Melanotan I

What is melanotan I?

Melanotan I is afamelanotide, a synthetic 13-amino-acid analog of alpha-melanocyte-stimulating hormone that darkens skin by activating the melanocortin 1 receptor.

University of Arizona researchers, including Hadley and Dorr, designed melanotan I and melanotan II as long-acting, enzyme-resistant melanocortin analogs; melanotan I is the linear one and was tested for skin tanning (Peptides, 2006). A 1997 University of Arizona study described it as [Nle4, D-Phe7]-alpha-MSH and recorded tanning of the forehead, arms and neck in three male volunteers that persisted three weeks after dosing ended (Biopharmaceutics & Drug Disposition, 1997). The FDA label for afamelanotide gives the same sequence.

The main human evidence is for erythropoietic protoporphyria (EPP), a rare genetic disorder that causes severe pain after light exposure. Two randomized, placebo-controlled trials of an afamelanotide implant, with 74 patients in the European Union and 94 in the United States, found longer pain-free time in direct sunlight than placebo (New England Journal of Medicine, 2015).

Is melanotan I FDA-approved?

Afamelanotide is FDA-approved only as Scenesse, an implant approved on October 8, 2019, for adults with erythropoietic protoporphyria; injectable melanotan I vials are not.

Scenesse (NDA 210797, Clinuvel) is a bioresorbable rod placed under the skin by a trained health care professional. Its label indication is to increase pain-free light exposure in adults with a history of phototoxic reactions from EPP; it has no tanning or cosmetic indication. The European Commission authorized Scenesse on December 22, 2014, under exceptional circumstances (EMA). Research-market melanotan I is sold as vials of powder, outside both approvals.

The Scenesse label warns of serious hypersensitivity reactions, including anaphylaxis, and darkening of existing moles and freckles, and recommends a full-body skin exam twice a year (DailyMed). A research vial adds a question no label answers. Melanotan II is a different, cyclic molecule that FDA lists among compounding safety risks, citing case reports that include melanoma (FDA). The two names are one numeral apart, and only an identity test tells them apart in a vial.

Before trusting any melanotan I label, check that batch’s published result in our latest tests or in Janoshik's public results database. No results are published for melanotan I yet in our index. When the first published result arrives, a vendor leaderboard appears above.

Dosing math: use the free peptide calculator to work out reconstitution and syringe units — then check your vial’s published batch result before relying on the label.