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Peptide

PT-141 (Bremelanotide)

PT-141 (Bremelanotide, brand name Vyleesi) is a synthetic cyclic heptapeptide melanocortin receptor agonist derived from the tanning peptide Melanotan II. It was FDA-approved in June 2019 for treating hypoactive sexual desire disorder (HSDD) in premenopausal women. Unlike PDE5 inhibitors, PT-141 works through central nervous system pathways to enhance sexual desire rather than peripheral blood flow.

Research notice. This page is for education and research. Peptides may not be FDA-approved for human use and may only be legally available for research. Talk to a qualified clinician before considering any peptide.

Best evidence
Grade A
Conditions studied
3
Outcomes
8
Graded outcomes
3401

Evidence by condition

  • Strong
  • Moderate
  • Limited
  • Very limited

3 conditions, plus general outcomes

Hypoactive Sexual Desire Disorder

Hypoactive Sexual Desire Disorder: outcomes studied for PT-141 (Bremelanotide)
GradeOutcomeEffectSizeStudiesPeopleStudies list
Sexual Desire (FSDS-DAO)

Two Phase 3 RECONNECT trials (n=1202) showed bremelanotide significantly improved desire scores on the FSDS-DAO (Female Sexual Distress Scale-Desire/Arousal/Orgasm) compared to placebo across all subgroups.

Improves (the measure goes up)Moderate effect37 studies

Studies that measured sexual desire (fsds-dao)

and 27 more in the citations list

Sexual Distress

Bremelanotide significantly decreased distress associated with low sexual desire in premenopausal women with HSDD in two Phase 3 randomized controlled trials.

Improves (the measure goes down)Moderate effect37 studies

Studies that measured sexual distress

and 27 more in the citations list

Sexually Satisfying Events

Sexually satisfying events increased by 0.7 per month with bremelanotide vs 0.2 with placebo in a 12-week dose-finding trial of 293 premenopausal women.

Improves (the measure goes up)Small effect33 studies

Studies that measured sexually satisfying events

and 23 more in the citations list

Long-Term Efficacy

During the 52-week open-label extension of RECONNECT, sustained improvements in HSDD symptoms were maintained with no new safety signals observed.

Improves (the measure goes up)Moderate effect29 studies

Studies that measured long-term efficacy

and 19 more in the citations list

Female Sexual Dysfunction

Female Sexual Dysfunction: outcomes studied for PT-141 (Bremelanotide)
GradeOutcomeEffectSizeStudiesPeopleStudies list
Subjective Sexual Arousal

Early studies showed bremelanotide positively affected subjective sexual arousal in women with female sexual arousal disorder.

Improves (the measure goes up)Moderate effect37 studies

Studies that measured subjective sexual arousal

and 27 more in the citations list

Erectile Dysfunction

  • Erectile Function (ED Patients): improves
  • Erectile Response: improves
Erectile Dysfunction: outcomes studied for PT-141 (Bremelanotide)
GradeOutcomeEffectSizeStudiesPeopleStudies list
Erectile Function (ED Patients)

PT-141 was effective in Viagra-responsive ED patients, demonstrating a central mechanism distinct from PDE5 inhibitors.

Improves (the measure goes up)Moderate effect36 studies

Studies that measured erectile function (ed patients)

and 26 more in the citations list

Erectile Response

In Phase 1 studies, intranasal PT-141 induced statistically significant erectile responses in healthy males and ED patients at doses >7mg, with onset in approximately 30 minutes.

Improves (the measure goes up)Moderate effect34 studies

Studies that measured erectile response

and 24 more in the citations list

General

  • Blood Pressure: improves
General: outcomes studied for PT-141 (Bremelanotide)
GradeOutcomeEffectSizeStudiesPeopleStudies list
Blood Pressure

2 preclinical studies support this finding. Primarily preclinical evidence.

Improves (the measure goes down)Small effect15 studies

Studies that measured blood pressure

and 5 more in the citations list

Key findings

  • Sexual Desire (FSDS-DAO)Hypoactive Sexual Desire DisorderImproves (the measure goes up)
  • Sexual DistressHypoactive Sexual Desire DisorderImproves (the measure goes down)
  • Sexually Satisfying EventsHypoactive Sexual Desire DisorderImproves (the measure goes up)

Studies cited

39 studies from PubMed

  1. Female Sexual Desire, Arousal, and Orgasmic Dysfunctions: A Systematic Review and Meta-Analysis of Treatment Options.Journal of minimally invasive gynecology, 2026 · PMID 40543759
  2. 2024 SOGC, 2024 NCCN, 2022 ESO-ESMO, and 2018 ASCO: a comparison of female cancer survivorship guidelines for the management of sexual health concerns.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2025 · PMID 40518469
  3. Practical considerations and emerging approaches for the management of vasomotor and sexual symptoms in breast cancer patients on endocrine therapies.Expert review of clinical pharmacology, 2025 · PMID 41088800
  4. Intravenous peptides and amino acids for erectile dysfunction: a narrative review of current applications and future directions.Expert opinion on pharmacotherapy, 2025 · PMID 40069591
  5. A Comprehensive Review of Novel FDA-Approved Psychiatric Medications (2018-2022).Cureus, 2024 · PMID 38646400
  6. Prespecified and Integrated Subgroup Analyses from the RECONNECT Phase 3 Studies of BremelanotideJ Womens Health (Larchmt), 2022 · PMID 35230162
  7. An evaluation of bremelanotide injection for the treatment of hypoactive sexual desire disorderExpert Opin Pharmacother, 2022 · PMID 36242769
  8. Safety Profile of Bremelanotide Across the Clinical Development Program.Journal of women's health (2002), 2022 · PMID 35147466
  9. Management of Hypertension with Female Sexual Dysfunction.Medicina (Kaunas, Lithuania), 2022 · PMID 35630054
  10. Effect of bremelanotide on body weight of obese women: Data from two phase 1 randomized controlled trials.Diabetes, obesity & metabolism, 2022 · PMID 35170192
  11. The neurobiology of bremelanotide for the treatment of hypoactive sexual desire disorder in premenopausal womenCNS Spectr, 2021 · PMID 33455598
  12. BremelanotideLiverTox, 2021 · PMID 34436837
  13. Failure of a Meta-analysis: A Commentary on Glen Spielmans's "Re-Analyzing Phase III Bremelanotide Trials for 'Hypoactive Sexual Desire Disorder in Women'".Journal of sex research, 2021 · PMID 33835907
  14. Bremelanotide: New Drug Approved for Treating Hypoactive Sexual Desire DisorderAnn Pharmacother, 2020 · PMID 31893927
  15. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 TrialsObstet Gynecol, 2019 · PMID 31599089
  16. Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire DisorderObstet Gynecol, 2019 · PMID 31607241
  17. Bremelanotide: First ApprovalDrugs, 2019 · PMID 31429064
  18. Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder.Obstetrics and gynecology, 2019 · PMID 31599847
  19. Responder Analyses from a Phase 2b Dose-Ranging Study of Bremelanotide.The journal of sexual medicine, 2019 · PMID 31277966
  20. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials.Obstetrics and gynecology, 2019 · PMID 31599840
  21. Female Sexual Dysfunction and the Placebo Effect: A Meta-analysis.Obstetrics and gynecology, 2018 · PMID 29995725
  22. Phase I Randomized Placebo-controlled, Double-blind Study of the Safety and Tolerability of Bremelanotide Coadministered With Ethanol in Healthy Male and Female Participants.Clinical therapeutics, 2017 · PMID 28189361
  23. Usefulness of ambulatory blood pressure monitoring to assess the melanocortin receptor agonist bremelanotide.Journal of hypertension, 2017 · PMID 27977473
  24. RETRACTED: Evaluation of the safety and efficacy of bremelanotide, a melanocortin receptor agonist, in female subjects with arousal disorder: a double-blind placebo-controlled, fixed dose, randomized study.The journal of sexual medicine, 2008 · PMID 18179455
  25. Gateways to clinical trials.Methods and findings in experimental and clinical pharmacology, 2008 · PMID 18806898
  26. Gateways to clinical trials.Methods and findings in experimental and clinical pharmacology, 2008 · PMID 19088949
  27. Melanocortins in the treatment of male and female sexual dysfunctionCurr Top Med Chem, 2007 · PMID 17584134
  28. Bremelanotide: an overview of preclinical CNS effects on female sexual functionJ Sex Med, 2007 · PMID 17958619
  29. Gateways to clinical trials.Methods and findings in experimental and clinical pharmacology, 2007 · PMID 18040531
  30. An effect on the subjective sexual response in premenopausal women with sexual arousal disorder by bremelanotide (PT-141), a melanocortin receptor agonistJ Sex Med, 2006 · PMID 16839319
  31. Gateways to clinical trials.Methods and findings in experimental and clinical pharmacology, 2006 · PMID 17235418
  32. Gateways to clinical trials.Methods and findings in experimental and clinical pharmacology, 2005 · PMID 16082427
  33. Gateways to clinical trials.Methods and findings in experimental and clinical pharmacology, 2005 · PMID 16179960
  34. Gateways to clinical trials.Methods and findings in experimental and clinical pharmacology, 2005 · PMID 16395422
  35. Double-blind, placebo-controlled evaluation of the safety, pharmacokinetic properties and pharmacodynamic effects of intranasal PT-141, a melanocortin receptor agonist, in healthy males and patients with mild-to-moderate erectile dysfunctionInt J Impot Res, 2004 · PMID 14963471
  36. Evaluation of the safety, pharmacokinetics and pharmacodynamic effects of subcutaneously administered PT-141, a melanocortin receptor agonist, in healthy male subjects and in patients with an inadequate response to Viagra.International journal of impotence research, 2004 · PMID 14999221
  37. Gateways to clinical trials.Methods and findings in experimental and clinical pharmacology, 2004 · PMID 15319808
  38. Gateways to clinical trials.Methods and findings in experimental and clinical pharmacology, 2004 · PMID 15349141
  39. Gateways to clinical trials.Methods and findings in experimental and clinical pharmacology, 2004 · PMID 15672123