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of substances compounding pharmacies may use and placed in Category 2 (significant safety risk); the nomination was withdrawn and the FDA removed it from that category in April 2026, with an advisory committee review planned, which does not make it legal to compound or sell. 1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 cyclic seven-amino-acid analog of alpha-melanocyte-stimulating hormone, developed at the University of Arizona in the 1990s as a potential sunless tanning drug. Unlike Melanotan I, it was never carried through to approval; its erection-inducing side effect was spun out as bremelanotide (Vyleesi), which is approved for low sexual desire in premenopausal women. 2
Melanotan II itself has no approved form anywhere. It is sold online as a lyophilized powder for self-injection. The FDA placed it in Category 2 of its compounding bulk-substance list, flagging significant safety risks; the nominator later withdrew, the FDA removed it from the category in April 2026, and 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. At MC1R on skin melanocytes it drives eumelanin production, hence the tan. At MC4R in the hypothalamus it triggers penile erection, suppresses appetite, and causes nausea and yawning; MC3R activation adds to the metabolic effects. The 1996 pilot study recorded this full set of 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 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 somnolence and fatigue at the highest trial dose, and a stretching-and-yawning complex preceded spontaneous erections lasting one to five hours after injections. 2
Since then the published human literature consists of case reports: a 20-year-old woman with fair skin who developed melanoma after a course of Melanotan II combined with sunbed use, and dermatology reports from 2008 and 2009 of users whose moles darkened, enlarged, or changed in ways that mimicked melanoma. These reports cannot prove causation, 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
Known acute effects from the pilot study and case reports are nausea, flushing, fatigue, appetite loss, and prolonged erections. Darkening and changes in moles are frequent enough that dermatologists have warned about melanoma being missed or possibly promoted. Because the products are unregulated, users do not know what they are injecting, and there are no data 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 and, after the nomination was withdrawn in 2026, 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