Melanotan I (afamelanotide) regulatory status
Current status of Melanotan I (afamelanotide) in the United States: FDA approved. In sport: Not WADA prohibited. Details, sources, and the dated timeline follow.
By the PeptideAgent Editorial Team. Draft, pending editorial review. Last verified
What is the current status of Melanotan I (afamelanotide)?
- FDA and compounding
- FDA approved as Scenesse (afamelanotide) implant on October 8, 2019, for adults with a history of phototoxic reactions from erythropoietic protoporphyria; the European Medicines Agency approved it in 2014. It is dispensed only through certified specialist centers because insertion requires training. Afamelanotide is not on any 503A or 503B bulks list; as the active ingredient of an approved drug it could in principle be compounded in another dosage form, but injectable Melanotan I sold online for tanning is not a compounded prescription product and is marketed unlawfully.
- WADA
- Not WADA prohibited
- Access path
- Prescription from a specialist in erythropoietic protoporphyria at a certified treatment center (Scenesse implant).
- Not available for tanning or cosmetic use through any licensed channel.
- Products sold online as Melanotan I injections are not lawful for human use and are not verified for purity.
Full Melanotan I (afamelanotide) page: evidence, dosing in the literature, and sources
How has the status of Melanotan I (afamelanotide) changed over time?
- FDA
FDA approves Scenesse (afamelanotide) for erythropoietic protoporphyria
FDA approved afamelanotide implant (Scenesse) to increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria. Afamelanotide is the only approved melanotan-class peptide.
Regulatory: FDA approvedSource: Drugs@FDA: Scenesse (afamelanotide) NDA 210797
Sources
Numbered citations in the answers above point here, followed by the regulatory sources on record for Melanotan I (afamelanotide) and the source of each dated event.
- [1]FDA prescribing information for Scenesse (afamelanotide) implant, via DailyMedFDA, 2026
- [2]FDA: Compounding and the FDA, questions and answersFDA, 2026
- [3]FDA: Certain bulk drug substances for use in compounding that may present significant safety risks (Category 2 list and withdrawn nominations, current as of April 22, 2026)FDA, 2026
- [4]WADA Prohibited ListWADA, 2026
- [5]Drugs@FDA: Scenesse (afamelanotide) NDA 210797FDA, 2019
From the blog
- Melanotan 1 before and after: what the afamelanotide trials measured
Melanotan 1 is afamelanotide, approved only as an implant for a rare light sensitivity disease. What the tanning and approval trials measured, what happens to moles, and why tanning use is unapproved.