As of September 2026, Melanotan II has never been approved by the FDA or the EMA. One small placebo-controlled study, in ten men in 1998, looked at erections. The other human data on this record are case reports, and they include kidney injury and melanoma. It is sold only as an unregulated research chemical, and purity varies widely between sellers. So nothing on the outside of a vial tells you what is inside.
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What is Melanotan II?
Melanotan II is a lab-made compound modeled on melanocyte-stimulating hormone and meant to tan skin without UV light. It was developed in the 1980s at the University of Arizona. It was never developed into a medicine approved by the FDA or the EMA, and it circulates as an unregulated tanning product.
Does Melanotan II work?
Nobody knows. One double-blind, placebo-controlled crossover study in ten men, published in 1998, looked at erections. Its abstract does not say the men were assigned by chance, so it is not counted here. The other human data on this record are case reports with no comparison group.
What we found. 0 completed randomized trials counted. 1 double-blind, placebo-controlled crossover study in ten men, from 1998. Its abstract does not say the men were assigned by chance, so it is not counted. 4 published case reports in people.
| Study | Tested in | Status | What it shows |
|---|---|---|---|
| Case report on Melanotan II as a possible cause of renal infarction | People | Published | It named Melanotan II as a possible cause of renal infarction, a loss of blood supply to part of the kidney |
| Case report on systemic toxicity and rhabdomyolysis after Melanotan II | People | Published | Use was associated with body-wide toxic effects and with rhabdomyolysis, a breakdown of muscle |
| Case report on melanoma associated with Melanotan II use | People | Published | Melanoma was diagnosed in a patient who had used it, which raised a possible causal concern |
| Case report on eruptive dysplastic nevi after melanotan use | People | Published | Multiple new dysplastic nevi, a kind of atypical mole, were seen after melanotan use |
| Melanotan II and erections in ten men with erectile dysfunction | People | Published in 1998. Double-blind, placebo-controlled, crossover | The authors reported that it started erections in men whose erectile dysfunction had no known physical cause. Ten men, short term |
A case report can raise a warning. It cannot show how often the harm happens.
How we count a trialIs Melanotan II safe?
Published case reports describe kidney injury, rhabdomyolysis (a breakdown of muscle), priapism (a prolonged erection), new moles and melanoma in people who used it. These reports have no comparison group, so nobody knows how often such events happen against the background rate. The record adds that purity varies widely between unregulated sellers, which adds to the risk and leads on to the vial.
Is Melanotan II legal?
- United States
- Not approved by the FDA. It is sold only as an unregulated research chemical.
- European Union
- No marketing authorisation from the EMA.
- Sport
- Not named on WADA's list. That is not clearance.
- Related medicine
- Melanotan II was the chemical starting point later modified into bremelanotide, the ingredient in Vyleesi, which the FDA approved. That approval does not extend to Melanotan II.
Not medical advice. Approval and sport status as of . Medical disclaimer
What is in a vial sold as Melanotan II?
Melanotan II is sold only as an unregulated research chemical, and the record says purity varies widely between sellers. No vial sold today has been through a trial. A "research use only" label guarantees nothing about purity. A certificate of analysis counts only if it names your lot number, a lab with no stake in the result, and the method used. Purity and identity are separate tests.
Three questions to ask the seller:
- Which lot number is this certificate for?
- Who ran the test, and are they independent of you?
- Does the report confirm identity by mass spectrometry, or purity alone?
What don't we know?
- Whether Melanotan II caused the harms in the case reports. The reports stop at a possible link.
- What share of users are harmed. No study has measured it.
- Whether it does what users hope for. One ten-man study from 1998 is not enough to say.
- What is in any given vial. Purity varies widely between sellers.
The other side
A personal result is real to the person who had it. It cannot show how often the reported harms occur, or what else was in the vial.
What would change this record?
- A study or a safety registry that follows confirmed Melanotan II users forward in time and tracks skin and kidney outcomes.
Change log
- Corrected: the record said no controlled human study exists. One small placebo-controlled study from 1998 is now listed. The count stays at zero, because its abstract does not say it was randomized.
- Record checked. No change logged yet.
Three questions to ask next
- What does 'research use only' actually mean?
- How can you tell if a peptide vendor is legitimate?
- How do you read a certificate of analysis?
Ask better questions.
More questions about Melanotan II
Is Melanotan II approved by the FDA?
- No. Melanotan II has never been approved by the FDA or the EMA. It is sold only as an unregulated research chemical.
Does Melanotan II cause melanoma?
- Nobody knows. One published case report describes melanoma diagnosed in a patient who had used it, and it raises a possible causal concern. With no controlled study of skin cancer risk, the true rate against the background rate is unknown.
Has Melanotan II been tested in people?
- Once, on a small scale. A double-blind, placebo-controlled crossover study in ten men was published in 1998. The other human data on this record are case reports.
Is Melanotan II the same as Melanotan I?
- No. Melanotan I is another name for afamelanotide, which the FDA and the EMA approved for one rare disorder of painful light sensitivity. Melanotan II has never been approved by the FDA or the EMA.
Is Melanotan II the same as bremelanotide?
- No. Melanotan II was the chemical starting point that was later modified into bremelanotide, the ingredient in the FDA-approved medicine Vyleesi. Melanotan II itself has never been approved by the FDA or the EMA.
Record checked on . Each source shows the date it was checked.
In the same group
Often confused with Afamelanotide (Scenesse). The FDA and the EMA approved afamelanotide, also called Melanotan I, for one rare light-sensitivity disorder, and they have never approved Melanotan II.