Melanotan-1 / Melanotan-2

What are Melanotan-1 and Melanotan-2?

Both substances are laboratory-made analogs of α-melanocyte-stimulating hormone (α-MSH), which is produced in the brain and skin. Afamelanotide is a 13-amino-acid peptide in which two amino acids of the natural hormone are changed, and it is also referred to in the literature as Melanotan-1. ^[2] According to the product information approved by the European Medicines Agency (EMA), afamelanotide binds mainly to the melanocortin-1 receptor (MC1R), stays bound longer than the natural hormone, and can increase production of the dark pigment eumelanin in the skin independently of sun or artificial UV light; the darkening of skin color gradually fades if a new implant is not applied. ^[1]

Melanotan II, on the other hand, is a non-selective melanocortin receptor agonist. The authors of a case report from Sweden summarize the substance’s effects in humans as increased skin pigmentation, spontaneous erection and sexual arousal. ^[8] Another case report from the US explains that the skin effect arises from the MC1 receptor and the sexual effects from the MC3 and MC4 receptors in the central nervous system. ^[7] Bremelanotide (PT-141), another peptide that acts on melanocortin receptors and was developed for sexual desire disorder, is covered on a separate page.

Afamelanotide: what was shown in licensed use?

EPP is a severe light-sensitivity disease with acute phototoxicity; patients experience unbearable pain when exposed to light, and their quality of life falls markedly. In the two multicenter, randomized, double-blind, placebo-controlled studies that formed the basis of afamelanotide’s license, patients received a subcutaneous implant or placebo every 60 days (74 patients in the EU study, 94 in the US study). The primary outcome was the number of hours spent in direct sun without pain. ^[3]

In both studies, quality-of-life scales improved in the afamelanotide group; side effects were mostly mild, and serious side effects were judged not to be drug-related. The studies were funded by various sources, mainly the drug’s manufacturer. ^[3] The EMA licensed the product under “exceptional circumstances” because complete data could not be provided owing to the rarity of the disease, and it reassesses new information every year. ^[1]

Warnings in the product information

According to the EU product information, afamelanotide is prescribed only by specialist physicians at recognized porphyria centers and administered by physicians trained by the marketing authorization holder. The product information lists the following points: ^[1]

• Skin monitoring: Afamelanotide can darken existing pigmented lesions; a full-body skin examination every six months is recommended. Special attention is needed in people with a personal or family history of melanoma, familial atypical mole-melanoma syndrome or another skin cancer.
• Sun protection: It is recommended that the sun protection measures the patient uses for EPP be continued during treatment.
• Contraindications: Severe liver disease, liver failure and kidney failure.
• Pregnancy: Not used in pregnancy; women of childbearing age use an effective contraceptive method during and for three months after treatment.
• Long-term safety: Data are limited; safety has not been evaluated in clinical studies longer than 2 years. Not used over the age of 70.
• Side effects: In pooled data from 425 patients, the most common were nausea (about 19%), headache (20%) and implant site reactions (21%); hypersensitivity reactions including anaphylaxis were reported with uncommon frequency. Melanocytic nevus (mole) is also listed in the side effect table.

That this level of monitoring is foreseen even in licensed use explains why unsupervised use of the same class of drug carries a separate risk.

Tanning injections and nasal sprays

A 2017 review by Dutch dermatologists writes that unsupervised use of untested synthetic α-MSH analogs known as “melanotan I and II” is increasing, that these products are used mainly for their tanning effects, and that they have become part of the “tanning culture” of certain communities. The review states that uncertainties in preparation, administration and dosing make illegal melanotans risky, and that afamelanotide is, as of the publication date, the only α-MSH analog approved in a limited number of medical indications. ^[4] In a case reported from Denmark, the authors report that unlicensed use of Melanotan II has become widespread among young people who go to gyms. ^[5]

In recent years, products are also sold as nasal sprays. Australia’s drug authority, the TGA, reported in a warning published in August 2026 that it had analyzed nasal sprays seized in an investigation: in five bottles labeled with the same amount, the estimated Melanotan II amount varied between 22 mg and 54 mg. The TGA stated that this inconsistency increases the likelihood of side effects and that consumers cannot be sure of the product’s content, strength and quality. ^[11] According to the same authority, Melanotan II is in the prescription-only drug category in Australia, is not approved as a tanning agent, and no Melanotan II product is registered in the country’s drug register; 27 administrative fines totaling AUD 101,412 were issued to a person alleged to have supplied products illegally, and the fines were paid in May 2026. ^[11]

In the UK, the MHRA explained in a freedom-of-information response that injectable products and pens containing Melanotan II are regarded as medicines, while nasal sprays are classified as medicines only when sold with a claim to treat or prevent a disease. ^[10]

Mole changes and melanoma: what do case reports say?

The most discussed risk associated with melanotan is changes in moles and melanoma. According to the 2017 review, a growing number of case reports link unsupervised use of melanotan I and II to changes in existing moles and the appearance of new (dysplastic) moles; four case reports describe melanomas developing from existing moles during or shortly after melanotan use. The review explicitly notes that there is no proof of a definite link between these cases and the substance. ^[4]

Case reports do not prove that an association exists: a significant share of users also sunbathe or use tanning beds, which is a known risk factor for melanoma. The authors of the Danish case stress that, because it is an unlicensed and incompletely tested substance, the type and extent of the side effects of Melanotan II are unknown. ^[5] The FDA also notes that serious side effects, including melanoma, are discussed in published case reports for Melanotan II. ^[9]

The assumption that a tanned appearance protects against the sun has not been tested for unlicensed products. Even in EPP patients receiving afamelanotide, the product information foresees continued sun protection measures and a six-monthly skin examination; the purpose of these examinations is to catch UV-induced skin cancers and changes in pigmented lesions early. ^[1]

Other serious side effects: priapism and renal infarction

Priapism. In the US, a 55-year-old man presented to the emergency room with a painful erection lasting 30 hours after a subcutaneous injection of Melanotan II. The condition, which did not resolve with blood aspiration from the penis and drug injection, required surgical intervention; new-onset erectile dysfunction developed during follow-up. The patient had been using the substance for more than 6 years before each summer to tan. According to the authors, this is the third case of priapism reported after Melanotan II in the literature. ^[7]

Renal infarction. In Sweden, an infarction affecting about half of the right kidney was found in a previously healthy 45-year-old man. In the product sample the patient brought, Melanotan II was confirmed by forensic analysis and no other pharmacological substance was found; coagulation tests and the search for an embolic source were normal. The authors attribute the event “most likely” to Melanotan II but note as a limitation that the level of the substance was not measured in the patient’s blood. The same report states that 215 inquiries about Melanotan II side effects were recorded at the Swedish Poisons Information Centre between 2008 and 2019, and that muscle breakdown (rhabdomyolysis) and kidney failure had previously been reported in the literature. ^[8]

The FDA’s assessment also mentions case reports involving posterior reversible encephalopathy syndrome (PRES) and sympathomimetic toxidrome. ^[9] For general peptide side effects and injection-related risks: Peptide side effects.

What do regulators say?

• FDA (US): In the list in which it evaluates substances proposed for use in pharmacy compounding, the FDA included Melanotan II among substances that may present significant safety risks; on the page dated April 22, 2026, the substance appears in the table of substances “previously in category 2 and withdrawn by the nominators.” The FDA’s rationale is the risk of immune response because of aggregation or peptide impurities in some routes of administration, and the serious side effects in published case reports. This list is not an approval list. ^[9]
• MHRA (UK): The MHRA received 16 suspected side effect reports for Melanotan II between January 1, 2012 and December 31, 2022. The agency stresses that a report does not show that the event was caused by the product and that the number of reports is not equal to the actual number of side effects. The MHRA’s advice is that people using Melanotan II injections or nasal sprays stop using them immediately and report side effects; the sale, supply and advertising of unlicensed medicines is prohibited under UK legislation, and the agency has been taking action to remove melanotan products from the market for more than 10 years. ^[10]
• TGA (Australia): The TGA states that tanning products containing Melanotan II may carry serious health risks, have not been evaluated for quality, safety and efficacy, and that the supply and advertising of unapproved therapeutic products is prohibited. ^[11]

Is melanotan banned in sport?

WADA’s 2026 Prohibited List does not name melanotan, afamelanotide or Melanotan II. Class S0 of the list prohibits at all times, in and out of competition, pharmacological substances that are not covered in another section of the list and are not approved by any governmental health authority for therapeutic use in humans (drugs in preclinical or clinical development or discontinued, designer drugs). ^[12] Since Melanotan II has no approved human use, this definition is directly relevant for licensed athletes. ^{[4] [11]} Because the definition depends on the approval of a governmental health authority, afamelanotide, which is licensed in the EU, does not fall within this class.

What is the status of melanotan in Türkiye?

The guide covering the legal status of peptides in general: Are peptides legal? The meaning of the “for research purposes” label: What does research peptide mean?

Evidence table: claim, population and limits

Limits of this guide

This page summarizes the published evidence and official documents on melanotan and afamelanotide. It contains no individualized dose, preparation, administration method, cycle length or product source. Afamelanotide is a drug used only in adults diagnosed with EPP, at specialist centers; there is no licensed melanocortin product for tanning. The regulatory situation can change; the information on this page is valid as of October 2026.