Melanotan I: evidence, FDA status and research

Sold as a safe way to tan without sun. It darkened skin in a 65-person trial. The approved version is a different product for a rare sun-pain disease.

Sold for

Melanotan I is sold as the 'safer' tanning peptide, the one that became a real drug, promising a tan without sun and protection against burning.

Studies say

A 65-person placebo-controlled trial showed more melanin and less UV damage in fair skin, and two trials in 168 porphyria patients led to approval of the implant, so the evidence is grade B for tanning and the approved product is a different formulation for a rare disease.

Why grade B. For the tanning use it is sold for, the evidence is one placebo-controlled trial in 65 fair-skinned volunteers that measured melanin density and UV damage markers, a surrogate for sunburn protection. The approved use in erythropoietic protoporphyria rests on two randomized placebo-controlled trials totaling 168 patients. The tanning use has one trial with surrogate endpoints, which is B; no trial has tested cosmetic tanning in the general population or compared it with sunscreen. ¹²

FDA. Melanotan I is the same molecule as afamelanotide, which the FDA approved in 2019 as the Scenesse implant for adults with erythropoietic protoporphyria. Injectable 'Melanotan I' sold online for tanning is not approved by the FDA for any use and is sold as a research chemical. ²

Written from 3 cited sources. Last refreshed 2026-10-27. Not physician reviewed.

What this means for you

What people take it for: Tanning without sun.
Can a US doctor prescribe it?: No. Tanning injections are not approved and are sold as research chemicals. The same molecule is approved as an implant for a rare disease.
Properly tested in people?: Partly: some human trials, with gaps: a 65-person trial for tanning; the rare disease use has two trials in 168 patients.

Evidence checklist

Randomised controlled trial Placebo-controlled tanning trial, 65 volunteersyes
Human study over 100 people Tanning trial had 65; EPP trials 168no
More than one research group Trial data from related groupsno information
Clinical outcomes, not surrogate markers Melanin and DNA damage markers, not sunburnno
Human safety data beyond case reports Short trials; online product untestedno

Drawn from the cited studies below. A dash means the sources give no information.

What it is

Melanotan I is [Nle4-D-Phe7]-alpha-melanocyte-stimulating hormone, a 13-amino-acid analog of the natural pigment hormone alpha-MSH with two amino acid substitutions that make it more potent and longer-lasting. It was designed at the University of Arizona in the 1980s. The pharmaceutical name is afamelanotide. ¹

Clinuvel developed afamelanotide as a slow-release implant placed under the skin, and the FDA approved it in October 2019 as Scenesse to increase pain-free light exposure in adults with erythropoietic protoporphyria (EPP), a rare genetic disorder in which sunlight causes burning skin pain. The powder sold online as 'Melanotan I' for tanning is a different, unregulated product with the same sequence. ²

How it works

Alpha-MSH binds the melanocortin 1 receptor (MC1R) on melanocytes, the pigment cells in the skin, and tells them to make eumelanin, the brown-black pigment. Melanotan I does the same thing more strongly and for longer. More eumelanin absorbs more UV radiation before it reaches DNA, which is why the 2006 trial measured both pigment and markers of UV damage. Melanotan I is fairly selective for MC1R, unlike Melanotan II, which also hits the brain receptors that cause nausea, erections, and appetite changes. ¹

What human research shows

A 2006 trial gave 65 fair-skinned volunteers Melanotan I or placebo by injection over three months. Melanin density rose in every treated subject, most in people with the least baseline pigment: 41 percent in burn-prone (low minimal erythema dose) skin versus 12 percent in less sensitive skin. After a standardized UV exposure, sunburn cells in the epidermis fell by more than half and thymine dimers, a direct DNA damage marker, fell by 59 percent in the low-MED group. ¹

Two randomized, placebo-controlled trials of the afamelanotide implant in EPP, 94 patients in the US and 74 in Europe, found more hours of pain-free direct sunlight (median 69.4 versus 40.8 hours over six months in the US trial), fewer phototoxic reactions, and better quality of life. Adverse events were mostly mild. These trials used the implant, not the injectable powder. ²

Study	Model	Finding
Melanotan I photoprotection trial (Barnetson 2006)	Humans, n=65 fair-skinned volunteers, placebo-controlled, 3 months	Melanin rose 41 percent in burn-prone skin, with sunburn cells and thymine dimers after UV exposure cut by more than half. ¹
Afamelanotide implant in EPP (Langendonk 2015)	Humans, n=168 across two randomized double-blind placebo-controlled trials	More pain-free sunlight hours and fewer phototoxic reactions; led to FDA approval of Scenesse in 2019. ²
Analysis of online Melanotan products (2013)	Laboratory analysis of products sold on the internet	Content and purity varied; some products were mislabeled or contaminated. ³

Safety

In the EPP trials the implant's adverse events were mostly mild: nausea, headache, injection-site reactions, and darkening of skin and moles. The label advises full-body skin checks because the drug darkens existing moles and could in theory mask melanoma. ²

Injectable Melanotan I bought online has no quality control, and the 2006 trial, the only tanning study, had 65 participants over three months. Long-term effects on moles and melanoma risk in people using it for cosmetic tanning over years are unknown. A 2013 analysis of seized products found variable content and contaminants. ¹³

Questions for your clinician

Is there any controlled human trial for cosmetic tanning?
How would my moles be monitored?
Is the product sold online the same as the approved implant?

Questions people ask

Is Melanotan I FDA-approved?

As afamelanotide in the Scenesse implant, yes, for erythropoietic protoporphyria in adults since 2019. As an injectable tanning product sold online, no. ²

Does Melanotan I protect against sunburn?

In one 65-person trial, treated fair skin had more melanin and fewer markers of UV damage after a controlled exposure. That is a laboratory surrogate, not a trial of real-world sunburn or skin cancer. ¹

What is the difference between Melanotan I and Melanotan II?

Melanotan I is a linear peptide selective for the skin's MC1R receptor. Melanotan II is a shorter cyclic peptide that also activates MC3R and MC4R in the brain, causing erections, nausea, and appetite loss alongside tanning. ¹

Is it safe to buy online?

Online products are unregulated and have been found to vary in content and purity. The approved form is a physician-placed implant for a rare disease. ²³

Citations

Barnetson 2006, J Invest Dermatol: [Nle4-D-Phe7]-alpha-MSH increased pigmentation and decreased UV damage in fair-skinned volunteers pubmed.ncbi.nlm.nih.gov
Langendonk 2015, NEJM: Afamelanotide for erythropoietic protoporphyria pubmed.ncbi.nlm.nih.gov
2013, J Pharm Biomed Anal: Analysis of melanotan products purchased on the internet doi.org