Melanotan 1 is the research-market name for afamelanotide, an analogue of the skin-darkening hormone alpha-MSH first made at the University of Arizona. Unlike most compounds on this site it has an approved product, so its figures come in two kinds: a label for a slow-release implant, and older per-kilogram injection studies. Medibact's Melanotan 1 guide covers the molecule and its evidence; this page stays with figures.
What the label states
SCENESSE (Clinuvel) was first approved in the US in 2019. The label read on 2026-09-27 (DailyMed, published 2026-05-13):
| Element | SCENESSE label |
|---|---|
| Indication | increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria (EPP) |
| Form | one bioresorbable rod, about 1.7 cm × 1.45 mm |
| Amount | 16 mg afamelanotide (18 mg afamelanotide acetate) |
| Route and interval | subcutaneous, above the anterior supra-iliac crest, every 2 months |
| Who gives it | a health care professional trained in the implantation procedure |
| Peak and half-life | median Tmax 36 h; mean Cmax 3.7 ng/mL; apparent half-life about 15 h |
The label's efficacy trials measured time in sunlight without pain. In CUV039, 48 adults received three implants over 180 days and 45 received vehicle; the median pain-free time in direct sunlight between 10 am and 6 pm was 64.1 hours against 40.5 hours over the 180 days. The safety tables pool 125 people on SCENESSE and 119 on vehicle through month 6: nausea 19% vs 14%, skin hyperpigmentation 4% vs 0%, melanocytic nevus 4% vs 2%.
The injection studies
Before the implant, afamelanotide was tested as a daily injection in small studies of white men:
| Study | People | Route and dose | Finding |
|---|---|---|---|
| Levine et al., JAMA 1991 (PMID 1658407) | 28 men, skin types I–IV | 10 subcutaneous injections over 12 days, dose not in abstract | skin darkened; peak 1–3 weeks after the last dose |
| Ugwu et al., Biopharm Drug Dispos 1997 (PMID 9113347) | 3 men, crossover | 0.16 mg/kg IV and oral; 0.08–0.21 mg/kg subcutaneous; 10 doses over 2 weeks | subcutaneous fully bioavailable; oral undetectable; half-life 0.8–1.7 h |
Scaled to body weight, the injected amounts are large:
| Body weight | 0.08 mg/kg | 0.16 mg/kg | 0.21 mg/kg |
|---|---|---|---|
| 60 kg | 4.8 mg | 9.6 mg | 12.6 mg |
| 70 kg | 5.6 mg | 11.2 mg | 14.7 mg |
| 80 kg | 6.4 mg | 12.8 mg | 16.8 mg |
A single 0.16 mg/kg injection at 70 kg exceeds a 10 mg research vial, and the two-week, ten-dose course totals about 112 mg — more afamelanotide than six SCENESSE implants, a year of the labelled schedule, release (96 mg).
Three figures that are easily confused
| Figure | Where it comes from | Per day, averaged |
|---|---|---|
| 16 mg every 2 months | SCENESSE label | about 0.27 mg (270 mcg) |
| 0.16 mg/kg daily | 1990s injection studies | about 11.2 mg at 70 kg |
| 250 mcg per injection | a protocol page updated 2026-08-05 (daily for 1–2 weeks, then 2–3 times a week) | 250 mcg on daily days |
The online figure sits close to the implant's daily average and about 45 times below the studied injection dose. The similarity to the implant is in milligrams only: the implant releases its dose over weeks, while an injected solution in the 1997 study was mostly gone within hours. No study has tested 250 mcg injections, and the page stating it describes it as a community figure.
Units per vial size
Units on a U-100 syringe = mg ÷ mg/mL × 100. Research vials in this site's data are 5 mg and 10 mg:
| Amount | 5 mg + 2 mL (2.5 mg/mL) | 5 mg + 1 mL (5 mg/mL) | 10 mg + 3 mL (3.33 mg/mL) | 10 mg + 2 mL (5 mg/mL) | 10 mg + 1 mL (10 mg/mL) |
|---|---|---|---|---|---|
| 250 mcg | 10 | 5 | 7.5 | 5 | 2.5 |
| 500 mcg | 20 | 10 | 15 | 10 | 5 |
| 1 mg | 40 | 20 | 30 | 20 | 10 |
| 5.6 mg (0.08 mg/kg at 70 kg) | more than the vial | more than the vial | 168 | 112 | 56 |
At the online figure the readings fall to 2.5–10 units, where the syringe's 1-unit marks matter most; the insulin syringe units page covers the smaller barrels, the mg to units page the formula, and the calculator any other vial. The Melanotan II dosage page reports the cyclic analogue, whose human doses were also per kilogram.
What is not established
No regulator has reviewed an injected afamelanotide dose, and SCENESSE is not labelled for tanning or for anyone without EPP. Its trials enrolled mostly white adults (98% in the efficacy trials), and the label lists new or changing moles among its adverse reactions. Whether a research vial sold as Melanotan 1 contains afamelanotide, and how much, is not known without an assay. Nothing on this page is a dose or a schedule.
Sources and dates
Opened 2026-09-27: the SCENESSE (afamelanotide) implant label, Clinuvel, DailyMed set id 94f53286-11dd-7fbb-e053-2a95a90a7c48 (published 2026-05-13), sections 1, 2, 6.1, 11, 12.3 and 14; PubMed abstracts for Levine et al., JAMA 1991 (PMID 1658407), Ugwu et al., Biopharm Drug Dispos 1997 (PMID 9113347) and Langendonk et al., NEJM 2015 (PMID 26132941), from a search for afamelanotide, melanotan-1 and NDP-MSH with the clinical-trial filter (17 records); one protocol page (updated 2026-08-05) quoted for what it states. Per-kilogram, per-day and unit figures are arithmetic by this site. Corrections go to the contact page.