Melanotan I (Afamelanotide)

Evidence in perspective

The named U.S. product label is the appropriate source for its approved use, contraindications and handling. SCENESSE controlled-release subcutaneous implant: apparent half-life is approximately 15 hours in a study of 12 healthy adults; median time to peak was 36 hours. These results cannot be transferred to melanotan powder injections. Renal and hepatic impairment effects are unknown. A label extraction is not an independent appraisal of every supporting trial or approval of other products with the same ingredient.

Who was studied

The population specified by this product label; other indications and jurisdictions remain outside this check.

What the sources found

Increased pain-free light exposure in adults with erythropoietic protoporphyria; not a generic tanning indication.

Regulatory scope

U.S. label record for NDA210797. This does not confer authorization on other products using the ingredient name.

What remains unknown

Named-product label sections were expanded for pharmacokinetics, contraindications and selected handling or interaction details on September 7, 2026. This is not a complete trial-program appraisal or clinician sign-off. Other formulations, patient-specific decisions and other jurisdictions require separate assessment.

How it works

SCENESSE afamelanotide implant

Consult the product label for pharmacology. A mechanism does not extend its approved indications.

Approved product exists

Approval applies to a particular product and indication. It does not extend to every use, route, compounded preparation or research vial sold under the same compound name. Check the current prescribing information.

Understanding the evidence

Reported adverse effects

• Serious hypersensitivity and pigmentation changes require monitoring, including regular skin examinations.

Named U.S. presentation only; selected label sections.

Source · Warnings and precautions / boxed warning