Melanotan I
Afamelanotide (Melanotan I)
Also known as: Afamelanotide, Scenesse
An FDA-approved melanocortin agonist that increases skin pigmentation to protect people with a rare light-sensitivity disorder.
Overview
Melanotan I, or afamelanotide, is a melanocortin receptor agonist approved by the FDA in 2019 as Scenesse. It is used to increase pain-free light exposure in adults with erythropoietic protoporphyria, a rare inherited condition of severe skin light sensitivity, by stimulating protective pigmentation. Unlike the unapproved Melanotan II, it is a licensed medicine for this specific indication.
Mechanism of action
Agonizes the melanocortin-1 receptor to stimulate eumelanin production, increasing photoprotective skin pigmentation.
Key studies & citations
- Human2015
Afamelanotide for erythropoietic protoporphyria
Two RCTs (74 EU and 94 US patients): pain-free sun exposure was longer with afamelanotide implants (US median 69.4 vs 40.8 hours; EU 6.0 vs 0.8 hours) with fewer phototoxic reactions.
New England Journal of Medicine - Human2024
Scenesse (afamelanotide) implant: prescribing information
FDA-approved label (original approval October 2019): 16 mg implant to increase pain-free light exposure in adults with a history of phototoxic reactions from EPP.
U.S. FDA (Drugs@FDA label)
Frequently asked questions
Is Melanotan I the same as Melanotan II?
No. Melanotan I (afamelanotide) is an approved medicine for a rare light-sensitivity disorder. Melanotan II is unapproved and flagged by regulators for tanning and libido use.