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For information & educational purposes only — not medical advice, no dosing or usage recommendation.

Machine-assisted translation — the German original version is authoritative.

Melanocortin System

Melanocortin System

Melanotan I (Afamelanotid)

Afamelanotid · Scenesse · MT-1 · Melanotan-1

Prescription

"Melanotan I" is afamelanotide — an α-MSH analogue that selectively activates the MC1R and stimulates the formation of eumelanin. As a controlled-release implant under the name Scenesse it is approved (EMA 2014, FDA 2019) — but exclusively for the prevention of phototoxicity in erythropoietic protoporphyria (EPP), a rare intolerance to light. The product sold on the gray market as a "melanotan 1" tanning vial is not this tested implant.

Regulatory status

Approved · prescription-only

Approved as Scenesse for EPP (EMA and FDA) — no approval as a tanning agent.

Drug class

Selective α-MSH/MC1R analogue (afamelanotide)

Half-life (informative)

As a depot implant, released over several days.

Studied in the literature

As a subcutaneous implant, applied by a physician, in the approved EPP indication.

Mechanism of action

Melanotan I (Afamelanotid)

Afamelanotide selectively activates the MC1R and increases eumelanin synthesis, which protects the skin from light damage. It is more selective than melanotan II and therefore triggers fewer MC3R/MC4R effects (such as priapism).

The approval concerns a rare disease, not cosmetic tanning.

Research history

Afamelanotide stems from the same melanocortin research as melanotan II and was developed by Clinuvel as a controlled-release implant (Scenesse). EMA approval in 2014, FDA approval in 2019 — in each case for EPP.

Regulatory status by region

EU·EMA-approved (Scenesse, 2014)

Approved under special conditions for the prevention of phototoxicity in EPP.

USA·FDA-approved (Scenesse, 2019)

Approved for adults with EPP.

Research areas

  • Erythropoietic protoporphyria (approved indication)
  • Other photodermatoses and photoprotection (research)

Documented effects (from the literature)

  • Reactions at the implant site, headache, nausea.
  • Skin darkening; well studied in the EPP application.

Safety concerns & caution

  • Use belongs in specialized hands (implant, follow-up monitoring, skin surveillance).
  • Cosmetic off-label tanning is not the approved indication.

Risks of gray-market purchase

  • "Melanotan 1" tanning vials are not Scenesse — identity, purity, and sterility are untested.
  • The tanning obscures the fact that this is an unapproved product.

Frequently asked questions

Is melanotan 1 (afamelanotide) approved?

Yes — but as the Scenesse implant only for the rare light disease EPP, not for cosmetic tanning.

Is the gray-market tanning vial the same as Scenesse?

No. Scenesse is a controlled-release implant placed by a physician. Gray-market vials are untested products of unknown content.

Sources

Primary and reference sources for your own reading.

Related substances

Unfamiliar terms? Look them up in the glossary or read the fundamentals.

This profile is for information and education only. It is not medical advice and deliberately contains no dosing or usage details. Decisions about use belong in a doctor’s hands.