Development snapshotVerified 2026-09-05
Pilot Phase 1 human study demonstrated tanning activity and dose-limiting adverse effects.
Phase 1 (historical) · Historical clinical development
Melanotan II was studied in a pilot Phase 1 human program and later small controlled sexual-function studies, but it did not become an FDA-approved tanning or sexual-function medication.
Research sourcePublished 1998
Synthetic Melanotropic Peptide Initiates Erections in Men with Psychogenic Erectile Dysfunction
Human intervention · Double-blind placebo-controlled crossover study
A small controlled crossover study demonstrated direct human erectogenic effects of Melanotan II.
Research sourcePublished 1996
Evaluation of Melanotan-II in a Pilot Phase-I Clinical Study
Human intervention · Phase 1 human study
This early Phase 1 study provides direct human exposure evidence for Melanotan II and documented melanocortin-related effects and adverse events.