Melanotan 1 (Melanotan I) is afamelanotide, a lab-made version of alpha-MSH, the hormone that tells skin cells to make pigment. Under the brand name Scenesse, it is FDA-approved as an implant for adults with erythropoietic protoporphyria (EPP), a rare inherited condition that makes light exposure painful.[1][2] It is not approved for cosmetic tanning, and tanning products sold online as “Melanotan 1” are unregulated.[14]
What is Melanotan 1?
Melanotan 1 was created at the University of Arizona alongside Melanotan 2. It is a linear peptide that was tested clinically for tanning the skin.[12] It binds the melanocortin 1 (MC1) receptor on pigment cells, which increases melanin production in the skin.[13]
Because it is more stable and active than the natural hormone,[13] it darkens skin without sun exposure. In a 1991 trial, 28 healthy men given 10 injections over 12 days tanned, while those given placebo did not.[10]
Melanotan 1 and Scenesse: what is approved
Scenesse is a 16 mg implant made by Clinuvel.[1]
- US: approved October 8, 2019,[2] to increase pain-free light exposure in adults with a history of phototoxic reactions from EPP.[1]
- European Union: authorised December 22, 2014, for preventing phototoxicity in adults with EPP. It was authorised under “exceptional circumstances” because the disease is so rare that complete data could not be collected.[3]
In EPP, a substance called protoporphyrin builds up in the skin and causes severe, painful reactions to light. The skin pigment that afamelanotide induces has been shown to improve light tolerance.[5]
What the research shows
Erythropoietic protoporphyria
An early 2009 report described an alpha-MSH analog used in EPP,[17] and two randomized phase 3 trials followed, published in 2015:[4]
| Trial | People | Pain-free time in direct sun (median) |
|---|---|---|
| US, 6 months | 94 | 69.4 hours vs 40.8 hours with placebo |
| EU, 9 months | 74 | 6.0 hours vs 0.8 hours with placebo |
In the EU trial, phototoxic reactions also fell (77 vs 146), and quality of life improved in both trials.[4]
Real-world data from Europe point the same way. In Italy and Switzerland, 115 patients used more than 1,000 implants over up to 8 years, with quality-of-life scores rising from 31% to about 74% of the maximum.[5] A German safety study of 200 patients found 91% stayed on treatment,[6] and in 20 Austrian patients, median time in light before a burn rose from 15 to 250 minutes.[7] Several of the German authors received research support from, or worked for, Clinuvel.[6]
Vitiligo
In a 2015 trial of 55 adults with vitiligo, those who added monthly afamelanotide implants to narrowband UV-B light therapy regained more color than those on light therapy alone (48.6% vs 33.3% at day 168). The benefit was clearest in darker skin types (IV to VI).[8] A larger phase 3 vitiligo trial, planned for 200 people, is under way.[9] Afamelanotide is not approved for vitiligo.
Tanning
Melanotan 1 was first developed as a “sunless” tan. In a 1997 study of three men, injections under the skin tanned the forehead, arms and neck; the tan peaked about a week after dosing and was still visible 3 weeks after the last dose. Side effects were occasional stomach upset and facial flushing.[11] Its developers suggested such a tan might lower skin cancer risk,[12] but that has never been shown, and no regulator has approved it for tanning.
Melanotan 1 dosage
For Scenesse, the label dose is:[1]
- One 16 mg implant every 2 months, inserted under the skin above the hip bone.
- Only by a trained health professional who has completed Clinuvel’s training.
In Europe, one implant is given every 2 months before expected and during increased sunlight exposure, a specialist at a porphyria centre decides how long treatment lasts, and patients are watched for 30 minutes afterwards for allergic reactions.[3] The implant gives an apparent half-life of about 15 hours.[1]
Early research used injections of 0.08 to 0.21 mg per kg under the skin, five days a week for 2 weeks; taken by mouth, the peptide was not absorbed.[11] There is no approved dose for tanning. Our peptide calculator converts milligrams into syringe units, but it cannot make an unregulated product’s contents reliable.
Melanotan 1 side effects
Most common side effects with Scenesse over the first 6 months of trials:[1]
- Implant site reactions (21%)
- Nausea (19%)
- Sore throat (7%), cough (6%) and tiredness (6%)
- Skin darkening, dizziness, moles (melanocytic nevi) and respiratory infections (4% each)
The label also warns about:[1]
- Serious allergic reactions, including anaphylaxis.
- Darkening of moles and freckles, with a full-body skin exam recommended twice a year.
Long-term European studies recorded mainly minor side effects, especially nausea.[5] There are no human pregnancy data.[1]
Melanotan 1 vs Melanotan 2
| Melanotan 1 (afamelanotide) | Melanotan 2 | |
|---|---|---|
| Structure | Linear peptide[12] | Ring-shaped, shorter peptide[12] |
| Studied for | Skin tanning[12] | Erectile dysfunction[12]; also used unregulated for tanning[14] |
| Approval | Scenesse, for EPP[1] | Not approved anywhere |
Melanotan 2 also led to PT-141, which is approved for low sexual desire in women. For other skin peptides, see our skin category page.
Unregulated “Melanotan 1” tanning products
Melanotan 1 and 2 are sold online, mainly to tan the skin. A 2017 dermatology review warned that these products raise questions about how they are made, stored and dosed, and linked both to changes in existing moles and new atypical moles. It noted four case reports of melanoma during or soon after melanotan use, while stressing that a causal link has not been proven.[14]
The Danish Medicines Agency calls Melanotan an illegal product whose effect is undocumented and whose possible side effects have not been studied.[15]
Is Melanotan 1 legal?
- US: Scenesse is a prescription drug for EPP.[2] Other afamelanotide or “Melanotan 1” products are not approved.
- EU: Scenesse is authorised for EPP only.[3]
- UK: in a 2024 reply to a request about Melanotan II, the MHRA said the sale of unauthorised medicines is not permitted and that it has repeatedly removed Melanotan products from the market for over 10 years. That reply did not address Melanotan 1 specifically.[16]
- Denmark: Melanotan is called an illegal product.[15]
This is general information, not legal advice.
