MELANOTAN2.XYZ explains one synthetic melanocortin peptide, its chemistry and the rules around it. There is no shop here.
Melanotan 2
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Rules & safety

Rules and safety

In brief: No medicines regulator has approved Melanotan 2 for any use. Several have issued public warnings about unlicensed products, and research-grade material is not made or tested for human use.

Unlike its relatives afamelanotide and bremelanotide, Melanotan 2 has never been through a full approval process. Its legal position therefore depends largely on how a product is presented and on each country's medicines law.

What regulators have said

  • United Kingdom: since 2008 the MHRA has warned that injectable Melanotan products are unlicensed medicines that have not been tested for safety, quality or effectiveness, and it has repeatedly acted to remove them from sale.
  • Ireland: the HPRA has reminded the public that Melanotan 2 is not authorised by any medicines regulator, listing new or darkening moles, possible loss of vision, muscle tremors, stroke and anaphylaxis among the serious risks.
  • Denmark: the Danish Medicines Agency issued warnings in 2008 and 2011, pointing out that the product's effects and side effects had never been investigated.
  • United States: the FDA has not approved Melanotan 2. In 2007 it sent a warning letter to a company marketing it, treating the product as an unapproved new drug.
  • Australia: the TGA classes Melanotan II as prescription-only, has approved no product containing it, and found inconsistent amounts in seized products it tested.

Sport

The World Anti-Doping Agency's Prohibited List includes a catch-all section (S0) for substances without approval for human therapeutic use. Athletes should check with their national anti-doping organisation before handling any such product.

Reported safety concerns

Most safety information comes from case reports and reviews by doctors who treated people after unsupervised use. They describe associations, not proven causes, and the amount taken and the purity of the product are usually unknown.

  • Moles and pigment cells: clusters of new moles appearing within weeks (eruptive naevi), and changes in existing moles that made them hard to tell apart from melanoma under dermoscopy. A few melanomas have been reported during or soon after use, although a direct link has not been proven.
  • Common short-term effects: nausea, facial flushing, headache, loss of appetite, yawning and tiredness, broadly matching what the 1996 pilot study recorded.
  • Serious systemic reactions: single case reports of rhabdomyolysis (muscle breakdown) with kidney injury, of renal infarction, and of posterior reversible encephalopathy syndrome, a form of brain swelling.
  • Priapism: a painful, prolonged erection has been described after a large amount was taken.
  • Injection hazards: regulators point to infection and contamination when powders are mixed and injected outside medical settings.

Why the risks are hard to judge

  • No long-term data: no study has followed people over years.
  • Uncertain contents: products sold online may contain more or less peptide than labelled, or something else entirely.
  • Broad receptor action: because it acts on several receptor types, effects can appear in the skin, brain, gut and blood vessels at the same time.
  • Unstudied groups: nothing is known about pregnancy, adolescents or people with existing illness.

Summary

Melanotan 2 is an unapproved compound that medicines regulators actively warn against outside legitimate research. Anyone with a health question about it should speak to a doctor.

This page is general information, not legal advice.

Sources

  1. Evans-Brown M, Dawson RT, Chandler M, McVeigh J. Use of melanotan I and II in the general population. BMJ. 2009;338:b566. PMID 19224885
  2. Cousen P, Colver G, Helbling I. Eruptive melanocytic naevi following melanotan injection. Br J Dermatol. 2009;161(3):707-708. PMID 19575725
  3. Mang R, Krahl D, Assmann T. Dermoscopic changes in melanocytic nevi during use of melanotan II [in German]. Hautarzt. 2012;63(11):880-884. PMID 23052015
  4. Nelson ME, Bryant SM, Aks SE. Melanotan II injection resulting in systemic toxicity and rhabdomyolysis. Clin Toxicol (Phila). 2012;50(10):1169-1173. PMID 23121206
  5. Devlin J, Pomerleau A, Foote J. Melanotan II overdose associated with priapism. Clin Toxicol (Phila). 2013;51(4):383. PMID 23537392
  6. Kaski D, Stafford N, Mehta A, et al. Melanotan and the posterior reversible encephalopathy syndrome. Ann Intern Med. 2013;158(9):707-708. PMID 23648958
  7. Hjuler KF, Lorentzen HF. Melanoma associated with the use of melanotan-II. Dermatology. 2014;228(1):34-36. PMID 24355990
  8. Habbema L, Halk AB, Neumann M, Bergman W. Risks of unregulated use of alpha-melanocyte-stimulating hormone analogues: a review. Int J Dermatol. 2017;56(10):975-980. PMID 28266027
  9. Peters B, Hadimeri H, Wahlberg R, Afghahi H. Melanotan II: a possible cause of renal infarction: review of the literature and case report. CEN Case Rep. 2020;9(2):159-161. PMID 31953620
  10. Health Products Regulatory Authority (Ireland). Reminder of serious health risks with Melanotan 2 self-tan products. hpra.ie
  11. Danish Medicines Agency. Warning against the tanning product Melanotan (20 June 2011). laegemiddelstyrelsen.dk
  12. Therapeutic Goods Administration (Australia). Melanotan II tanning peptide products found to be inconsistently dosed. tga.gov.au
  13. Medicines and Healthcare products Regulatory Agency. Freedom of information response on Melanotan II (FOI 24/274). gov.uk