Melanotan: clinical evidence record
Also known as: Melanotan I, Afamelanotide, Scenesse, Melanotan II, MT-II
Oliver Mackman · Editorial director · Best Business Loans Ltd (16833937)
Last updated 2026-05-22
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AI-friendly summary · Melanotan
Afamelanotide (Melanotan I) is licensed as Scenesse in the EU and US for erythropoietic protoporphyria. Melanotan II has no marketing authorisation in any Western jurisdiction. MHRA has issued multiple public warnings about unregulated Melanotan II supply.
Mechanism of action
How Melanotan works
Melanotan I is a 13-amino-acid linear analogue of alpha-melanocyte-stimulating hormone (alpha-MSH) that selectively binds the MC1R receptor to stimulate melanin synthesis. Melanotan II is a cyclic heptapeptide with broader melanocortin-receptor activity (MC1R, MC3R, MC4R, MC5R) and additional effects on appetite and sexual function.
Top peer-reviewed citations
Selection of the most-cited peer-reviewed literature on Melanotan. Where a verified PMID or DOI is shown, the citation links to the original record. Other citations list the title, authors, journal and year so the reader can locate the paper through the journal index or the PubMed search linked below. PeptideClear publishes editorial commentary, not clinical guidance.
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Afamelanotide for Erythropoietic Protoporphyria
Langendonk JG, Balwani M, Anderson KE, et al.. The New England journal of medicine, 2015.
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Long-term observational study of afamelanotide in 115 patients with erythropoietic protoporphyria
Biolcati G, Marchesini E, Sorge F, et al.. The British journal of dermatology, 2015.
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alpha-Melanocyte-stimulating hormone-induced eruptive nevi
Cardones AR, Grichnik JM. Archives of dermatology, 2009.
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Melanocortin peptide therapeutics: historical milestones, clinical studies and commercialization
Hadley ME, Dorr RT. Peptides, 2006.
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Pharmacokinetics and Pharmacodynamics of Afamelanotide and its Clinical Use in Treating Dermatologic Disorders
Minder EI, Barman-Aksoezen J, Schneider-Yin X. Clinical pharmacokinetics, 2017.
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Afamelanotide: A Review in Erythropoietic Protoporphyria
Kim ES, Garnock-Jones KP. American journal of clinical dermatology, 2016.
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Risks of unregulated use of alpha-melanocyte-stimulating hormone analogues: a review
Habbema L, Halk AB, Neumann M, et al.. International journal of dermatology, 2017.
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Melanotan II injection resulting in systemic toxicity and rhabdomyolysis
Nelson ME, Bryant SM, Aks SE. Clinical toxicology (Philadelphia, Pa.), 2012.
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Melanotan-associated melanoma
Paurobally D, Jason F, Dezfoulian B, et al.. The British journal of dermatology, 2011.
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Melanotan and the posterior reversible encephalopathy syndrome
Kaski D, Stafford N, Mehta A, et al.. Annals of internal medicine, 2013.
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Depigmented Facial and Neck Patches Following Melanotan Use in a Patient With Atopic Dermatitis and Alopecia Areata
Ume A, Chambers S, Worswick S. Clinical and experimental dermatology, 2026.
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Insights into Tanning Biology and Tanning Products
Resnick G, Khajeh-Afzaly M, Yousefian F, et al.. The Journal of clinical and aesthetic dermatology, 2026.
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Changes in Oral Mucosa Associated with Melanotan II Injections: A Case Report
Bonchev A. Life (Basel, Switzerland), 2026.
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Unregulated Melanotan Use Promoted via Social Media: Emerging Dermatologic and Public Health Risks
Sidhu AS, Konig DJ, Yu-Corpuz BX, et al.. International journal of dermatology, 2026.
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Investigation of the stability profile of therapeutic α-MSH analogue: Insights from liquid chromatography-high resolution mass spectrometry analysis of afamelanotide
Chawathe A, Sharma N. Journal of pharmaceutical and biomedical analysis, 2026.
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Sunless Tanners in Dermatology: A Review of Ingredients, Efficacy, and Safety Profiles
Black TA, Hatch J, Laughter MR, et al.. Journal of drugs in dermatology : JDD, 2026.
Full PubMed search: https://pubmed.ncbi.nlm.nih.gov/?term=melanotan+afamelanotide.
Registered clinical trials
As of 2026-07-13, Melanotan has 1 interventional trial listed on ClinicalTrials.gov and the ISRCTN registry. Registration means a study is planned, running or completed. It is not evidence of efficacy, and a listing is not an endorsement.
| Study | Phase | Status | Location | Registry |
|---|---|---|---|---|
| Melanotan II (MT-II) as an Adjunct to NB-UVB Phototherapy for Repigmentation in Stable Nonsegmental Vitiligo NCT07437560 | Phase 2 | Recruiting | China | ClinicalTrials.gov |
Source: ClinicalTrials.gov and the ISRCTN registry, refreshed 2026-07-13. See the peptide clinical-trials tracker for the full picture across compounds.
UK regulatory status
Plain-English summary of where Melanotan sits under the four UK and international frameworks that govern peptide supply. Editorial commentary, not legal advice.
- Misuse of Drugs Act 1971: Not controlled under the Misuse of Drugs Act 1971.
- Psychoactive Substances Act 2016: Not scheduled under the Psychoactive Substances Act 2016.
- MHRA medicines classification: No UK marketing authorisation as a medicine.
- WADA Prohibited List: Not currently listed on the WADA Prohibited List.
Risks and unknowns
What the literature does not yet show about Melanotan
Known concerns
- Melanotan has been studied in randomised human trials, which is a materially stronger position than most compounds on this site. Trial populations, endpoints and durations are still narrower than everyday use, so results describe the trial, not every person.
- 1 registered interventional trials exist for Melanotan and 1 are recruiting, so the evidence base is actively moving. A registration is not a result, and a recruiting trial has by definition not reported.
- Melanotan holds no UK marketing authorisation, so nothing you can buy has been assessed by a regulator, released by batch, or dispensed by an accountable pharmacy. Purity, dose accuracy and sterility rest entirely on the seller's own documentation.
Open questions in the literature
- Long-term outcomes beyond the duration of the published trials are unknown, and the published trials are considerably shorter than the periods over which people actually use these compounds.
- Interactions between Melanotan and prescribed medicines are not systematically studied, which matters most for anyone already on treatment for a long-term condition.
Regulatory note
No UK marketing authorisation as a medicine. Not currently listed on the WADA Prohibited List. The moment a UK seller or commentator makes a therapeutic claim, MHRA can treat the product as an unlicensed medicinal product.
Important: PeptideClear publishes encyclopedia commentary only and does not recommend human use. Speak to a UK-registered prescriber before any medical decision.
Related reading on PeptideClear
Frequently asked questions
What is the evidence level for Melanotan?
What is the UK regulatory status of Melanotan?
Has Melanotan been tested in human clinical trials?
Where can I read the source literature for Melanotan?
Last verified 2026-05-22. Editorial commentary, not legal or clinical advice. Citations without a linked identifier can be located through the PubMed search and the journal index.