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Sexual health & melanocortin

Afamelanotide

Also called Scenesse, [Nle4, D-Phe7]-α-MSH, melanotan I, CUV1647

Afamelanotide is a lab-made, longer-lasting copy of the skin-darkening hormone α-MSH. It is given as a tiny implant under the skin every two months. The FDA approved it in 2019 as Scenesse for adults with erythropoietic protoporphyria (EPP), a rare condition that makes sunlight painful.

FDA-approvedApproved by the FDA for at least one use after large human trials.

All printable flashcards

Drawn from its published sequence: 13 residues, one bead each.

Overview

Afamelanotide is a lab-made, longer-lasting copy of the skin-darkening hormone α-MSH. It is given as a tiny implant under the skin every two months. The FDA approved it in 2019 as Scenesse for adults with erythropoietic protoporphyria (EPP), a rare condition that makes sunlight painful.

How it works

Established: it binds mainly to the melanocortin-1 receptor (MC1R) on skin pigment cells and increases eumelanin (dark pigment) without needing sun or UV exposure. The extra pigment helps shield the skin from light that triggers pain in EPP.

What research shows

  • Trial CUV039 (n=93, 180 days): median pain-free direct sun exposure 64 hours vs 41 hours on placebo 2.
  • Trial CUV029 (n=74, 270 days): median 6 hours vs 0.75 hours on placebo 2.
  • Safety population across three vehicle-controlled trials: 244 adults with EPP 1.
  • Not approved for vitiligo anywhere; Phase 3 CUV105 topline expected December 2026 3.

Doses studied in people

Study or labelDose usedSource
FDA label (Scenesse), adults with EPPOne 16 mg implant inserted subcutaneously by a trained healthcare professional every 2 months1

The only verified dose is the FDA-labeled 16 mg implant every 2 months, placed by a trained professional.

Read this first: these are the amounts given to participants in published studies or written on official prescribing labels, reported for reference. They are not recommendations. Trial doses were chosen for specific patients under medical supervision, and a dose that is safe in one person can be harmful in another.

Safety

  • Implant-site reaction 21% (vs 10%), nausea 19% (vs 14%), throat pain, cough, fatigue, skin darkening and new/darker moles in trials 1.
  • Causes general skin darkening and darkening of existing moles and freckles; full-body skin exams twice a year are recommended 12.
  • Patients should continue sun protection 2.

Report side effects of any drug or product to the FDA through MedWatch. For a possible poisoning in the US, call Poison Control at 1-800-222-1222.

Storage and stability

Per label: refrigerate at 2–8°C and protect from light.

General lab handling, not instructions for personal use. See Storage and stability.

History

Developed by Australian company Clinuvel. FDA approved Scenesse on October 8, 2019 (Priority Review, Orphan Drug) for adults with a history of phototoxic reactions from EPP. It is also approved for adult EPP in Europe, Canada, Israel and Australia. Clinuvel is testing it in vitiligo (Phase 3 CUV105 results expected Dec 2026) and planned an EMA filing for adolescent EPP in H2 2026 6.

Common questions

Is afamelanotide FDA-approved?

Yes. FDA approved it as Scenesse on October 8, 2019, to increase pain-free light exposure in adults with erythropoietic protoporphyria (EPP) 12. It is also approved for adult EPP in Europe, Canada, Israel and Australia, but not for vitiligo 3.

What did the trials show?

In one 180-day trial of 93 people, median pain-free direct sun exposure was 64 hours versus 41 hours on placebo 2. In a 270-day trial of 74 people, it was 6 hours versus 0.75 hours 2.

How is afamelanotide given?

Per the FDA label, one 16 mg implant is placed under the skin every 2 months by a trained healthcare professional 1.

What are the side effects?

Implant-site reactions (21% versus 10%), nausea, throat pain, cough and fatigue were reported in trials 1. It darkens the skin and existing moles, so full-body skin exams twice a year are recommended 12.

How is afamelanotide stored?

The label says to keep it refrigerated at 2 to 8°C and protected from light 1.

Is afamelanotide banned in sport?

It is not named on WADA's 2026 list, and as an approved drug it does not fall under the S0 non-approved substances rule 5.

Related compounds

Sexual health & melanocortinEarly human dataFlashcard

Melanotan II

MT-II · MT2

Melanotan II is a lab-made peptide that copies a skin-darkening hormone (α-MSH).

Sexual health & melanocortinFDA-approvedFlashcard

PT-141 (bremelanotide)

bremelanotide · Vyleesi

Bremelanotide, often called PT-141, is a lab-made peptide that acts on melanocortin receptors in the brain.

Sources

  1. Scenesse (afamelanotide) implant — FDA Prescribing Information (2019) FDA label
  2. FDA approves first treatment to increase pain-free light exposure in patients with a rare disorder (Oct 8, 2019) Regulatory
  3. Clinuvel ASX announcement (July 28, 2026) Regulatory
  4. FDA: Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (updated May 14, 2026) Regulatory
  5. WADA 2026 Prohibited List (official English text, Dutch Treaty Series Trb. 2026, 25) Regulatory
  6. Clinuvel clinical and financial update (Feb 2, 2026) Regulatory

Last reviewed 2026-10-25 · How we research · Found an error? See our corrections policy.