Mechanism of Action
Activates MC3R and MC4R receptors in the CNS hypothalamus to modulate sexual arousal pathways — unlike PDE5 inhibitors which act peripherally. Selective vs non-selective Melanotan II.
Clinical Use
FDA-approved for HSDD in premenopausal women. Off-label use in men for erectile dysfunction (emerging data).
Contraindications
Cardiovascular disease. Not for use with sexual stimulation drugs. Transient hypertension common.
Evidence Summary
FDA-approved 2019. Phase III RECONNECT trials demonstrated significant improvement in satisfying sexual events and sexual desire vs placebo.
Key Studies
- 1.Clayton et al., J Sex Med 2016 — Phase IIb dose-finding and safety profile
- 2.Simon et al., J Sex Med 2014 — safety and efficacy in premenopausal women
- 3.Kingsberg et al., J Sex Med 2019 — RECONNECT trial results and HSDD outcomes
Evidence Gaps
Nausea common side effect. FDA approval limited to premenopausal women. Male data emerging only.
Emerging Research
Male sexual dysfunction applications. Broader melanocortin-based sexual health research.