Melanotan I

Investigated uses

• Erythropoietic protoporphyria with an approved implant; photoprotection in controlled trials.

Mechanism and hypotheses

• Afamelanotide is an alpha-melanocyte-stimulating-hormone analogue that activates melanocortin-1 receptors and increases eumelanin production in the skin.
• Hypothesized: Photoprotection evidence from a controlled-release implant cannot establish the pharmacology, exposure or safety of a reconstituted gray-market “Melanotan-1” vial.

Human evidence

• Randomized trials in erythropoietic protoporphyria supported afamelanotide implant approval by increasing pain-free light exposure. Limitations: Implant-specific pharmacokinetics and professional administration; not evidence for a reconstituted vial.

Safety highlights

• Headache, implant-site reactions, nausea and hyperpigmentation-related effects are described with Scenesse.
• Serious hypersensitivity, including anaphylaxis, has been reported postmarketing.

Regulatory context

Scenesse is FDA-approved as an afamelanotide implant; no FDA approval was identified for a lyophilized “Melanotan-1” vial.