Scenesse (afamelanotide)

FDA-approved as Scenesse, an implant for a rare disease that makes light on the skin painful. It is not approved for tanning.

AI illustration of an amber vial labeled Afamelanotide — AI illustration

FDA statusFDA approved

Approved in the US (2019) and Europe (2014), for EPP only.

Proof it works in people for light pain in the rare disease EPPSome

Two placebo trials plus long real-world studies. Still small, because EPP is rare.

Safety data in peopleLimited

A few hundred people, some followed for up to 8 years. Mostly mild side effects.

Three separate grades: the law says yes, but only for EPP. Proof is good for EPP light pain. Safety data covers a few hundred people, not millions.

By the Peptide Science Desk Editorial TeamFact-checked against FDA and official sources · Oct 28, 2026Not yet reviewed by a licensed clinician. How we check facts

What is it?

Afamelanotide is a lab-made copy of alpha-MSH, the body signal that tells skin to make dark pigment (melanin). It was made to last longer than the natural signal, and it was first called "melanotan I." Today the only approved form is Scenesse, a tiny rod a trained health care worker puts under the skin.

Why do people use it?

People with erythropoietic protoporphyria (EPP) feel burning pain within minutes of sun or bright light. Their skin builds up a light-sensitive chemical. Scenesse darkens the skin, which acts like a shield from inside. Online, "melanotan I" vials are sold for tanning. That is a different thing and not approved.

Does it really work?

Yes, for EPP light pain. In the US trial, people on Scenesse spent a median 69.4 pain-free hours in direct sun over 6 months, vs 40.8 hours on placebo. Real-world studies in Italy, Switzerland and Germany found people kept using it for years, and their quality of life went up. It has not been shown to help any other disease yet.

Studies in people

We found 7 studies in people. Five are about EPP. The other two tested it for vitiligo and stroke, which are not approved uses.

Study design	People	What they measured	What they found	Year	Journal	PubMed
2 randomized, placebo-controlled trials (US and Europe)	168 adults with EPP (94 US, 74 EU)	Hours in direct sun without pain	More pain-free hours: median 69.4 vs 40.8 (US) and 6.0 vs 0.8 (EU). Fewer painful light reactions.	2015	N Engl J Med	PMID 26132941
Small open study, no placebo	5 people with EPP	How much light skin could take before pain	Could stay in sunlight up to 24 times longer than before.	2009	Photochem Photobiol	PMID 19656325
Long-term observation (Italy and Switzerland)	115 people with EPP, up to 8 years	Quality of life, side effects, who kept using it	Quality-of-life score rose from 31% to 74%. Side effects were minor, mostly nausea.	2015	Br J Dermatol	PMID 25494545
Observation, 3 years (Swiss group)	39 people with EPP	Time in sun before a burn reaction	Went from about 10 minutes to about 180 minutes (medians). 97.4% kept using it.	2020	Orphanet J Rare Dis	PMID 32811524
Safety study after approval (Germany)	200 people with EPP	Side effects and quality of life in normal use	Safety matched the trials. Quality of life went up, and 91% stayed on it.	2025	Photodermatol Photoimmunol Photomed	PMID 40082741
Randomized trial with light therapy (not an approved use)	55 adults with vitiligo (28 vs 27)	Color coming back in white patches	Color came back faster with afamelanotide plus light therapy than light alone.	2015	JAMA Dermatol	PMID 25230094
Tiny first test in stroke (not an approved use)	6 people after a stroke	Safety	No drug-related harms seen. One person died of a second stroke, judged not caused by the drug. Paid for by the maker.	2023	BMC Neurol	PMID 37496004

Official labels

We read each of these 7 papers on PubMed on October 28, 2026.

The numbers in a chart

Scenesse (afamelanotide): pain-free hours in direct sun

Median hours, people with EPP, 2 placebo-controlled trials

US trial, 6 months94 people

69.4 h

40.8 h

EU trial, 9 months74 people

6.0 h

0.8 h

More pain-free time in both trials. The two trials counted sun time in different ways, so compare within a trial, not across.

Show the numbers as a table

Scenesse (afamelanotide): pain-free hours in direct sun: Median hours, people with EPP, 2 placebo-controlled trials
Trial	Scenesse	Placebo
US trial, 6 months 94 people	69.4 h	40.8 h
EU trial, 9 months 74 people	6.0 h	0.8 h

Langendonk et al., NEJM 2015. Rare disease, so the trials were small. Sources: Langendonk et al., NEJM 2015 (PMID 26132941).

More charts: Peptides by the numbers

Is it safe? Side effects

The label’s most common side effects: reactions where the implant goes in (21% vs 10% on placebo), nausea, sore throat, cough, tiredness, dizziness and sleepiness.
It darkens skin and can darken moles and freckles. The label asks for a full skin check twice a year.
Serious allergic reactions, including anaphylaxis, have been reported. People with EPP still need to protect themselves from light.
Unregulated "melanotan" tanning products have been linked in case reports to changing moles and melanoma (a skin cancer).

Is it legal in the US?

Yes, for adults with EPP. The FDA approved Scenesse in 2019, and it must be put in by a trained health care worker. "Melanotan I" sold online for tanning is not Scenesse and is not an approved medicine.

What this means for Scenesse

A doctor may prescribe an approved drug for other uses ("off-label"). Tanning is not a use any trial has tested. (FDA)
"Melanotan I" vials sold online "for research" are not Scenesse. No one checks what is in them. (FDA)
Bringing unapproved copies into the US for yourself is, in most cases, illegal, the FDA says. (FDA)

Banned in sports? Drug tests

Not named on the banned list.

Afamelanotide (Scenesse) is not named on WADA's 2026 list. It is an approved medicine, so the "not approved" rule (S0) does not fit. But WADA says its list is not complete. Check it on GlobalDRO.com or ask USADA.

Check work, NCAA, and military rules for Scenesse

Talk to your doctor

If you have EPP, ask a skin or porphyria doctor if Scenesse fits you and how often to get skin checks. If you want a tan, ask about safer options. No study supports melanotan for tanning. We never share doses or tell you where to buy. Print our doctor questions sheet.

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Not medical advice. Medical disclaimer.