Melanotan and the Approved Drug It Is Not

There is an approved melanocortin‑1 receptor agonist. It is called afamelanotide, it went through phase 3 trials, and it is approved in the EU and, since October 2019, in the US^[2] for one thing: preventing phototoxicity in adults with erythropoietic protoporphyria, a rare disorder in which sunlight causes pain. It is given as a biodegradable controlled-release implant containing 16 mg, under medical supervision.^[1] Melanotan II sold online for cosmetic tanning is not that drug, and the difference is the whole point.

What the approved one is for

Erythropoietic protoporphyria is a genetic condition in which exposure to light causes burning pain. In the phase 3 trial CUV039, afamelanotide improved light tolerance: patients spent more time in direct sunlight without pain, and it took longer for the first symptoms of phototoxicity to appear under a standardized light source. It was generally well tolerated, with no drug-related serious adverse events reported; common reactions were headache and implant-site reactions.^[1]

Look closely at that indication. The drug is approved to let people with a painful genetic photosensitivity disorder go outside. It is not approved to make anyone browner, and the trials measured pain-free time in sunlight, not appearance.

The four differences that matter

What we are not claiming, and why

Melanotan is frequently discussed in connection with changing moles and with melanoma. There is published case-report literature on that association. The most-cited example has no abstract we could read, only a title and errata. We did not verify those case details, so we are not building a claim on them.

What can be said without that literature is enough to act on. A compound that stimulates melanocytes, taken at an unmeasured dose, without supervision, for a cosmetic purpose, by people who are by definition seeking more pigment change than their skin produces on its own, is not a situation in which anyone is monitoring their moles. That is a reason for caution regardless of what any individual case report says.

• Melanotan is not approved anywhere for cosmetic tanning.
• Products sold under the name are research chemicals with no identity, purity or dose guarantee.
• The existence of an approved melanocortin agonist for a rare photosensitivity disorder is not evidence for an unapproved analog used cosmetically.
• Any new, changing or asymmetric mole is worth showing to a doctor, and more so if you are using something that acts on melanocytes.

Bremelanotide (PT-141), a melanotan II analog, did become an approved drug, for one narrow use; see what the PT-141 evidence shows. For the regulatory position on research-use peptides generally, see what FDA actually said about BPC-157. Full profiles of individual peptides are at /peptides.