Library / Skin and hair

Afamelanotide

Also known as Scenesse, Melanotan I, CUV1647

Approved medicine

Synthetic analogue of alpha melanocyte stimulating hormone that increases skin melanin. Approved only as an implant for the rare light sensitivity disorder erythropoietic protoporphyria, not for cosmetic tanning.

Prescription medicine. Only a prescriber can decide whether a medicine suits you and at what dose. This page is information, not a recommendation.

Background

A synthetic analogue of alpha melanocyte stimulating hormone first made at the University of Arizona in the 1980s (known then as Melanotan I). The Australian company Clinuvel developed it as the Scenesse implant for erythropoietic protoporphyria.

How it is thought to work

It switches on the melanocortin 1 receptor on pigment cells, increasing eumelanin (dark pigment) in the skin. The extra pigment helps protect people with erythropoietic protoporphyria from light induced pain.

What is claimed, and the evidence

Claim	Evidence	Notes
Increasing pain free light exposure in adults with erythropoietic protoporphyria	Approved use	Approved by the FDA, EMA and TGA as a 16 mg implant placed under the skin every 2 months. Two randomised trials (n = 74 and 94) showed more pain free time in sunlight than placebo.
Cosmetic sunless tanning	No published evidence	Not an approved use. Illegally sold injectable 'Melanotan' products are marketed for tanning; afamelanotide is approved only as an implant for EPP.

Side effects

Effect	How often	Notes
Implant site reactions (discolouration, bruising, redness, pain, swelling)	Common	21% with Scenesse vs 10% with placebo in the label trials.
Nausea	Common	19% vs 14% with placebo.
Sore throat and cough	Common	Oropharyngeal pain 7% and cough 6% in label trials.
Fatigue, dizziness, sleepiness	Uncommon	Fatigue 6%, dizziness 4%, somnolence 2%.
Skin darkening and darkening of existing moles or freckles	Uncommon	Skin hyperpigmentation 4% and new or changed melanocytic naevi 4% in trials; expected from how it works.
Serious allergic reactions including anaphylaxis Serious	Case reports	Reported after marketing; the implant should be removed and treatment stopped.

Warnings

Serious allergic reactions, including anaphylaxis, have been reported after marketing.
It darkens existing moles and freckles, so the label recommends a full skin check twice a year.
Unapproved injectable 'Melanotan' tanning products are not the same as the approved implant. Unapproved products bought online are not checked by any regulator for purity, sterility or strength; they may be contaminated, underdosed, overdosed or contain a different substance to the label.

Regulatory status

Australia: Approved (ARTG, Scenesse implant, 2020) for prevention of phototoxicity in adults with erythropoietic protoporphyria. Schedule 4.
United States: FDA approved (Scenesse, 2019) to increase pain free light exposure in adults with erythropoietic protoporphyria.
European Union: Authorised by the European Commission (Scenesse, 2014) for erythropoietic protoporphyria.

Sources

Also in Skin and hair

From the VialOwl library, reviewed 26 September 2026. For education and general information. It is not medical advice and not a recommendation to use Afamelanotide.