Melanotan 1 (afamelanotide, Scenesse): approved dosage
Not a recommendation, not treatment guidance. This page shows only the dosing in the official product information, with sources. The dose is always decided by the doctor who prescribes the medicine. Fimea warns against using injectable peptides bought online: Fimea warning.
Source of the dosing: Scenesse (afamelanotide), EMA summary of product characteristics (EMA), date of the text 7 Oct 2026 [1]official; SCENESSE (afamelanotide), FDA prescribing information, date of the text 8/2024 [2]official
Melanotan 1 is the same molecule as afamelanotide, whose only authorised product is the Scenesse implant (afamelanotide). In the EU it is approved for the prevention of phototoxicity in adults with erythropoietic protoporphyria (EPP) [1]official.
The unregulated product sold online under the name melanotan 1 is not Scenesse. According to a dermatology review, afamelanotide is the only approved alpha-MSH analogue, and the preparation, administration and dosage of unregulated products raise open questions [5]B. The dosing on this page applies only to the Scenesse implant [1]official.
Only specialists in recognised porphyria centres may prescribe it, and the implant is placed by a doctor trained by the marketing authorisation holder [1]official. The figures in the table come from the summary of product characteristics and the FDA label, not from individual studies [1, 2]official.
Dosing in the product information
| Product and step | Indication | Dose | Frequency | Duration | Source and level |
|---|---|---|---|---|---|
| Scenesse (afamelanotide), EU | Prevention of phototoxicity in adults with erythropoietic protoporphyria | One 16 mg implant under the skin above the supra-iliac crest | Every two months, before expected and during increased sunlight exposure | At the specialist's discretion | [1]official |
| SCENESSE (afamelanotide), United States | To increase pain-free light exposure in adults with a history of phototoxic reactions from EPP | One 16 mg implant under the skin above the anterior supra-iliac crest | Every two months | Not set in the label | [2]official |
Evidence levels: official = official product information · regulator = a regulator's assessment or decision, not research evidence · 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or meta-analysis · B = observational human study or case series · C = animal study · D = cell or laboratory study · E = not peer-reviewed
Notes
The implant does not release the active substance evenly over two months: most is released in the first 48 hours and over 90% by day 5, and the implant itself is absorbed by the body in 50-60 days [1]official.
According to the summary of product characteristics there are limited data on four to six implants a year. The pivotal trial gave three implants two months apart [1]official.
The implant dose cannot be converted into an injected dose: according to the summary of product characteristics the half-life is about 30 minutes [1]official, and in a small study under the skin it was 0.8-1.7 hours [4]A.
What points the other way or is uncertain
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 [3]regulator.
The EMA and the FDA report the same pivotal trial with different figures. According to the summary of product characteristics, the median time in direct sunlight between 10:00 and 18:00 over 180 days was 69.4 hours with treatment and 40.8 hours with placebo [1]official. In the FDA label the median hours in direct sunlight on pain-free days were 64.1 and 40.5 [2]official.
- Melanotan 1 (afamelanotide, Scenesse): the full substance page
- Melanotan 1 (afamelanotide, Scenesse): why no calculator preset
- Are peptides legal in Finland?
- All dose pages and calculators
Read the research yourself: sources
- 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
- U.S. Food and Drug Administration. SCENESSE (afamelanotide) implant, for subcutaneous use: prescribing information. Revised 08/2024. Read 14 Oct 2026. FDA
- European Medicines Agency. Scenesse (afamelanotide): EPAR, overview and authorisation details. Marketing authorisation issued 22 Dec 2014, authorised under exceptional circumstances. Read 14 Oct 2026. EMA
- Ugwu SO, et al. Skin pigmentation and pharmacokinetics of melanotan-I in humans. Biopharm Drug Dispos. 1997;18:259-269. PMID 9113347
- 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. PMID 28266027
- Biolcati G, Marchesini E, Sorge F, et al. Long-term observational study of afamelanotide in 115 patients with erythropoietic protoporphyria. Br J Dermatol. 2015;172:1601-1612. PMID 25494545
Section 10 of the summary of product characteristics (date of revision) is blank; the date is the product information update date shown on the EMA page, 7 Oct 2026. The FDA label shows "Revised: 08/2024".
Content is general information about research, not medical advice. If you have symptoms, contact a healthcare professional.