Afamelanotide vs Melanotan I
An implant that lets people with a rare sun-pain disease stay in daylight longer. Trials in 168 adults show it works for that, but none show it works for tanning. Sold as a safe way to tan without sun. It darkened skin in a 65-person trial. The approved version is a different product for a rare sun-pain disease.
Afamelanotide has the stronger evidence, grade A (strong human evidence) against grade B for Melanotan I. Afamelanotide: FDA approved. Melanotan I: Not approved.
Evidence
AStrong human evidence
BSome human evidence
Human studies cited
Animal or cell studies cited
Why the grade
Two randomized, double-blind, placebo-controlled trials in 168 adults with EPP (94 in the United States, 74 in the European Union) showed more pain-free hours in sunlight, and a 117-patient post-authorisation cohort followed for about two years confirmed the effect in routine practice. Consensus guidelines recommend it for preventing phototoxic symptoms. The evidence is strong for EPP and nonexistent for the tanning use the compound is also known for.
For the tanning use it is sold for, the evidence is one placebo-controlled trial in 65 fair-skinned volunteers that measured melanin density and UV damage markers, a surrogate for sunburn protection. The approved use in erythropoietic protoporphyria rests on two randomized placebo-controlled trials totaling 168 patients. The tanning use has one trial with surrogate endpoints, which is B; no trial has tested cosmetic tanning in the general population or compared it with sunscreen.
FDA
FDA approved
Afamelanotide is FDA-approved and sold as Scenesse, a subcutaneous implant, approved in October 2019 to increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria (EPP). The European Medicines Agency authorised it for the same disease in 2014.
Not approved
Melanotan I is the same molecule as afamelanotide, which the FDA approved in 2019 as the Scenesse implant for adults with erythropoietic protoporphyria. Injectable 'Melanotan I' sold online for tanning is not approved by the FDA for any use and is sold as a research chemical.
Sold for
Afamelanotide is best known as the first drug for EPP, a rare disease in which sunlight causes burning pain, and in its earlier life as a candidate 'sunless tan' because it darkens skin.
Melanotan I is sold as the 'safer' tanning peptide, the one that became a real drug, promising a tan without sun and protection against burning.
Studies say
Randomized trials show it lengthens the time EPP patients can spend in sunlight without pain, which earns grade A for that indication; there are no trials supporting cosmetic tanning.
A 65-person placebo-controlled trial showed more melanin and less UV damage in fair skin, and two trials in 168 porphyria patients led to approval of the implant, so the evidence is grade B for tanning and the approved product is a different formulation for a rare disease.
Class
MC1R agonist
MC1R agonist
Route
Implant
Injection