Melanotan II: what it is, what the studies show and where it stands
Melanotan II is a synthetic cyclic seven-amino-acid analog of alpha-melanocyte stimulating hormone. In small human studies it darkened skin and caused erections.
At a glance
US Not approved
Canada Not authorized
Group Skin and hair
Sources 12
Checked 10 Oct 2026What is Melanotan II?
Melanotan II is a synthetic cyclic seven-amino-acid analog of alpha-melanocyte stimulating hormone. In small human studies it darkened skin and caused erections. It has never been approved as a medicine. [1]
Other names: MT-II, Melanotan-II, Melanotan-2.
How it has been given to people: subcutaneous injection in the human studies.
Looking for doses? Melanotan II dosage chart and vial math
Is Melanotan II approved in the US and Canada?
United States: Not FDA approved. FDA told consumers to stop using it in 2007, and it sits on FDA's list of compounding substances that were in Category 2 (significant safety risks) before their nominations were withdrawn. [10]
Canada: Not authorized. Health Canada lists Melanotan I and II among unauthorized injectable peptide drugs it has seized and tells consumers not to buy or use them. [12]
Both were checked on 10 Oct 2026 against the regulators' own product databases.
Which approved products contain Melanotan II?
No approved medicine containing Melanotan II was found in the US or Canada. Anything sold under this name is not a regulated product, so there is no label to check a dose against.
What human studies of Melanotan II exist?
The 4 findings listed here: 4 from smaller or observational human studies.
In the 3-man pilot study, two men had measurably darker skin on the face, upper body and buttock one week after five low doses. [1]
In 10 men with psychogenic erectile dysfunction, 8 developed erections after Melanotan II. Tip rigidity above 80% lasted a mean 38.0 minutes against 3.0 minutes with placebo. [2]
In 10 men with erectile dysfunction and organic risk factors, erections were reported after 12 of 19 Melanotan II injections against 1 of 21 placebo doses. [3]
Across the 20 men in the two erectile dysfunction studies, 17 had an erection after Melanotan II without sexual stimulation. [4]
What are the side effects of Melanotan II?
Reported in human studies or on a label:
- Nausea was reported at most dose levels in the pilot study. [1]
- The highest pilot dose, 0.03 mg/kg, caused Grade II sleepiness and fatigue in one of two men. [1]
- Unprompted erections came and went for 1 to 5 hours after a dose, with stretching and yawning. [1]
- At 0.025 mg/kg, severe nausea followed 4 of 19 injections in one study. [3]
- Across the two erectile dysfunction studies, 12.9% of men had severe nausea at 0.025 mg/kg. [4]
- Case report: a 39-year-old man who injected 6 mg bought online developed a racing heart, muscle breakdown (rhabdomyolysis) and kidney dysfunction, and spent 3 days in intensive care. The product was confirmed as Melanotan II by mass spectrometry. [5]
- Case report: melanoma in a 20-year-old woman three months after a 3 to 4 week course of self-injections combined with sunbed use. A single case cannot prove cause. [6]
- Case report: prolonged painful erection (ischemic priapism) after a subcutaneous injection, which needed surgery. [7]
- Case report: kidney infarction that the authors judged most likely due to Melanotan II. [8]
- Case report: mucosal melanoma in the upper jaw of a 22-year-old woman who had used a Melanotan II nasal spray for tanning. A single case cannot prove cause. [9]
- FDA's summary of the published case reports. [10]
How does Melanotan II compare with others in its group?
These are the peptides filed under skin and hair. The last column says whether a randomized human trial is on record for each.
| Peptide | US | Canada | Half-life | Randomized human trial |
|---|---|---|---|---|
| GHK-Cu | Not approved | Not authorized | Not found | Yes |
| Melanotan II | Not approved | Not authorized | Not found | No |
What could not be found
These were searched for and did not turn up. They are listed so a missing number is not mistaken for a hidden one.
- Human half-life: no human pharmacokinetic study was found. The one pharmacokinetic paper found on PubMed was done in rats (PMID 7981427).
- No approved label anywhere, so no official dose, contraindications, interaction list or storage instructions.
- No fixed-milligram trial dose: every trial dose found is set per kilogram of body weight.
- No controlled human trial after 2000 was found, and no human trial of a nasal spray or of dosing longer than 2 weeks.
- A Health Canada advisory about Melanotan II alone was not found; it is named in Health Canada's general advisories on injectable peptides.
- ClinicalTrials.gov search for melanotan returned one record (NCT07437560, vitiligo, first posted 2026-02-27). It gives no dose and its own summary calls it an example study record, so it is not used here.
- Melanotan II is not named in the WADA 2026 Prohibited List. Whether the list's general class of non-approved substances S0 covers it was not determined.
Melanotan II questions
Is Melanotan II approved in the US?
Not FDA approved. FDA told consumers to stop using it in 2007, and it sits on FDA's list of compounding substances that were in Category 2 (significant safety risks) before their nominations were withdrawn.
Is Melanotan II authorized in Canada?
Not authorized. Health Canada lists Melanotan I and II among unauthorized injectable peptide drugs it has seized and tells consumers not to buy or use them.
Has Melanotan II been tested in a randomized human trial?
No randomized human trial was found. What exists is listed under the studies heading on this page.
Sources
Each one was opened on 10 Oct 2026 and matched to the line it supports.
- Dorr RT et al. Evaluation of melanotan-II, a superpotent cyclic melanotropic peptide in a pilot phase-I clinical study. Life Sci 1996. PubMed 8637402.
- Wessells H et al. Synthetic melanotropic peptide initiates erections in men with psychogenic erectile dysfunction: double-blind, placebo controlled crossover study. J Urol 1998. PubMed 9679884.
- Wessells H et al. Effect of an alpha-melanocyte stimulating hormone analog on penile erection and sexual desire in men with organic erectile dysfunction. Urology 2000. PubMed 11018622.
- Wessells H et al. Melanocortin receptor agonists, penile erection, and sexual motivation: human studies with Melanotan II. Int J Impot Res 2000. PubMed 11035391.
- Nelson ME et al. Melanotan II injection resulting in systemic toxicity and rhabdomyolysis. Clin Toxicol (Phila) 2012. PubMed 23121206.
- Hjuler KF et al. Melanoma associated with the use of melanotan-II. Dermatology 2014. PubMed 24355990.
- Mallory CW et al. Melanotan Tanning Injection: A Rare Cause of Priapism. Sex Med 2021. PubMed 33460908.
- Peters B et al. Melanotan II: a possible cause of renal infarction: review of the literature and case report. CEN Case Rep 2020. PubMed 31953620.
- Yassin Alsabbagh A et al. Melanotan II nasal spray: a possible risk factor for oral mucosal malignant melanoma? Int J Oral Maxillofac Surg 2025. PubMed 40210573.
- US Food and Drug Administration Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks 2026. fda.gov.
- US Food and Drug Administration FDA Issues Warning Letter to Melanocorp, Inc. For Illegal Sale of Melanotan II 2007. web.archive.org.
- Health Canada Think twice before injecting peptides bought online: unauthorized products can seriously harm you 2026. recalls-rappels.canada.ca.
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