Reviewed by Peptide Treatments Medical Advisory Board (Medical Advisory Board)
PT-141: Evidence Summary
Evidence summary for PT-141 across studied indications. Each indication is graded using our evidence tier system based on the quality and quantity of available clinical data.
Back to PT-141 overview| Indication | Evidence Tier | Trial Count | Summary |
|---|---|---|---|
| Female sexual dysfunction (HSDD) | Tier A | 6 | FDA-approved as Vyleesi for premenopausal HSDD based on two Phase 3 RCTs (n=1,247) |
| Male erectile dysfunction | Tier B | 4 | Phase II/III data showing efficacy in PDE5 non-responders; not FDA-approved for this indication |
| Antidepressant-induced sexual dysfunction | Tier C | 1 | Limited data suggesting benefit for SSRI-induced sexual dysfunction |
References (10)
- Bremelanotide for Hypoactive Sexual Desire Disorder: RECONNECT Phase 3 Trials — Kingsberg SA, et al. . Obstetrics & Gynecology (2019) PMID: 31893927
- Bremelanotide Phase 3 RECONNECT efficacy and safety data — Various . Journal of Women's Health (2019)
- Bremelanotide for male erectile dysfunction Phase 2 study . Journal of Sexual Medicine (2010) PMID: 17584134
- Phase 2 erectile dysfunction study in PDE5 non-responders . Urology (2005) PMID: 16517052
- Phase 2 study in female sexual arousal disorder . Journal of Sexual Medicine (2012) PMID: 36162944
- An evaluation of bremelanotide injection for the treatment of hypoactive sexual desire disorder . Expert opinion on pharmacotherapy (2023) PMID: 36242769
- The neurobiology of bremelanotide for the treatment of hypoactive sexual desire disorder in premenopausal women . CNS spectrums (2022) PMID: 33455598
- Bremelanotide for Treatment of Female Hypoactive Sexual Desire . Neurology international (2022) PMID: 35076581
- Targeting the central melanocortin system for the treatment of metabolic disorders . Nature reviews. Endocrinology (2023) PMID: 37365323
- Female Syrian hamster analyses of bremelanotide, a US FDA approved drug for the treatment of female hypoactive sexual desire disorder . Neuropharmacology (2025) PMID: 39793696