Melanotan I (afamelanotide)
Melanotan I: What The Studies Actually Say
Under its other name, afamelanotide, it is a real approved drug: a slow-release implant for one rare disease where light causes burning pain. It has never been approved for tanning, and the tanning studies were small and short.
Updated 22 September 2026
Before you read this
This page explains what published studies found. That is all it is. It is not medical advice, and it is not instructions for using anything. Nothing here is meant to find, treat, cure or stop any illness. The compounds discussed on this site, retatrutide included, are not approved by the FDA for use in people. Research compounds are sold for laboratory use only — not for use in humans or animals. A study tells you what happened to the people in it. It does not tell you what would happen to you. What you do with what you read here is your responsibility, so talk to a doctor first. This page is published by Ascend Vials, which sells research compounds.
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Melanotan I has a second name: afamelanotide. Under that name it is a real, approved medicine. Just not for tanning.
Here is what the studies found about the disease it is approved for, about tanning, and about everything else. Every claim has a link. Read them yourself.
The 30-second version
- Melanotan I and afamelanotide are the same molecule. As an implant called SCENESSE it is approved in the US, Europe, Australia and Canada — only for adults with EPP, a rare disease where light causes burning pain.
- In the main US trial, people on it got 69 hours of pain-free sun in 6 months, against 41 on a dummy implant — about an hour a week. The FDA's own recount made the result borderline.
- It does darken skin, but the tanning studies were small and short. It is not approved for tanning anywhere.
- Side effects include nausea, reactions where the implant goes in, and darker moles and freckles. Serious allergic reactions were added to the US label in 2024.
- Long-term skin cancer risk is unknown. The FDA's safety registry does not report until 2031.
- Vials sold online as "Melanotan I" are not the approved implant. Nothing sold online has been shown to match what the studies used. No study has checked.
The numbers, from the real studies
EPP — erythropoietic protoporphyria — is a rare inherited disease where light on the skin causes severe burning pain. In the US, afamelanotide is approved to give adults with EPP more pain-free time in light. FDA label
The trial the US approval rests on had 94 adults with EPP. Each got three implants over six months — the drug or a dummy — and kept a diary of their time in the sun. New England Journal of Medicine, 2015 · FDA review
That gap is about 29 hours in six months — roughly one extra hour of pain-free sun a week. It counts the 89 people who handed in at least one diary. The number of painful light reactions did not differ between the groups, and about 97% of the people in the trial were white. NEJM, 2015 · FDA review
Now the fine print. The FDA redid the math on all 93 people who got an implant. The medians became 64.1 hours against 40.5. Scientists usually want a number called the p-value under 0.05 before they trust a result. The company's count got 0.044. The FDA's got 0.055. FDA review
The European trial had 74 adults over nine months. Median pain-free time in direct sun was 6.0 hours on the drug against 0.8 on placebo, and painful light reactions ran 77 against 146. NEJM, 2015
The third trial is the one almost nobody mentions. It had 77 adults and missed the goals it was designed to hit. Afterwards, the company and outside experts picked a new goal — pain-free hours in direct sun — and used it in the other two trials. The European trial was still running blind when its goal was switched. The FDA said the third trial "cannot be used to support efficacy." FDA review
That does not make the result fake. It does mean the finish line was drawn after the first race was run.
Outside the trials, the numbers get much bigger
Clinics in Europe and the US have tracked their own patients. Their numbers are far more impressive. They also have no dummy-implant group — each one compares people with themselves before treatment.
| People | Dummy-implant group? | What it found | |
|---|---|---|---|
| US trial, 2015 | 94 | Yes | 69 vs 41 hours of pain-free sun in 6 months |
| European trial, 2015 | 74 | Yes | 6.0 vs 0.8 hours of pain-free sun in 9 months |
| Swiss clinic, 2020 | 39 | No | Time in sun before a reaction: 10 → 180 minutes |
| Dutch clinic, 2020 | 117 | No | 6.1 more hours a week outside |
| Boston clinic, 2024 | 29 | No | Time in sun before symptoms: 12.5 → 120 minutes |
| Austrian clinic, 2026 | 20 | No | Time before a burn: 15 → 250 minutes |
Read the whole table. The biggest numbers come from the rows with no comparison group. Without one, nobody can tell how much of a change was the drug.
Details get lost, too. In the Dutch study, reactions hurt less, but they did not come less often or end sooner. JAMA Dermatology, 2020
Sources: US and European trials · Swiss clinic · Dutch clinic · Boston clinic · Austrian clinic
What it is
Afamelanotide is a lab-made copy of alpha-MSH, the body's own signal for making skin pigment. Two of its 13 building blocks are swapped, which makes it last longer and act more strongly than the natural hormone. FDA label
It was developed at the University of Arizona, where it got the name Melanotan I, and first tested for tanning in people in 1991. JAMA, 1991 Today the company Clinuvel sells it as SCENESSE: a dissolving rod about 1.7 cm long, placed under the skin by a trained clinician once every two months. FDA label
It is not Melanotan II. That is a different, ring-shaped molecule, and nothing on this page is about it. Life Sciences, 1996
How it darkens skin
It locks onto a receptor called MC1R on the skin's pigment cells, which then make more eumelanin — the brown-black pigment — with or without sun. FDA label In seven volunteers, forearm eumelanin roughly doubled after two weeks of shots. The red-yellow pigment did not change significantly. Photochemistry and Photobiology, 2000
In EPP, a substance called protoporphyrin builds up in the skin, and light sets it off. The idea is that more pigment in the top layer of skin soaks up the light first. FDA review
Here is the odd part. The implant empties fast: over 90% of the drug is out by day 5. FDA review The pigment lasts much longer. In one small study it peaked around day 15 and was still up at day 60. British Journal of Dermatology, 2011 That is why one implant every two months is enough.
The tanning studies are real — and small
This is the part most people come for.
| Year | People | Placebo group? | What it found |
|---|---|---|---|
| 1991 | 28 men | Yes | Skin darkened; on placebo it did not |
| 1997 | 3 men | No | Swallowed, it never showed up in the blood |
| 2000 | 7 | No | Forearm brown-black pigment up 98% |
| 2004 | 8, 12 and 8 | In 1 of 3 | Same tan with less time in the sun |
| 2006 | 65 | Yes | Pigment up 41% in people who burn easily |
| 2006 | 77 | Yes | Pigment up, more with some versions of the MC1R gene |
Read the whole table. The biggest tanning study had 77 people. Where the length is given, the longest ran three months.
Sources: 1991 · 1997 · 2000 · 2004 · 2006, 65 people · 2006, 77 people
In the 1991 trial, every man wore strong sunscreen, and the tan peaked one to three weeks after the last shot. JAMA, 1991
The 2006 study of 65 people looked at damage. After a measured dose of UV, sunburn cells fell by more than half in people who burn easily, and one type of UV damage to DNA fell 59%. Journal of Investigative Dermatology, 2006
None of these studies measured skin cancer. They measured pigment and damaged cells over weeks to months. Less damage after a lamp test is not the same as fewer cancers, and no study here has shown that it is.
The tan does not bring vitamin D with it, either. In 230 people with EPP, afamelanotide alone did not raise vitamin D. British Journal of Dermatology, 2024
And none of this made it a tanning drug. No regulator checked for this guide has approved it for tanning. FDA label · EU label
What else it has been tested for
| Biggest study in people | What it found | Approved for it? | |
|---|---|---|---|
| EPP | 94 people, dummy implant | More pain-free sun; borderline in FDA's recount | Yes, adults only |
| Tanning | 77 people, placebo | Darker skin | No |
| Vitiligo | 55 people, no placebo | More color back with light therapy | No |
| Sun rash (polymorphic light eruption) | 31 people, placebo | No statistical result posted | No |
| Hives from sunlight | 5 people, no control | Smaller hives | No |
| Stroke | 6 people, no control | Cannot show benefit | No |
Read the whole table. The first row stands on controlled trials. Every row under it is small, unfinished, or both.
In vitiligo, adding implants to light therapy brought back more color after 168 days — 48.6% against 33.3% — but there was no dummy implant. JAMA Dermatology, 2015 A bigger trial was due to finish in June 2026 and has posted no results. Trial record The stroke study was paid for by the company, and one of its 6 patients died of a second stroke, judged unrelated to the drug. BMC Neurology, 2023
Other rows: sun rash trial · hives from sunlight, 2011
What to expect
These side effects showed up more often than on the dummy implant, in 244 adults with EPP across three trials, over six months. FDA label
| Placebo | Afamelanotide | |
|---|---|---|
| Reaction where the implant went in | 10% | 21% |
| Nausea | 14% | 19% |
| Sore throat | 5% | 7% |
| Cough | 3% | 6% |
| Tiredness | 3% | 6% |
| Darker skin | 0% | 4% |
| Dizziness | 3% | 4% |
| New or changed moles | 2% | 4% |
| Chest or airway infection | 3% | 4% |
| Sleepiness | 1% | 2% |
About a third of people on the drug also had mild darkening where the implant went in. NEJM, 2015 In the early tanning studies, the side effects were nausea and brief flushing of the face. Archives of Dermatology, 2004
Three bigger things:
Serious allergic reactions. Anaphylaxis, hives and swelling under the skin were reported after the drug went on sale. The US label added them in August 2024. FDA label
Moles. It can darken existing moles and freckles. Both the US and European labels tell doctors to check the whole skin twice a year. FDA label · EU label In 15 patients, moles changed by five months and were back to normal by twelve, with no signs pointing to cancer. Photochem Photobiol Sci, 2021 In the US trial, one patient on the drug had a mildly abnormal mole removed. The FDA said it was unclear whether the drug played a part. FDA review
Driving. The European label says it has a moderate effect on driving, especially in the 72 hours after an implant, because of sleepiness, tiredness, dizziness and nausea. EU label
If you have heard it boosts libido or curbs appetite: no study in this guide shows either. The European label lists lower libido as a rare side effect, and appetite going up or down as uncommon ones. EU label
Approved — for one disease, in adults
- United States: approved on October 8, 2019, as SCENESSE, for adults with EPP. The label still says it has not been shown safe or effective in children. Approval letter · FDA label
- Europe: approved on December 22, 2014, under "exceptional circumstances," because the disease is too rare to collect complete data. Only specialists at porphyria centres may prescribe it. EMA · EU label In 2024 the company withdrew a request to extend it to teenagers, after regulators said the evidence was not strong enough. EMA
- Australia: approved in 2020 for adults with EPP, according to the company. We could not confirm it on the regulator's own site. Clinuvel, 2020
- Canada: approved. Health Canada lists it as approved as of July 2026. Health Canada · Clinuvel, 2026
None of them has approved it for tanning, for anyone under 18, or for any other use on this page. FDA label · EU label
What is still unknown
- Skin cancer over years. Safety has not been studied in clinical trials longer than two years. EU label The FDA's required registry watches for melanoma and other skin cancers for at least eight years. Its final report is due in 2031. Approval letter In mice it did not make melanoma grow or spread, but the FDA says there is no accurate animal model to test whether it could cause melanoma. Mouse study, 1992 · FDA review
- Heart rhythm. The FDA required a heart-rhythm study, with a report originally due in 2022. We found no published result. Approval letter
- Children, pregnancy, and kidney or liver disease. No established safety. The European label says not to use it in pregnancy or breastfeeding. FDA label · EU label
What is in the bottle is not what was studied
One more thing.
Every EPP result on this page came from Clinuvel's implant, placed by a trained clinician. The tanning results came from research studies in enrolled volunteers. FDA label · JAMA, 1991
No study has ever shown that a vial sold online as "Melanotan I" is the same thing. Not the same purity. Not the same strength. Not proof it is sterile. Not even proof it is the same molecule.
And a vial is not an implant. Injected in a 1997 study, half the drug was gone from the blood in one to two hours. From the implant, blood levels take about 15 hours to halve. 1997 study · FDA label The implant's results do not carry over.
Doctors have published cases of a sudden dark skin spot, and of dark bands across the nails, after injections of unlicensed "melanotan." The reports do not say whether it was Melanotan I or II. Case report, 2011 · Case report, 2013
So take every number on this page for what it is. It describes the drug the studies used, in the people they studied. It describes nothing else.
How to check a number yourself
You are going to see more claims about this peptide. In a reel. In a comment. On somebody's store page.
Here is how to tell a real one from a marketing one. Five questions. About ten seconds each.
1. Is there a link to a study?
A real number comes from a paper you can open. No link means it is a claim, not a result. Search pubmed.gov yourself — and search both names. Almost all the recent research is filed under afamelanotide.
2. How big was it, and how long did it run?
Small studies swing. The EPP trials had 74 to 94 people; the biggest tanning study had 77. And safety has not been studied in trials past two years, so a claim about years of use is not from a trial.
3. Was there a group that got nothing?
The dummy implant is the whole point. People on it still logged 40.8 hours of pain-free sun. Without that group, all 69.4 hours would have looked like the drug. The clinics that turn 10 minutes into 180 have no such group.
4. Was the goal picked before the study started?
A fair test names its finish line first. Here, the first trial missed its goals, and the measure that won approval was chosen afterwards. The FDA knew. It is still worth knowing.
5. Who paid for it?
The EPP trials and the stroke study were run by the company that sells the drug. FDA review · BMC Neurology, 2023 That is normal. It matters more when that company is the only one who has seen the data.
Now run those five on this page
Every number above links to its source. The study sizes are in the tables. The dummy-implant numbers are in the chart. The switched goal has its own paragraph.
The claims you will hear most — a safe way to tan, protection from skin cancer, more libido, less appetite — have no study on this page behind them.
That is the whole difference: a number you can check, and a number you are asked to believe.
This page has a date on it, near the top. When new studies publish, this page changes.
Read the studies yourself
- US and European EPP trials, NEJM 2015 — the main one
- FDA review, 2019 — the recount and the third trial
- FDA label · approval letter, 2019
- EU label · EMA overview · EMA, teenager request
- Australia, Clinuvel 2020 · Canada, Health Canada · Canada, Clinuvel 2026
- Clinics: Swiss, 2020 · Dutch, 2020 · Boston, 2024 · Austrian, 2026
- Tanning: 1991 · 1997 · 2000 · 2004 · 2006, 65 people · 2006, 77 people
- Pigment timing and sun hives, 2011 · vitamin D, 2024
- Other uses: vitiligo, 2015 · vitiligo trial · sun rash trial · stroke, 2023
- Safety: moles, 2021 · melanoma in mice, 1992 · case report, 2011 · case report, 2013
- Melanotan II, Life Sciences 1996 — the different molecule
Everything above describes what clinical studies gave to enrolled patients and volunteers under medical supervision. This is not advice, a plan, or instructions. Afamelanotide is approved only as the prescription implant SCENESSE, for adults with EPP. It is not approved for tanning anywhere. Research compounds are not for human or animal use.