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ApprovedMelanocortin agonist

Afamelanotide

Scenesse, Melanotan-1, MT-1, NDP-alpha-MSH

The approved melanotan. Same family as the tanning peptide people buy from research suppliers, but with an FDA approval, an implant, and a rare disease indication.

FDA-approved

FDA-approved in October 2019 as Scenesse, to increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria. Granted priority review and orphan drug designation. No approval for cosmetic tanning.

What it is

Afamelanotide is a synthetic tridecapeptide analogue of alpha-melanocyte stimulating hormone. It binds predominantly to the MC1 receptor, which drives melanin production in the skin.

It is, chemically, melanotan-1. The compound people buy as melanotan-2 is a different, shorter, less selective molecule from the same family. That difference in selectivity is most of the reason one of these has an FDA approval and the other has case reports.

What it is actually approved for

Erythropoietic protoporphyria, a rare inherited disorder in which sunlight causes severe burning pain within minutes of exposure. Before 2019 there was no approved treatment to extend the time these patients could spend in light.

The approved use is not cosmetic. The pigmentation that afamelanotide produces is the therapeutic mechanism: more melanin absorbs more light before it reaches the protoporphyrin that causes the reaction. Tanning is the point, but the endpoint is pain-free minutes outdoors, not appearance.

Why the delivery method matters

Scenesse is a 16 mg implant placed under the skin above the hip by a clinician, every two months. It is not a vial and syringe.

That design is deliberate. It gives controlled release over the exposure season, and it keeps dosing under clinical supervision, including the twice-yearly full body skin examination the label requires. A melanocortin agonist that stimulates melanocytes indefinitely is a drug you want someone looking at moles for.

The contrast with the grey market version is stark. Melanotan-2 is self-injected daily, at doses nobody established, by people with no dermatological monitoring, for appearance. Same receptor family, entirely different risk structure.

Practical notes

  • This is not obtainable as a research chemical, and material sold as melanotan-1 is not Scenesse. An implant manufactured for an orphan indication and a lyophilised vial from an unregulated supplier share a molecule and nothing else.
  • Skin surveillance is part of the treatment. The label calls for full body examination twice a year. Any melanocortin agonist warrants that, and the approved product is the only one where it is built into the protocol.
  • The approval is narrow on purpose. EPP affects a very small population with a severe, well-defined problem. That is what orphan designation is for, and it does not generalise into evidence for cosmetic use.

Side effects and warning signs

Commonly reported

  • Skin darkening, which is the pharmacology rather than a side effect
  • Implant-site reactions
  • Nausea
  • Headache
  • Fatigue

Stop and get medical help

  • Any new or changing pigmented lesion. Full body skin examination twice yearly is part of the approved labelling, not an optional extra
  • Signs of hepatic impairment, since the drug has not been studied in that population

Sources

  1. FDA prescribing information, SCENESSE (afamelanotide) implantregulatory
  2. FDA approval letter, NDA 210797, October 2019regulatory

From the community

Discussion for this compound concentrates in r/Peptides.

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