DermatologyFDA Approved

Afamelanotide (Scenesse)

Overview

A synthetic 13-amino acid analog of alpha-melanocyte-stimulating hormone (alpha-MSH) with a substitution of norleucine at position 4 that confers enhanced potency and enzymatic stability. Afamelanotide activates melanocortin-1 receptors (MC1R) on melanocytes, stimulating eumelanin production independent of UV exposure. The resulting increase in skin eumelanin provides photoprotection by absorbing UV radiation and scavenging reactive oxygen species.

Key Research Findings

FDA-approved in 2019 for prevention of phototoxicity in adults with erythropoietic protoporphyria (EPP). Phase 3 trial demonstrated significantly more time spent in direct sunlight without phototoxic reactions vs. placebo (Langendonk et al., NEJM, 2015). Administered as a subcutaneous biodegradable implant every 2 months. Represents the first and only FDA-approved treatment for EPP. Also being investigated for vitiligo and other photodermatoses.

Route of Administration

Subcutaneous implant

Regulatory Status

FDA Approved

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