Melanotan I
Melanotan I is the research name for afamelanotide, a lab-made version of alpha-MSH, the hormone that tells skin to make melanin pigment. Two of its amino acids differ from the natural hormone. The approved medicine (Scenesse) is a small dissolvable implant placed under the skin. Powder sold in vials as Melanotan I is not that approved product.
Approval status
Afamelanotide is approved as an implant (Scenesse) for adults with erythropoietic protoporphyria (EPP): by the EMA in 2014 and by the FDA in 2019. Injectable powder sold as Melanotan I is not this approved product. Australia's TGA says melanotan tanning products are not approved and buyers cannot know what they contain.2310
What it’s used or studied for
- Approved use
Increases pain-free light exposure in adults with EPP, a rare inherited light sensitivity, as an implant (FDA 2019; EMA 2014, as prevention of phototoxicity).234
- Human studies
Vitiligo: in a randomized trial, the implant plus narrowband UVB light gave faster, greater repigmentation than UVB alone, mainly in darker skin.5
- Human studies
Solar urticaria (hives from light): a study of five patients found weaker skin reactions to light after an implant.6
- Human studies
Sunless tanning: small trials in healthy volunteers in the 1990s and 2000s found that injections darkened the skin. Not approved for tanning.78
Each label shows how strong the evidence is: an approved use, human studies, animal or lab studies only, or a popular claim with no published studies. Being studied is not the same as being proven safe or effective.
Side effects
Common
- Implant site reaction
- Nausea
- Sore throat
- Cough
- Tiredness
- Skin darkening
- Dizziness
- New moles
Serious or rare
- Serious allergic reactions, including anaphylaxis
- Darkening of existing moles and freckles
- Mole changes and melanoma reported with unregulated melanotan use (case reports)
Common effects are from the Scenesse implant label. Early injection studies also reported nausea and facial flushing. A review links unregulated melanotan I and II to changing moles and four melanomas, without proof that the drug caused them.289
Cautions
- The label recommends a full-body skin exam twice yearly to check existing moles and new pigmented spots.2
- Do not use after a serious allergic reaction to afamelanotide.2
- The implant is meant to be placed by a healthcare professional trained in the procedure.2
- There are no data on use in pregnancy or breastfeeding.2
- Unregulated melanotan products may be impure, and the UK MHRA has warned that shared needles can spread blood-borne viruses.1011
Sources
- PubChem: Afamelanotide (CID 16197727)
- FDA label: Scenesse (afamelanotide) implant (DailyMed)
- EMA: Scenesse (afamelanotide) EPAR
- Langendonk JG et al. Afamelanotide for erythropoietic protoporphyria. N Engl J Med 2015
- Lim HW et al. Afamelanotide and narrowband UV-B phototherapy for vitiligo: a randomized multicenter trial. JAMA Dermatol 2015
- Haylett AK et al. Systemic photoprotection in solar urticaria with afamelanotide. Br J Dermatol 2011
- Levine N et al. Induction of skin tanning by subcutaneous administration of a potent synthetic melanotropin. JAMA 1991
- Dorr RT et al. Melanotan-1 combined with UV light or sunlight for tanning in volunteers. Arch Dermatol 2004
- Habbema L et al. Risks of unregulated use of alpha-MSH analogues: a review. Int J Dermatol 2017
- TGA (Australia): Melanotan tanning products
- Langan EA et al. Melanotropic peptides: more than just 'Barbie drugs' and 'sun-tan jabs'? Br J Dermatol 2010 (review)
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