Melanotan 1 is the research name for afamelanotide, a 13 amino acid version of alpha-MSH, the hormone that tells skin cells to produce melanin. Sold as Scenesse, it has been FDA approved since October 2019.
It is worth understanding how it differs from Melanotan 2, which is far more commonly discussed online. Melanotan 1 is selective. It mainly acts on the MC1 receptor, the one controlling pigment. Melanotan 2 is much less selective and hits several melanocortin receptors, which is why it produces the extra effects it is known for, including nausea, appetite suppression, and sexual arousal.
That selectivity is why Melanotan 1 became an approved medicine and Melanotan 2 did not.
Its approved use is narrow and has nothing to do with cosmetic tanning. It treats erythropoietic protoporphyria, a rare inherited condition in which sunlight causes severe pain within minutes. Increased melanin gives those patients protection they cannot otherwise get.
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Afamelanotide reached approval through the ordinary route: clinical trials in a defined patient group showing a measurable benefit.
In erythropoietic protoporphyria, sunlight triggers severe burning pain within minutes of exposure, and there was no effective treatment before this. Trials showed patients could tolerate meaningfully more time in daylight, which for that group is a large change in daily life. The FDA approved it in October 2019 and European regulators had approved it earlier.
The mechanism is straightforward and not in dispute. Activating MC1 receptors increases eumelanin production, and eumelanin absorbs ultraviolet light.
The important gap is that none of this evidence addresses cosmetic use. The trials studied people with a rare light sensitivity disorder using a clinician-placed implant. They did not study healthy adults injecting it to tan, which is how the peptide is mostly used outside medicine. The safety record that supports the approval does not automatically transfer to that use, especially since increasing pigment does not remove ultraviolet damage risk or the need to watch for skin cancer.