PT-141 — Complete Research Guide (2026)
Last updated 2026-06-25
TL;DR
A melanocortin receptor agonist approved (as Vyleesi) for hypoactive sexual desire disorder in premenopausal women.
What is PT-141?
PT-141, generic name bremelanotide, is a cyclic melanocortin-receptor agonist and a metabolite of Melanotan II. It is FDA-approved (2019) as Vyleesi for acquired, generalised hypoactive sexual desire disorder (HSDD) in premenopausal women.
Its molecular formula is C50H68N14O10 and the label reports a terminal half-life of roughly 2–3 hours. The approved product is a subcutaneous, as-needed autoinjector.
Approval is specific: Vyleesi is indicated for premenopausal women with HSDD. It is not approved for men or for erectile dysfunction.
How does PT-141 work?
Bremelanotide activates melanocortin receptors (notably MC4R) in the central nervous system, modulating neural pathways involved in sexual desire rather than acting directly on vascular tissue.
This central mechanism distinguishes it from PDE5 inhibitors used for erectile dysfunction. [INFOGRAPHIC: Melanocortin (MC4R) central pathway]
What does the research say about PT-141?
- In the two phase-3 RECONNECT RCTs (1,267 randomised), bremelanotide 1.75 mg significantly increased sexual desire (+0.35, P<.001) and reduced associated distress (−0.33, P<.001) versus placebo. [1]
- A 52-week open-label extension (684 enrolled) reported no new safety signals and sustained desire benefits. [2]
- An early-phase RCT (n=18 premenopausal women) found more participants reported moderate/high desire after bremelanotide versus placebo (P=0.0114). [5]
Clinical research & studies
The references below are the primary sources cited throughout this guide. Each links directly to PubMed or the regulator. Where evidence is preclinical (animal or in-vitro), that is stated rather than implied.
- [1] Bremelanotide for the treatment of hypoactive sexual desire disorder: two randomized phase-3 trials (RECONNECT) — Kingsberg SA et al., Obstet Gynecol 2019. (two phase-3 RCTs, 1,267 randomised)
- [2] Long-term safety and efficacy of bremelanotide for hypoactive sexual desire disorder — Simon JA et al., Obstet Gynecol 2019. (52-week open-label extension, 684 enrolled)
- [3] Prespecified and integrated subgroup analyses from the RECONNECT phase-3 studies of bremelanotide — Clayton AH et al., J Womens Health 2022. (integrated subgroup analysis (n=1,202))
- [4] The patient experience of premenopausal women treated with bremelanotide for HSDD: RECONNECT exit study — Kingsberg SA et al., J Sex Med 2021. (patient-reported exit study)
- [5] An effect on the subjective sexual response in premenopausal women with sexual arousal disorder by bremelanotide (PT-141) — Diamond LE et al., J Sex Med 2006. (early-phase RCT, n=18)
Dosing context
The approved product is administered subcutaneously on an as-needed basis ahead of anticipated activity, with a stated maximum frequency in the label — reported here only as published context.
This is not medical advice or a usage recommendation. Bremelanotide is a prescription medicine to be used only under a licensed prescriber.
Side effects & safety profile
The most common adverse effects in the trial program were nausea (around 40% in the long-term extension), flushing and headache. Transient increases in blood pressure and decreases in heart rate are described in the label.
The approved label restricts use to premenopausal women and advises against use in uncontrolled hypertension or known cardiovascular disease.
PT-141 sold as a research chemical is not the quality-assured Vyleesi product and falls outside this regulated evidence base.
Stacking & combinations
Because bremelanotide can affect blood pressure, the label cautions about combinations; it is a metabolite of Melanotan II but, unlike it, is an approved, characterised medicine.
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Frequently asked questions
As Vyleesi, bremelanotide is approved for acquired, generalised hypoactive sexual desire disorder (HSDD) in premenopausal women. It is not approved for men or for erectile dysfunction.
References
- [1] Bremelanotide for the treatment of hypoactive sexual desire disorder: two randomized phase-3 trials (RECONNECT) — Kingsberg SA et al., Obstet Gynecol 2019. PMID: 31599840. View sourceStudy: two phase-3 RCTs, 1,267 randomisedSignificantly increased sexual desire (+0.35) and reduced distress (−0.33) vs placebo.
- [2] Long-term safety and efficacy of bremelanotide for hypoactive sexual desire disorder — Simon JA et al., Obstet Gynecol 2019. PMID: 31599847. View sourceStudy: 52-week open-label extension, 684 enrolledNo new safety signals; nausea 40.4%, flushing 20.6%, headache 12.0%; benefits sustained.
- [3] Prespecified and integrated subgroup analyses from the RECONNECT phase-3 studies of bremelanotide — Clayton AH et al., J Womens Health 2022. PMID: 35230162. View sourceStudy: integrated subgroup analysis (n=1,202)Benefit consistent across age, weight, BMI and baseline testosterone subgroups.
- [4] The patient experience of premenopausal women treated with bremelanotide for HSDD: RECONNECT exit study — Kingsberg SA et al., J Sex Med 2021. PMID: 33538638. View sourceStudy: patient-reported exit studyTreated women reported meaningful improvement in desire and reduced distress.
- [5] An effect on the subjective sexual response in premenopausal women with sexual arousal disorder by bremelanotide (PT-141) — Diamond LE et al., J Sex Med 2006. PMID: 16839319. View sourceStudy: early-phase RCT, n=18More participants reported moderate/high desire after bremelanotide vs placebo (P=0.0114).