DermatologyFDA Approved

Afamelanotide (Scenesse)

Subcutaneous implant

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.

Mechanism of Action

The resulting increase in skin eumelanin provides photoprotection by absorbing UV radiation and scavenging reactive oxygen species..

Research Summary & Key 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.

Clinical Status

FDA Approved

Afamelanotide (Scenesse) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.

Administration Routes

Subcutaneous implant

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Disclaimer: This information is provided for educational and research purposes only. It is not intended as medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before starting any peptide therapy. The Peptide Association does not endorse or recommend any specific treatment protocol.