How do the two records compare?
One is an approved medicine with three completed randomized trials behind it, and the other has one small controlled study from 1998 and no completed randomized trial. Neither is named on WADA's list, and that is not clearance. A completed randomized trial is a finished study that assigns people by chance to the compound or to a comparison. The Table counts only those.
| Melanotan II (MT-2) | Afamelanotide (Scenesse) | |
|---|---|---|
| What it is | A lab-made compound modeled on melanocyte-stimulating hormone, meant to tan skin without UV light | A lab-made version of alpha-melanocyte-stimulating hormone, approved for one rare disorder |
| Human evidence | Grade D: no randomized trial | Grade A: large trials |
| Completed randomized trials | 0 | 3+ |
| Approved? | Not approved in the US or the EU | Approved in the US and the EU |
| Sport | Not named on WADA's list | Not named on WADA's list |
| Checked on | 22 Sep 2026 | 22 Sep 2026 |
- A lab-made compound modeled on melanocyte-stimulating hormone, meant to tan skin without UV light
- Grade D: no randomized trial
- 0
- Not approved in the US or the EU
- Not named on WADA's list
- 22 Sep 2026
- A lab-made version of alpha-melanocyte-stimulating hormone, approved for one rare disorder
- Grade A: large trials
- 3+
- Approved in the US and the EU
- Not named on WADA's list
- 22 Sep 2026
Every cell but the first is a field from the records. A plus sign marks a floor: the afamelanotide record counts three trials in one row, so the plus stands until each has its own row and registry ID.
What does each name stand for?
Scenesse is the brand name of afamelanotide, a lab-made version of alpha-melanocyte-stimulating hormone, a natural hormone that triggers skin pigment production. Melanotan II is a different lab-made compound, modeled on melanocyte-stimulating hormone and meant to tan skin without UV light.
The two share an origin that both records give. Both compounds were created in the 1980s at the University of Arizona as possible sunless-tanning compounds. Afamelanotide was licensed to an Australian company and became a medicine, approved in the EU in 2015 and in the US in 2019. Melanotan II was never developed into a medicine approved by the FDA or the EMA, and it circulates as an unregulated tanning product.
Two more names add to the confusion. The afamelanotide record lists "Melanotan I" as another name for afamelanotide, so Melanotan I and Melanotan II are different compounds with different records. And Melanotan II was the chemical starting point later modified into bremelanotide, the ingredient in Vyleesi, which the FDA approved. That approval does not reach Melanotan II.
What was tested in people, and under which name?
Afamelanotide went through three randomized trials against a dummy version without the drug, the basis for its approval, under the trial names CUV029, CUV030 and CUV039. Melanotan II has one small placebo-controlled study on its record, in ten men in 1998. The rest of its human data are case reports.
Across the three trials, 244 people in total, those given afamelanotide tolerated significantly more pain-free sunlight than those given the dummy version. Monitoring since the approvals has confirmed skin darkening and the need for continued skin checks.
The Melanotan II record holds four published case reports:
- renal infarction, a loss of blood supply to part of the kidney, with Melanotan II as a possible cause;
- systemic toxicity with rhabdomyolysis, a breakdown of muscle;
- a melanoma diagnosed in a person who had used it, raising a possible causal concern;
- eruptive dysplastic nevi, new atypical moles, after melanotan use.
A case report has no comparison group. It can raise a warning, and it cannot say how often the harm happens. The fourth report's title says "melanotan" with no number, so it may not be about Melanotan II alone.
Which one is approved, and for what?
Scenesse is approved, for one use on its record: reducing light sensitivity in adults with erythropoietic protoporphyria, or EPP. The EMA approved it in 2015 and the FDA in 2019.
EPP is a rare genetic disorder that causes severe, painful skin reactions to light. Tanning is not an approved use: EPP is the one approved use on its record. Because it darkens skin and existing moles, its label requires skin exams. Melanotan II has never been approved by the FDA or the EMA, for tanning or for anything else, and it is sold as an unregulated research chemical. Our records check those two regulators only.
What is banned in sport?
Neither name is on WADA's list, by both records, and that is not clearance. Neither record has a sport source behind that line.
The site's other pages describe WADA's class S0: it bans, at all times, any substance with no current approval from a government health authority for human use. Melanotan II has no US or EU approval, so that class may reach it without naming it. If you compete, check both names on Global DRO, the checker the anti-doping agencies run.
What can nobody tell you about your vial?
Nobody can tell you from the outside what a vial sold as melanotan holds. Melanotan II is sold as an unregulated research chemical, and its record says purity varies widely between sellers. No vial sold today has been through a trial.
The approved product is a different case. Scenesse comes with medical care attached and skin exams on its label. The afamelanotide record holds no sign that afamelanotide itself is sold outside medical channels. It does say that related, unapproved Melanotan peptides circulate for cosmetic tanning, with safety concerns of their own. Because Melanotan I is another name for afamelanotide, a vial labeled "Melanotan" alone tells you neither which compound was meant nor what is inside. 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. The checklist scores a seller on 20 criteria.
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 answer?
- For Melanotan II: a study or a safety registry that follows confirmed users forward in time and tracks skin and kidney outcomes. Its record names that as the change that would improve its evidence.
- For afamelanotide: longer-term registry or safety-monitoring data confirming no excess cancer risk in pigmented skin spots. The approval question is already settled on its record.
- A decision by the FDA or the EMA on Melanotan II, in either direction. Neither record mentions one.
Three questions to ask next
Every source below sits on one of the two records, checked 22 Sep 2026.
Regulators
- [1] FDA label, SCENESSE (afamelanotide) implant, NDA 210797 (opens in new tab). FDA, 2019. From the afamelanotide record
- [2] Updated FDA label (opens in new tab). FDA, 2024. From the afamelanotide record
Journals and papers
- [3] Pharmacokinetics and Pharmacodynamics of Afamelanotide (opens in new tab). From the afamelanotide record Paywalled
- [4] Melanotan II: a possible cause of renal infarction (opens in new tab). From the Melanotan II record Paywalled
- [5] Melanotan II injection resulting in systemic toxicity and rhabdomyolysis (opens in new tab). From the Melanotan II record Paywalled
- [6] Melanoma associated with the use of melanotan-II (opens in new tab). From the Melanotan II record Paywalled
- [7] Eruptive Dysplastic Nevi Following Melanotan Use (opens in new tab). From the Melanotan II record