Melanotan 1 (afamelanotide): research, side effects and approved use
In short
Melanotan 1 is the same molecule as afamelanotide, which has an EU marketing authorisation for a rare light-sensitivity disease [11]regulator. The approved product is an implant placed under the skin by a doctor, not an injection or a nasal spray, and tanning is not an approved use [10]official.
- The EU granted the marketing authorisation on 22 December 2014 under exceptional circumstances, and the FDA approved the same product in the United States on 8 October 2019. The indication is erythropoietic protoporphyria (EPP) in adults [11, 13]regulator.
- The evidence is among the strongest on this site, but it concerns EPP only: two randomised placebo-controlled multicentre trials, 74 patients in Europe and 94 in the United States, published in the New England Journal of Medicine [2]A.
- The approved form is a 16 mg implant under the skin every two months, placed by a trained doctor [10]official.
- Taken by mouth, the substance was not detected in the bloodstream at all [3]A. This suggests that capsules taken by mouth would not work either, but the capsules sold online have not themselves been tested, and there is no human study of the nasal spray.
- Injected under the skin, its half-life was short, 0.8-1.7 hours [3]A.
What is melanotan 1?
Melanotan 1 is a synthetic analogue of alpha-melanocyte-stimulating hormone (alpha-MSH), and its drug name is afamelanotide [10]official. Chemically it is [Nle4-D-Phe7]-alpha-MSH, a modified version of the body's own hormone. The literature also uses the abbreviation NDP-MSH [6]A [9]B.
This is the key distinction on this page. Melanotan 1 and afamelanotide are the same molecule, but the approved medicine and the research chemical sold online are not the same product. The approved product is an implant placed by a trained doctor in one rare disease [10]official. Melanotan 1 sold online is a powder sold for injection or as a spray, for a different use, with no control of dose or purity [12]regulator.
Melanotan 1 is not the same substance as Melanotan II, even though the names are close. Melanotan 1 is one of the skin-related substances in the Peptides A-Z list.
Evidence at a glance
Each cell gives the kind of study and its source. The letter is the evidence level, not the result.
| Claimed effect | Humans | Animals | Cells |
|---|---|---|---|
| Less light sensitivity (EPP) | Two randomised placebo-controlled trials, 74 and 94 patients [2]A; authorised in the EU in 2014 and in the US in 2019 [11, 13]regulator | - | - |
| Pain-free time in the sun | Median 64.1 hours vs 40.5 hours with placebo over 180 days [1]official | - | - |
| Skin darkening | Measured by reflectance in humans [3]A; three phase 1 studies with UV exposure [4]A | - | - |
| Vitiligo | Randomised trial with narrowband UVB, 28 and 27 patients [5]A | - | - |
| Effect in MC1R variant carriers | Melanin measured in 77 people [6]A | - | - |
| Taken by mouth | No detectable levels in the blood [3]A | - | - |
| Safety | Nausea, headache and implant site reactions in about one in five [10]official; full skin check twice a year [1, 10]official | - | - |
"-" = no such study is known.
What is melanotan 1 used for?
The only approved use of melanotan 1 is the afamelanotide implant for erythropoietic protoporphyria (EPP) in adults. In the EU the indication is prevention of phototoxicity [10]official; in the US it is to increase pain-free light exposure [1]official.
- Erythropoietic protoporphyria: a rare and severe light-sensitivity disease in which light causes severe pain and clearly impairs quality of life [2]A. The marketing authorisation rests on this [11, 13]regulator.
- Vitiligo: a randomised trial together with narrowband UVB therapy [5]A. Not an approved use.
- Other: acute stroke as a phase 2a feasibility study [7]B and acne [8]B. Not approved uses.
Claims online. Online, melanotan 1 is sold for tanning. Skin darkening has been measured in studies [3, 4]A, but tanning is not an approved use [10]official.
How does melanotan 1 work?
Melanotan 1 activates the melanocortin-1 receptor (MC1R), which increases eumelanin production in the skin independently of sunlight or artificial light [1, 10]official. In practice the skin darkens without UV exposure.
According to the summary of product characteristics, eumelanin protects against light in several ways: it filters UV and visible light and acts as an antioxidant. The darkening fades gradually unless a new implant is placed [10]official.
The effect has also been measured in people with MC1R gene variants: their melanin increased even more than in people without the variants [6]A.
Has melanotan 1 been studied in humans?
Afamelanotide has been studied in humans: there are two randomised placebo-controlled trials [2]A, and the afamelanotide implant (Scenesse) is an approved medicine [11, 13]regulator. The powder or spray sold online under the name melanotan 1 is not an approved medicine.
The evidence behind the approval
Two multicentre trials, randomised, double-blind and placebo-controlled. Participants had erythropoietic protoporphyria: 74 patients in the European Union and 94 in the United States, randomised 1:1. The product was given as a 16 mg implant under the skin every 60 days, five implants in the EU trial and three in the US trial. Follow-up lasted 270 and 180 days. The trials measured the type and duration of time spent in sunlight, the number and severity of phototoxic reactions, adverse events and quality of life [2]A.
According to the FDA label, in the 180-day trial the median number of pain-free hours in direct sunlight between 10 am and 6 pm was 64.1 hours with treatment and 40.5 hours with placebo [1]official.
Pharmacokinetics and three routes
Three male volunteers received melanotan 1 into a vein, by mouth and under the skin in a randomised crossover design, ten doses over two weeks. The dose under the skin was fully absorbed compared with the dose into a vein, but taken by mouth the substance was not detected in the bloodstream at all. Harms were minor, and the skin tanned significantly on the forehead and the other measured areas [3]A.
Tanning with UV exposure
Three phase 1 studies looked at safety together with UVB light or sunlight. In the first, four people received melanotan 1 at 0.08 mg per kg per day under the skin and four received saline for ten days, after which the neck was irradiated with three times the minimal erythema dose. In the second, 12 participants, the dose was raised to 0.16 mg per kg for ten days, and UVB was given to the buttock for five days during or after treatment. In the third, eight participants were randomised to sunlight on half of the back, or sunlight plus melanotan 1 at 0.16 mg per kg [4]A.
Vitiligo and other uses
A randomised multicentre trial compared combination therapy, an afamelanotide implant plus narrowband UVB, with narrowband UVB alone. It included 28 and 27 patients with non-segmental vitiligo covering 15-50% of the skin. After a month of UVB, the combination group received 16 mg of afamelanotide under the skin monthly for four months [5]A.
Afamelanotide has also been studied in acute stroke as a phase 2a feasibility study [7]B and in acne [8]B. Antibodies were sought in 26 EPP patients who had received it for up to six years: 23 had none, and in three the antibodies were present before treatment and did not change during it [9]B.
Who studies melanotan 1?
The trials behind the approval were multicentre trials in Europe and the United States [2]A. In the EU the marketing authorisation holder is Clinuvel Europe Limited [11]regulator, and according to the FDA label the doctors who place the implant are trained in the company's programme [1]official.
Who wrote this page: the editorial team
This page was written by the Molecular Recovery editorial team. The draft was made with the help of AI, and the claims were checked against the sources (AI policy). The page has not been medically reviewed. How we work: About us.
How long does melanotan 1 stay in the body?
Melanotan 1 leaves the bloodstream quickly: injected under the skin, the elimination half-life was 0.8-1.7 hours and the absorption half-life 0.07-0.79 hours. Clearance was 0.12-0.19 litres per kg per hour, and at most 3.9% of the dose was excreted in urine [3]A. According to the summary of product characteristics, the half-life is about 30 minutes [10]official.
The implant does not release the substance evenly over two months. According to the summary of product characteristics, most of it is released in the first 48 hours and over 90% by day 5. In most studies blood levels were below the limit of quantitation by day 10, and the implant itself is absorbed by the body in 50-60 days [10]official.
Taken by mouth, the substance was not detected in the bloodstream at all [3]A.
What are the side effects of melanotan 1?
The most common side effects of melanotan 1 in the trials of the approved product were nausea, headache and implant site reactions, mostly mild [10]official. The most important expected effect is skin darkening, which is checked regularly [1, 10]official.
What users report. In the Reddit accounts we compiled (not research), 43 of 77 people (56%) reported some harm, most often: flushing (18, 23%), nausea or vomiting (12, 16%) and uneven or unwanted darkening (freckles, face, lips) (11, 14%). People tend to post when something goes wrong, so this share does not tell how common harms are. In the accounts melanotan 1 gets mixed up with melanotan II: 73 of 91 accounts came from the melanotan II users' forum, and several writers themselves suspected that the product sold as melanotan 1 was in fact melanotan II. The approved afamelanotide implant (Scenesse) was not mentioned in a single account. The harms in detail: Melanotan 1 user experiences.
Reported in humans
The safety data in the summary of product characteristics come from pooled data on 425 patients. About 19% had nausea, 20% headache and 21% implant site reactions, mainly discolouration, pain, bruising and redness. Hypersensitivity reactions, including anaphylaxis, have been reported uncommonly, so the patient is observed for 30 minutes after the implant is placed [10]official.
In the pharmacokinetic study, harms were minor: occasional stomach upset and facial flushing [3]A.
The medicine can darken existing moles and other pigmented lesions, so a full skin examination is recommended twice a year [1, 10]official. This is a real monitoring requirement, not a cosmetic note: darker skin makes changes in moles harder to spot. Special caution is needed if the patient or the family has had melanoma [10]official.
Mole changes reported by users of tanning peptides are covered on the Melanotan II page.
The number and severity of phototoxic reactions and the adverse events were recorded in both phase 3 trials [2]A.
What has not been studied
The safety of the routes used online has not been studied. The published human studies used the implant [2, 5]A or supervised doses under the skin [3, 4]A. No human study of a nasal spray is known.
Long-term use for tanning has not been studied. According to the summary of product characteristics, the safety of the approved product has not been evaluated in clinical studies longer than two years [10]official. Side effects of peptides in general: side effects in studies.
Interactions and who has no data
No specific interaction studies of melanotan 1 have been done. According to the summary of product characteristics, medicines that reduce blood clotting, such as warfarin, acetylsalicylic acid and NSAIDs, may increase bruising or bleeding at the implant site [10]official.
According to the summary of product characteristics, the product should not be used during pregnancy or breastfeeding, and women of childbearing potential must use effective contraception during treatment and for three months after. Safety and efficacy under 18 years have not been established, and it should not be used in people over 70. Liver or kidney impairment is a contraindication [10]official.
What speaks against it and what is unknown
The strongest counter-evidence is about the route, and it was measured directly: taken by mouth, melanotan 1 was not detected in the bloodstream at all [3]A.
Contrary evidence
- Route. Taken by mouth, the substance was not detected in the blood [3]A. This does not directly apply to nasal sprays, which are absorbed differently, but it shows that the route matters and the substance is not absorbed from anywhere. There are no published human data on nasal sprays, so nothing is known about the levels they reach.
- Half-life. Injected under the skin, the elimination half-life was 0.8-1.7 hours [3]A, so an injection would leave the blood within hours. The approved product is an implant that releases the substance over a few days [10]official.
- Indication. The marketing authorisation covers erythropoietic protoporphyria, a rare and severe disease [2]A [11]regulator. Tanning is not an approved use, even though skin darkening has been measured in studies [3, 4]A.
- Incomplete data. The EU authorisation was granted under exceptional circumstances because, as the disease is rare, it has not been possible to collect complete information on benefits and safety [11]regulator.
What the evidence does not support
- "Melanotan 1 sold online is the same product as the approved afamelanotide": it is not. The molecule is the same, but the product, route, dose control and indication differ [10]official [12]regulator.
- "A nasal spray or capsule works": by mouth no levels were detected [3]A, and there are no published human data on sprays.
- "Melanotan 1 lets you tan safely without supervision": in the studies UV exposure was given in measured doses, as multiples of the minimal erythema dose [4]A, not freely.
- "The milligrams in the vial match the approved dose": the approved dose is a 16 mg implant every two months [10]official, which is not the same as an injected dose.
Melanotan 1 dosage: the approved product and studies
Melanotan 1 has an approved dosage, but it applies to the afamelanotide implant in one disease, and the implant is placed by a doctor trained for it [10]official. Below are the dosing in the summary of product characteristics and the doses used in studies. They are not recommendations.
| Product or study | Who | Dose and route | Duration |
|---|---|---|---|
| Approved product (Scenesse) | Adults with erythropoietic protoporphyria | 16 mg implant under the skin above the supra-iliac crest every two months, before expected and during increased sunlight exposure; placed by a trained doctor | Duration of treatment at the specialist's discretion [10]official |
| Phase 3 trials | 74 patients in the EU, 94 in the US | 16 mg implant every 60 days; 5 implants in the EU, 3 in the US | 270 and 180 days [2]A |
| Vitiligo trial | 28 combination, 27 UVB alone | 16 mg implant under the skin monthly, with narrowband UVB | 4 months [5]A |
| Pharmacokinetics | 3 male volunteers | 0.16 mg/kg into a vein and by mouth; 0.08-0.21 mg/kg under the skin | 10 doses in 2 weeks [3]A |
| Phase 1 UV studies | 4 + 4, then 12, then 8 participants | 0.08 or 0.16 mg/kg per day under the skin, UVB or sunlight in measured doses | 10 days, UV 5 days [4]A |
What the numbers do not tell you. The approved 16 mg dose is an implant and cannot be converted into an injected dose, because injected the substance is gone within hours [3]A and from the implant it is released over a few days [10]official. The mg-per-kg doses of the phase 1 studies were given under supervision for ten days, not as continuous use, and UV exposure was measured and limited [4]A. Approved dosing with sources: melanotan 1 approved dosage. The calculator page explains why the vial calculator does not apply to an implant.
Melanotan 1 or melanotan 2: what is the difference?
Melanotan 1 and melanotan 2 are different molecules, and their evidence is in a completely different class.
The afamelanotide implant (Scenesse) is an approved medicine with two randomised placebo-controlled multicentre trials in the New England Journal of Medicine [2]A and marketing authorisations in the EU and the US [11, 13]regulator. The powder sold online under the name melanotan 1 is not an approved medicine. Melanotan 2 is a different substance with no marketing authorisation: Melanotan II.
No published head-to-head human study of the two is known, but the difference in approval status is clear: one is an approved medicine, the other is not.
Is melanotan 1 legal in Finland?
Afamelanotide is an approved prescription medicine in the EU, but the melanotan 1 powder sold online is a different thing and has no marketing authorisation [11]regulator [12]regulator.
- EU. The European Commission granted Scenesse (afamelanotide) a marketing authorisation valid throughout the EU on 22 December 2014. It was authorised under exceptional circumstances and is designated an orphan medicine. The indication is prevention of phototoxicity in adults with erythropoietic protoporphyria [11]regulator.
- United States. The FDA approved the SCENESSE implant (afamelanotide) on 8 October 2019 as a new molecular entity with priority review and orphan status [13]regulator. The indication is to increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria [1]official.
- Who gives it. Only specialists in recognised porphyria centres may prescribe it, and the implant is placed by a doctor trained for it [10]official. It cannot be bought or administered by the user. Ask the treating specialist about availability in Finland; Fimea's medicines search shows the product's status.
- Medicines list. Annex 1 of Fimea's decision 230/2025 names afamelanotide, and Annex 1 A names melanotan I. Substances in Annex 1 A are always treated, by their effect, like prescription-only medicines, so melanotan 1 sold online is also controlled as a medicine in Finland [14]regulator.
- Melanotan 1 sold online. Melanotan 1 sold as a research chemical has no marketing authorisation. Fimea has warned against using injectable peptides bought online and reminds that a "research use only" label means the product is not intended for humans [12]regulator. Overview: peptides and the law in Finland.
For this substance the label means something extra: because an approved medicine exists, the version sold as a research chemical is not "the same thing, cheaper" but a different product without oversight.
This is not legal advice. Disclaimer.
How to assess a melanotan 1 product?
On the certificate of analysis (COA) of a melanotan 1 product, check the measurement method and that the batch number matches the vial, and for this substance also the name. Liquid chromatography (HPLC) shows purity, mass spectrometry (MS) shows whether the molecule is the right one. How to read one: how to read a COA.
On names: melanotan 1 and melanotan 2 are different molecules, and the similar names are the best-known source of mix-ups in this area. The name afamelanotide means the same molecule as melanotan 1, and the literature also uses [Nle4-D-Phe7]-alpha-MSH and the abbreviation NDP-MSH [6]A [9]B. Check the label.
The certificate says nothing about sterility, endotoxins or what happened to the product in transit. Nor does it say anything about dose or route, which is exactly where the online product differs most from the approved one. Handling: mixing and storage.
FAQ
What is melanotan 1?
A synthetic analogue of the hormone alpha-MSH, with the drug name afamelanotide. It activates the melanocortin-1 receptor and increases eumelanin in the skin independently of sunlight [1, 10]official.
Melanotan 1 or melanotan 2?
Different molecules. Afamelanotide has an approved product, the Scenesse implant [11, 13]regulator, with two randomised placebo-controlled trials [2]A; melanotan 2 has neither. No head-to-head human study of the two is known.
What is the half-life of melanotan 1?
Short. Injected under the skin, the elimination half-life was 0.8-1.7 hours [3]A, and the summary of product characteristics gives about 30 minutes [10]official. From the implant, most is released within a couple of days [10]official.
Does melanotan 1 work as a nasal spray?
Unknown. No human study of a nasal spray is known. Taken by mouth, the substance was not detected in the bloodstream at all [3]A, so the route matters.
Is there a 10 mg melanotan 1 product?
There is no approved 10 mg product. The only authorised product is the 16 mg implant, placed by a doctor [10]official. The milligrams in a vial sold online for injection are a different product.
What side effects does melanotan 1 have?
In the trials of the approved product the most common were nausea, headache and implant site reactions, mostly mild [10]official. A full skin examination is recommended twice a year [1, 10]official.
Melanotan 1 experiences: what do studies say?
In the trials of the approved implant the most common harms were nausea, headache and implant site reactions [10]official.
What do users themselves report about Melanotan 1?
In the Reddit accounts of 77 people we compiled (not research), 35 (45%) reported some benefit and 43 (56%) some harm. The accounts are self-selected and prove neither that it works nor that it is safe: Melanotan 1 user experiences.
Does melanotan 1 tan without sun?
Yes, it increases eumelanin independently of light exposure [1, 10]official, and skin darkening has been measured in humans [3]A. But the approved use is not tanning; it is light sensitivity in a rare disease [10]official.
Is melanotan 1 legal in Finland?
Afamelanotide is an approved prescription medicine in the EU, placed by a trained doctor [10]official [11]regulator. Melanotan 1 sold online as a research chemical has no marketing authorisation, and Fimea has warned against injectable peptides bought online [12]regulator. This is not legal advice.
Read the research yourself: sources
Every source opens the original publication or the regulator's page. The level shows what the source itself reports.
- U.S. Food and Drug Administration. SCENESSE (afamelanotide) implant, for subcutaneous use: prescribing information. Revised 08/2024. Read 14 Oct 2026. FDA official
- Langendonk JG, et al. Afamelanotide for Erythropoietic Protoporphyria. N Engl J Med. 2015;373:48-59. PMID 26132941 A
- Ugwu SO, et al. Skin pigmentation and pharmacokinetics of melanotan-I in humans. Biopharm Drug Dispos. 1997;18:259-269. PMID 9113347 A
- Dorr RT, 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;140:827-835. PMID 15262693 A
- Lim HW, et al. Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial. JAMA Dermatol. 2015;151:42-50. PMID 25230094 A
- Fitzgerald LM, et al. Effect of MELANOTAN, [Nle(4), D-Phe(7)]-alpha-MSH, on melanin synthesis in humans with MC1R variant alleles. Peptides. 2006;27:388-394. PMID 16293341 A
- Stanislaus V, et al. A feasibility and safety study of afamelanotide in acute stroke patients: an open label, proof of concept, phase IIa clinical trial. BMC Neurol. 2023;23:281. PMID 37496004 B
- Böhm M, et al. Beneficial effects of the melanocortin analogue Nle4-D-Phe7-alpha-MSH in acne vulgaris. J Eur Acad Dermatol Venereol. 2014;28:108-111. PMID 22845050 B
- Lengweiler S, et al. Evaluation of the immunogenicity of the synthetic alpha-melanocyte-stimulating hormone (alpha-MSH) analogue afamelanotide ([Nle4-D-Phe7]-alpha-MSH, Scenesse) in erythropoietic protoporphyria patients by ELISA detecting both anti-afamelanotide and anti-alpha-MSH antibodies. Skin Pharmacol Physiol. 2015;28:103-113. PMID 25402764 B
- European Medicines Agency. Scenesse 16 mg implant (afamelanotide): summary of product characteristics (EPAR product information, last updated on the EMA website 7 Oct 2026). Read 14 Oct 2026. EMA official
- European Medicines Agency. Scenesse (afamelanotide): EPAR, overview and authorisation details. Marketing authorisation issued 22 Dec 2014, authorised under exceptional circumstances; orphan designation 8 May 2008. Read 14 Oct 2026. EMA regulator
- Fimea. Fimea warns: do not use injectable peptides purchased online (29 Jun 2026). Fimea regulator
- U.S. Food and Drug Administration. Drugs@FDA: NDA 210797, SCENESSE (afamelanotide) 16 mg implant. Original approval 10/08/2019 (type 1, new molecular entity; priority review; orphan). Read 14 Oct 2026. FDA regulator
- Finland. Lääkeluettelo (Fimea medicines list), 230/2025, annex 1 ("Afamelanotidi") and annex 1 A ("Melanotaani I"). Finlex regulator
Research sources checked in PubMed 13-14 Oct 2026. The EMA EPAR page and summary of product characteristics, the FDA label and Drugs@FDA read 14 Oct 2026.
Evidence levels: A = randomised human trial or meta-analysis · B = observational human study or case series · C = animal study · D = cell or laboratory study · E = not peer-reviewed · regulator = a regulator's assessment or decision, not research evidence. The marker official means official product information (summary of product characteristics or label); it is not research evidence. For a review, the level shows what kind of research the statement rests on. No level: statements that something has not been studied, reviews' interpretations, named hypotheses and the general rules in our certificate-of-analysis guide.
Content is general information about research, not medical advice. If you have symptoms, contact a healthcare professional.