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Afamelanotide (Scenesse)

Also known as Scenesse, Melanotan I and NDP-MSH.

Approved in the US and the EU for adults with EPP, a rare disorder of painful skin reactions to light. Skin cancer risk over many years is still being tracked.

SerTyrSerNleGluHisPheArgTrpGlyLysProVal
13 amino acids, in order. A double ring marks a mirror-image, modified or non-standard one. End caps, bridges and anything attached to the chain are not drawn. Source: PubChem.
Human evidence
Grade A

Large trials

Completed randomized trials
3+

The plus sign marks a floor: the record counts more trials than it lists.

Approved?
US and EU

Approved in the US and the EU

Sport (WADA)
Not named

Not named on WADA's list. That is not clearance.

Checked on .

How we count a trial
Short answer

As of September 2026, afamelanotide is an approved medicine in the US and the EU for adults with EPP, a rare disorder of painful skin reactions to light. The approval rests on three randomized trials. Skin cancer risk over many years is still being tracked. A vial that reaches you outside medical care was not in those trials, and you cannot see from the outside what it holds.

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What is afamelanotide?

Afamelanotide is a lab-made version of alpha-MSH, a natural hormone that triggers skin pigment production. It was created in the 1980s at the University of Arizona as a possible sunless-tanning compound. An Australian company, later Clinuvel, licensed it and developed it as a medicine, approved in the EU in 2015 and in the US in 2019.

Does afamelanotide work?

For its approved use, the FDA and the EMA reviewed the trials and approved it. That use is reducing light sensitivity in adults with erythropoietic protoporphyria (EPP), a rare genetic disorder that causes severe, painful skin reactions to light.

What we found. 3+ completed randomized trials counted on the record. 2 study rows listed below. The first row names all three trials, so the number shows with a plus sign until each trial has a row of its own.

Studies on the afamelanotide record: each study, what it was tested in, its status and what it shows.
Approval trials CUV029, CUV030 and CUV039PeopleCompleted. The basis for approval, 244 people in totalPeople given afamelanotide tolerated significantly more pain-free sunlight than people given a dummy version without it
Monitoring of skin color changes after approvalPeopleOngoing since the 2015 and 2019 approvalsConfirmed skin darkening and the need for continued skin checks
How we count a trial

Is afamelanotide safe?

This record flags one effect. Afamelanotide darkens skin and existing moles, and its label requires skin exams for that reason. Monitoring since approval has confirmed the darkening. The trials behind the approval were short, and data on skin cancer risk over many years are still being collected. That is the picture for the maker's product. Anything else carrying the name is the subject of the next section.

What is in a vial sold as afamelanotide?

The trials above tested the maker's product. This 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. If a vial reached you outside medical care, none of those trials tested it, and the checklist lists what to ask the seller.

What don't we know?

  • Whether it raises skin cancer risk over many years. Those data are still being collected.
  • What long use does to moles and other pigmented spots. The approval trials were short.
  • Whether it helps in any condition besides EPP. This record lists no trial outside EPP.
  • What is in any vial that did not come through medical care.

The other side

The approved product comes with medical care attached. Its label requires skin exams, because it darkens skin and moles. Three randomized trials stand behind the approval. The open questions are skin cancer risk over many years, and any vial from outside that care.

What would change this record?

  • Longer-term registry or safety-monitoring data confirming no excess cancer risk in pigmented skin spots.

Change log

  • Amino acid sequence corrected. Position 7 is the mirror-image (D) form of phenylalanine. The record had listed the standard form. PubChem (opens in new tab)
  • Record checked. No change logged yet.
Every change on the Table

Three questions to ask next

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More questions about afamelanotide

What is afamelanotide used for?

To reduce light sensitivity in adults with EPP, a rare genetic disorder that causes painful skin reactions to light. That is its approved use in the US and the EU.

Is afamelanotide approved for tanning?

No. It was created as a possible sunless-tanning compound, and the one approved use on this record is EPP.

Is afamelanotide the same as Melanotan I?

Yes, on this record. It lists Melanotan I and NDP-MSH as other names for afamelanotide.

Is afamelanotide the same as Melanotan II?

No. Afamelanotide is an approved medicine for EPP. Melanotan II has never been approved by the FDA or the EMA, and its record holds no controlled human trial.

Is afamelanotide banned in sport?

It is not named on WADA's list. The record gives no sport source for that. If you compete, check the current List.
Sources

Record checked on . Each source shows the date it was checked.

Other approved drugs

In the same group

Often confused with Melanotan II (MT-2). Melanotan II has never been approved by the FDA or the EMA and has no controlled human trial, while afamelanotide is an approved medicine for one rare disorder.

All 18 in this group
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