For research and educational purposes only. Not medical advice.
PT-141 Reference
Educational, not medical advice reference for PT-141: Sexual Health; regulatory status, evidence posture, source review, and schedule notes. Als…
Reference summary
Bremelanotide is a synthetic cyclic heptapeptide melanocortin receptor agonist (binds MC1R through MC5R; central HSDD effect attributed primarily to MC4R) developed by Palatin Technologies. Phase 2b dose-finding work (Clayton 2016 and related reports) compared 0.75 mg, 1.25 mg, and 1.75 mg subcutaneous doses and selected the 1.75 mg dose for Phase 3 on the balance of efficacy and tolerability. The pivotal Phase 3 RECONNECT program (Kingsberg 2019, Obstet Gynecol, PMID 31599840) consisted of two identically designed double-blind placebo-controlled trials (Study 301 NCT02333071 and Study 302 NCT02338960) in premenopausal women with acquired generalized HSDD, randomized 1,267 women (1,247 in the safety population, 1,202 in the mITT efficacy population). Both trials met the co-primary endpoints (FSFI desire-domain score and FSDS-DAO item 13 distress score) with statistically significant but modest absolute effect sizes versus placebo. This entry displays Vyleesi label-reference fields plus pivotal-trial and dose-finding context; it does not approve research-vial or intranasal PT-141 protocols.
Regulatory and posture
- Categories
- Sexual Health
- Aliases
- Bremelanotide, Vyleesi
- Evidence posture
- human
- Regulatory status
- FDA-approved as Vyleesi (bremelanotide) on June 21, 2019 (NDA 210557) for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. Not indicated for men, postmenopausal women, or sexual-performance enhancement. Research-vial intranasal and lyophilized-powder preparations sold online are not the FDA-approved product and have not been reviewed by FDA for purity, identity, or dose accuracy.
- Content review status
- label verified
Selected public sources
- DailyMed Vyleesi prescribing information
- FDA accessdata: Vyleesi (bremelanotide) NDA 210557 multidiscipline review (initial US approval June 21, 2019)
- PubMed: Kingsberg SA, Clayton AH, Portman D, et al. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials (RECONNECT). Obstet Gynecol 2019;134(5):899-908 (PMID 31599840)
- ClinicalTrials.gov: RECONNECT Study 301 bremelanotide Phase 3 HSDD trial (NCT02333071)
- ClinicalTrials.gov: RECONNECT Study 302 bremelanotide Phase 3 HSDD trial (NCT02338960)
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