Evidence gradeAApproved drug or multiple human RCTs
Human studies25published, approximate count
Half-lifeAbout 15 hourstime for levels to halve
Route studiedSubcutaneous implant (approved)plus subcutaneous injection (early research only)
What it is
Melanotan-1 is the research name for afamelanotide, a 13-amino-acid copy of alpha-MSH, the hormone that tells pigment cells to make dark melanin. Two amino acids were swapped at the University of Arizona in 1980 so it lasts far longer in the body than the natural hormone. It binds the MC1 receptor on melanocytes, and the skin darkens without sun exposure.
It is the only melanotan with a real approval. As Scenesse, a 16 mg implant the size of a grain of rice placed under the skin above the hip every 2 months, it is approved in the EU (2014) and the US (2019) for adults with erythropoietic protoporphyria, a rare genetic disease where a few minutes of sunlight cause burning pain. In two placebo-controlled trials, patients on the implant could stay in direct sun longer without pain, for example a median 69.4 hours over 6 months versus 40.8 hours on placebo in the US study.
Read the full overview 1 more
What people buy online as 'Melanotan 1' for cosmetic tanning is a different thing: an unregulated powder of unknown purity, injected daily, with no approval for tanning anywhere. Early Arizona volunteer studies did show daily injections darkened the face, neck and forearms and roughly doubled eumelanin in forearm skin, but the approved product's label still asks for a full skin check twice a year because it darkens existing moles and freckles.
Synthetic linear analog of human alpha-melanocyte-stimulating hormone (alpha-MSH) with norleucine at position 4 and D-phenylalanine at position 7, first made at the University of Arizona in 1980
Mechanism
How Melanotan-1 (afamelanotide) works
What it binds to, and what happens inside the body after that, step by step.
TargetMelanocortin 1 receptor (MC1R), agonist
Afamelanotide binds and activates the melanocortin 1 receptor (MC1R) on melanocytes, the pigment cells in skin. That raises cAMP inside the cell and switches melanin production toward eumelanin, the brown-black pigment that absorbs light. The darker skin filters the visible light that triggers pain in protoporphyria. It works without UV exposure, unlike a normal tan.
1Binds MC1RThe peptide docks on MC1R on melanocytes. The Nle4 and D-Phe7 swaps make it resist breakdown and bind longer than natural alpha-MSH.
2cAMP risesMC1R is a Gs-coupled receptor, so activation raises cAMP and turns on the MITF transcription factor.
3Eumelanin productionTyrosinase and related enzymes shift output toward eumelanin. In volunteers, forearm eumelanin rose about 98% after 10 daily injections.
4Pigment moves to skin cellsMelanosomes carrying the new pigment transfer to surrounding keratinocytes, which visibly darkens skin over 1 to 2 weeks.
5Light is filteredThe darker skin absorbs more visible and UV light before it reaches the blood vessels where protoporphyrin causes phototoxic pain.
The research
What the studies show
Human results and animal results are kept apart below. A result in rats tells you a mechanism is plausible. It does not tell you what happens in a person.
AEvidence
For EPP the evidence is solid: two multicenter placebo-controlled RCTs (168 patients combined) plus a third trial on the FDA label show more pain-free time in sunlight and fewer phototoxic reactions, and 8 years of observational data in 115 patients show sustained quality-of-life gains. For vitiligo there is one small RCT (55 patients) showing faster repigmentation when added to UV-B light; Phase III results are pending. For cosmetic tanning there are only small 1990s and 2000s volunteer studies showing it darkens skin; no trial has tested whether cosmetic users are better off, and nobody has studied the unregulated powders.
How far the evidence reachesHighest rung: Regulatory approval
Cell studiesIn a dish None listed
Animal studiesRodents and other models None listed
Small human studiesOpen-label, case series 4 key studies below
Preclinical: tells you a mechanism is plausibleHuman: tells you what happened in people (25 published studies, approx.)
In people 6
Randomized trial2015
Afamelanotide for Erythropoietic Protoporphyria (Langendonk et al., NEJM)
168 adults with EPP in two trials (74 in the EU, 94 in the US)
Pain-free direct sun exposure over 6 months was a median 69.4 hours on afamelanotide vs 40.8 hours on placebo in the US trial (P=0.04); phototoxic reactions were 77 vs 146 in the EU trial.
Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo (Lim et al., JAMA Dermatology)
55 adults with nonsegmental vitiligo, skin types III to VI
Repigmentation at day 168 was 48.6% with implant plus UV-B vs 33.3% with UV-B alone, and the face started repigmenting at 41 vs 61 days; the benefit was seen in darker skin types IV to VI, not type III.
Effects of a superpotent melanotropic peptide combined with solar UV radiation on tanning (Dorr et al., Archives of Dermatology)
28 healthy volunteers across three phase 1 studies
In the first study, the 3 of 4 MT-1 subjects who tanned had 47% fewer sunburn cells after UV-B; in the third, sunlight-only controls needed 50% more sun time to reach the same tan.
Skin pigmentation and pharmacokinetics of melanotan-I in humans (Ugwu et al.)
3 healthy men, IV, oral and subcutaneous dosing
Subcutaneous dosing was fully bioavailable, oral dosing produced no detectable blood levels, and the tan peaked 1 week after dosing and was still present at 3 weeks.
No preclinical studies are listed as key studies here. The human data above carries the evidence.
Gaps in the research
What nobody has measured yet
These are questions the published research has not answered.
01Whether long-term MC1R stimulation changes melanoma risk; no carcinogenicity studies were done for the label.
02Results of the Phase III vitiligo trial (CUV105), with topline data scheduled for December 2026.
03Safety and dosing in children and teenagers with EPP.
04Content, purity and dose of the unregulated 'Melanotan 1' powders sold for tanning; none have been tested in published studies.
05Effects of the daily-injection regimens used by cosmetic users, which differ from the 2-monthly implant.
06How liver or kidney impairment changes drug levels.
History
Melanotan-1 (afamelanotide) from discovery to today
1980Sawyer, Hruby and Hadley at the University of Arizona publish [Nle4, D-Phe7]-alpha-MSH, a potent alpha-MSH analog with very long activity.
1997First human pharmacokinetic study shows subcutaneous MT-1 is fully absorbed and darkens skin; oral dosing does not work.
2004Arizona phase 1 studies show MT-1 plus sunlight tans faster and with fewer sunburn cells than sunlight alone.
2014European Medicines Agency approves Scenesse (afamelanotide 16 mg implant) for adults with erythropoietic protoporphyria.
2015NEJM publishes the two placebo-controlled EPP trials; JAMA Dermatology publishes the vitiligo RCT.
2019FDA approves Scenesse in October for adults with EPP, the first US treatment for the disease.
2025Phase III vitiligo trial CUV105 completes enrollment (210 patients by the company's July 2026 count); topline results are scheduled for December 2026.
Approval or regulatory milestoneResearch milestone
Regulation
Legal and regulatory status
FDA-approved An FDA-approved prescription product exists for this molecule.
Approved products
ScenessePrevention of phototoxicity in adults with erythropoietic protoporphyria (EPP)EU (EMA), 2014
ScenesseIncrease pain-free light exposure in adults with a history of phototoxic reactions from EPPUS (FDA), 2019
Scenesse is approved only for adults with EPP. It is not approved for cosmetic tanning, vitiligo or any other use. A Phase III vitiligo trial (CUV105, 210 patients, implant every 3 weeks plus narrowband UV-B vs UV-B alone) has finished enrolling; in July 2026 the company said topline results are due in December 2026, and none had been published as of this review. An EU application to extend the label to adolescents (narrowed during review to ages 15 to 17 and over 60 kg) was withdrawn on April 24, 2024, because the company could not supply the safety and efficacy data EMA asked for. Afamelanotide is not named on the WADA Prohibited List, and because it is an approved drug it falls outside the S0 catch-all for unapproved substances. Powders sold online as 'Melanotan 1' are unregulated research chemicals, not Scenesse.
Sport (WADA)
Not on the World Anti-Doping Agency prohibited list as a named substance.
Compounding pharmacies
Afamelanotide is the active ingredient of an FDA-approved drug and is not on FDA's 503A Category 1 or Category 2 bulk substance lists (list updated May 14, 2026). The approved product is a controlled-release implant given by a trained clinician; there is no FDA-reviewed compounded or injectable version.
About 15 hours from the implant (FDA label); 0.8 to 1.7 hours after a plain subcutaneous injection
Routes studied
Subcutaneous implant (approved), Subcutaneous injection (early research only)
Bioavailability
Subcutaneous dosing was fully bioavailable compared with IV in a 1997 study. Oral and transdermal dosing produced no measurable blood levels.
Notes
The implant releases drug over a few days: in 12 healthy adults the median time to peak was 36 hours and most had no measurable drug after 96 hours, yet skin darkening lasts much longer because melanin, once made, stays in the skin for weeks. Plain injections in early studies were cleared within a couple of hours. The effect of liver or kidney disease on its blood levels has not been studied.
Single-dose clearance
How much of Melanotan-1 (afamelanotide) is left after a single dose
50%left after 15 hours
Half-lifeAbout 15 hours
About 97% cleared75 hours
Simple first-order model from the published half-life. Real clearance varies with dose, route, kidney and liver function and formulation. This is not a dosing schedule.
Members
Doses used in published studies
This table records the doses that trials and approved labels used, with the source for each row. It is a record of research, not a recommendation, and it is open to free members.
Doses used in published research and approved labels4 rows
Study or labelDoseRouteFrequencyDurationSource
Checking membershipEach row names the trial or label, the dose, route, frequency, duration and a link to the source. Free account, no card.
Implant site reaction21% vs 10% on placebo in the label trials: discoloration, bruising, redness, pain or swelling where the implant went in.Common
Nausea19% vs 14% on placebo; also the main side effect in long-term use.Common
Darkening of moles, freckles and skinExpected from how it works. The label recommends a full-body skin exam twice a year to watch existing and new pigmented spots.Common
Fatigue, dizziness, sleepinessFatigue 6% vs 3%, dizziness 4% vs 3%, somnolence 2% vs 1% on placebo in the label trials.Uncommon
Facial flushingReported after daily injections in early volunteer studies.Uncommon
Darkening of lips and gumsOral pigmentation has been reported with afamelanotide.Uncommon
Groups with specific risks
The FDA label lists no formal contraindications, but safety in pregnancy, breastfeeding and children has not been established.
People with a personal or family history of melanoma or many atypical moles were not well represented in trials; pigment changes need close dermatology follow-up.
Severe liver disease: trial patients had EPP without significant liver involvement, and liver impairment effects are unknown.
Interactions
No drug interaction studies have been done, per the FDA label.
Sun and light protection must continue during treatment; the label says the implant does not replace it.
Combining with tanning beds or other melanocortin drugs (melanotan-2, bremelanotide) has not been studied and adds pigment stimulation.
What people say online, checked against the studies
Tap a claim to see what the studies found.
The claim"Melanotan 1 is the 'safe, approved' melanotan, so the tanning vials online are fine."Not supportedThe evidence does not back this
The approval covers one product: the Scenesse implant made under drug manufacturing standards, for EPP. Vials sold online are unregulated powders with no verified identity, purity or dose, and are not approved for tanning anywhere.
The claim"It gives you a tan without sun."SupportedHuman evidence backs this
Volunteer studies in the 1990s and 2000s showed daily injections darkened the face, neck and forearms and raised eumelanin without UV. The effect is stronger when combined with sunlight.
The claim"A melanotan tan means you can skip sunscreen."Not supportedThe evidence does not back this
The FDA label tells EPP patients to keep using sun and light protection. Early data showed fewer sunburn cells, but no study has shown that it prevents skin cancer.
The claim"Melanotan 1 causes melanoma."UntestedNobody has measured this in people
No study has tested this. Case reports of new or changing moles and melanomas exist mostly for unregulated melanotan products, and they cannot prove cause. Long-term EPP data up to 8 years did not show a cancer signal, but those studies were not designed to find one.
The claim"Melanotan 1 boosts libido like Melanotan 2."Not supportedThe evidence does not back this
Afamelanotide mainly acts on MC1R in the skin. The sexual effects seen with melanotan-2 and bremelanotide come from MC4R in the brain, and spontaneous erections are not a reported side effect of afamelanotide.
Handling
Storage and stability
Dry powder (lyophilized)
Not applicable to Scenesse, which is a solid implant. The label says to keep it in the refrigerator at 2 to 8 C (36 to 46 F), protected from light.
Mixed with water (reconstituted)
Scenesse is never reconstituted. No published stability data exist for research-grade afamelanotide powders after mixing.
New Melanotan-1 (afamelanotide) research, explained when it is published
One email when a trial reads out, a label changes or the FDA acts on a peptide. Free, no selling of peptides, unsubscribe any time.
Frequently asked questions
What is the difference between Melanotan 1 and Melanotan 2?
Melanotan 1 (afamelanotide) is a 13-amino-acid linear peptide that mainly hits the MC1 receptor on pigment cells, and it is an approved drug. Melanotan 2 is a smaller ring-shaped peptide that hits several melanocortin receptors, including MC4R in the brain, so it also causes nausea, appetite loss and spontaneous erections. Melanotan 2 has never been approved anywhere.
Is Melanotan 1 FDA approved?
Yes, as Scenesse, a 16 mg implant approved in October 2019 for adults with erythropoietic protoporphyria. It is not approved for tanning, and products labeled 'Melanotan 1' sold online are not Scenesse.
How long does a Scenesse implant last?
The label calls for one implant every 2 months. Drug levels in blood drop within about 4 days, but the extra pigment it triggers lasts for weeks.
Does afamelanotide work for vitiligo?
In one 55-patient trial, adding the implant to narrowband UV-B light gave faster and more repigmentation than light alone, mostly in darker skin types. A 210-patient Phase III trial has finished enrolling, with topline results scheduled for December 2026. It is not approved for vitiligo.
Is Melanotan 1 banned in sport?
Afamelanotide is not named on the WADA Prohibited List and, as an approved drug, does not fall under the S0 rule for unapproved substances. Athletes should still check with their anti-doping agency.
Will it make my moles darker?
Yes, it can. The FDA label warns that it can darken existing moles and freckles and recommends a full-body skin exam twice a year.