Is Melanotan I FDA-approved?

Only as Scenesse: the afamelanotide implant is FDA-approved for the use in its label, and it's prescription only. Injectable melanotan products sold online are not FDA-approved.

Checked 1 Nov 2026. The sources are below.

Melanotan I

Also: afamelanotide, Scenesse, NDP-MSH, [Nle4-D-Phe7]-α-MSH, CUV1647

Status label in the Peptimes Library
FDA Approved
Routes in Peptimes
SubcutaneousOther
Updated
1 Nov 2026

US regulatory status

FDA approval belongs to the product below, for its route and the uses in its label. Label uses are shortened unless quoted.

  • Scenesse (afamelanotide) implant

    Subcutaneous implant

    "To increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP)".

    Source: DailyMed label, checked 1 Nov 2026

  • Prescription

    Prescription only. Drugs@FDA lists the product above as "Prescription".

    Source: Drugs@FDA, checked 1 Nov 2026

  • Investigational

    No, for the product and uses above.

    Source: Drugs@FDA, checked 1 Nov 2026

How to track it in Peptimes

Add Melanotan I in My Protocols and set the schedule you already follow: days of the week, times of day and a start date. Peptimes never suggests an amount when you log or schedule a dose. Its Library entry shows the status label “FDA Approved”. That approval belongs to Scenesse, the afamelanotide implant, for the use in its label. Injectable melanotan products sold online are not FDA-approved, and they don’t share Scenesse’s approval.

  • Routes: subcutaneous or Other. Choose the one that matches each dose.
  • Logging: the amount you took, the route and how you feel.
  • Injection sites: subcutaneous doses record the site, and Insights shows where you’ve injected and how recently. It never suggests where to inject next. Other doses skip this step.
  • Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the peptide tracker app page.

Peptimes is a tracking app, not medical advice. Talk to a licensed clinician about your treatment. Peptimes doesn’t sell Melanotan I or any other compound.

More sources

  • FDA, Drugs@FDA, NDA 210797 (Scenesse), checked 1 Nov 2026: product, route (implant, subcutaneous) and marketing status. It is the only FDA-approved afamelanotide product.
  • FDA, Global Substance Registration System, Afamelanotide, checked 1 Nov 2026: its sequence of 13 amino acids and the names [Nle4,D-Phe7]-α-MSH and CUV1647.

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