Every tanning-peptide conversation eventually reaches the same objection: but one of these is an approved drug. That is true, and it is worth being precise about, because the approval is narrow and says nothing about the products sold for tanning. This page sets out what afamelanotide is, what regulators approved and on what evidence, what its label warns about, and where its research is heading. It does not recommend any product or treatment, and anyone with a light-sensitivity disorder or a question about their own skin is best served by a dermatologist.
One molecule, three names
Afamelanotide is the drug name for melanotan I: a 13-amino-acid copy of alpha-melanocyte-stimulating hormone (alpha-MSH), the body's signal for pigment cells to make dark eumelanin, built by University of Arizona researchers in the 1980s. Scenesse is the brand name of the only approved product containing it, made by Clinuvel (the EU authorisation is held by Clinuvel Europe Limited, Dublin). Peptide Lexicon's melanotan I entry covers the molecule itself.
The FDA label spells out the sequence, Ac-Ser-Tyr-Ser-Nle-Glu-His-(D)Phe-Arg-Trp-Gly-Lys-Pro-Val-NH2, with a molecular weight of 1,646.85. Against natural alpha-MSH it carries two substitutions, norleucine at position 4 and D-phenylalanine at position 7. That is the whole chemical story: the approved drug and the "MT1" sold in vials share a name, and nothing more is known about the second.
What was approved, where and when
| Regulator | Date | What was approved |
|---|---|---|
| European Commission (on EMA's opinion of 23 Oct 2014) | 22 Dec 2014 | Scenesse for adults with erythropoietic protoporphyria, authorised under "exceptional circumstances" because complete information on benefits could not be obtained, partly owing to the disease's rarity. EMA reviews new information every year. |
| FDA (US) | 8 Oct 2019 | Scenesse implant, NDA 210797, a new molecular entity, "to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP)". Last labelling supplement approved 12 Aug 2024. |
Erythropoietic protoporphyria is a rare inherited disorder in which a pigment precursor builds up in the blood and skin, so that visible light (not just ultraviolet) causes severe burning pain within minutes. People with EPP often spend their lives avoiding daylight. That is the population the drug was developed for, and the reason the approval exists.
Neither approval mentions tanning. Neither covers healthy skin.
How the approved product is given
The label is specific in a way that matters to the comparison with online products. Each Scenesse implant is a white rod about 1.7 cm long and 1.45 mm wide, holding 16 mg of afamelanotide mixed into a polymer (poly DL-lactide-co-glycolide) that dissolves slowly under the skin. It is inserted above the hip, every two months, by a healthcare professional who has completed the manufacturer's training programme, using a dedicated cannula. Patients are told to keep using sun and light protection throughout.
That controlled-release design is the product. A liquid injection of a powder labelled "melanotan I" delivers the same molecule, if it is the same molecule, in a completely different way that no trial behind the approval tested.
What the trials measured
Two randomized, double-blind trials against a dummy implant support the approval (published together as Langendonk et al., New England Journal of Medicine, 2015, PMID 26132941). The primary endpoint in both was time in direct sunlight on days without pain, recorded by patients in diaries.
| Trial | Patients | Length | Pain-free time in direct sunlight, median |
|---|---|---|---|
| CUV039 (US, NCT01605136) | 93 (48 drug, 45 dummy) | 180 days, 3 implants | 64.1 hours vs 40.5 hours |
| CUV029 (EU, NCT00979745) | 74 (38 drug, 36 dummy) | 270 days, 5 implants | 6.0 hours vs 0.75 hours |
Figures are from the FDA label's clinical-studies section. The two numbers are so different because the trials counted different things: the US trial counted hours in direct sun between 10 am and 6 pm, the European one only days on which "most of the day" was spent in direct sun between 10 am and 3 pm. Both favoured the drug. Neither measured skin colour as an outcome, and the people enrolled were 98% white, with a mean age of 40.
What the label warns about
This is the part of the record most relevant to readers of this site, because it is the only regulator-reviewed safety table that exists for any melanotan. From the FDA label, pooled across three vehicle-controlled trials of 244 adults with EPP (125 on the drug, 119 on the dummy implant), through month 6:
| Adverse reaction | Scenesse | Dummy implant |
|---|---|---|
| Implant-site reaction | 21% | 10% |
| Nausea | 19% | 14% |
| Oropharyngeal pain | 7% | 5% |
| Cough | 6% | 3% |
| Fatigue | 6% | 3% |
| Skin hyperpigmentation | 4% | 0% |
| Melanocytic naevus (moles) | 4% | 2% |
| Dizziness | 4% | 3% |
The label's warnings section adds two things. First, serious allergic reactions, including anaphylaxis, have been reported since approval. Second, the drug "may lead to generalized increased skin pigmentation and darkening of pre-existing nevi and ephelides because of its pharmacologic effect", and "a full body skin examination (twice yearly) is recommended" to monitor existing and new pigmented lesions. Carcinogenicity studies were not conducted.
Put plainly: the one version of melanotan made to a pharmaceutical standard, given under supervision to adults with a disease, comes with a manufacturer-reviewed instruction that treated patients have their skin checked every six months. The case reports of changing moles in people using unregulated melanotan are collected on our melanotan side effects page; what they can and cannot show is set out there.
What the registry holds
On 27 September 2026, ClinicalTrials.gov returned 23 studies naming afamelanotide as an intervention. Counted by condition:
- Erythropoietic protoporphyria: 6 (the approval programme, an extension study and a pharmacokinetic study)
- Vitiligo: 5
- Xeroderma pigmentosum: 2; and one each in variegate porphyria, polymorphic light eruption (two records), solar urticaria, acne, actinic keratoses in transplant patients, patients having photodynamic therapy, and acute stroke
- Healthy volunteers: 2, one measuring drug levels from the implant and one measuring whether it helps skin repair DNA damage after ultraviolet light
None of the 23 studies cosmetic tanning. The healthy-volunteer work treats pigment as a possible protection against light damage, not as an appearance outcome.
Europe PMC's copy of MEDLINE held 399 records mentioning afamelanotide on the same date; four carried the randomized-controlled-trial publication type, and none was flagged as retracted. (PubMed's own search was unavailable when this page was written, so the literature count comes from Europe PMC.)
Vitiligo: where the research is going
Vitiligo is the other place afamelanotide has a controlled trial. In a 2015 study, 55 adults with nonsegmental vitiligo covering 15% to 50% of the body were randomized to narrowband UV-B light therapy alone or light therapy plus a 16 mg afamelanotide implant monthly for four months. The combination group responded better at day 56, and repigmentation on the face and upper limbs was faster (Lim et al., JAMA Dermatology, 2015, PMID 25230094). A 200-person phase 3 trial comparing the combination with light therapy alone (NCT06109649) began in October 2023 and was listed as active, not recruiting, in September 2026.
The logic there is the reverse of cosmetic tanning: restoring pigment to patches that have lost it, alongside a controlled medical light dose. It is also not an approval.
Why the approved drug does not stand behind the unapproved ones
Three differences separate Scenesse from the products sold as tanning peptides, and each is a matter of record rather than opinion:
- The molecule. Most "tanning peptide" products are melanotan II, a different, shorter, ring-shaped molecule. Its closest approved relative is not afamelanotide but bremelanotide, a sexual-desire drug; the comparison is set out on our melanotan I vs melanotan II page.
- The product. Scenesse is a manufactured implant with a stated composition, release profile and batch testing. A vial labelled "research use only" has none of those checked by a regulator, which is the point the UK's medicines regulator makes about unauthorised melanotan products. Laboratory tests of vials sold as tanning injections found less peptide than the label stated.
- The population and purpose. The approval rests on adults with a painful disease, supervised, with twice-yearly skin checks. Nothing in it was designed to answer whether darkening healthy skin is worth its risks, and no trial has asked.
For the wider picture of tanning products and what regulators have said about them, see our tanning peptides overview. Peptifact's melanotan II dosage page reports published figures with their sources for readers researching the unapproved compound.