What it is
Melanotan II is a lab-made copy of part of a natural hormone called α-MSH. This hormone tells skin cells to make melanin, the dark pigment in skin. Melanotan II is shaped as a closed ring. The ring shape makes it very strong and makes it last a long time.
It does not only act on the skin. It also switches on related targets (receptors) in other places, including the brain. So the early human studies saw more than tanning. People also had erections that came on by themselves. They also had nausea (feeling sick), yawning and less hunger. The researchers had not been looking for these effects.
No medicine with Melanotan II has ever been approved anywhere. US and Australian regulators have acted against people selling it as a tanning shot or nasal spray. The UK regulator says it has taken melanotan products off sale many times. Tests have shown these products often do not contain what the label says.
Melanotan II (Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-NH2, C50H69N15O9, 1024.2 g/mol) is a cyclic heptapeptide based on α-MSH(4-10). A lactam bridge between Asp5 and Lys10 constrains the His-D-Phe-Arg-Trp core, and Nle4 with D-Phe7 carries over the stability gains of afamelanotide. Its developers describe it as a non-selective melanocortin receptor agonist (Wessells et al. 2000), and pharmacology studies use it as an MC3R and MC4R agonist. Melanocortin receptor agonism on melanocytes drives eumelanin synthesis via Gs and cAMP; central melanocortin receptor agonism is thought to explain the erectile, appetite-suppressing and yawning–stretching effects.
No published human pharmacokinetic study was found for this article. Bremelanotide, the approved drug in the same family, differs from Melanotan II only by a C-terminal carboxylic acid in place of the amide, and its label reports a subcutaneous half-life of about 2.7 hours; that figure should not be assumed to apply to Melanotan II.
Who made it and when
Melanotan II was made at the University of Arizona in the late 1980s. The team was led by Victor Hruby and Mac Hadley. The same team made Melanotan I. They wanted a stronger way to tan without the sun.
In 1996, a tiny safety study tested it in three men. Two of them got a tan. The men also had erections, which the study was not looking for. In 1998, a second study tested it in ten men with erection problems. This side effect became the more promising lead. A company called Palatin Technologies later made bremelanotide, an almost identical drug. It became the approved medicine Vyleesi. Melanotan II itself was never fully developed as a medicine.
Al-Obeidi, Hadley, Hruby and colleagues described cyclic lactam α-MSH analogues designed with molecular-dynamics modelling in J Med Chem in 1989. Dorr et al. (Life Sci 1996) reported a single-blind, alternating-day, placebo-controlled pilot in three healthy men at 0.01 to 0.03 mg/kg subcutaneously, noting increased pigmentation in two of the three men, intermittent spontaneous erections for 1–5 hours after dosing depending on the dose, mild nausea and, at 0.03 mg/kg, grade II somnolence and fatigue in one man. Wessells et al. (J Urol 1998) ran a double-blind crossover in 10 men with psychogenic erectile dysfunction at 0.025 mg/kg.
Palatin Technologies developed bremelanotide (PT-141), which differs from Melanotan II only at the C-terminus; early Palatin studies used an intranasal formulation (Diamond et al. 2004) before the programme moved to subcutaneous injection. No company is known to be developing Melanotan II itself for approval.
What the data say
There is very little good human evidence. One study had three men. Another had ten men. Both were in the 1990s. No human trial of Melanotan II was registered on ClinicalTrials.gov when this was checked (1 November 2026). The early studies showed darker skin and erections. Nausea was the most common complaint.
Most of what we know about safety comes from case reports. These are reports by doctors about single patients. The patients had bought unregulated products. Doctors saw moles that suddenly got darker or more common. They saw a small number of melanomas (a serious skin cancer). They also saw painful erections that would not go away. Some people had PRES, a brain-swelling condition. Some had muscle breakdown. Case reports cannot prove the drug caused these problems. No one knew what was really in the products. No study has checked whether Melanotan II protects against skin cancer.
Controlled data: n=3 (Dorr 1996) and n=10 (Wessells 1998; erections in 8 of 10, mean tip rigidity above 80% for 38.0 vs 3.0 minutes, p=0.0045). Wessells et al. also reported a study in men with organic erectile dysfunction (Urology 2000). No registered human trial of melanotan II was found on ClinicalTrials.gov as of 2026-11-01.
Case literature: Habbema et al. (Int J Dermatol 2017) reviewed reports of eruptive and changing naevi with unregulated melanotan use and four melanomas arising from existing moles during or shortly after use, noting that conclusive evidence of causation is lacking. Further reports include posterior reversible encephalopathy syndrome (Kaski et al., Ann Intern Med 2013), priapism (Devlin 2013; Dreyer 2019; Mallory 2021), systemic toxicity with rhabdomyolysis (Nelson 2012) and, in 2026, five primary melanomas in situ in one patient who also used tanning beds and anabolic hormones (Vadner and Smith, JAAD Case Rep 2026;73:111-114, PMID 42328529). Dickson et al. (Cureus 2025;17:e98297, PMID 41487785) report a 65-year-old woman whose abdominal “Melanotan” injection sites (product not specified) ulcerated and were diagnosed as pyoderma gangrenosum, healing on prednisolone and topical steroid; the authors describe it as the first reported melanotan-induced case. Ume et al. (Clin Exp Dermatol 2026;51:1971-1974, PMID 42212476) describe vitiligo-like depigmentation of the neck, jaw and cheeks after about 1.5 months of daily self-injection of an unverified melanotan product, with partial repigmentation after stopping. Sidhu et al. (Int J Dermatol 2026;65:1343-1344, PMID 41559011) describe unregulated melanotan use promoted via social media, and Moiz et al. (Mo Med 2026;123:337-343, PMID 42757290) list melanotan II among unapproved “biohacking” injectables, citing contamination, dosing and carcinogenesis risks. FDA cited melanoma, PRES, sympathomimetic toxidrome and priapism when it placed Melanotan II in Category 2.
Regulatory picture
Here are three separate facts.
Approval: The FDA has not approved any product with Melanotan II. No other major regulator has either.
Pharmacy mixing (compounding): In 2023, the FDA put Melanotan II in “Category 2”. This is its list of substances that may be seriously unsafe when pharmacies mix them. By April 2026, the FDA said whoever put it forward had withdrawn it from that list. That does not make it allowed. It is still not on the list of ingredients pharmacies may use.
Enforcement: In 2007, the FDA warned an American seller. The owner was later found guilty. The UK regulator (MHRA) says it has taken melanotan products off sale many times for more than 10 years. In August 2026, Australia’s regulator (TGA) reported fines for illegal supply. Its lab also found nasal sprays with the wrong amount of drug.
Approval: none. No IND-stage programme with a US sponsor could be verified.
Compounding: Melanotan II was placed in Category 2 of the interim 503A policy on 2023-09-29. FDA’s page updated 2026-04-22 lists it among substances “previously in category 2 of the interim policies” that “were withdrawn by the nominators”. It is not a component of an approved drug, has no USP monograph and is not on the 503A bulks list (21 CFR 216.23), and it was not reviewed at the July 2026 Pharmacy Compounding Advisory Committee meeting. This article records compounding status as unknown.
Enforcement: FDA issued a warning letter on 2007-08-30 to a US company selling Melanotan II; its president pleaded guilty in 2015 to conspiracy under 18 U.S.C. 371 and FDA proposed permanent debarment on 2016-08-05. In Australia Melanotan II is a prescription-only medicine with no product on the ARTG; the TGA’s advisory of 2026-08-17 reported 27 infringement notices, paid in May 2026. The UK’s MHRA stated in 2021 that melanotan tanning products are not automatically medicines under UK law but that it had removed such products from sale for over 10 years. In sport it is not named on WADA’s list and falls under S0, non-approved substances.
