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Prescription / GLP-1

Melanotan 1 (Afamelanotide): Uses, Dose, Side Effects, vs Melanotan 2

Melanotan 1 is afamelanotide, approved as the Scenesse implant for a rare light disorder. Its label dose, trial results, side effects and how it differs from MT-2.

Sebastian Hunter, Founder and EditorWritten bySebastian Hunter, Founder and EditorI'm a 42-year-old senior advisor and distance runner who came to peptides as a sceptic. I'm not a doctor: I read the research, run my own experiment and keep honest notes. Read full bio

The short version

Melanotan 1 is afamelanotide. As Scenesse, a 16 mg implant placed under the skin every 2 months, it is a prescription medicine in the US, EU and Australia. It treats erythropoietic protoporphyria (EPP), a rare inherited disorder that makes light painful. It darkens skin without sun, and its trial record is far larger than Melanotan 2's. Melanotan 1 powder sold online, mostly for tanning, is labelled as the same peptide, but no regulator checks those vials and they have no approved dose.

  • Melanotan 1 and afamelanotide are the same peptide. The approved product is the Scenesse implant.
  • The label dose is one 16 mg implant every 2 months, inserted by a trained clinician, for EPP only.
  • It darkens skin without sun or UV, but no regulator has approved it for tanning.
  • Its label lists no erections or libido changes. Melanotan 2 caused erections in 8 of 10 men in one small trial.

Melanotan 1 is afamelanotide, a lab-made version of the hormone that tells skin cells to make melanin. It is approved as Scenesse, a 16 mg implant, for adults with erythropoietic protoporphyria (EPP), a rare inherited disorder that makes light painful. Vials sold online as Melanotan 1, mostly for tanning Habbema 2017 - Habbema L, Halk AB, Neumann M et al. Risks of unregulated use of alpha-melanocyte-stimulating hormone analogues: a review. Int J Dermatol. 2017;56(10):975-980., in the references below, are labelled as the same peptide. No regulator checks them, and they have no approved dose.

Its label says it darkens skin without sun exposure. Unlike Melanotan 2, it has Phase 3 trials and an approved label, and erections are not among its listed side effects.

What is Melanotan 1?

Melanotan 1 (also written MT-1, MT-I or Melanotan I) is a 13-amino-acid analogue of alpha-melanocyte-stimulating hormone (α-MSH). It matches the natural hormone except at 2 positions Böhm 2025 - Böhm M, Robert C, Malhotra S et al. An overview of benefits and risks of chronic melanocortin-1 receptor activation. J Eur Acad Dermatol Venereol. 2025;39(1):39-51., in the references below, and it is more active and more stable Minder 2017 - Minder EI, Barman-Aksoezen J, Schneider-Yin X. Pharmacokinetics and Pharmacodynamics of Afamelanotide and its Clinical Use in Treating Dermatologic Disorders. Clin Pharmacokinet. 2017;56(8):815-823., in the references below. Chemists write it as [Nle4-D-Phe7]-α-MSH; afamelanotide is its drug name.

It was first made in 1980 Minder 2017 - Minder EI, Barman-Aksoezen J, Schneider-Yin X. Pharmacokinetics and Pharmacodynamics of Afamelanotide and its Clinical Use in Treating Dermatologic Disorders. Clin Pharmacokinet. 2017;56(8):815-823., in the references below. University of Arizona researchers tested it as a sunless tan, and tested a second, shorter, ring-shaped peptide, Melanotan II, for erectile dysfunction Hadley 2006 - Hadley ME, Dorr RT. Melanocortin peptide therapeutics: historical milestones, clinical studies and commercialization. Peptides. 2006;27(4):921-30., in the references below. Clinuvel companies hold all three approvals: Clinuvel Inc in the US, Clinuvel Europe in the EU and Melbourne-based Clinuvel Pharmaceuticals in Australia.

What is Melanotan 1 approved for?

Afamelanotide is approved for one condition: erythropoietic protoporphyria in adults. In EPP, an inherited enzyme shortfall lets a light-sensitive compound build up in the blood and skin. Light then causes itching and burning pain within a short time, followed by swelling and redness like sunburn, as the TGA’s assessment report describes.

  • European Union: authorised on 22 December 2014 to prevent phototoxicity in adults with EPP. The EMA approved it under “exceptional circumstances”, because complete data on its benefits could not be collected, partly because the disease is so rare.
  • United States: FDA approved Scenesse on 8 October 2019 (Drugs@FDA). The label’s indication is “to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria”.
  • Australia: the TGA registered it on 18 November 2020 (ARTG 327947), to prevent phototoxicity in adults with EPP.

It is not approved for tanning. The label says its safety and effectiveness in children have not been established. Clinuvel is testing it in vitiligo, and I found no approval for that use. In FDA’s approvals database, I found one afamelanotide product: the Scenesse implant.

Melanotan 1 dose

The label dose is one 16 mg implant under the skin every 2 months. The implant is a rod about 1.7 cm long that releases the drug slowly and dissolves.

  • A healthcare professional trained by Clinuvel inserts it above the front of the hip bone, then watches the patient for 30 minutes.
  • In the EU it is given before and during the sunny months. Three implants a year are recommended, and 4 is the maximum.
  • Patients keep using sun and light protection during treatment, as the label instructs.

From the implant, afamelanotide’s half-life is about 15 hours, the label says. In 9 of 12 healthy adults, the last measurable blood level was at 96 hours. The tan lasts much longer: after early injection courses, it was still present 3 weeks after the last dose Ugwu 1997 - Ugwu SO, Blanchard J, Dorr RT et al. Skin pigmentation and pharmacokinetics of melanotan-I in humans. Biopharm Drug Dispos. 1997;18(3):259-69., in the references below.

No regulator has set a dose for the injectable powder sold online.

What the trials show

Erythropoietic protoporphyria

Two randomised, placebo-controlled trials gave patients a 16 mg implant or a dummy implant every 60 days Langendonk 2015 - Langendonk JG, Balwani M, Anderson KE et al. Afamelanotide for Erythropoietic Protoporphyria. N Engl J Med. 2015;373(1):48-59., in the references below:

  • US trial, 94 patients, 3 implants: median pain-free time in direct sunlight over 6 months was 69.4 hours, against 40.8 hours on placebo.
  • EU trial, 74 patients, 5 implants: 6.0 hours against 0.8 hours over 9 months, with fewer painful reactions (77 against 146).

Quality of life improved in both. Clinuvel funded the trials, with others.

Longer follow-up in routine care points the same way:

Tanning in healthy volunteers

Swallowed or applied to the skin, it gave no measurable blood levels and no tan Minder 2017 - Minder EI, Barman-Aksoezen J, Schneider-Yin X. Pharmacokinetics and Pharmacodynamics of Afamelanotide and its Clinical Use in Treating Dermatologic Disorders. Clin Pharmacokinet. 2017;56(8):815-823., in the references below.

Vitiligo

A randomised trial in 55 adults with vitiligo added a monthly 16 mg implant to narrowband UV-B light therapy for half of them. At day 168, repigmentation was 48.6% with the implant and 33.3% with light alone. The effect was clearer in darker skin Lim 2015 - Lim HW, Grimes PE, Agbai O et al. Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial. JAMA Dermatol. 2015;151(1):42-50., in the references below. Clinuvel’s April 2026 update describes a larger pivotal trial due to start in the second half of 2026.

Moderate human evidence

Multiple randomised trials, though with limitations. Two Phase 3 randomised trials in EPP (168 patients), long-term patient cohorts, and a randomised vitiligo trial. Tanning in healthy volunteers rests on smaller trials of short injection courses, from 1991 to 2006.

Melanotan 1 side effects

The Scenesse label pools 3 placebo-controlled trials: 125 people on afamelanotide and 119 on dummy implants, over 6 months. These reactions affected more than 2% of patients:

Side effectAfamelanotidePlacebo
Implant-site reaction (bruising, discolouration, redness, pain, itching)21%10%
Nausea19%14%
Sore throat7%5%
Cough6%3%
Fatigue6%3%
Skin darkening4%0%
Dizziness4%3%
New or changed moles4%2%
Respiratory infection4%3%
Sleepiness2%1%
Non-acute porphyria2%0%
Skin irritation2%0%

The label carries two warnings:

  • Allergic reactions. Serious reactions, including anaphylaxis, have been reported since approval. Anyone who has one should not be given it again.
  • Skin changes. It can darken the skin generally, and darken existing moles and freckles. The label recommends a full-body skin check twice a year.

The early injection studies reported occasional stomach upset, nausea and brief facial flushing Ugwu 1997 - Ugwu SO, Blanchard J, Dorr RT et al. Skin pigmentation and pharmacokinetics of melanotan-I in humans. Biopharm Drug Dispos. 1997;18(3):259-69., in the references below Dorr 2004 - Dorr RT, Ertl G, Levine N et al. Effects of a superpotent melanotropic peptide in combination with solar UV radiation on tanning of the skin in human volunteers. Arch Dermatol. 2004;140(7):827-35., in the references below.

A dermatology review describes case reports of changed and new moles in people using unregulated Melanotan I and II, and 4 melanomas arising from existing moles. The authors note there is no conclusive evidence the drugs caused them Habbema 2017 - Habbema L, Halk AB, Neumann M et al. Risks of unregulated use of alpha-melanocyte-stimulating hormone analogues: a review. Int J Dermatol. 2017;56(10):975-980., in the references below. In approved use, a review of melanocortin drugs reports more than 1,000 patients treated with afamelanotide and no melanoma events Böhm 2025 - Böhm M, Robert C, Malhotra S et al. An overview of benefits and risks of chronic melanocortin-1 receptor activation. J Eur Acad Dermatol Venereol. 2025;39(1):39-51., in the references below.

Get urgent care for swelling of the face or throat, hives or trouble breathing. See a dermatologist about any mole that changes.

Melanotan 1 vs Melanotan 2

FeatureMelanotan 1 (afamelanotide)Melanotan 2
StructureLinear, 13 amino acidsShorter and ring-shaped
Main targetMC1R, the skin’s pigment receptor, most stronglyNon-selective; crosses into the brain
ApprovalScenesse: EU 2014, US 2019, Australia 2020No approved product
Approved dose16 mg implant every 2 monthsNone
Human trialsTwo Phase 3 trials (168 patients), plus volunteer and vitiligo trials3 small studies, 23 men
ErectionsNot among the label’s side effects8 of 10 men in one trial
Nausea19% vs 14% on placeboCommon in the small trials

Both act on melanocortin receptors, the family α-MSH works through. The Scenesse label says afamelanotide binds mainly to MC1R, which drives eumelanin in skin. A review of melanocortin drugs ranks its other targets below that: MC3R, then MC4R and MC5R Böhm 2025 - Böhm M, Robert C, Malhotra S et al. An overview of benefits and risks of chronic melanocortin-1 receptor activation. J Eur Acad Dermatol Venereol. 2025;39(1):39-51., in the references below. The same review calls Melanotan 2 non-selective and says it crosses into the brain. It links that to Melanotan 2’s fatigue, appetite loss and erections Böhm 2025 - Böhm M, Robert C, Malhotra S et al. An overview of benefits and risks of chronic melanocortin-1 receptor activation. J Eur Acad Dermatol Venereol. 2025;39(1):39-51., in the references below.

Erections are the clearest difference. In a 1996 pilot, Melanotan 2 caused spontaneous erections at several doses Dorr 1996 - Dorr RT, Lines R, Levine N et al. Evaluation of melanotan-II, a superpotent cyclic melanotropic peptide in a pilot phase-I clinical study. Life Sci. 1996;58(20):1777-84., in the references below, and in a 1998 trial 8 of 10 men had erections on it Wessells 1998 - Wessells H, Fuciarelli K, Hansen J et al. Synthetic melanotropic peptide initiates erections in men with psychogenic erectile dysfunction: double-blind, placebo controlled crossover study. J Urol. 1998;160(2):389-93., in the references below. Erections and libido changes are not among the reactions in the Scenesse label.

No trial has compared the two head to head. Melanotan 1 has the larger trial record and a regulator-reviewed label, but only for EPP and only as the implant. For Melanotan 2’s dosing record and published harms, see Melanotan and Melanotan 2 dosage.

Research-vial Melanotan 1 vs the Scenesse implant

Online, Melanotan 1 is also sold as 10 mg vials of freeze-dried powder. On 3 October 2026, three US sellers listed a 10 mg vial at $39 to $55. Each labels it for research use only, not for human use, and posts a certificate of analysis. These are research-use products, not the approved medicine.

US legal status - FDA-approved · prescription only

Afamelanotide is FDA-approved only as Scenesse, a 16 mg implant for adults with erythropoietic protoporphyria. Powder sold as Melanotan 1 for research use is not the approved product and has no approved human use.

AU legal status - TGA-registered · prescription only

Scenesse is on the ARTG (327947) for adults with erythropoietic protoporphyria. The Poisons Standard lists afamelanotide in Schedule 4 (prescription only) and cross-references the name Melanotan I.

Regulators reach their own conclusions on their own timelines. Where these two disagree, the difference is the point - not an error.

The approvals cover only Scenesse, for EPP. In the EU, the EMA says only specialist doctors in recognised EPP centres prescribe it. In Australia, the Poisons Standard in force from 1 October 2026 makes afamelanotide prescription only, and its index lists Melanotan I under that entry. Selling the powder “for research use” does not approve it for people; see research peptides and the law.

Regulatory changes for this compound and others, as they happen: US peptide regulation tracker.

Common questions

Is Melanotan 1 FDA approved?

Yes, in one form and for one use. FDA approved afamelanotide as Scenesse, a 16 mg implant, on 8 October 2019, for adults with erythropoietic protoporphyria. It is not approved for tanning, and the injectable powder sold online as Melanotan 1 for research use is not an approved product.

Does Melanotan-1 make you tan?

Yes. In a randomised trial in 28 healthy men, 10 injections over 12 days darkened the skin of both burn-prone and easy-tanning men, with no change on placebo. The Scenesse label says it raises eumelanin in the skin without sun or UV exposure. No regulator has approved it for tanning.

How long does it take to see Melanotan-1 results?

In early trials of 10 injections over about 2 weeks, darker skin was measurable by the end of the course. It kept deepening afterwards, peaking 1 to 3 weeks after the last dose. In the EPP trials of the implant, the benefit was measured over 6 to 9 months.

How long does a Melanotan-1 tan last?

In early injection studies, the tan peaked about a week after the last dose and was still present 3 weeks later. Combined with sunlight, it lasted at least 3 weeks longer than a sun-only tan. I found no study that tracked how long it takes to fade fully. The approved implant is repeated every 2 months.

What are the benefits of taking Melanotan-1?

The proven benefit is in erythropoietic protoporphyria. In two Phase 3 trials, people on the implant spent more pain-free time in sunlight and reported better quality of life. One trial found fewer painful reactions. In healthy volunteers it darkened skin and, in one trial, more than halved sunburn cells in burn-prone people after a measured UV dose. In a vitiligo trial, it sped up repigmentation alongside light therapy.

Is Melanotan 1 or 2 better?

No trial has compared them. Melanotan 1 has Phase 3 trials and an approved label, but only as an implant for EPP. Its label says it binds mainly to MC1R, the skin's pigment receptor. Melanotan 2 has no approved product. A review calls it non-selective and says it crosses into the brain, which it links to fatigue, appetite loss and erections. Neither is approved for tanning.

Does Melanotan 1 change hair color?

I found no published human study reporting hair colour changes with afamelanotide, and the Scenesse label does not list them. The label does list general skin darkening and darker moles and freckles, and recommends a full-body skin check twice a year.

What are the side effects of Melanotan 1?

In the Scenesse trials, the most common were implant-site reactions (21% vs 10% on placebo) and nausea (19% vs 14%). Others were sore throat, cough, fatigue, skin darkening, dizziness and new moles. Serious allergic reactions, including anaphylaxis, have been reported since approval. The label recommends a full-body skin check twice a year because moles and freckles can darken.

What is the Melanotan 1 dose?

The approved dose is one 16 mg Scenesse implant placed under the skin every 2 months by a trained healthcare professional. In the EU, 3 implants a year are recommended and 4 is the maximum. No regulator has set a dose for the injectable powder sold online.

How much does Melanotan 1 cost?

The approved product, Scenesse, is an implant fitted by a trained clinician, so what you pay depends on the treating centre and your insurance. Separately, on 3 October 2026 three US research-chemical sellers listed a 10 mg vial of Melanotan 1 powder at $39 to $55. Those vials are labelled for research use only, not for human use, and they are not the approved product.

Does Melanotan 1 increase libido?

I found no trial reporting that it does. Erections and libido changes are not among the side effects in the Scenesse label. Those effects belong to Melanotan 2, which caused erections in 8 of 10 men in one small trial.

References (26 sources)

Bibliographic detail is fetched from PubMed, not written by me - so a citation here cannot drift from the paper it names. Study design comes from PubMed's own tags rather than my judgement.

  1. 1.Langendonk JG, Balwani M, Anderson KE et al. Afamelanotide for Erythropoietic Protoporphyria. N Engl J Med. 2015;373(1):48-59.Randomised trialPMID 26132941full text
  2. 2.Biolcati G, Marchesini E, Sorge F et al. Long-term observational study of afamelanotide in 115 patients with erythropoietic protoporphyria. Br J Dermatol. 2015;172(6):1601-1612.StudyPMID 25494545
  3. 3.Wensink D, Wagenmakers MAEM, Barman-Aksözen J et al. Association of Afamelanotide With Improved Outcomes in Patients With Erythropoietic Protoporphyria in Clinical Practice. JAMA Dermatol. 2020;156(5):570-575.StudyPMID 32186677full text
  4. 4.Levine N, Sheftel SN, Eytan T et al. Induction of skin tanning by subcutaneous administration of a potent synthetic melanotropin. JAMA. 1991;266(19):2730-6.Randomised trialPMID 1658407
  5. 5.Ugwu SO, Blanchard J, Dorr RT et al. Skin pigmentation and pharmacokinetics of melanotan-I in humans. Biopharm Drug Dispos. 1997;18(3):259-69.Randomised trialPMID 9113347
  6. 6.Dorr RT, Dvorakova K, Brooks C et al. Increased eumelanin expression and tanning is induced by a superpotent melanotropin [Nle4-D-Phe7]-alpha-MSH in humans. Photochem Photobiol. 2000;72(4):526-32.Clinical trialPMID 11045725
  7. 7.Dorr RT, Ertl G, Levine N et al. Effects of a superpotent melanotropic peptide in combination with solar UV radiation on tanning of the skin in human volunteers. Arch Dermatol. 2004;140(7):827-35.Randomised trialPMID 15262693
  8. 8.Barnetson RS, Ooi TK, Zhuang L et al. [Nle4-D-Phe7]-alpha-melanocyte-stimulating hormone significantly increased pigmentation and decreased UV damage in fair-skinned Caucasian volunteers. J Invest Dermatol. 2006;126(8):1869-78.Randomised trialPMID 16763547
  9. 9.Hadley ME, Dorr RT. Melanocortin peptide therapeutics: historical milestones, clinical studies and commercialization. Peptides. 2006;27(4):921-30.ReviewPMID 16412534
  10. 10.Minder EI, Barman-Aksoezen J, Schneider-Yin X. Pharmacokinetics and Pharmacodynamics of Afamelanotide and its Clinical Use in Treating Dermatologic Disorders. Clin Pharmacokinet. 2017;56(8):815-823.ReviewPMID 28063031
  11. 11.Böhm M, Robert C, Malhotra S et al. An overview of benefits and risks of chronic melanocortin-1 receptor activation. J Eur Acad Dermatol Venereol. 2025;39(1):39-51.ReviewPMID 39082868full text
  12. 12.Lim HW, Grimes PE, Agbai O et al. Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial. JAMA Dermatol. 2015;151(1):42-50.Randomised trialPMID 25230094
  13. 13.Habbema L, Halk AB, Neumann M et al. Risks of unregulated use of alpha-melanocyte-stimulating hormone analogues: a review. Int J Dermatol. 2017;56(10):975-980.ReviewPMID 28266027
  14. 14.Dorr RT, Lines R, Levine N et al. Evaluation of melanotan-II, a superpotent cyclic melanotropic peptide in a pilot phase-I clinical study. Life Sci. 1996;58(20):1777-84.Clinical trialPMID 8637402
  15. 15.Wessells H, Fuciarelli K, Hansen J et al. Synthetic melanotropic peptide initiates erections in men with psychogenic erectile dysfunction: double-blind, placebo controlled crossover study. J Urol. 1998;160(2):389-93.Clinical trialPMID 9679884
  16. 16.SCENESSE (afamelanotide) implant, full prescribing information, revised 08/2024: 16 mg implant every 2 months, warnings, and the adverse-reaction table from 3 vehicle-controlled trials (125 vs 119 patients).- US Food and Drug Administration (label by Clinuvel Inc)label
  17. 17.Drugs@FDA - SCENESSE, NDA 210797: afamelanotide 16 mg subcutaneous implant, prescription, approved 8 October 2019, orphan designation.- US Food and Drug Administrationregulatory
  18. 18.openFDA Drugs@FDA query for the active ingredient afamelanotide, run 3 October 2026: one application, NDA 210797 (SCENESSE implant).- US Food and Drug Administration (openFDA)database
  19. 19.EMA - Scenesse EPAR: authorised 22 December 2014 under exceptional circumstances for prevention of phototoxicity in adults with EPP; marketing authorisation holder Clinuvel Europe Limited; one implant every 2 months, 3 a year recommended, maximum 4.- European Medicines Agencyregulatory
  20. 20.TGA - Australian Public Assessment Report for afamelanotide (Scenesse), 11 March 2021: decision 22 October 2020, ARTG entry 18 November 2020, ARTG 327947, and a description of EPP.- Therapeutic Goods Administration, Australian Governmentregulatory
  21. 21.TGA - ARTG entry 327947, SCENESSE afamelanotide (as acetate) 16 mg implant vial: sponsor Clinuvel Pharmaceuticals Ltd, ARTG date 18 November 2020, licence status active, checked 3 October 2026.- Therapeutic Goods Administration, Australian Governmentdatabase
  22. 22.Therapeutic Goods (Poisons Standard - October 2026) Instrument 2026, in force from 1 October 2026. Afamelanotide is listed in Schedule 4 (prescription only); the index cross-references it as melanocyte stimulating hormone and Melanotan I.- Federal Register of Legislation, Australian Governmentstatute
  23. 23.CLINUVEL press release, 24 April 2026 - final EMA scientific advice for its pivotal Phase III vitiligo study (CUV107, 300 patients), planned to start in the second half of 2026.- GlobeNewswire (CLINUVEL Pharmaceuticals)news
  24. 24.American Peptides - MELANOTAN-1 product page: 10 mg lyophilised vial, $55.00 as of 3 October 2026, labelled for laboratory and research use only.- American Peptides (seller)other
  25. 25.Core Peptides - Melanotan 1 (Afamelanotide) 10 mg product page: $43.00 as of 3 October 2026, labelled not for human consumption.- Core Peptides (seller)other
  26. 26.BioEdge Research Labs - Melanotan 1 10 mg product page: $39.00 sale price ($43.00 regular) as of 3 October 2026, labelled for in vitro research only.- BioEdge Research Labs (seller)other

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