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Afamelanotide

Melanocortin 1 receptor (MC1R) agonist

Status

Approved

Approved as a slow-release implant (Scenesse) for adults with erythropoietic protoporphyria in the EU (2014), US (2019), Australia (2020) and Canada (July 2026); vitiligo use is still in trials, with Phase III CUV105 results expected in December 2026 and a pivotal CUV107 study planned.

Evidence

Moderate

Three randomized, vehicle-controlled trials in a rare disease (244 adults in total) showed a consistent but moderate gain in pain-free sun exposure.

Afamelanotide is a lab-made version of alpha-MSH, the hormone that tells skin cells to make dark pigment. Given as a small dissolving implant (Scenesse), it protects adults with erythropoietic protoporphyria, a rare disorder causing painful reactions to light.

Structure

13 residues

Point at a bead, or focus the chain and use the arrow keys, to name it. Pick a chemistry to highlight it.

D-form (mirror image), shown in lower case

Sequence as text
Ac-S-Y-S-Nle-E-H-D-Phe-R-W-G-K-P-V-NH2

What it is used for

  • Preventing light-induced pain (phototoxicity) in adults with erythropoietic protoporphyria (approved)
  • Repigmenting vitiligo in darker skin, combined with narrowband UVB light (studied)
  • Cosmetic tanning (claimed, unproven)

How it works

Afamelanotide binds the melanocortin 1 receptor (MC1R) on melanocytes, the pigment cells of the skin, switching on production of eumelanin (brown-black pigment) independently of sun or UV exposure. In erythropoietic protoporphyria, a light-sensitive chemical (protoporphyrin) builds up in the skin and causes burning pain in visible light; the extra pigment is thought to reduce how much light penetrates the skin.

How strong the evidence is

ModerateAt least one good randomised trial, or consistent smaller human trials.

Two randomized trials published together (Langendonk 2015, NEJM) found adults with EPP on afamelanotide spent more time in direct sunlight without pain than those on placebo: median 69.4 versus 40.8 hours over 6 months in the US study, and 6.0 versus 0.8 hours in the EU study, with fewer phototoxic reactions and better quality of life. In a randomized trial of 55 vitiligo patients, adding afamelanotide to narrowband UVB gave faster and greater repigmentation, mainly in darker skin types (Lim 2015). A larger Phase III vitiligo trial, CUV105 (210 patients), is due to report in December 2026.

Risks and side effects

  • Implant-site reactions, nausea, headache and sore throat
  • Generalised skin darkening and darkening of existing moles and freckles; twice-yearly full-skin checks are advised
  • Serious hypersensitivity reactions, including anaphylaxis, reported after marketing
  • Must be implanted by a trained healthcare professional; unlicensed 'melanotan' products are not equivalent

Label dosing

Label: one 16 mg implant inserted under the skin above the hip bone by a trained healthcare professional every 2 months.

Summarised from the official prescribing information. Not a recommendation: dosing is decided with a prescriber.

Regulatory status

RegionYearApproved for
EUEMA2014Prevention of phototoxicity in adults with erythropoietic protoporphyria (EPP)
USFDA2019Increasing pain-free light exposure in adults with phototoxic reactions from EPP
AUTGA2020Erythropoietic protoporphyria in adults
CAHealth Canada2026Prevention of phototoxicity in adults with EPP

Status by country

JurisdictionStatusSource
USUnited StatesAuthorised medicineSource 1
EUEuropean UnionAuthorised medicineSource 2
UKUnited KingdomAuthorised medicineSource 9
AUAustraliaAuthorised medicineSource 10
CACanadaAuthorised medicineSource 11
Whether a medicine containing it is authorised, checked in each regulator’s records on Oct 1, 2026.

Status of every peptide by country

Trials of Afamelanotide to watch

  1. Phase 3Active, not recruiting

    Afamelanotide plus NB-UVB in vitiligo(opens the source in a new tab)

    A Study to Compare the Efficacy and Safety of SCENESSE and Narrow-Band Ultraviolet (NB-UVB) Light Versus NB-UVB Light Alone in Patients With Vitiligo

    Primary completion expected December 2025200 participantsSponsor: Clinuvel, Inc.NCT06109649

All trials to watch

Timeline

  1. 2026

    1. Approved, CA (Health Canada)Prevention of phototoxicity in adults with EPP

  2. 2025

    1. Afamelanotide plus NB-UVB in vitiligo

  3. 2020

    1. Approved, AU (TGA)Erythropoietic protoporphyria in adults

  4. 2019

    1. Approved, US (FDA)Increasing pain-free light exposure in adults with phototoxic reactions from EPP

  5. 2014

    1. Approved, EU (EMA)Prevention of phototoxicity in adults with erythropoietic protoporphyria (EPP)

Sources

  1. 01SCENESSE (afamelanotide) implant label(opens the source in a new tab) DailyMed, U.S. National Library of Medicine, 2026
  2. 02Scenesse (afamelanotide): EPAR(opens the source in a new tab) European Medicines Agency, 2014
  3. 03Afamelanotide for erythropoietic protoporphyria(opens the source in a new tab) N Engl J Med, 2015
  4. 04Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial(opens the source in a new tab) JAMA Dermatol, 2015
  5. 05SCENESSE approved for EPP in Canada(opens the source in a new tab) CLINUVEL Pharmaceuticals (ASX announcement), 2026
  6. 06Update: SCENESSE in vitiligo(opens the source in a new tab) CLINUVEL Pharmaceuticals (ASX announcement), 2026
  7. 07Afamelanotide (CID 16197727)(opens the source in a new tab) PubChem, NCBI, 2026
  8. 08Risks of unregulated use of alpha-melanocyte-stimulating hormone analogues: a review(opens the source in a new tab) Int J Dermatol, 2017
  9. 09UK list of drugs under Additional Monitoring (August 2026)(opens the source in a new tab) Medicines and Healthcare products Regulatory Agency, 2026
  10. 10SCENESSE afamelanotide (as acetate) 16 mg implant vial (327947)(opens the source in a new tab) Therapeutic Goods Administration
  11. 11Drug Product Database: Scenesse (DIN 02569825)(opens the source in a new tab) Health Canada, 2026
  1. Cosmetic ingredientArgirelineSNARE-modulating hexapeptide (cosmetic ingredient)6
  2. Not approvedCollagen peptidesHydrolysed collagen (food supplement)No single sequence·
  3. Cosmetic ingredientGHK-CuCopper-binding tripeptide (cosmetic ingredient)3
  4. Not approvedMelanotan IINon-selective melanocortin receptor agonist (research peptide)7 WADA banned
  5. Cosmetic ingredientPalmitoyl pentapeptide-4Signal peptide (cosmetic ingredient)5

Educational information, not medical advice. Talk to a licensed clinician before starting, stopping or changing any medicine.