{"id":"pt-141","name":"PT-141","aliases":["bremelanotide","Vyleesi","melanocortin agonist"],"url":"https://lyoresearch.com/compounds/pt-141","class":{"id":"melanocortins","name":"Melanocortin agonists","url":"https://lyoresearch.com/classes/melanocortins"},"summary":"PT-141, sold as Vyleesi, is a melanocortin-receptor agonist approved in the United States in 2019 for premenopausal women with hypoactive sexual desire disorder. Two phase 3 trials in 1,267 women found statistically significant but small improvements in desire and distress scores against placebo. Nausea affected 40% of participants and 18% stopped because of side effects. Use in men, and for erectile function, is unapproved and far less studied.","overall_grade":"A","overall_grade_meaning":"established in humans","human_trials":"2 phase 3 RCTs (n=1,267)","regulatory_status":"Approved (Rx, US)","molecule":{"formula":"C50H68N14O10","molecular_weight":"1025.2","cas":"189691-06-3","pubchem_cid":9941379,"note":null},"pharmacokinetics":{"basis":"label","route":"Subcutaneous injection, as needed before sexual activity","half_life":"About 2.7 hours","licensed_regimen":"1.75 mg subcutaneously at least 45 minutes before anticipated sexual activity; no more than 1 dose per 24 hours and no more than 8 doses per month","product":"Vyleesi (bremelanotide)","source":{"title":"Vyleesi prescribing information (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf"}},"outcomes":[{"outcome":"Sexual desire (premenopausal women, HSDD)","grade":"A","grade_meaning":"established in humans","effect_size":"small","adverse":false,"human_studies":"2 phase 3 RCTs","evidence":"RECONNECT studies, 24 weeks: FSFI desire-domain change +0.5 to +0.6 vs +0.2 on placebo. Statistically significant, clinically modest.","references":[{"citation":"VYLEESI (bremelanotide injection) US prescribing information — RECONNECT phase 3 studies (NCT02333071, NCT02338960).","where":"FDA label, initial US approval 2019","url":"https://www.accessdata.fda.gov/spl/data/3dca0cf9-a278-4c25-af93-d65f1f523504/3dca0cf9-a278-4c25-af93-d65f1f523504.xml"}],"verbatim":{"text":"From baseline to end-of-study, women taking bremelanotide had statistically significant increases in sexual desire (study 301: 0.30, P<.001; study 302: 0.42, P<.001; integrated studies 0.35, P<.001) and statistically significant reductions in distress related to low sexual desire (study 301: -0.37, P<.001; study 302: -0.29, P=.005; integrated studies -0.33, P<.001) compared with placebo.","citation":"Kingsberg SA, et al. Bremelanotide for the treatment of hypoactive sexual desire disorder: two randomized phase 3 trials (RECONNECT).","url":"https://pubmed.ncbi.nlm.nih.gov/31599840/"}},{"outcome":"Sexual distress (same population)","grade":"A","grade_meaning":"established in humans","effect_size":"small","adverse":false,"human_studies":"2 phase 3 RCTs","evidence":"Significant reduction in distress score versus placebo on the co-primary endpoint.","references":[{"citation":"VYLEESI (bremelanotide injection) US prescribing information — RECONNECT phase 3 studies (NCT02333071, NCT02338960).","where":"FDA label, initial US approval 2019","url":"https://www.accessdata.fda.gov/spl/data/3dca0cf9-a278-4c25-af93-d65f1f523504/3dca0cf9-a278-4c25-af93-d65f1f523504.xml"}]},{"outcome":"Erectile function / use in men","grade":"C","grade_meaning":"weak human evidence","effect_size":"small","adverse":false,"human_studies":"Earlier phase 2 work","evidence":"Developed originally for erectile dysfunction; intranasal programme was stopped over blood-pressure increases. The approved product and indication are for women.","references":[{"citation":"VYLEESI (bremelanotide injection) US prescribing information — RECONNECT phase 3 studies (NCT02333071, NCT02338960).","where":"FDA label, initial US approval 2019","url":"https://www.accessdata.fda.gov/spl/data/3dca0cf9-a278-4c25-af93-d65f1f523504/3dca0cf9-a278-4c25-af93-d65f1f523504.xml"}]},{"outcome":"Nausea","grade":"A","grade_meaning":"established in humans","effect_size":"large","adverse":true,"human_studies":"Phase 3","evidence":"40% vs 1% on placebo; caused discontinuation in 8%. Overall discontinuation for adverse events 18% vs 2%.","references":[{"citation":"VYLEESI (bremelanotide injection) US prescribing information — RECONNECT phase 3 studies (NCT02333071, NCT02338960).","where":"FDA label, initial US approval 2019","url":"https://www.accessdata.fda.gov/spl/data/3dca0cf9-a278-4c25-af93-d65f1f523504/3dca0cf9-a278-4c25-af93-d65f1f523504.xml"}]},{"outcome":"Flushing and headache","grade":"A","grade_meaning":"established in humans","effect_size":"moderate","adverse":true,"human_studies":"Phase 3","evidence":"Flushing 20.3% vs 0.3%; headache 11.3% vs 1.9%; injection-site reactions 13.2% vs 8.4%.","references":[{"citation":"VYLEESI (bremelanotide injection) US prescribing information — RECONNECT phase 3 studies (NCT02333071, NCT02338960).","where":"FDA label, initial US approval 2019","url":"https://www.accessdata.fda.gov/spl/data/3dca0cf9-a278-4c25-af93-d65f1f523504/3dca0cf9-a278-4c25-af93-d65f1f523504.xml"}]}],"regions":[{"region":"European Union","status":"Not authorised","note":"Vyleesi has no EU marketing authorisation. Vials sold online are unauthorised medicinal products."},{"region":"United States","status":"Approved (Vyleesi), prescription-only","note":"Approved in 2019 for hypoactive sexual desire disorder in premenopausal women. 'Research' vials are unapproved drugs."},{"region":"United Kingdom","status":"Not licensed","note":"No MHRA licence; unlicensed medicine when supplied for human use."},{"region":"Australia","status":"Not registered","note":"Not on the ARTG; prescription-only substance."},{"region":"Canada","status":"Not authorised","note":"No DIN. Bremelanotide was among the products Health Canada seized in August 2025."},{"region":"Sport (WADA)","status":"Not on the list","note":"An approved drug that is not named in any section."}],"faq":[{"q":"Does PT-141 work?","a":"For its approved indication, yes, by a statistically significant but small margin: desire scores improved by about 0.5 points more than placebo on a scale where the clinical meaning of that difference is debated. It is approved because it beat placebo, not because the effect is large."},{"q":"Can men use PT-141?","a":"It is not approved for men. The original erectile-dysfunction programme was halted over blood-pressure increases with the intranasal formulation. Off-label use in men rests on far weaker evidence than the approval implies."},{"q":"Why does it cause so much nausea?","a":"Melanocortin receptors are involved in nausea pathways as well as arousal. Forty percent of trial participants experienced it, and 8% stopped because of it."}],"references":[{"cite":"VYLEESI (bremelanotide injection) US prescribing information — RECONNECT phase 3 studies (NCT02333071, NCT02338960).","where":"FDA label, initial US approval 2019","url":"https://www.accessdata.fda.gov/spl/data/3dca0cf9-a278-4c25-af93-d65f1f523504/3dca0cf9-a278-4c25-af93-d65f1f523504.xml","note":"1,267 premenopausal women across two 24-week trials; efficacy and adverse-event figures on this page come from the label."},{"cite":"Kingsberg SA, et al. Bremelanotide for the treatment of hypoactive sexual desire disorder: two randomized phase 3 trials (RECONNECT).","where":"Obstet Gynecol, 2019;134:899–908","url":"https://pubmed.ncbi.nlm.nih.gov/31599840/","note":"1,267 premenopausal women; peer-reviewed report of the two RECONNECT trials."}],"last_reviewed":"2026-09-02","literature_searched_to":"2026-09-02","changelog":[{"date":"2026-09-02","note":"Initial publication from the FDA label and phase 3 programme."}],"license":"CC BY 4.0 — cite as “LYO Research” with a link.","methodology":"https://lyoresearch.com/methodology"}