Melanotan-1 — questions, answered plainly.

Melanotan-1 (afamelanotide) is a synthetic 13-residue analogue of α-melanocyte-stimulating hormone (α-MSH) with two stabilising substitutions (Nle⁴ and D-Phe⁷). It is FDA-approved as Scenesse for erythropoietic protoporphyria phototoxicity prevention.

FDA approval (2019) is for the prevention of phototoxicity in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP). EU approval (under the same Scenesse brand) preceded the US approval. No other indications are approved.

Langendonk et al. 2015 (NEJM, PMID 26132941; n=168 across two trials, 74 EU + 94 US) reported that subcutaneous afamelanotide implants were associated with increased pain-free sun exposure duration and improved quality of life in adults with EPP.

The approved product (Scenesse) is supplied as a controlled-release subcutaneous implant administered only by Clinuvel-authorised healthcare professionals. Self-injection from unregulated sources is not equivalent to the approved product.

The compound is sometimes promoted in unregulated channels as a cosmetic tanning agent. This off-label use is not endorsed here and is associated with adverse events documented in the dermatology literature. Approval is restricted to EPP phototoxicity prevention.

FDA approval is indication-specific (EPP only). Synthetic Melanotan-1 sold through unregulated channels is not equivalent to the approved Scenesse implant and may carry purity, dose, and contamination risks.