Is Melanotan I (MT-1) FDA-Approved?

Is melanotan 1 FDA-approved? This one has a surprising answer: the same molecule is FDA-approved — but under a different name, for a rare medical condition, and not for tanning or cosmetic use.

Melanotan I is the peptide now known generically as afamelanotide, which the FDA approved under the brand name SCENESSE. But that approval is narrow, and it does not make research-labeled "MT-1" tanning products FDA-approved.

What Is Melanotan I?

Melanotan I is a synthetic analog of alpha-melanocyte-stimulating hormone (alpha-MSH). It stimulates the production of eumelanin, the pigment responsible for darker skin tone. During pharmaceutical development, this compound was given the generic name afamelanotide.

Source: FDA prescribing information for SCENESSE (afamelanotide) implant.

What Is the Approved Product, and What Is It For?

The FDA approved SCENESSE on October 8, 2019, to increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria (EPP) — a rare inherited disorder in which sunlight causes severe skin pain. It is delivered as an implant placed under the skin by a healthcare professional.

Source: FDA approval letter and Drug Trials Snapshots: SCENESSE, NDA 210797.

So Is "MT-1 for Tanning" FDA-Approved?

No. The FDA approval covers a specific implant, administered by a clinician, for a specific rare disease. It does not approve melanotan I for cosmetic tanning, and it does not make research-labeled injectable "MT-1" products the same as the approved implant.

Source: FDA questions and answers about drug compounding.