At a Glance
| Feature | Detail |
|---|---|
| Name / structure | Afamelanotide, [Nle4, D-Phe7]-alpha-MSH, a linear 13-amino-acid analogue of alpha-MSH; research name Melanotan I (MT-1) |
| Origin | University of Arizona (1980s), developed to approval by Clinuvel |
| Mechanism | Melanocortin-1 receptor (MC1R) agonist: shifts melanocytes to eumelanin production |
| Used for | Approved: phototoxicity in erythropoietic protoporphyria (EPP). Studied: vitiligo. Grey market: cosmetic tanning |
| Route | Approved: 16 mg subcutaneous implant. Grey market: SC injection of reconstituted powder |
| Typical dose | Label: 16 mg implant every 2 months. Practice: 250–500 mcg SC daily loading, then 1–3× weekly |
| Evidence level | Moderate for EPP (two randomised phase 3 trials plus registries); Limited for tanning in healthy people (small open-label phase 1 studies) |
| Regulatory status | EMA authorised 22 Dec 2014 (exceptional circumstances); FDA approved 2019 for adults with EPP; WADA 2026: not named on the Prohibited List |
Melanotan 1 is the rare grey-market peptide with an approved twin. The same molecule, afamelanotide, is sold as Scenesse, a rice-grain-sized implant that porphyria specialists place under the skin of people with erythropoietic protoporphyria (EPP). For these patients a few minutes of sunlight can cause hours to days of burning pain, and the implant lets many of them go outside again.
That makes Melanotan 1 interesting and confusing in equal parts. The approved implant has randomised trials, a label and years of registry data. A vial of “MT-1” bought online has none of that, even if the peptide inside is correct. My view: if you want to understand what afamelanotide does, read the EPP trials. If you want a tan, the evidence is a handful of small studies from the 1990s and 2000s, at much higher doses than people inject today.
How it works
Alpha-MSH binds MC1R on melanocytes and switches pigment production from reddish pheomelanin toward brown-black eumelanin, which absorbs and scatters light. In EPP, protoporphyrin accumulates in the skin and turns visible light into tissue-damaging energy. More eumelanin means less light reaches the protoporphyrin, so the threshold for pain rises [10].
Afamelanotide carries two substitutions (norleucine at position 4, D-phenylalanine at position 7) that make it far more potent and longer-lasting than natural alpha-MSH [6]. Unlike Melanotan 2, it is linear and largely selective for MC1R, which is why erections and strong appetite effects are not part of its profile. Nausea still is.
What the evidence shows
Erythropoietic protoporphyria (the approved use)
| Study | Design | n | Dose | Finding |
|---|---|---|---|---|
| Langendonk 2015, US trial [1] | Randomised, double-blind, placebo-controlled | 94 | 16 mg implant every 60 days (3 implants) | Median pain-free direct sunlight 69.4 h vs 40.8 h on placebo over 6 months (P=0.04) |
| Langendonk 2015, EU trial [1] | Randomised, double-blind, placebo-controlled | 74 | 16 mg implant every 60 days (5 implants) | Median pain-free sunlight 6.0 h vs 0.8 h; phototoxic reactions 77 vs 146 (P=0.04); quality of life improved |
| Biolcati 2015 [4] | Long-term observational, Italy and Switzerland | 115 | 1,023 implants over up to 8 years | EPP quality-of-life score rose from 31 % to about 74 % of maximum and stayed there; adverse events mostly mild nausea |
| Homey 2025 [5] | Post-authorisation safety study, Germany | 200 | Per label | Safety consistent with the trials; 91 % still on treatment; quality of life improved (co-authored by the manufacturer) |
The absolute gains in hours look modest on paper. For people who previously avoided daylight altogether, the treatment-continuation data in the registries suggest they matter.
Vitiligo (studied, not approved)
After a four-patient case series [3], a randomised trial in 55 adults with generalised vitiligo added 16 mg implants monthly for 4 months to narrowband UV-B. Repigmentation was faster and greater with the combination (48.6 % vs 33.3 % at day 168), with the clearest benefit in skin types IV to VI [2]. Nausea and minor infections were more common with afamelanotide.
Tanning in healthy volunteers
The original MT-1 studies at the University of Arizona used daily subcutaneous injections. Seven volunteers who received 0.16 mg/kg/day for 10 days tanned at face, neck and forearm sites, with higher skin eumelanin [6]. In three further open-label phase 1 studies, 0.16 mg/kg combined with UV-B or sunlight produced tanning that lasted at least 3 weeks longer than sunlight alone, and the sun-only group needed 50 % more exposure for the same tan [7]. Side effects were nausea and transient facial flushing. These studies were small, open-label and short.
Dosing
For informational purposes only — this summarises doses used in research and practice; it is not a prescription or individual medical advice.
| Goal | Dose | Route | Frequency / timing | Cycle length | Basis |
|---|---|---|---|---|---|
| EPP phototoxicity | 16 mg implant | SC implant (above the iliac crest) by a trained professional | Every 2 months, before and during the high-light season | EU: 3 implants per year recommended, maximum 4 | Label [11][12]; Trial [1] |
| Vitiligo (adjunct to NB-UV-B) | 16 mg implant | SC implant | Monthly | 4 implants | Trial [2] (not approved) |
| Tanning (research) | 0.16 mg/kg (about 11 mg at 70 kg) | SC injection | Daily, or 5 days/week with sun exposure | 10 days to 4 weeks | Trial [6][7] |
| Tanning, loading (grey market) | 250–500 mcg | SC injection | Daily, often combined with UV | 2–4 weeks | Practice protocol (Pepdex, Stacktrax) |
| Tanning, maintenance (grey market) | 250–500 mcg | SC injection | 1–3× weekly | Through the season | Practice protocol (same two sources) |
| Tanning, forum variants | 0.35–0.4 mg daily, then every other day; or 1 mg twice weekly | SC injection | As stated | Variable | Anecdotal (forum thread) |
What stands out: the research doses were about 20 to 40 times higher per injection than the grey-market protocols, and the implant releases 16 mg over weeks. Community protocols at 250–500 mcg come from no trial. They are conventions borrowed from Melanotan 2, a more potent molecule.
For injection technique and reconstitution basics, see the peptide injection guide.
What people report: what works and what doesn’t
Reported to work
- In EPP, the implant lets many patients spend real time outdoors, which matches the trials and the high continuation rates in registries [1][4][5].
- Grey-market users report a gradual, natural-looking tan with UV exposure and less nausea than Melanotan 2 (glp1forum).
Mixed or unclear
- Speed: many users see little colour at 2 weeks and switch to Melanotan 2 out of impatience; others find the nausea and flushing similar to MT-2 (r/Melanotan2).
- No head-to-head comparison of side effects between MT-1 and MT-2 exists.
Reported not to work, or disappointing
- Little or no tan without UV exposure at community doses.
- Nausea for about 10 minutes after injection, facial flushing in the first week, and in one report a flu-like illness after the first doses (r/Melanotan2).
- Darkening of freckles and moles, the same pattern seen with the approved implant.
What a proper trial would need to show for cosmetic use: that low-dose repeated injections produce a meaningful tan without increasing atypical moles over several seasons, compared with sun exposure alone. That trial has not been done.
Implant versus injection: why they are not the same
The approved product and the grey-market vial share a molecule and little else.
- Release profile. Scenesse is a solid, dissolvable implant designed to release 16 mg slowly after it is placed under the skin, so one implant covers about two months. Reconstituted powder injected daily gives short peaks. The trials that established efficacy and safety in EPP used the implant [1]; the daily-injection studies in healthy volunteers used about 11 mg per day for 10 days [6][7]. Community doses of 250–500 mcg per injection sit in neither data set.
- Who places it. The implant is inserted by a trained professional in a recognised centre, after which patients are observed for 30 minutes for allergic reactions [12], and skin checks are built into follow-up. In Germany, porphyria centres such as those in Düsseldorf and Chemnitz contributed patients to the national post-authorisation study [5].
- What is being treated. EPP patients start from a disease that makes light painful. Healthy people seeking a tan start from normal skin, so any risk, however small, buys only a cosmetic effect.
- What is known about the product. The implant has a manufacturing standard, a batch record and a pharmacovigilance system. A research-chemical vial has a label and, at best, a certificate from the seller.
If someone with EPP or suspected EPP is reading this: the route to afamelanotide is a porphyria specialist, not a peptide vendor. Diagnosis needs measurement of protoporphyrin in blood, and the specialist centre can also advise on liver monitoring, which matters in EPP regardless of treatment.
Safety and side effects
From the US label (three randomised trials, 125 patients on afamelanotide vs 119 on vehicle) [11]: implant-site reactions 21 % vs 10 %, nausea 19 % vs 14 %, oropharyngeal pain 7 % vs 5 %, cough, fatigue, skin hyperpigmentation 4 % vs 0 %, dizziness, and melanocytic nevi 4 % vs 2 %. Serious hypersensitivity, including anaphylaxis, has been reported since approval. The label recommends a full-body skin examination twice a year because afamelanotide darkens existing moles and freckles.
The long-term EPP registries have not shown a safety signal beyond mild nausea and pigment changes [4][5]. Those patients are monitored by specialists. Grey-market users are not, and the case-report literature on unregulated alpha-MSH analogues includes changing moles and melanoma, though most of those cases involve Melanotan 2 [8].
Points that apply to anyone considering the molecule:
- People with a history of melanoma, dysplastic nevus syndrome or many atypical moles are poor candidates, because the pigment stimulus acts on moles too.
- Pregnancy and breastfeeding: no adequate data.
- Grey-market powder means unknown content, purity and sterility, no slow-release formulation, and doses chosen by forum convention. Researchers surveying users note that it can be bought online with relative ease [9], which says nothing about whether it is safe.
Legal and regulatory status
- United States. Scenesse (afamelanotide 16 mg implant) was approved by the FDA in 2019 to increase pain-free light exposure in adults with a history of phototoxic reactions from EPP, and must be implanted by a trained healthcare professional [11]. Cosmetic tanning is off-label, and powders sold as MT-1 are unapproved drugs.
- EU and Germany. The EMA authorised Scenesse on 22 December 2014 under exceptional circumstances, with additional monitoring and post-authorisation registry studies. It is prescribed only by specialists in recognised EPP centres [12]. Selling MT-1 powder for human use is supply of an unauthorised medicine.
- Sport. Afamelanotide is not named on the WADA 2026 Prohibited List, and as an approved medicine it does not fall under the S0 catch-all for non-approved substances. Athletes should still confirm with their national anti-doping organisation.
How it fits
| Melanotan 1 / afamelanotide | Melanotan 2 | PT-141 / bremelanotide | |
|---|---|---|---|
| Receptor selectivity | Mainly MC1R | MC1R, MC3R, MC4R | MC4R, MC3R |
| Approved | Yes (EPP) | No | Yes (HSDD) |
| Erections / libido | Not a typical effect | Common | Intended effect |
| Best evidence | Randomised trials, registries | Three small studies, case reports | Randomised trials |
Afamelanotide is the most thoroughly studied melanocortin peptide for skin. If the question is “which tanning peptide has real human data”, this is the answer, with the caveat that the data come from patients with a rare disease using an implant, not from healthy people injecting powder.
Related Articles
- Melanotan 2: Tanning Peptide, Real Risks, No Approval
- PT-141 (Bremelanotide): Evidence and Uses
- GHK-Cu for Skin: Anti-Aging Evidence and Protocols
- Peptide Injection Guide
- Peptide Sourcing: Quality and Grey-Market Risks
Frequently asked questions
Is Melanotan 1 the same as afamelanotide?
Yes. Melanotan 1 (MT-1) was the research name of [Nle4, D-Phe7]-alpha-MSH, which received the international nonproprietary name afamelanotide. The approved product is Scenesse, a 16 mg slow-release implant. Powders sold online as 'Melanotan 1' claim to be the same molecule but are not the approved product.
What is Scenesse approved for?
Scenesse is approved in the EU (since December 2014) and the US (since 2019) for adults with erythropoietic protoporphyria (EPP), a rare inherited disease in which light exposure causes severe burning pain. It increases the time patients can spend in light without pain.
What is the dose of afamelanotide?
The approved dose is one 16 mg implant placed under the skin every 2 months by a trained professional. The EU label recommends three implants a year and a maximum of four. Grey-market tanning protocols use 250–500 mcg injections daily for 2–4 weeks, then 1–3 times a week, which has never been tested in a trial.
Is Melanotan 1 safer than Melanotan 2?
Afamelanotide is more selective for the pigment receptor and has been tested in randomised trials and long-term registries, so far more is known about it. That knowledge applies to the approved implant. Grey-market powders carry the same purity and dosing uncertainty as any unregulated injectable, and moles still darken on afamelanotide.
Does afamelanotide work for vitiligo?
In a randomised trial of 55 adults with vitiligo, adding monthly 16 mg implants to narrowband UV-B gave faster and greater repigmentation than UV-B alone, mainly in darker skin types. It is not approved for vitiligo.
References
- Langendonk JG, Balwani M, Anderson KE, et al. Afamelanotide for Erythropoietic Protoporphyria. N Engl J Med. 2015. PMID: 26132941. https://pubmed.ncbi.nlm.nih.gov/26132941/
- 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. PMID: 25230094. https://pubmed.ncbi.nlm.nih.gov/25230094/
- Grimes PE, Hamzavi I, Lebwohl M, et al. The efficacy of afamelanotide and narrowband UV-B phototherapy for repigmentation of vitiligo. JAMA Dermatol. 2013. PMID: 23407924. https://pubmed.ncbi.nlm.nih.gov/23407924/
- Biolcati G, Marchesini E, Sorge F, et al. Long-term observational study of afamelanotide in 115 patients with erythropoietic protoporphyria. Br J Dermatol. 2015. PMID: 25494545. https://pubmed.ncbi.nlm.nih.gov/25494545/
- Homey B, Schelonke K, Schlegel CM, et al. German Cohort Observational Study to Investigate the Short- and Long-Term Safety and Clinical Effectiveness of Afamelanotide 16 mg (SCENESSE) in Patients With Erythropoietic Protoporphyria (EPP). Photodermatol Photoimmunol Photomed. 2025. PMID: 40082741. https://pubmed.ncbi.nlm.nih.gov/40082741/
- 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. PMID: 11045725. https://pubmed.ncbi.nlm.nih.gov/11045725/
- 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. PMID: 15262693. https://pubmed.ncbi.nlm.nih.gov/15262693/
- Habbema L, Halk AB, Neumann M, et al. Risks of unregulated use of alpha-melanocyte-stimulating hormone analogues: a review. Int J Dermatol. 2017. PMID: 28266027. https://pubmed.ncbi.nlm.nih.gov/28266027/
- Callaghan DJ 3rd. A glimpse into the underground market of melanotan. Dermatol Online J. 2018. PMID: 30142729. https://pubmed.ncbi.nlm.nih.gov/30142729/
- Minder EI, Schneider-Yin X. Afamelanotide (CUV1647) in dermal phototoxicity of erythropoietic protoporphyria. Expert Rev Clin Pharmacol. 2015. PMID: 25470471. https://pubmed.ncbi.nlm.nih.gov/25470471/
- SCENESSE (afamelanotide) implant. US Prescribing Information, via openFDA (label effective May 2026). https://api.fda.gov/drug/label.json?search=openfda.generic_name:afamelanotide
- European Medicines Agency. Scenesse: European public assessment report. https://www.ema.europa.eu/en/medicines/human/EPAR/scenesse
Disclaimer: This article is for information and education only and is not a prescription or individual medical advice. Scenesse is a prescription medicine for EPP; Melanotan 1 sold online is not an approved product.