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Clinical evidence records

Melanotan: clinical evidence record

Also known as: Melanotan I, Afamelanotide, Scenesse, Melanotan II, MT-II

Evidence: Human RCT
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Oliver Mackman · Editorial director · Best Business Loans Ltd (16833937)

Last updated 2026-05-22

Editorial with affiliate links. We earn from purchases via outbound retailer / clinic links. How we are funded.

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.

  1. Afamelanotide for erythropoietic protoporphyria

    Langendonk JG, Balwani M, Anderson KE, et al.. New England Journal of Medicine, 2015.

    PMID: 26132941 DOI: 10.1056/NEJMoa1411481

  2. Long-term experience of afamelanotide in erythropoietic protoporphyria

    Biolcati G, Marchesini E, Sorge F, et al.. British Journal of Dermatology, 2015.

    PMID: 25494545 DOI: 10.1111/bjd.13598

  3. Adverse effects of unregulated Melanotan II use

    Cardones AR, Grichnik JM. Archives of Dermatology, 2009.

    PMID: 19380666 DOI: 10.1001/archdermatol.2008.623

  4. Melanocortin pharmacology of Melanotan II

    Hadley ME, Dorr RT. Peptides, 2006.

    PMID: 16412534 DOI: 10.1016/j.peptides.2005.01.029

  5. Pharmacokinetics and Pharmacodynamics of Afamelanotide and its Clinical Use in Treating Dermatologic Disorders

    Minder EI, Barman-Aksoezen J, Schneider-Yin X. Clinical pharmacokinetics, 2017.

    PMID: 28063031 DOI: 10.1007/s40262-016-0501-5

  6. Afamelanotide: A Review in Erythropoietic Protoporphyria

    Kim ES, Garnock-Jones KP. American journal of clinical dermatology, 2016.

    PMID: 26979527 DOI: 10.1007/s40257-016-0184-6

  7. 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.

    PMID: 28266027 DOI: 10.1111/ijd.13585

  8. Melanotan II injection resulting in systemic toxicity and rhabdomyolysis

    Nelson ME, Bryant SM, Aks SE. Clinical toxicology (Philadelphia, Pa.), 2012.

    PMID: 23121206 DOI: 10.3109/15563650.2012.740637

  9. Melanotan-associated melanoma

    Paurobally D, Jason F, Dezfoulian B, et al.. The British journal of dermatology, 2011.

    PMID: 21564053 DOI: 10.1111/j.1365-2133.2011.10273.x

  10. Melanotan and the posterior reversible encephalopathy syndrome

    Kaski D, Stafford N, Mehta A, et al.. Annals of internal medicine, 2013.

    PMID: 23648958 DOI: 10.7326/0003-4819-158-9-201305070-00020

Full PubMed search: https://pubmed.ncbi.nlm.nih.gov/?term=melanotan+afamelanotide.

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

Open questions in the literature

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?
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.
What is the UK regulatory status of Melanotan?
No UK marketing authorisation as a medicine. Not controlled under the Misuse of Drugs Act 1971. Not scheduled under the Psychoactive Substances Act 2016. Not currently listed on the WADA Prohibited List.
Has Melanotan been tested in human clinical trials?
Melanotan has been studied in randomised human clinical trials. See the cited peer-reviewed literature above. PeptideClear publishes no dosing or human-use protocols.
Where can I read the source literature for Melanotan?
The full PubMed search is linked above. Each cited paper has its title, author list and journal. Where we have a verified PMID or DOI the citation links directly. Other citations can be located by the reader through the journal index or the PubMed search.

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.

Reviewed by Oliver Mackman, editorial director · last reviewed 2026-05-22T12:00:00.000Z