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Afamelanotide

Melanocortin receptor agonist · Scenesse

UK status
Licensed, but not for anything cosmetic
Availability
Specialist centres, for one rare condition
Evidence base
Human RCT for its licensed indication
Controlled drug
No

Sequence

A synthetic analogue of alpha-MSH, also called Melanotan I.

The short version

What it does

Lets people with a rare inherited condition tolerate light. For them, sunlight causes severe burning pain within minutes, and this raises the threshold at which that starts.

How it does it

Increases the pigment in your skin, which absorbs light before it can trigger the reaction that causes the pain. It is delivered as a small implant under the skin, not an injection you give yourself.

The catch

This is the licensed cousin of melanotan II, and it is licensed for one rare disease, not for tanning. That distinction gets deliberately blurred by people selling the unlicensed version.

Everything below goes into the detail, with sources.

Afamelanotide is the compound melanotan II is constantly confused with, and the confusion is useful to somebody. This one went through proper development, got approved by two major regulators, and is used in specialist centres for a rare and genuinely awful condition.

At a glance

Compound type
Peptide, an alpha-MSH analogue
Also called
Melanotan I
Brand
Scenesse
Route
An implant placed under the skin by a clinician
Frequency
Every two months, in its licensed use
Licensed indication
Erythropoietic protoporphyria, a rare inherited light-sensitivity disorder
Approvals
EMA 2014, FDA 2019
Not licensed for
Tanning, cosmetic use, or anything else
In sport
Check the current WADA Prohibited List and UKAD.

01What it is

Erythropoietic protoporphyria, EPP, is a rare inherited disorder in which sunlight causes severe burning pain in the skin within minutes, without necessarily any visible burn. People with it often live indoors. There has been almost nothing to offer them.

Afamelanotide, also called Melanotan I, is a synthetic analogue of alpha-MSH that increases skin pigmentation. More pigment absorbs more light before it reaches the point of triggering the reaction, which raises the time someone can tolerate being outside.

The distinction that gets blurred deliberately

Afamelanotide is Melanotan I. The unlicensed tanning product sold online is melanotan II. They are different molecules with different receptor profiles, and only one of them has ever been approved for anything.

Sellers of melanotan II frequently point at Scenesse as evidence that "melanotan is an approved medicine". It is not the same compound, and the approval is for a rare disease, not for a tan.

02How it came about

Afamelanotide came out of the same 1980s University of Arizona research on alpha-MSH analogues that produced melanotan II and, on a separate branch, bremelanotide.

It was developed by Clinuvel Pharmaceuticals as an implant, and approved by the European Medicines Agency in 2014 and the FDA in 2019 for EPP in adults. In the UK it is used through specialist centres, and NHS access has been decided through national commissioning rather than being routinely available.

Afamelanotide is a licensed medicine, and the licence is narrow: prevention of phototoxicity in adults with erythropoietic protoporphyria. That is it.

What "licensed" covers here

It is delivered as an implant placed under the skin by a trained clinician, in a specialist service, every two months. It is not something a person obtains and administers themselves, and it is not licensed or available for cosmetic tanning anywhere in the world.

Access in the UK runs through specialist porphyria services. If you think you might have EPP, that is a diagnosis for a dermatologist and a specialist centre, and the condition is often missed for years.

04How it works

It binds melanocortin-1 receptors on pigment cells, increasing production of eumelanin, the darker pigment. That pigment absorbs light energy, raising the threshold before phototoxic reactions begin.

Melanotan II is less selective, acting on a broader range of melanocortin receptors, which is why its reported effects extend well beyond skin colour into appetite and sexual function. That selectivity difference is the pharmacological reason the two compounds ended up in completely different places.

05What it is not

Claims that attach themselves to this compound and do not hold up.

  • Not licensed for tanning, anywhere in the world, for anyone.
  • Not melanotan II. A different molecule with a broader receptor profile and no approval.
  • Not self-administered. It is an implant placed by a clinician in a specialist service.
  • Not a sunscreen. Even in its licensed use it raises a tolerance threshold rather than making light safe.

06What the evidence shows

Approval rests on randomised controlled trials in adults with EPP, reporting increased pain-free time in sunlight and improved quality of life. Regulators in both Europe and the US assessed that evidence and approved it.

The trials were small, because the condition is rare. That is a limitation of studying rare disease rather than a weakness in the drug, and regulators account for it.

There is no trial evidence for cosmetic use, because no such trials have been run.

What is not known

Anything outside EPP. Long-term data is accumulating through registries, as is normal for a rare disease drug, and the effect of raising pigmentation over decades on skin cancer risk is monitored rather than settled.

07Reported harms

Its licensed product information carries the full frequency table. Reported effects include nausea, headache, fatigue, implant site reactions and darkening of existing moles or freckles. Because it changes the appearance of pigmented lesions, skin monitoring is part of its licensed use.

That monitoring requirement is worth noting for anyone who has used unlicensed melanotan II: the same concern about changing moles applies, without anyone checking.

08Interactions and cautions

Covered in its product information. As a specialist-administered medicine, interactions are managed by the prescribing service rather than left to the patient to work out.

09Stopping

Pigmentation fades over months and light tolerance returns to baseline. In its licensed use, treatment is repeated seasonally rather than being a one-off course.

10Monitoring

Skin surveillance is part of licensed use, specifically for changes in pigmented lesions. Also general dermatological review, through the specialist service.

11Questions worth asking

Take these to a doctor or pharmacist. A good clinician will not mind being asked, and the answers are specific to you in a way nothing on this page can be.

  1. Do I actually have EPP, and has a specialist confirmed it?
  2. If I have unexplained burning skin pain in sunlight, has anyone investigated porphyria?
  3. Am I clear this is not the compound sold online for tanning?

12Common questions

Is afamelanotide the same as melanotan?

It is Melanotan I. The unlicensed tanning product sold online is melanotan II, a different molecule with a broader receptor profile. Only afamelanotide has ever been approved for anything.

Can I get Scenesse for tanning?

No. It is licensed only for preventing phototoxicity in adults with erythropoietic protoporphyria, delivered as an implant by a clinician in a specialist service. There is no cosmetic indication anywhere in the world.

Does its approval mean melanotan II is safe?

No. They are different compounds. Melanotan II has no approval anywhere, selling it in the UK is illegal, and the MHRA has issued repeated warnings about it.

What is erythropoietic protoporphyria?

A rare inherited disorder where sunlight causes severe burning pain in the skin within minutes, often without a visible burn. It is frequently misdiagnosed for years, and it is diagnosed and managed through specialist porphyria services.

13Sources

Links go to the authoritative source. Where a document sits behind a paywall or moves around, the full citation is given so you can find it yourself.

  1. Scenesse product informationEuropean Medicines Agency
  2. US prescribing informationFDA
  3. Afamelanotide trials in EPPPubMed
  4. Melanotan II record/compounds/melanotan-ii/
  5. PT-141 record/compounds/pt-141/

14Change history

Every substantive change to this record is logged here with its date. Corrections are made openly, not quietly.

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