Also known as: Afamelanotide
Melanotan I (afamelanotide) is a synthetic 13-amino-acid analog of the natural hormone alpha-melanocyte-stimulating hormone (α-MSH). It has a substantial research record, including phase 3 human trials, regulatory review, and ongoing animal and lab work.
Established: afamelanotide is a synthetic analog of α-MSH that binds mainly to the melanocortin-1 receptor (MC1R) and is reported to increase eumelanin in melanocyte studies [1]. Substituting norleucine at position 4 and D-phenylalanine at position 7 makes it more stable and potent than natural α-MSH, and MC1R activation raises cAMP, which turns on melanin-making enzymes in melanocytes [2]. Proposed: MC1R signaling has also been linked to antioxidant activity, DNA repair and modulation of inflammation [3], and a 2026 mouse study tied the same molecule (NDP-MSH) to MC1R–cAMP/PKA signaling in the brain [4].
| Study | Model | Reported result | Source |
|---|---|---|---|
| EU and US phase 3 trials [5] | Human Two multicenter trials in adults, randomized 1:1, double-blind, placebo-controlled; 74 (EU, 180 days) and 94 (US, 270 days) participants | Primary endpoint: a prespecified light-exposure measure (see publication). Published. | Peer-reviewed N Engl J Med 2015 |
| UV response in healthy volunteers [6] | Human Exploratory, open-label, single-centre study; 9 healthy adults analyzed; single implant | Exploratory pigmentation study in 9 adults; see publication for design. Published. | Peer-reviewed Photochem Photobiol Sci 2026 |
| Phase 2a feasibility study [7] | Human Open-label, single-centre, non-randomized; 6 adults during acute hospital admission; followed to day 42 | Primary endpoint: safety (treatment-emergent adverse events to day 42). Published. | Peer-reviewed BMC Neurol 2023 |
| CUV105 phase 3 trial [8] | Human Randomized, multicenter, 200+ adults at 37 sites; compared with phototherapy alone; 20 weeks plus 6-month follow-up | Primary endpoint: share of participants reaching at least 50% repigmentation score. Recruitment completed 2025; results not yet verified as published. | Company-reported CLINUVEL press release 2025 |
| NDP-MSH in LPS inflammation model [4] | Mouse LPS-induced inflammation model, male C57BL/6J mice | NDP-MSH restored sucrose preference after LPS and lowered prefrontal IL-1β; the PKA inhibitor H89 blocked the IL-1β effect. | Peer-reviewed Front Pharmacol 2026 |
| Reproductive toxicology [1] | Rat Fertility, embryofetal and pre/postnatal development studies, rats | No effects on fertility or embryofetal development at the levels tested. | Company-reported FDA prescribing information 2024 |
Human trials are listed for research context only; outcomes are reported in the linked publications. Animal and lab results do not establish effects in humans.
PureLab does not supply this compound. This page summarizes published research only.
