Melanotan-1

The name Melanotan-1 is commonly associated with afamelanotide, a synthetic alpha-MSH analogue. The clinical and regulatory evidence here concerns the specified Scenesse implant or research-grade afamelanotide used in named studies. A preparation marketed under the Melanotan-1 name is not thereby the regulated medicine.

Adult EPP evidence

One 2015 publication reports two distinct randomized trials of the afamelanotide implant in erythropoietic protoporphyria (EPP): 94 participants in the US and 74 in Europe. The US trial found a median 69.4 pain-free hours of direct sunlight over 180 days versus 40.8 with placebo. The European trial found 6.0 versus 0.8 hours over 270 days, with fewer phototoxic reactions. These endpoints concern light exposure in EPP, not cosmetic tanning. Langendonk et al., PMID 26132941

A German post-authorisation cohort reports outcomes among 200 treated patients but includes no untreated comparison group. A separate Austrian cohort of 20 treated patients reported improved patient-reported light tolerance and quality of life compared with baseline. Selection, follow-up, and measurement differences limit causal interpretation of both cohorts; they do not add another randomized trial. German cohort, PMID 40082741 · Austrian cohort, PMID 41793078

Approval is product- and indication-specific

The FDA lists Scenesse marketing approval on 8 October 2019 to increase pain-free light exposure in adults with a history of phototoxic reactions from EPP. Its label describes an afamelanotide implant administered by a trained healthcare professional. The EMA describes its authorisation as prevention of phototoxicity in adults with EPP. Neither record approves a cosmetic tanning product or establishes that other formulations are equivalent. FDA orphan product record · current US label, DailyMed SPL v11 · EMA product record

The current US Scenesse implant label warns of serious hypersensitivity, including anaphylaxis, and recommends twice-yearly full-body skin examinations to monitor pre-existing and new pigmentary lesions because existing nevi and freckles may darken. These warnings concern the regulated implant used for the adult EPP indication; they do not establish the safety or identity of products sold as Melanotan-1. Current US Scenesse label

Other research and limits

A small randomized vitiligo trial compared afamelanotide implant plus narrowband UV-B with narrowband UV-B alone in 55 adults with selected skin phototypes. Repigmentation outcomes favored the combination in that study, but this does not establish an approved vitiligo indication or a benefit from afamelanotide alone. Lim et al., PMID 25230094

Melanotan-II is a different analogue; its evidence cannot be transferred to afamelanotide. A seller’s name or claim cannot establish identity, formulation, sterility, or equivalence to Scenesse. This dossier does not provide dosing, purchasing, or self-treatment guidance and is not medical advice.