Melanotan II
Melanocortin agonist (MC1R/MC3R/MC4R)
Also Melanotan 2, Melanotan-2, MT-2, MT-II, MT2, MTII
- Evidence
- CAnimal and cell studies
- FDA status
- Not approvedas of 2026-10-26
- Route
- Injection
- Studies cited
- 1 human0 animal or cell
It is an injection sold for a deep tan, less appetite and better erections. The only study had 3 men, and the rest is case reports of harm, including changing moles.
Sold for
Melanotan II is the 'Barbie drug' of gym and tanning culture, sold online as an injectable that gives a deep tan, suppresses appetite, and improves erections.
Studies say
A three-man pilot study in 1996 showed it darkens skin and causes erections and nausea, and the rest of the literature is case reports of harm, which is grade C evidence.
Why grade C. The human evidence is a 1996 pilot phase 1 study in three men, plus case reports of melanoma and changing moles in users. No controlled trial of Melanotan II has been published for tanning or any other use. 2345
FDA. Not approved by the FDA for any use and sold as an unregulated gray-market product. Melanotan II was nominated for the FDA's list of substances compounding pharmacies may use and placed in Category 2 (significant safety risk); the nomination was withdrawn and the FDA removed it from that category in April 2026, with an advisory committee review planned, which does not make it legal to compound or sell. 1
Written from 5 cited sources. Last refreshed 2026-10-27. Not physician reviewed.
What this means for you
- What people take it for
- Tanning, appetite and erections
- Can a US doctor prescribe it?
- No. It is not approved and is sold as an unregulated product.
- Properly tested in people?
- Not properly: animal or lab studies, or small uncontrolled human reports. One report of 3 men.
Evidence checklist
- Randomised controlled trial Three-man pilot study; case reports onlyno
- Human study over 100 people Three menno
- More than one research group No independent controlled studyno
- Clinical outcomes, not surrogate markers No health outcome measuredno
- Human safety data beyond case reports Case reports of harm; no long-term datano
Drawn from the cited studies below. A dash means the sources give no information.
What it is
Melanotan II is a ring-shaped peptide of seven amino acids. It is a lab-made version of a natural hormone, alpha-melanocyte-stimulating hormone. The University of Arizona developed it in the 1990s. The goal was a drug that tans skin without sun. Unlike Melanotan I, it never reached approval. One side effect was erections. That led to a spin-off drug, bremelanotide (Vyleesi). Vyleesi is approved for low sexual desire in premenopausal women. 2
Melanotan II itself has no approved form anywhere. Sellers offer it online as a freeze-dried powder to inject. The FDA put it in Category 2 of its compounding bulk-substance list. That category flags significant safety risks. The nominator later withdrew. The FDA removed it from the category in April 2026. A Pharmacy Compounding Advisory Committee review is planned before the end of February 2027. 1
How it works
Melanotan II is a non-selective melanocortin agonist. It acts on several receptors. At MC1R on skin melanocytes, it drives eumelanin production. That makes the tan. At MC4R in the hypothalamus, it triggers erection and suppresses appetite. It also causes nausea and yawning. MC3R activation adds to the metabolic effects. The 1996 pilot study saw all of these effects in its three volunteers. 2
What human research shows
The 1996 pilot phase 1 study gave three healthy men Melanotan II or saline on alternating days for two weeks. Two men developed measurable darkening of the face, upper body and buttocks a week after dosing stopped. Mild nausea occurred at most dose levels. One man had marked sleepiness and fatigue at the highest trial dose. After injections, a stretching-and-yawning pattern came first. Then came spontaneous erections lasting one to five hours. 2
Since then the published human literature has been case reports. One was a 20-year-old woman with fair skin who developed melanoma after a course of Melanotan II combined with sunbed use. Dermatology reports from 2008 and 2009 described users whose moles darkened, grew or changed in ways that looked like melanoma. These reports cannot prove cause. But they are the only outcome data available. 345
| Study | Model | Finding |
|---|---|---|
| Pilot phase 1 study (Dorr 1996) | Humans, n=3 healthy men, single-blind placebo-controlled | Increased pigmentation in two of three men; nausea, somnolence, and spontaneous erections at trial doses. 2 |
| Melanoma associated with Melanotan II (2014) | Human case report, 20-year-old woman | Melanoma diagnosed three months after a course of Melanotan II used with sunbeds. 5 |
Safety
The pilot study and case reports show these acute effects: nausea, flushing, fatigue, appetite loss and long erections. Moles often darken or change. Dermatologists have warned that melanoma could be missed or even promoted. Nobody regulates the products, so users do not know what they inject. No data exist on long-term use or on cancer risk over years. 1235
Questions for your clinician
- How should I watch moles if I have used a tanning peptide?
- Is there any controlled trial of this compound?
- How do I know what is in the product I bought?
Questions people ask
Is Melanotan II FDA-approved?
No. It has never been approved for anything. The FDA listed it as a significant safety risk for compounding. The nomination was withdrawn in 2026. After that, the FDA removed it from that category pending an advisory committee review. None of that permits sale. 1
Citations
- FDA: Certain bulk drug substances for use in compounding may present significant safety risks fda.gov
- Dorr 1996, Life Sci: Evaluation of melanotan-II in a pilot phase 1 clinical study pubmed.ncbi.nlm.nih.gov
- 2008, Arch Dermatol: Melanotan-associated changes in melanocytic nevi doi.org
- 2009, Br J Dermatol: Melanotan II use and atypical naevi doi.org
- 2014, Dermatology: Melanoma associated with the use of melanotan-II pubmed.ncbi.nlm.nih.gov