Peptide Graded

PT-141

Does PT-141 work?

Partly: two trials in 1,267 women, but for men only two small studies from 2004.

BSome human evidenceNot approvedas of 2026-10-26

For the approved use there are two randomized, placebo-controlled phase 3 trials (RECONNECT, 1,267 women combined), which is A-level evidence, though a re-analysis argues the effect on desire is small. For the use PT-141 is actually sold for online, libido and erections in men, the evidence is two small 2004 studies, one of a nasal spray that was later abandoned and one of an injection, so the compound as marketed sits at B. 2561011

The RECONNECT program ran two identical 24-week randomized, double-blind, placebo-controlled trials in 1,267 premenopausal women with HSDD. Both met their two main goals. Bremelanotide improved the desire domain of the Female Sexual Function Index by about 0.3 to 0.4 points more than placebo, on a 1.2-to-6 scale. It cut distress scores by a similar small amount. It did not raise the number of satisfying sexual events. The gains lasted in a 52-week open-label extension. In all, 684 women entered it and 272 completed it. An earlier 12-week phase 2b dose-finding trial in 327 women used satisfying sexual events as its main goal. It found a small increase at the higher doses, 0.7 more per month against 0.2 on placebo. 5612

A later independent analysis of the RECONNECT data made two points. First, the desire and distress scales have little proof of validity in women with HSDD. Second, eight of the eleven registered efficacy outcomes had not been published. The analysis covered those eight, including total sexual function and distress scores. It found effects from nil to small. 2

Evidence checklist

  • Randomised controlled trial RECONNECT trials, placebo-controlled
  • Human study over 100 people RECONNECT, 1,267 premenopausal women
  • More than one research group Phase 3 by sponsor; one reanalysis
  • Clinical outcomes, not surrogate markers Questionnaire scores; no extra satisfying events
  • Human safety data beyond case reports Nausea ~40%; blood pressure effects in trials

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More on PT-141

Citations

  1. Dhillon 2019, Drugs: bremelanotide, first approval doi.org
  2. Spielmans 2024, J Sex Res: small effects, questionable outcomes, bremelanotide for HSDD doi.org
  3. Vyleesi (bremelanotide) prescribing information, DailyMed dailymed.nlm.nih.gov
  4. Sildenafil prescribing information, DailyMed dailymed.nlm.nih.gov
  5. Kingsberg 2019, Obstet Gynecol: bremelanotide for HSDD in premenopausal women, two randomized phase 3 trials (RECONNECT) doi.org
  6. Simon 2019, Obstet Gynecol: long-term safety and efficacy of bremelanotide, RECONNECT open-label extension doi.org
  7. FDA Drugs@FDA: Vyleesi NDA 210557 approval record accessdata.fda.gov
  8. Ann Pharmacother 2024: review of bremelanotide for HSDD doi.org
  9. J Clin Invest 2022: crossover fMRI study of bremelanotide in women with HSDD doi.org
  10. Diamond 2004, Int J Impot Res: intranasal PT-141 and erectile response in men doi.org
  11. Rosen 2004, Int J Impot Res: subcutaneous PT-141 in healthy men and men with an inadequate response to sildenafil doi.org
  12. Clayton 2016, Womens Health: bremelanotide phase 2b dose-finding trial in HSDD doi.org

Reference information only, not medical advice. Drawn from the PT-141 article, fact-checked against the cited sources. No dosing anywhere on this site.