Library / Skin and hair
Melanotan II
Also known as MT-II, MT2
Failed trials
Synthetic cyclic analogue of alpha melanocyte stimulating hormone that darkens skin and affects sexual arousal. Early human studies did not lead to approval; case reports describe serious adverse effects.
Not an approved medicine. Melanotan II is not an approved medicine for this use in Australia or the United States. This page summarises published research for information only. It is not a recommendation to use Melanotan II, and VialOwl does not sell or supply it.
Background
Melanotan II is a synthetic, ring shaped copy of part of alpha melanocyte stimulating hormone. It was developed at the University of Arizona in the late 1980s and 1990s while researching sunless tanning as a way to reduce skin cancer, and the first small human study was published in 1996. The approved sexual desire drug bremelanotide was later derived from it.
How it is thought to work
It switches on several melanocortin receptors at once. Activating MC1R in pigment cells darkens the skin, while activating MC3R and MC4R in the brain affects appetite, sexual arousal and erections.
What is claimed, and the evidence
| Claim | Evidence | Notes |
|---|---|---|
| Skin tanning without sun exposure | Small human studies | A 1996 pilot phase I study in 3 men showed increased pigmentation; never approved. |
| Erections and sexual desire in men with erectile dysfunction | Small human studies | Placebo controlled crossover studies in 20 men found erections in 17; severe nausea in about 13 per cent at the dose tested. Not developed further for this use. |
| Protection against skin cancer or sunburn | No published evidence | Not shown in humans; case reports instead describe melanoma arising in users. |
| Appetite suppression and weight loss | No published evidence | Suggested by the receptor biology and user reports; no human trials. |
Side effects
| Effect | How often | Notes |
|---|---|---|
| Nausea | Common | Reported at most dose levels in early studies; severe in about 13 per cent at 0.025 mg/kg in the ED studies. |
| Yawning and stretching | Common | Frequently reported in human studies. |
| Spontaneous erections | Common | Occurred for hours after dosing in early studies. |
| Facial flushing, tiredness, somnolence | Common | Reported in early human studies and user reports. |
| New or darkening moles and freckles | Common | Widely reported; the pigmenting effect is not selective. |
| Melanoma Serious | Case reports | Multiple case reports of melanoma, including in young users combining it with sunbeds, and one of oral mucosal melanoma after nasal spray use. |
| Priapism (prolonged painful erection) Serious | Case reports | Case reports, including one with loss of erectile function at follow up. |
| Rhabdomyolysis, kidney injury and sympathomimetic toxicity Serious | Case reports | Case report of muscle breakdown and kidney dysfunction after an internet product was injected; a case of kidney infarction also reported. |
| Posterior reversible encephalopathy syndrome (brain swelling) Serious | Case reports | Case reports cited by FDA. |
Warnings
- Case reports link Melanotan II to melanoma and to new or changing moles; any changing mole needs medical review.
- Serious case reports also include priapism, kidney injury, rhabdomyolysis and brain swelling (PRES).
- Prescription only (Schedule 4) in Australia and not approved as a tanning agent; the TGA found seized nasal sprays labelled 30 mg contained between 22 and 54 mg.
- Unapproved products are not assessed by the TGA for quality, safety or efficacy and may be contaminated, non-sterile, underdosed, overdosed or contain a different substance altogether.
Regulatory status
- Australia
- Not included on the ARTG (unapproved). Schedule 4 in the Poisons Standard.
- United States
- Not FDA approved. Nomination withdrawn and removed from 503A Category 2 in April 2026; FDA previously cited serious adverse events including melanoma and posterior reversible encephalopathy syndrome.
Sources
- PubMed: Evaluation of melanotan-II, a superpotent cyclic melanotropic peptide in a pilot phase-I clinical study
- PubMed: Melanocortin receptor agonists, penile erection, and sexual motivation: human studies with Melanotan II
- PubMed: Melanoma associated with the use of melanotan-II
- TGA: Melanotan II tanning peptide products found to be inconsistently dosed (17 August 2026)
- FDA: Certain bulk drug substances for use in compounding that may present significant safety risks (updated 22 April 2026)
- PubMed: Melanotan II injection resulting in systemic toxicity and rhabdomyolysis
- Poisons Standard June 2026 (Federal Register of Legislation)
Also in Skin and hair
From the VialOwl library, reviewed 26 September 2026. For education and general information. It is not medical advice and not a recommendation to use Melanotan II.