Database→Afamelanotide

Tier 1SkinAnti-inflammatoryImmunePREMIUM

Afamelanotide

Afamelanotide (SCENESSE) · [Nle4-D-Phe7]-alpha-MSH · Melanotan I · Selective MC1R Agonist

FDA approved October 2019 (Priority Review, Orphan Drug designation) for erythropoietic protoporphyria (EPP) in adults. EMA approved 2014 (predating FDA). First-in-class designation. September 2025 EMA label update: year-round dosing approved, removing the recommended annual cap of four implants. Clinuvel Pharmaceuticals. Marketed as SCENESSE (afamelanotide 16 mg subcutaneous implant).

For research and educational purposes only · Not medical advice · Consult a qualified physician before any human use

Profile Overview

Afamelanotide (SCENESSE) is the first FDA-approved alpha-MSH analogue, indicated for increasing pain-free light exposure in adults with erythropoietic protoporphyria (EPP). A selective MC1R agonist delivered as a subcutaneous bioresorbable implant every two months, it stimulates eumelanin production without UV-induced cellular damage. Two Phase 3 RCTs (n=244 pooled) demonstrated 56% more pain-free sunlight hours and an 8-fold difference in outdoor pain-free time versus placebo. A Phase 3 vitiligo trial (CUV105, n=200 fully enrolled) has topline results expected second half 2026.

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Full Profile: Premium Members Only

The complete Afamelanotide profile includes all use cases with full evidence reviews, mechanism of action deep dive, safety analysis, evidence table, dosing guidance, and stack compatibility data.

For research and educational purposes only · Not medical advice · Consult a qualified physician before any human use