Afamelanotide

Is Afamelanotide FDA-approved?

Approved by the FDA. A licensed clinician has to decide it is right for you and prescribe it. Scenesse is FDA-approved for one rare disease and administered by trained professionals. RUO or tanning products are unapproved copies.

As of September 28, 2026.

What does the evidence say about Afamelanotide?

Controlled trials support the approved rare-disease indication; cosmetic tanning use is not FDA-approved.

What are the risks and side effects of Afamelanotide?

• Skin darkening and changes in moles can occur.
• The approved implant requires professional administration and skin monitoring.
• Online tanning products have not been reviewed for identity, sterility or safety.
• Approval for a rare disease does not establish cosmetic use as safe.

What should you ask a clinician about Afamelanotide?

• Does a skin change or mole need examination?
• Why is an online Melanotan I product different from Scenesse?

These save with the compound when you add it to My Journal, so they’re on the printout for your visit.

Where can I get Afamelanotide?

1 provider list Afamelanotide on DiscoverMedica, lowest listed price first.

† Prices as listed by the provider when we checked; they change.

Sources

• DailyMed: Scenesse prescribing information
• FDA: Scenesse approval information

Educational information only, not medical advice. It does not replace a conversation with a licensed clinician.