Dermatology · FDA Approved
Afamelanotide (Scenesse)
FDA-approved
01 · Overview
A synthetic 13-amino acid analog of alpha-melanocyte-stimulating hormone (alpha-MSH), [Nle4-D-Phe7]-alpha-MSH, with norleucine at position 4 and D-phenylalanine at position 7 (PMID 25402764). Afamelanotide activates melanocortin-1 receptors (MC1R) and can stimulate eumelanin production without exposure to UV radiation (PMID 33507118).
The resulting increase in skin eumelanin is intended to provide photoprotection.
02 · Research summary & key findings
FDA-approved in October 2019 (Scenesse) for adults with erythropoietic protoporphyria (EPP) (PMID 31796929). Two randomized placebo-controlled trials of the subcutaneous implant given every 60 days found longer pain-free time in direct sunlight, fewer phototoxic reactions in the EU study, and improved quality of life (Langendonk et al., NEJM, 2015) (PMID 26132941). Described as the first effective approved medical treatment for EPP; common adverse events were headache, fatigue, and nausea (PMID 33507118). In a randomized trial in vitiligo, adding afamelanotide to narrowband UV-B gave faster and greater repigmentation than UV-B alone, mainly in darker skin types (PMID 25230094).
03 · Regulatory status
Afamelanotide (Scenesse) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.
Afamelanotide (Scenesse) is an FDA-approved medicine prescribed for the conditions on its label. It is not part of our intake, so we do not propose protocols for it. If you think it may be relevant to you, talk to your own doctor. How to ask your doctor.
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04 · Administration routes
- Subcutaneous implant
References
- [1]Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial JAMA Dermatol, 2015. PMID 25230094
- [2]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 Skin Pharmacol Physiol, 2015. PMID 25402764
- [3]Afamelanotide for Erythropoietic Protoporphyria N Engl J Med, 2015. PMID 26132941
- [4]Patients with porphyria bask in sunlight of FDA approval Nat Biotechnol, 2019. PMID 31796929
- [5]Afamelanotide for prevention of phototoxicity in erythropoietic protoporphyria Expert Rev Clin Pharmacol, 2021. PMID 33507118
Primary literature
- PubMed: "Afamelanotide"
Peer-reviewed literature indexed by the National Library of Medicine.
- ClinicalTrials.gov: "Afamelanotide"
Registered interventional and observational studies, including status and phase.
- PubChem: "Afamelanotide"
Chemical structure, molecular properties, and bioactivity data.
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