Melanotan I / Afamelanotide research: studies, doses and safety
The molecule in an approved EPP implant; online tanning powder is a different formulation.
Also called: Melanotan-1, MT-I, MT1, NDP-α-MSH, NDP-MSH, Afamelanotide, CUV1647, Scenesse.
Melanocortin agonists · Predominantly MC1 melanocortin receptor agonist · Evidence: Approved drug.
60 human study records are listed, including 23 registrations, early dose studies and cohorts. Reports and participants overlap; this is not a unique-trial count.
Key studies
- First randomized tanning study: Active groups darkened significantly; placebo did not. Peak change 1–3 weeks after treatment. (source)
- Solution: injection, IV and oral PK: SC exposure was complete versus IV; no detectable drug after oral dosing. (source)
- Ten injections and skin biopsies: Mean forehead +49% in three participants; forearm +98% in seven, one week after dosing. (source)
- UVB study: 0.08 mg/kg: 3/4 active participants tanned; 47% fewer sunburn cells at the neck. (source)
- UVB study: 0.16 mg/kg: More skin sites darkened than in the lower-dose study; numerical arm effects not given. (source)
- Sunlight study: four weeks: Tanning lasted at least three weeks longer than sunlight-only control; controls needed 50% more sun exposure. (source)
Related to Melanotan I / Afamelanotide
- Bremelanotide: An as-needed injection for low libido before menopause; nausea is common.
- Melanotan II: An unapproved tanning peptide with small human trials and reports of serious harm.
- Setmelanotide: A daily injection approved for specific genetic obesity and acquired hypothalamic obesity.
- Retatrutide: An experimental weekly injection with phase 3 weight-loss results.
- GHK-Cu: A copper-binding skin peptide with small topical studies and untested systemic injections.
Sources
- 503B Bulk Drug Substances List, FDA · FDA · 2026
- Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act, FDA · FDA · 2026
- Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, FDA · FDA · 2026
- Compounding and the FDA: Questions and Answers, FDA · FDA · 2026
- DailyMed - SCENESSE- afamelanotide implant, 2026
- Product information, 2026
- Scenesse, 2026
- SCENESSE afamelanotide (as acetate) 16 mg implant vial (327947), 2026
- Scenesse, INN-afamelanotide, 2026
- The 2026 Prohibited List, World Anti-Doping Agency · WADA · 2026
- Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026, Australian Government · Australian Government · 2026
- Don’t risk using tanning products containing melanotan, 2025
- 4 Consideration of the evidence | Afamelanotide for treating erythropoietic protoporphyria | Guidance | NICE, 2024
- NDA/BLA Multi-disciplinary Review and Evaluation: NDA 210797 Scenesse (afamelanotide), 2019
- Acute impact of afamelanotide on UVR erythemal and melanogenic responses in healthy humans in vivo: an exploratory study., Griffin LL et al. · Photochemical & photobiological sciences : Official journal of the European Photochemistry Association and the European Society for Photobiology · 2026
Sources checked: 2026-10-18.
Information only, not medical advice. Peptifacts does not sell anything and does not link to sellers.