Afamelanotide

Overview

Afamelanotide is a melanocortin peptide analog. The research record considers pigmentation biology and clinical outcomes in erythropoietic protoporphyria, alongside distinct exploratory questions such as UV responses and vitiligo. These settings should be kept separate.

Evidence quality

WPF’s existing research atlas lists work on light tolerance and quality of life in erythropoietic protoporphyria, including observational reports, alongside an exploratory study of UV responses in healthy volunteers and reviews of other skin conditions. Study titles and machine-proposed rankings are discovery aids; they are not a claim that every listed use has demonstrated benefit.

Safety concerns

Observational results, case reports, and exploratory studies cannot substitute for controlled evidence, and a finding in one condition or age group must not be generalized to another.

Citations as of this version

• A Feasibility and Safety Study of Afamelanotide in Acute Stroke Patients – An Open Label, Proof of Concept, Phase Iia Clinical Trial
• PD03 Afamelanotide reduces the ultraviolet radiation erythemal response soon after application in healthy volunteers with skin phototypes II–III
• Afamelanotide Is Associated with Dose-Dependent Protective Effect from Liver Damage Related to Erythropoietic Protoporphyria.
• Clinical Experience with Afamelanotide for the Protoporphyrias in the United States
• Cryo-EM structure of afamelanotide-MC4R-Gs_Nb35 complex
• From darkness to light: Case report on afamelanotide-treatment in a 9-year-old child with erythropoietic protoporphyria.
• Afamelanotide in managing cutaneous phototoxicity in erythropoietic protoporphyria: a Scottish perspective.
• EMA , It's Time to Reconsider! 10 Years Afamelanotide for Treating Erythropoietic Protoporphyria
• 461 The effects of afamelanotide on UVR-induced DNA damage, acute inflammatory and DNA repair responses in human skin
• PD05 The effects of afamelanotide on ultraviolet radiation-induced acute inflammatory and DNA repair responses in healthy human skin
• 04111 Phlebotomy and afamelanotide as an efficient combined treatment of hepatoerythropoietic porphyria
• 04121 Afamelanotide for the treatment of cutaneous phototoxicity of erythropoietic protoporphyria: the Scottish experience
• Acute impact of afamelanotide on UVR erythemal and melanogenic responses in healthy humans in vivo: an exploratory study. (2026)
• Investigation of the stability profile of therapeutic α-MSH analogue: Insights from liquid chromatography-high resolution mass spectrometry analysis of afamelanotide. (2026)
• Afamelanotide improves quality of life and light tolerance in Austrian erythropoietic protoporphyria patients. (2026)
• German Cohort Observational Study to Investigate the Short- and Long-Term Safety and Clinical Effectiveness of Afamelanotide 16 mg (SCENESSE) in Patients With Erythropoietic Protoporphyria (EPP). (2025)
• The effects of cholecalciferol and afamelanotide on vitamin D levels in erythropoietic protoporphyria: a multicentre cohort study. (2024)
• Vitamin D status in patients with erythropoietic protoporphyria taking the systemic photoprotective agent afamelanotide. (2024)
• Erythropoietic protoporphyria and afamelanotide: a patient's perspective. (2024)
• Afamelanotide for Treatment of the Protoporphyrias: Impact on Quality of Life and Laboratory Parameters in a US Cohort. (2024)
• Afamelanotide in protoporphyria and other skin diseases: a review. (2024)
• Into the Light: Afamelanotide and the Treatment of Erythropoietic Protoporphyria in the United States. (2023)
• Erythropoietic protoporphyria in the Netherlands: Clinical features, psychosocial impact and the effect of afamelanotide. (2023)
• Association of quality of life measures with afamelanotide treatment in patients with erythropoietic protoporphyria and x-linked protoporphyria: A retrospective cohort study. (2023)
• A feasibility and safety study of afamelanotide in acute stroke patients - an open label, proof of concept, phase iia clinical trial. (2023)
• Clinical and dermoscopic changes of acquired melanocytic nevi of patients treated with afamelanotide. (2021)
• Afamelanotide: An Orphan Drug with Potential for Broad Dermatologic Applications. (2021)
• Afamelanotide for prevention of phototoxicity in erythropoietic protoporphyria. (2021)
• [Medicaments and oral healthcare. Hyperpigmentation of oral soft tissues due to afamelanotide]. (2020)
• Increased phototoxic burn tolerance time and quality of life in patients with erythropoietic protoporphyria treated with afamelanotide - a three years observational study. (2020)
• Afamelanotide implants and narrow-band ultraviolet B phototherapy for the treatment of nonsegmental vitiligo in Asians. (2020)
• Association of Afamelanotide With Improved Outcomes in Patients With Erythropoietic Protoporphyria in Clinical Practice. (2020)
• Pharmacokinetics and Pharmacodynamics of Afamelanotide and its Clinical Use in Treating Dermatologic Disorders. (2017)
• Afamelanotide: A Review in Erythropoietic Protoporphyria. (2016)
• Afamelanotide (CUV1647) in dermal phototoxicity of erythropoietic protoporphyria. (2015)
• Afamelanotide for Erythropoietic Protoporphyria. (2015)
• Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial. (2015)
• Evaluation of the immunogenicity of the synthetic α-melanocyte-stimulating hormone (α-MSH) analogue afamelanotide ([Nle4-D-Phe7]-α-MSH, Scenesse®) in erythropoietic protoporphyria patients by ELISA detecting both anti-afamelanotide and anti-α-MSH antibodies. (2015)
• Long-term observational study of afamelanotide in 115 patients with erythropoietic protoporphyria. (2015)
• The efficacy of afamelanotide and narrowband UV-B phototherapy for repigmentation of vitiligo. (2013)
• A review and update on melanocyte stimulating hormone therapy: afamelanotide. (2013)
• A bioassay for the detection of neutralizing antibodies against the α-melanocyte stimulating hormone analog afamelanotide in patients with erythropoietic protoporphyria. (2013)
• Afamelanotide (2012)
• Pseudoleucoderma after injections of afamelanotide in a patient with atopic dermatitis. (2011)
• Afamelanotide, an agonistic analog of α-melanocyte-stimulating hormone, in dermal phototoxicity of erythropoietic protoporphyria. (2010)

Regulatory status as of this version

• European Union — EMA: approved — Scenesse (afamelanotide) is indicated for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).
• United States — FDA: approved — SCENESSE (afamelanotide) is indicated to increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).