethylene glycol for bowel preparation in patients with constipation: a meta-analysis.

Content-verified record concerning Linaclotide: "Efficacy safety of linaclotide combined with polyethylene glycol for bowel preparation in patients with constipation: a meta-analysis." Abstract excerpt: In patients with chronic constipation, standard bowel preparation using polyethylene glycol (PEG) often results in inadequate intestinal cleansing, complicating colonoscopy. This study systematically assessed the efficacy and safety of linaclotide combined with PEG (linaclotide-PEG) compared to PEG alone. A systematic search was conducted in PubMed, EMBASE, Web of Science, CENTRAL, CNKI, VIP, and

Source: systematic_review_or_meta_analysis
DOI: 10.3389/fgstr.2026.1694950
PubMed: 42523615

Open original source

2017Insufficient evidence

Bioactivity of Oral Linaclotide in Human Colorectum for Cancer Chemoprevention.

Content-verified record concerning Linaclotide: "Bioactivity of Oral Linaclotide in Human Colorectum for Cancer Chemoprevention." Abstract excerpt: Guanylate cyclase C (GUCY2C) is a tumor-suppressing receptor silenced by loss of expression of its luminocrine hormones guanylin and uroguanylin early in colorectal carcinogenesis. This observation suggests oral replacement with a GUCY2C agonist may be an effective targeted chemoprevention agent. Linaclotide is an FDA-approved oral GUCY2C agonist formulated for gastric release, inducing fluid secr

Source: peer_reviewed_research
DOI: 10.1158/1940-6207.capr-16-0286
PubMed: 28396341

Open original source

2013Insufficient evidence

Linaclotide: a new option for the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation in adults.

Content-verified record concerning Linaclotide: "Linaclotide: a new option for the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation in adults." Abstract excerpt: Chronic idiopathic constipation (CC) and irritable bowel syndrome with predominant constipation (IBS-C) are the 2 most common conditions among functional gastrointestinal disorders. Despite current multiple therapeutic options, treatment remains challenging and dissatisfactory to many patients. Linaclotide is a novel therapeutic agent, which is a guanylate cyclase receptor agonist that stimulates

Source: peer_reviewed_research
DOI: 10.4137/cgast.s10550
PubMed: 24833940

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Scientific context

Chemistry and represented biological context

Existing reviewed chemistry is preserved as scientific context. Chemistry and mechanism information do not establish clinical efficacy or safety.

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Chemical identity

Molecular and structural record

Structured record

Molecular formula: C59H79N15O21S6
Molecular weight (Da): 1526.8
SMILES: CC1C(=O)NC2CSSCC3C(=O)NC(C(=O)NC(C(=O)NC(CSSCC(NC(=O)CNC(=O)C(NC2=O)C(C)O)C(=O)NC(CC4=CC=C(C=C4)O)C(=O)O)C(=O)NC(CSSCC(C(=O)N3)N)C(=O)NC(C(=O)N5CCCC5C(=O)N1)CC(=O)N)CC6=CC=C(C=C6)O)CCC(=O)O
InChI: InChI=1S/C59H79N15O21S6/c1-26-47(82)69-41-25-101-99-22-38-52(87)65-33(13-14-45(80)81)49(84)66-34(16-28-5-9-30(76)10-6-28)50(85)71-40(54(89)72-39(23-97-96-20-32(60)48(83)70-38)53(88)67-35(18-43(61)78)58(93)74-15-3-4-42(74)56(91)63-26)24-100-98-21-37(64-44(79)19-62-57(92)46(27(2)75)73-55(41)90)51(86)68-36(59(94)95)17-29-7-11-31(77)12-8-29/h5-12,26-27,32-42,46,75-77H,3-4,13-25,60H2,1-2H3,(H2,61,78)(H,62,92)(H,63,91)(H,64,79)(H,65,87)(H,66,84)(H,67,88)(H,68,86)(H,69,82)(H,70,83)(H,71,85)(H,72,89)(H,73,90)(H,80,81)(H,94,95)/t26-,27+,32-,33-,34-,35-,36-,37-,38-,39-,40-,41-,42-,46-/m0/s1
InChIKey: KXGCNMMJRFDFNR-WDRJZQOASA-N

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Research chronology

2006 · study · Temporal status not established
Linaclotide
other
2007 · study · Temporal status not established
Linaclotide, a new direction in the treatment of irritable bowel syndrome and chronic constipation.
peer_reviewed_research
2007 · study · Temporal status not established
Effect of 5 days linaclotide on transit and bowel function in females with constipation-predominant irritable bowel syndrome.
peer_reviewed_research
2009 · study · Temporal status not established
Pilot study on the effect of linaclotide in patients with chronic constipation.
peer_reviewed_research
2010 · study · Temporal status not established
Linaclotide, through activation of guanylate cyclase C, acts locally in the gastrointestinal tract to elicit enhanced intestinal secretion and transit.
peer_reviewed_research
2010 · study · Temporal status not established
Linaclotide is a potent and selective guanylate cyclase C agonist that elicits pharmacological effects locally in the gastrointestinal tract.
peer_reviewed_research
2010 · study · Temporal status not established
Guanylate cyclase C-mediated antinociceptive effects of linaclotide in rodent models of visceral pain.
peer_reviewed_research
2010 · study · Temporal status not established
Molecule of the month. Linaclotide acetate.
peer_reviewed_research
2010 · study · Temporal status not established
Constipation: Linaclotide--a stimulating new drug for chronic constipation.
peer_reviewed_research
2010 · study · Temporal status not established
Linaclotide - a secretagogue and antihyperalgesic agent - what next?
peer_reviewed_research
2010 · study · Temporal status not established
Linaclotide improves abdominal pain and bowel habits in a phase IIb study of patients with irritable bowel syndrome with constipation.
peer_reviewed_research
2010 · study · Temporal status not established
Efficacy of linaclotide for patients with chronic constipation.
peer_reviewed_research
2011 · study · Temporal status not established
Two randomized trials of linaclotide for chronic constipation.
peer_reviewed_research
2011 · study · Temporal status not established
Linaclotide, a synthetic guanylate cyclase C agonist, for the treatment of functional gastrointestinal disorders associated with constipation.
peer_reviewed_research
2011 · study · Temporal status not established
Optimized Fmoc solid-phase synthesis of the cysteine-rich peptide linaclotide.
peer_reviewed_research
2011 · study · Temporal status not established
The pharmacokinetics, pharmacodynamics, clinical efficacy, safety and tolerability of linaclotide.
peer_reviewed_research
2011 · study · Temporal status not established
Linaclotide: a novel approach to the treatment of irritable bowel syndrome.
peer_reviewed_research
2012 · study · Temporal status not established
Linaclotide for irritable bowel syndrome with constipation: a 26-week, randomized, double-blind, placebo-controlled trial to evaluate efficacy and safety.
peer_reviewed_research
2012 · study · Temporal status not established
A 12-week, randomized, controlled trial with a 4-week randomized withdrawal period to evaluate the efficacy and safety of linaclotide in irritable bowel syndrome with constipation.
peer_reviewed_research
2012 · study · Temporal status not established
Linaclotide: first global approval.
peer_reviewed_research
2012 · study · Temporal status not established
Linaclotide in the management of gastrointestinal tract disorders.
peer_reviewed_research
2012 · study · Temporal status not established
Linaclotide (Linzess) for constipation.
peer_reviewed_research
2012 · study · Temporal status not established
Linaclotide
other
2012 · study · Temporal status not established
Contrasting effects of linaclotide and lubiprostone on restitution of epithelial cell barrier properties and cellular homeostasis after exposure to cell stressors.
peer_reviewed_research
2012 · study · Temporal status not established
Elvitegravir/cobicistat, mirabegron, and linaclotide.
peer_reviewed_research
2012 · study · Temporal status not established
Linaclotide: promising IBS-C efficacy in an era of provisional study endpoints.
peer_reviewed_research
2013 · study · Temporal status not established
Randomised clinical trials: linaclotide phase 3 studies in IBS-C - a prespecified further analysis based on European Medicines Agency-specified endpoints.
peer_reviewed_research
2013 · study · Temporal status not established
An evaluation of the FDA responder endpoint for IBS-C clinical trials: analysis of data from linaclotide Phase 3 clinical trials.
peer_reviewed_research
2013 · study · Temporal status not established
Pharmacologic properties, metabolism, and disposition of linaclotide, a novel therapeutic peptide approved for the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation.
peer_reviewed_research
2013 · study · Temporal status not established
Linaclotide for constipation-predominant IBS.
peer_reviewed_research
2013 · study · Temporal status not established
Linaclotide in the treatment of patients with irritable bowel syndrome and constipation - analysis of an opportunity.
peer_reviewed_research
2013 · study · Temporal status not established
Linaclotide-a novel secretagogue in the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation.
peer_reviewed_research
2013 · study · Temporal status not established
Linaclotide: a novel compound for the treatment of irritable bowel syndrome with constipation.
peer_reviewed_research
2013 · study · Temporal status not established
Linaclotide inhibits colonic nociceptors and relieves abdominal pain via guanylate cyclase-C and extracellular cyclic guanosine 3',5'-monophosphate.
peer_reviewed_research
2013 · study · Temporal status not established
[Joint Statement of the German Society for Digestive and Metabolic Diseases (DGVS), the German Society for Neurogastroenterology and motility (DGNM) and the German Society for Internal Medicine (DGIM) for linaclotide-benefit assessment of the Institute for Quality and Efficiency in Health Care (IQWiG) in accordance with § 35a SGB V (dossier evaluation)].
systematic_review_or_meta_analysis
2013 · study · Temporal status not established
Linaclotide, novel therapy for the treatment of chronic idiopathic constipation and constipation-predominant irritable bowel syndrome.
peer_reviewed_research
2013 · study · Temporal status not established
Challenges of managing pain in constipation-predominant IBS: clinical perspectives on antinociceptive actions of linaclotide.
peer_reviewed_research
2013 · study · Temporal status not established
Linaclotide for treatment of irritable bowel syndrome--the view of European regulators.
peer_reviewed_research
2013 · study · Temporal status not established
A review of the clinical efficacy of linaclotide in irritable bowel syndrome with constipation.
peer_reviewed_research
2013 · study · Temporal status not established
Constella™(EU)-Linzess™(USA): the last milestone in the long journey of the peptide linaclotide and its implications for the future of peptide drugs.
peer_reviewed_research
2013 · study · Temporal status not established
Linaclotide: A new drug for the treatment of chronic constipation and irritable bowel syndrome with constipation.
systematic_review_or_meta_analysis
2013 · study · Temporal status not established
Effects of linaclotide in patients with irritable bowel syndrome with constipation or chronic constipation: a meta-analysis.
systematic_review_or_meta_analysis
2013 · study · Temporal status not established
Linaclotide: a new option for the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation in adults.
peer_reviewed_research
2014 · study · Temporal status not established
Impact of linaclotide treatment on work productivity and activity impairment in adults with irritable bowel syndrome with constipation: results from 2 randomized, double-blind, placebo-controlled phase 3 trials.
peer_reviewed_research
2014 · study · Temporal status not established
The impact of abdominal pain on global measures in patients with chronic idiopathic constipation, before and after treatment with linaclotide: a pooled analysis of two randomised, double-blind, placebo-controlled, phase 3 trials.
peer_reviewed_research
2014 · study · Temporal status not established
Responders vs clinical response: a critical analysis of data from linaclotide phase 3 clinical trials in IBS-C.
peer_reviewed_research
2014 · study · Temporal status not established
Linaclotide. A bacterial enterotoxin derivative with a laxative action, nothing more.
peer_reviewed_research
2014 · study · Temporal status not established
Clarification of linaclotide pharmacology presented in a recent clinical study of plecanatide.
peer_reviewed_research
2014 · study · Temporal status not established
Linaclotide: a novel agent for chronic constipation and irritable bowel syndrome.
peer_reviewed_research
2014 · study · Temporal status not established
Linaclotide: a review of its use in the treatment of irritable bowel syndrome with constipation.
peer_reviewed_research
2014 · study · Temporal status not established
Effect of linaclotide on severe abdominal symptoms in patients with irritable bowel syndrome with constipation.
peer_reviewed_research
2014 · study · Temporal status not established
Effect of linaclotide in irritable bowel syndrome with constipation (IBS-C): a systematic review and meta-analysis.
systematic_review_or_meta_analysis
2014 · study · Temporal status not established
Review article: Linaclotide for the management of irritable bowel syndrome with constipation.
peer_reviewed_research
2015 · study · Temporal status not established
Linaclotide in Chronic Idiopathic Constipation Patients with Moderate to Severe Abdominal Bloating: A Randomized, Controlled Trial.
peer_reviewed_research
2015 · study · Temporal status not established
A comparison of linaclotide and lubiprostone dosing regimens on ion transport responses in human colonic mucosa.
peer_reviewed_research
2015 · study · Temporal status not established
MRP4 Modulation of the Guanylate Cyclase-C/cGMP Pathway: Effects on Linaclotide-Induced Electrolyte Secretion and cGMP Efflux.
peer_reviewed_research
2015 · study · Temporal status not established
Economic evaluation of linaclotide for the treatment of adult patients with irritable bowel syndrome with constipation in the United States.
peer_reviewed_research
2016 · study · Temporal status not established
Cost-effectiveness of linaclotide compared to antidepressants in the treatment of irritable bowel syndrome with constipation in Scotland.
peer_reviewed_research
2016 · study · Temporal status not established
Economic Evaluation of Linaclotide for the Treatment of Adult Patients With Chronic Idiopathic Constipation in the United States.
peer_reviewed_research
2017 · study · Temporal status not established
Linaclotide activates guanylate cyclase-C/cGMP/protein kinase-II-dependent trafficking of CFTR in the intestine.
peer_reviewed_research
2017 · study · Temporal status not established
Optimizing the Use of Linaclotide in Patients with Constipation-Predominant Irritable Bowel Syndrome: An Expert Consensus Report.
peer_reviewed_research
2017 · study · Temporal status not established
Bioactivity of Oral Linaclotide in Human Colorectum for Cancer Chemoprevention.
peer_reviewed_research
2018 · study · Temporal status not established
Linaclotide in irritable bowel syndrome with constipation: A Phase 3 randomized trial in China and other regions.
peer_reviewed_research
2018 · study · Temporal status not established
Determining an optimal dose of linaclotide for use in Japanese patients with irritable bowel syndrome with constipation: A phase II randomized, double-blind, placebo-controlled study.
peer_reviewed_research
2018 · study · Temporal status not established
Randomized, double-blind, placebo-controlled study vs data in the daily practice using linaclotide in patients with irritable bowel syndrome with constipation.
peer_reviewed_research
2018 · study · Temporal status not established
Low-Dose Linaclotide (72 μg) for Chronic Idiopathic Constipation: A 12-Week, Randomized, Double-Blind, Placebo-Controlled Trial.
peer_reviewed_research
2018 · study · Temporal status not established
A randomized controlled and long-term linaclotide study of irritable bowel syndrome with constipation patients in Japan.
peer_reviewed_research
2018 · study · Temporal status not established
Dose-finding study of linaclotide in Japanese patients with chronic constipation: A phase II randomized, double-blind, and placebo-controlled study.
peer_reviewed_research
2018 · study · Temporal status not established
Health Care Resource Use and Costs Pre- and Post-Treatment Initiation With Linaclotide: Retrospective Analyses of a U.S. Insured Population.
peer_reviewed_research
2018 · study · Temporal status not established
Linaclotide inhibits colonic and urinary bladder hypersensitivity in adult female rats following unpredictable neonatal stress.
peer_reviewed_research
2018 · study · Temporal status not established
Long-term results of linaclotide in the treatment of constipation-type irritable bowel syndrome.
peer_reviewed_research
2018 · study · Temporal status not established
Linaclotide Attenuates Visceral Organ Crosstalk: Role of Guanylate Cyclase-C Activation in Reversing Bladder-Colon Cross-Sensitization.
peer_reviewed_research
2018 · study · Temporal status not established
Linaclotide improves gastrointestinal transit in cystic fibrosis mice by inhibiting sodium/hydrogen exchanger 3.
peer_reviewed_research
2018 · study · Temporal status not established
Chronic linaclotide treatment reduces colitis-induced neuroplasticity and reverses persistent bladder dysfunction.
peer_reviewed_research
2018 · study · Temporal status not established
Efficacy of linaclotide in irritable bowel syndrome with constipation: Real-world data.
peer_reviewed_research
2018 · study · Temporal status not established
Linaclotide for the treatment of chronic constipation.
peer_reviewed_research
2018 · study · Temporal status not established
Efficacy and tolerability of linaclotide in the treatment of irritable bowel syndrome with constipation in a real‑world setting - results from a German noninterventional study.
peer_reviewed_research
2019 · study · Temporal status not established
High-dose linaclotide is effective and safe in patients with chronic constipation: A phase III randomized, double-blind, placebo-controlled study with a long-term open-label extension study in Japan.
peer_reviewed_research
2019 · study · Temporal status not established
Safety and tolerability of linaclotide for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation: pooled Phase 3 analysis.
peer_reviewed_research
2019 · study · Temporal status not established
Linaclotide treatment reduces endometriosis-associated vaginal hyperalgesia and mechanical allodynia through viscerovisceral cross-talk.
peer_reviewed_research
2019 · study · Temporal status not established
Clinical response to linaclotide at week 4 predicts sustained response in irritable bowel syndrome with constipation and improvements in digestive and extra-digestive symptoms.
peer_reviewed_research
2019 · study · Temporal status not established
[Pharmacological and clinical profile of linaclotide (Linzess®), a novel therapeutic agent for irritable bowel syndrome with constipation and chronic constipation].
peer_reviewed_research
2019 · study · Temporal status not established
The Impact of Stool Consistency on Bowel Movement Satisfaction in Patients With IBS-C or CIC Treated With Linaclotide or Other Medications: Real-World Evidence From the CONTOR Study.
peer_reviewed_research
2019 · study · Temporal status not established
Linaclotide increases cecal pH, accelerates colonic transit, and increases colonic motility in irritable bowel syndrome with constipation.
peer_reviewed_research
2019 · study · Temporal status not established
Multicentre, non-interventional study of the efficacy and tolerability of linaclotide in the treatment of irritable bowel syndrome with constipation in primary, secondary and tertiary centres: the Alpine study.
peer_reviewed_research
2019 · study · Temporal status not established
Effectiveness and tolerability of linaclotide in the treatment of IBS-C in a "real-life" setting: Results from a Portuguese single-center study.
peer_reviewed_research
2019 · study · Temporal status not established
Long-term treatment with linaclotide of intestinal pseudo-obstruction secondary to Ehlers-Danlos syndrome.
peer_reviewed_research
2019 · study · Temporal status not established
Single-Dose Linaclotide Is Equal in Efficacy to Polyethylene Glycol for Bowel Preparation Prior to Capsule Endoscopy.
peer_reviewed_research
2020 · study · Temporal status not established
Randomised clinical trial: linaclotide vs placebo-a study of bi-directional gut and brain axis.
peer_reviewed_research
2020 · study · Temporal status not established
Efficacy and safety of linaclotide for opioid-induced constipation in patients with chronic noncancer pain syndromes from a phase 2 randomized study.
peer_reviewed_research
2020 · study · Temporal status not established
Tadalafil versus linaclotide in gastrointestinal dysfunction and depressive behavior in constipation-predominant irritable bowel syndrome.
peer_reviewed_research
2020 · study · Temporal status not established
The guanylate cyclase C agonist linaclotide ameliorates the gut-cardio-renal axis in an adenine-induced mouse model of chronic kidney disease.
peer_reviewed_research
2021 · study · Temporal status not established
Polyethylene glycol combined with linaclotide is an effective and well-tolerated bowel preparation regimen for colonoscopy: an endoscopist-blinded, randomized, controlled trial.
peer_reviewed_research
2021 · study · Temporal status not established
Randomized Trial of 2 Delayed-Release Formulations of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation.
peer_reviewed_research
2021 · study · Temporal status not established
The Use of Linaclotide in Children with Functional Constipation or Irritable Bowel Syndrome: A Retrospective Chart Review.
peer_reviewed_research
2021 · study · Temporal status not established
[Efficacy and Safety of Linaclotide in Elderly Patients].
peer_reviewed_research
2021 · study · Temporal status not established
Linaclotide for the treatment of refractory lower bowel manifestations of systemic sclerosis.
peer_reviewed_research
2021 · study · Temporal status not established
Improving the Gastrointestinal Stability of Linaclotide.
peer_reviewed_research
2021 · study · Temporal status not established
Efficacy of Linaclotide in Reducing Abdominal Symptoms of Bloating, Discomfort, and Pain: A Phase 3B Trial Using a Novel Abdominal Scoring System.
peer_reviewed_research
2022 · study · Temporal status not established
Efficacy and safety of linaclotide in patients with irritable bowel syndrome with constipation: Chinese sub-cohort analysis of a phase III, randomized, double-blind, placebo-controlled trial.
peer_reviewed_research
2022 · study · Temporal status not established
Linaclotide for treating patients with irritable bowel syndrome with predominant constipation: a multicentre study of real-world data in China.
peer_reviewed_research
2022 · study · Temporal status not established
Linaclotide utilization and potential for off-label use and misuse in three European countries.
peer_reviewed_research
2022 · study · Temporal status not established
Cost-Effectiveness of Linaclotide Compared to Osmotic Laxatives in the Treatment of Irritable Bowel Syndrome with Constipation in China.
peer_reviewed_research
2022 · study · Temporal status not established
Effects of linaclotide in the treatment of chronic constipation and irritable bowel syndrome with constipation: a meta-analysis.
peer_reviewed_research
2023 · study · Temporal status not established
A novel ultra-low-volume regimen combining 1 L polyethylene glycol and linaclotide versus 2 L polyethylene glycol for colonoscopy cleansing in low-risk individuals: a randomized controlled trial.
peer_reviewed_research
2023 · study · Temporal status not established
Linaclotide Reduced Response Time for Irritable Bowel Syndrome With Constipation Symptoms: Analysis of 4 Randomized Controlled Trials.
peer_reviewed_research
2023 · study · Temporal status not established
Cost impact of incorporating linaclotide into low-volume colonoscopy preparation.
peer_reviewed_research
2023 · study · Temporal status not established
Microbiota-derived butyrate dampens linaclotide stimulation of the guanylate cyclase C pathway in patient-derived colonoids.
peer_reviewed_research
2023 · study · Temporal status not established
A New Regioselective Synthesis of the Cysteine-Rich Peptide Linaclotide.
peer_reviewed_research
2023 · study · Temporal status not established
Linaclotide (Linzess) for functional constipation.
peer_reviewed_research
2023 · study · Temporal status not established
Editorial: repurposed linaclotide and the quest for abdominal pain management in irritable bowel syndrome.
peer_reviewed_research
2024 · study · Temporal status not established
Linaclotide for functional constipation in paediatric patients: phase III results.
peer_reviewed_research
2024 · study · Temporal status not established
Efficacy and safety of linaclotide in treating functional constipation in paediatric patients: a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial.
peer_reviewed_research
2024 · study · Temporal status not established
Randomized controlled trial of linaclotide in children aged 6-17 years with functional constipation.
peer_reviewed_research
2024 · study · Temporal status not established
Evaluation of the efficacy of polyethylene glycol in combination with different doses of linaclotide in a fractionated bowel preparation for colonoscopy: a prospective randomized controlled study.
peer_reviewed_research
2024 · study · Temporal status not established
Efficacy of Polyethylene Glycol Electrolyte Powder Combined With Linaclotide for Colon Cleansing in Patients With Chronic Constipation Undergoing Colonoscopy: A Multicenter, Single-Blinded, Randomized Controlled Trial.
peer_reviewed_research
2024 · study · Temporal status not established
Application of linaclotide in bowel preparation for colonoscopy in patients with constipation: A prospective randomized controlled study.
peer_reviewed_research
2024 · study · Temporal status not established
Efficacy of linaclotide in combination with polyethylene glycol for bowel preparation in Chinese patients undergoing colonoscopy polypectomy: protocol for a randomised controlled trial.
peer_reviewed_research
2024 · study · Temporal status not established
Safety and efficacy of linaclotide in children aged 2-5 years with functional constipation: Phase 2, randomized study.
peer_reviewed_research
2024 · study · Temporal status not established
Bowel preparation with linaclotide and 1 L polyethylene glycol plus ascorbic acid prior to colonoscopy in chronic constipated patients.
peer_reviewed_research
2024 · study · Temporal status not established
Ten years of successful linaclotide treatment in a patient with intestinal pseudo-obstruction due to Ehlers-Danlos syndrome.
peer_reviewed_research
2024 · study · Temporal status not established
Examining linaclotide for the treatment of chronic idiopathic constipation.
peer_reviewed_research
2024 · study · Temporal status not established
DRA involvement in linaclotide-stimulated bicarbonate secretion during loss of CFTR function.
peer_reviewed_research
2024 · study · Temporal status not established
The Effects of Combined Use of Linaclotide and Polyethylene Glycol Electrolyte Powder in Colonoscopy Preparation for Patients With Chronic Constipation.
peer_reviewed_research
2024 · study · Temporal status not established
Renoprotective effects of laxative linaclotide: Inhibition of acute kidney injury and fibrosis in a rat model of renal ischemia-reperfusion.
peer_reviewed_research
2024 · study · Temporal status not established
Safety and efficacy of linaclotide in children aged 7-17 years with irritable bowel syndrome with constipation.
peer_reviewed_research
2024 · study · Temporal status not established
Linaclotide for paediatric functional constipation.
peer_reviewed_research
2024 · study · Temporal status not established
Efficacy and safety of linaclotide in treatment-resistant chronic constipation: A multicenter, open-label study.
peer_reviewed_research
2024 · study · Temporal status not established
Comparative profiles of lubiprostone, linaclotide, and elobixibat for chronic constipation: a systematic literature review with meta-analysis and number needed to treat/harm.
systematic_review_or_meta_analysis
2024 · study · Temporal status not established
Linaclotide
other
2024 · study · Temporal status not established
The gut microbiota participates in the effect of linaclotide in patients with irritable bowel syndrome with constipation (IBS-C): a multicenter, prospective, pre-post study.
peer_reviewed_research
2025 · study · Temporal status not established
Effects of the combined use of linaclotide and oral sulfate solution in bowel preparation for patients with chronic constipation undergoing colonoscopy: protocol of a prospective, randomised, controlled, single-blind clinical trial from a single centre in China.
peer_reviewed_research
2025 · study · Temporal status not established
Efficacy of 1 L Polyethylene Glycol Plus Ascorbic Acid With Linaclotide Versus Senna for Bowel Preparation: A Multicenter, Endoscopist-Blinded, Randomized Controlled Trial (Apple Trial).
peer_reviewed_research
2025 · study · Temporal status not established
Efficacy of Linaclotide in Functional Dyspepsia and Constipation-Predominant Irritable Bowel Syndrome Overlap: A Randomized Trial.
peer_reviewed_research
2025 · study · Temporal status not established
Real-world safety of linaclotide in Chinese patients with irritable bowel syndrome with constipation: a multicenter, single-arm, prospective observational study.
peer_reviewed_research
2025 · study · Temporal status not established
Linaclotide Use for the Treatment of Constipation and Gastrointestinal Symptoms in People With Cystic Fibrosis.
peer_reviewed_research
2025 · study · Temporal status not established
Cost-Effectiveness of Vibrant System vs. Linaclotide in Chronic Idiopathic Constipation.
peer_reviewed_research
2025 · study · Temporal status not established
Characterization of disulfide bridges containing cyclic peptide Linaclotide and its degradation products by using LC-HRMS/MS.
peer_reviewed_research
2025 · study · Temporal status not established
Efficacy and Safety of Linaclotide as an Adjunct to Polyethylene Glycol in Bowel Preparation: A Meta-Analysis.
peer_reviewed_research
2025 · study · Temporal status not established
Combined linaclotide and polyethylene glycol electrolyte for colonoscopy preparation: a network meta-analysis of 14 randomized controlled trials.
systematic_review_or_meta_analysis
2025 · study · Temporal status not established
Safety and efficacy of linaclotide as an adjuvant for bowel preparation: A systematic review and meta-analysis.
systematic_review_or_meta_analysis
2026 · study · Temporal status not established
Short-term linaclotide plus polyethylene glycol in patients at increased risk of inadequate bowel preparation: A randomized, double-blind, multicenter trial.
peer_reviewed_research
2026 · study · Temporal status not established
Linaclotide in combination with compound polyethylene glycol powder enhances bowel preparation for colonoscopy in patients aged over 60 years: a multi-center, endoscopist-blind, randomized controlled trial.
peer_reviewed_research
2026 · study · Temporal status not established
Effect of Linaclotide on Colonic Motility Assessed With Intraluminal Colonic High-Resolution Manometry in Healthy Subjects. An Acute, Open Label, Randomized, Crossover, Reader-Blinded Study.
peer_reviewed_research
2026 · study · Temporal status not established
Efficacy and Safety of Linaclotide in Pediatric Patients of Functional Constipation: A Meta-analysis of Randomized Controlled Trials.
peer_reviewed_research
2026 · study · Temporal status not established
Effect of 3-Day Linaclotide Administration to Reduce the Polyethylene Glycol Volume for Colonoscopy Bowel Preparation: A Multicenter, Noninferiority, Randomized Controlled Trial.
peer_reviewed_research
2026 · study · Temporal status not established
Identification and Quantification of Structurally Related Peptide Impurity in Linaclotide by Liquid Chromatography-High Resolution Mass Spectrometry.
peer_reviewed_research
2026 · study · Temporal status not established
A post hoc analysis of linaclotide in pediatric patients with functional constipation and neurodevelopmental disorders.
peer_reviewed_research
2026 · study · Temporal status not established
Evaluating linaclotide for the treatment of functional constipation in children and adolescents.
peer_reviewed_research
2026 · study · Temporal status not established
Linaclotide for irritable bowel syndrome with constipation: integrating realworld evidence into the therapeutic puzzle.
peer_reviewed_research
2026 · study · Temporal status not established
The Efficacy of Single Dose Linaclotide in Polyethylene Glycol-Based Bowel Preparation: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
systematic_review_or_meta_analysis
2026 · study · Temporal status not established
Effect of linaclotide combined with polyethylene glycol on bowel preparation before colonoscopy in patients with constipation.
peer_reviewed_research
2026 · study · Temporal status not established
Linaclotide combined with polyethylene glycol for bowel preparation in colonoscopy: a systematic review and meta-analysis of randomized controlled trials.
systematic_review_or_meta_analysis
2026 · study · Temporal status not established
Adjunctive linaclotide improves bowel cleansing and patient experience in polyethylene glycol-based bowel preparation.
peer_reviewed_research
2026 · study · Temporal status not established
Evaluating linaclotide for the treatment of irritable bowel syndrome with constipation in children and adolescents.
peer_reviewed_research
2026 · study · Temporal status not established
Effect of Age and Age-Defined Menopausal Status on Linaclotide Efficacy and Safety in Adults With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation: Post Hoc Analyses of Phase 2b/3 Studies.
peer_reviewed_research
2026 · study · Temporal status not established
Efficacy safety of linaclotide combined with polyethylene glycol for bowel preparation in patients with constipation: a meta-analysis.
systematic_review_or_meta_analysis
2026 · regulatory · Temporal status not established
Regulatory review: approved
European Union — EMA
2026 · regulatory · Temporal status not established
Regulatory review: approved
United States — FDA
Date unavailable · study · Temporal status not established
Application of oral sulfate solution combined with linaclotide in bowel preparation for colonoscopy.
other
Date unavailable · study · Temporal status not established
Linaclotide for Bowel Preparation: Is "Afterload Reduction" Not Just for Heart Failure Anymore?
other
Date unavailable · study · Temporal status not established
Partially differentiated enterocytes in ileal and distal-colonic human F508del-CF-enteroids secrete fluid in response to forskolin and linaclotide
other
Date unavailable · study · Temporal status not established
A pharmacovigilance study of the association between linaclotide/plecanatide and muscle spasms based on food and drug administration adverse event reporting system.
other
Date unavailable · study · Temporal status not established
Constipation-predominant irritable bowel syndrome treatment options Linaclotide, Lubiprostone, Plecanatide, and Tenapanor: analysis of the FDA Adverse Event Reporting System (FAERS) database.
other
Date unavailable · study · Temporal status not established
Clinical Study on the Application of Low-Dose 2L Lactulose Combined with Linaclotide in Bowel Preparation Before Colonoscopy
other
Date unavailable · study · Temporal status not established
Efficacy of linaclotide as adjunct for bowel preparation in patients with chronic constipation: a pre-specified analysis of the APPLE trial.
other
Date unavailable · study · Temporal status not established
Efficacy and safety of Guanylyl cyclase C agonists (linaclotide and plecanatide) in patients with irritable bowel syndrome with constipation: a systematic review and meta-analysis of randomized controlled trials.
other
Date unavailable · study · Temporal status not established
Efficacy and safety of linaclotide plus polyethylene glycol for bowel preparation before colonoscopy in elderly Chinese patients: a systematic review and meta-analysis.
other
Date unavailable · study · Temporal status not established
Efficacy of Polyethylene Glycol Electrolyte Powder Combined with Linaclotide for Bowel Preparation for Colonoscopy in Children with Functional Constipation.
other

The represented chronology reflects records currently included in the governed dataset and does not claim to represent the entire scientific literature.

What still needs investigation

Claim traceability

No institutional claim record is currently represented for this peptide.

Evidence is missing or not represented as studied; this is not a conclusion that the intervention does not work.

Connections

Follow the scientific relationships

Connections appear only when they are represented by the project’s underlying records.

Open 3 represented connections ↓

institution

peer_reviewed_research

represented evidence source

institution

other

represented evidence source

institution

systematic_review_or_meta_analysis

represented evidence source

Traceability

Follow the record back to its source

The experience makes incomplete links visible instead of presenting a false impression of perfect provenance.

Source publication state

A governed source may be verified and approved for publication while its claim-to-evidence link is still incomplete.

Reviewer provenance state

“Human scientist reviewed: no” means that specific source-path attribution is not recorded. It does not silently negate the separate publication-review state.

Domain conclusion → Evidence

Connected

Evidence → Source

Connected

Source → Original record

Connected

Traceability documents how the project connects statements to records. It does not establish that a source is scientifically valid or that a claim is clinically true.

Reconciled for 6 domain conclusions and 0 featured studies.

Detailed study-to-domain mappings and original-source paths appear in the Linaclotide evidence-governance section.

Inspect the ranked source records

Observational archive

What contributors reported

Observational archive data is intentionally separated from published scientific evidence.

Observational boundary

Insufficient eligible observations are available for display under the current filters.

Insufficient eligible observations are currently represented to display aggregated findings for this peptide.

Regulatory context

Published jurisdictional records

Regulatory status is jurisdiction-specific and time-dependent. It is presented as context, not as a recommendation for use or a substitute for scientific evidence evaluation.

European Union — EMA

Regulator: EMA

approved

As of: 9/23/2026 · Temporal status not established

European Medicines Agency: Constella (linaclotide)

United States — FDA

Regulator: FDA

approved

As of: 9/23/2026 · Temporal status not established

FDA LINZESS (linaclotide) prescribing information

Research + media

Media connected to this scientific record

Only media explicitly linked through the project’s relationship system appears here.

No scientifically connected media is currently represented for this peptide.

Sources + provenance

Read the scientific record with its boundaries intact

The public record organizes reviewed evidence; it does not establish scientific truth by itself.

Association, mechanism, observation and regulatory status must not be represented as proof of clinical efficacy or safety.

Observational reports describe contributor experiences and cannot establish causation, effectiveness, safety or clinical benefit.

Contradictory and qualifying evidence must remain visible rather than being silently discarded.

Absence of represented evidence is not evidence that research does not exist.

Research gaps identify unresolved questions; they are not negative conclusions.

Regulatory status is distinct from scientific evidence quality.

Media relationships provide context and explanation; they do not increase the strength of scientific evidence.

A section with no represented records is an incomplete project record, not a scientific conclusion.

Researcher and institutional relationships are shown only when supported by represented records and must not be interpreted as rankings or endorsements.

Generated: 11/8/2026, 5:24:48 PM

global evidence atlas

Linaclotide research, ranked and separated by purpose

This is a deduplicated literature screening registry—not a claim that every mention directly proves efficacy or safety. Machine proposals remain visibly separate from governed human appraisal.

514Discoverable source universe

500Ranked screening records

6Research domains

0Accountably approved conclusions

SearchDomainEvidence class

500 matching records · ranked 2026-09-18

Page 1 of 20

#1Proposed tier Unassignedhuman interventionalAwaiting human appraisal

A post hoc analysis of linaclotide in pediatric patients with functional constipation and neurodevelopmental disorders.

Europe PMC · 2026 · PMID 41913506 · DOI 10.1002/jpn3.70424

human-interventional

#2Proposed tier Unassignedpreclinical animalAwaiting human appraisal

A targeted partial reduction cyanylation strategy coupled with HRMS for accurate disulfide bridge mapping in disulfide rich cyclic peptides.

Europe PMC · 2026 · PMID 42242129 · DOI 10.1016/j.chroma.2026.467160

preclinical-animal

#3Proposed tier Unassignedhuman interventionalAwaiting human appraisal

Adjunctive linaclotide improves bowel cleansing and patient experience in polyethylene glycol-based bowel preparation.

Europe PMC · 2026 · PMID 42009975 · DOI 10.1038/s41598-026-49852-x

human-interventional

#4Proposed tier Unassignedhuman interventionalAwaiting human appraisal

Application of oral sulfate solution combined with linaclotide in bowel preparation for colonoscopy.

Europe PMC · 2026 · PMID 41889509 · DOI 10.3389/fmed.2026.1696298

human-interventional

#5Proposed tier Unassignedpreclinical animalAwaiting human appraisal

Bali Chronic Constipation Roundtable Report: Chronic Constipation Management in Asia.

Europe PMC · 2026 · PMID 41261564 · DOI 10.5056/jnm25076

preclinical-animal

#6Proposed tier UnassignedsynthesisAwaiting human appraisal

Comparing various bowel preparation regimens in constipated patients undergoing colonoscopy: A systematic review and network meta-analysis of randomised controlled trials.

Europe PMC · 2026 · PMID 41684308 · DOI 10.1111/codi.70399

synthesis

#7Proposed tier Unassignedpreclinical animalAwaiting human appraisal

Constipation with bloating: a clinical approach to evaluation and management.

Europe PMC · 2026 · PMID 42319080 · DOI 10.1080/07853890.2026.2684172

preclinical-animal

#8Proposed tier Unassignedpreclinical animalAwaiting human appraisal

Correction: Application of oral sulfate solution combined with linaclotide in bowel preparation for colonoscopy.

Europe PMC · 2026 · PMID 42465095 · DOI 10.3389/fmed.2026.1903499

preclinical-animal

#9Proposed tier Unassignedpreclinical animalAwaiting human appraisal

Cost-Effectiveness of the 15 Drugs Selected for Initial Price Applicability Year 2027 by Centers for Medicare and Medicaid Services Drug Price Negotiation Program.

Europe PMC · 2026 · PMID 40939703 · DOI 10.1016/j.jval.2025.08.019

preclinical-animal

#10Proposed tier Unassignedpreclinical animalAwaiting human appraisal

Cost-utility analysis of treatment strategies for chronic constipation in Japan.

Europe PMC · 2026 · PMID 41165844 · DOI 10.1007/s00535-025-02302-3

preclinical-animal

#11Proposed tier Unassignedhuman interventionalAwaiting human appraisal

Effect of 3-Day Linaclotide Administration to Reduce the Polyethylene Glycol Volume for Colonoscopy Bowel Preparation: A Multicenter, Noninferiority, Randomized Controlled Trial.

Europe PMC · 2026 · PMID 40423516 · DOI 10.14309/ajg.0000000000003557

human-interventional

#12Proposed tier Unassignedhuman interventionalAwaiting human appraisal

Effect of Age and Age-Defined Menopausal Status on Linaclotide Efficacy and Safety in Adults With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation: Post Hoc Analyses of Phase 2b/3 Studies.

Europe PMC · 2026 · PMID 42702764 · DOI 10.1111/nmo.70429

human-interventional

#13Proposed tier Unassignedhuman interventionalAwaiting human appraisal

Effect of Linaclotide on Colonic Motility Assessed With Intraluminal Colonic High-Resolution Manometry in Healthy Subjects. An Acute, Open Label, Randomized, Crossover, Reader-Blinded Study.

Europe PMC · 2026 · PMID 41413756 · DOI 10.1111/nmo.70222

human-interventional

#14Proposed tier Unassignedhuman interventionalAwaiting human appraisal

Effect of linaclotide combined with polyethylene glycol on bowel preparation before colonoscopy in patients with constipation.

Europe PMC · 2026 · PMID 41658593 · DOI 10.3389/fmed.2026.1686654

human-interventional

#15Proposed tier Unassignedhuman interventionalAwaiting human appraisal

Efficacy and Safety of Linaclotide in Pediatric Patients of Functional Constipation: A Meta-analysis of Randomized Controlled Trials.

Europe PMC · 2026 · PMID 42695347 · DOI 10.1177/10600280261479335

human-interventional

#16Proposed tier UnassignedsynthesisAwaiting human appraisal

Efficacy and safety of Guanylyl cyclase C agonists (linaclotide and plecanatide) in patients with irritable bowel syndrome with constipation: a systematic review and meta-analysis of randomized controlled trials.

Europe PMC · 2026 · PMID 42038325 · DOI 10.3389/fphar.2026.1761301

synthesis

#17Proposed tier UnassignedsynthesisAwaiting human appraisal

Efficacy and safety of linaclotide plus polyethylene glycol for bowel preparation before colonoscopy in elderly Chinese patients: a systematic review and meta-analysis.

Europe PMC · 2026 · PMID 42482900 · DOI 10.3389/fmed.2026.1833539

synthesis

#18Proposed tier Unassignedpreclinical animalAwaiting human appraisal

Efficacy of Polyethylene Glycol Electrolyte Powder Combined with Linaclotide for Bowel Preparation for Colonoscopy in Children with Functional Constipation.

Europe PMC · 2026 · PMID 41780967 · DOI 10.1620/tjem.2026.j007

preclinical-animal

#19Proposed tier Unassignedpreclinical animalAwaiting human appraisal

Efficacy of linaclotide as adjunct for bowel preparation in patients with chronic constipation: a pre-specified analysis of the APPLE trial.

Europe PMC · 2026 · PMID 42681900 · DOI 10.5946/ce.2026.214

preclinical-animal

#20Proposed tier UnassignedsynthesisAwaiting human appraisal

Efficacy safety of linaclotide combined with polyethylene glycol for bowel preparation in patients with constipation: a meta-analysis.

Europe PMC · 2026 · PMID 42523615 · DOI 10.3389/fgstr.2026.1694950

synthesis

#21Proposed tier Unassignedhuman interventionalAwaiting human appraisal

Evaluating linaclotide for the treatment of functional constipation in children and adolescents.

Europe PMC · 2026 · PMID 42083746 · DOI 10.1080/14656566.2026.2669339

human-interventional

#22Proposed tier Unassignedhuman interventionalAwaiting human appraisal

Evaluating linaclotide for the treatment of irritable bowel syndrome with constipation in children and adolescents.

Europe PMC · 2026 · PMID 42425925 · DOI 10.1080/14656566.2026.2702388

human-interventional

#23Proposed tier Unassignedpreclinical animalAwaiting human appraisal

From Epithelial Sensing to Visceral Pain: Neuropod and Enterochromaffin Cells in Gut Neuroepithelial Circuits.

Europe PMC · 2026 · PMID 42278633 · DOI 10.3390/ijms27115109

preclinical-animal

#24Proposed tier Unassignedpreclinical animalAwaiting human appraisal

Identification and Quantification of Structurally Related Peptide Impurity in Linaclotide by Liquid Chromatography-High Resolution Mass Spectrometry.

Europe PMC · 2026 · PMID 41539984 · DOI 10.1002/rcm.70030

preclinical-animal

#25Proposed tier Unassignedpreclinical animalAwaiting human appraisal

Irritable Bowel Syndrome with Constipation: Diagnosis and Multisymptom Management Beyond Abdominal Pain and Bowel Movement Frequency: A Review.

Europe PMC · 2026 · PMID 42283961 · DOI 10.1007/s12325-026-03645-w

preclinical-animal

Count reconciliation: 514 discoverable source records match the peptide identity query; 500 are retained in this bounded, ranked screening view; 0 belong to the separate governed layer labeled “Accountably approved conclusions.” Domain totals overlap because one publication may inform several questions.

governance and regulatory context

Linaclotide: what this atlas does and does not establish

Last checked: 2026-09-18
Accountable publication approval: Not yet approved by a named accountable reviewer. Machine screening only.

No new outcome conclusion is inferred from discovery metadata. Named accountable approval is required for governed scientific conclusions.

1 FDA structured product label record(s) were identified for this compound name in openFDA. Label presence reflects an approved product exists under that name; it is not a claim about the specific formulation, dose, or use being discussed anywhere else on this page.

No machine-proposed evidence-strength grades exist yet for this compound; all screening records are unassigned pending further review.

Linaclotide evidence · ranking key

How evidence is ranked

A tier describes the evidentiary role and design strength of a source. It is not a popularity score, proof that every conclusion is correct, or a substitute for claim-level review.

Practice-defining evidence

Large, well-conducted randomized trials; prespecified major outcomes; rigorous systematic reviews or meta-analyses; and major regulatory assessments.

Strong supporting evidence

Smaller randomized trials, strong prospective cohorts, prespecified secondary analyses, and high-quality comparative-effectiveness studies.

Contextual evidence

Retrospective cohorts, claims-database studies, pharmacovigilance analyses, mechanistic human research, and well-documented case series.

Signal-generating evidence

Case reports, conference abstracts, preclinical research, hypothesis-generating analyses, and expert commentary.

Tier and confidence answer different questions

Tier classifies source design and evidentiary role. Confidence reflects risk of bias, sample size, comparator quality, outcome relevance, follow-up, missing data, directness, replication, reporting quality, and whether conclusions stay within the measured results.

Funding and conflicts are disclosed and considered, but sponsorship never automatically changes a tier. Corrections, retractions, and expressions of concern override the original rating.

Suggested citation

APA
World Peptide Foundation. (n.d.). Linaclotide — Peptide Scientific Intelligence. World Peptide Foundation. (Updated September 26, 2026.) https://www.worldpeptidefoundation.org/directory/linaclotide
AMA / Vancouver
World Peptide Foundation. Linaclotide — Peptide Scientific Intelligence. World Peptide Foundation website. Updated September 26, 2026. https://www.worldpeptidefoundation.org/directory/linaclotide