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PT-141: Research & Evidence

Established Evidence

Published research, clinical trial data, and evidence grading for PT-141 across studied indications.

Back to PT-141 overview

Research Summary

Bremelanotide (Vyleesi) was FDA-approved in June 2019 based on the RECONNECT Phase 3 program (2 trials, n=1,247) demonstrating statistically significant improvement in sexual desire and reduced distress in premenopausal women with HSDD. The total evidence base includes 60+ human studies, ~20 RCTs, and 5+ meta-analyses. Off-label use for male ED is supported by Phase 2 data showing IIEF-EF score improvement of +5.2 points and 50-65% success rates in PDE5 non-responders.

Evidence by Indication (3 indications)

Indication Tier Trials 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

Graded using our evidence tier methodology.

Citations (10 sources)

  1. 1. Bremelanotide for Hypoactive Sexual Desire Disorder: RECONNECT Phase 3 Trials Clinical Trial

    Kingsberg SA, et al. (2019), Obstetrics & Gynecology

  2. 2. Bremelanotide Phase 3 RECONNECT efficacy and safety data Clinical Trial

    Various (2019), Journal of Women's Health

  3. 3. Bremelanotide for male erectile dysfunction Phase 2 study Clinical Trial

    (2010), Journal of Sexual Medicine

  4. 4. Phase 2 erectile dysfunction study in PDE5 non-responders Clinical Trial

    (2005), Urology

  5. 5. Phase 2 study in female sexual arousal disorder Clinical Trial

    (2012), Journal of Sexual Medicine

  6. 6. An evaluation of bremelanotide injection for the treatment of hypoactive sexual desire disorder Study

    (2023), Expert opinion on pharmacotherapy

  7. 7. The neurobiology of bremelanotide for the treatment of hypoactive sexual desire disorder in premenopausal women Study

    (2022), CNS spectrums

  8. 8. Bremelanotide for Treatment of Female Hypoactive Sexual Desire Study

    (2022), Neurology international

  9. 9. Targeting the central melanocortin system for the treatment of metabolic disorders Study

    (2023), Nature reviews. Endocrinology

  10. 10. Female Syrian hamster analyses of bremelanotide, a US FDA approved drug for the treatment of female hypoactive sexual desire disorder Study

    (2025), Neuropharmacology