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Product Overview

PT-141 (Bremelanotide) Overview

PT-141 (bremelanotide) is a synthetic peptide and melanocortin receptor agonist approved in the United States for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Unlike other sexual enhancement therapies, PT-141 acts centrally by activating melanocortin receptors (primarily MC4R) in the hypothalamus, modulating neural pathways involved in sexual desire and arousal. This mechanism is distinct from phosphodiesterase-5 inhibitors, which act peripherally on vascular function.[1][2][3][4][5][6]

The efficacy and safety of PT-141 were established in the RECONNECT phase 3 trials, which demonstrated statistically significant improvements in sexual desire and reductions in distress related to low sexual desire compared to placebo, as measured by validated patient-reported outcomes (FSFI-desire domain and FSDS-DAO item 13). These benefits were consistent across age, weight, BMI, and baseline testosterone subgroups, and were observed regardless of hormonal contraceptive use or HSDD duration.[2][7][8]

In men, PT-141 has shown promise for the treatment of erectile dysfunction, with phase 2 data supporting its central mechanism of action and rapid onset of effect. Animal and human studies indicate that PT-141 increases sexual arousal and desire by enhancing dopamine release in the medial preoptic area of the hypothalamus, a key region for sexual function.[5][6][4]

PT-141 is a non-hormonal therapy and does not affect sex steroid levels, making it suitable for individuals seeking alternatives to hormone-based treatments. The most common adverse effects are nausea (up to 40%), flushing, and headache, which are generally mild to moderate and transient. PT-141 is not associated with hypotension or significant drug-drug interactions, including with ethanol. Transient increases in blood pressure and decreases in heart rate have been observed, but these effects are typically mild and resolve within hours.[1][4][2][3][9][10][8]

Patient-reported outcomes from exit surveys and interviews confirm improvements in sexual desire, arousal, and overall quality of sexual activity, as well as enhanced partner communication and emotional well-being. While some data suggest possible mood and stress benefits, these effects are secondary and not the primary indication for PT-141.[11][4]

In summary, PT-141 (bremelanotide) is a centrally acting melanocortin receptor agonist approved for acquired, generalized HSDD in premenopausal women, with demonstrated efficacy for increasing sexual desire and reducing distress, and additional evidence for use in male sexual dysfunction. It offers a non-hormonal, on-demand option for sexual health, with a favorable safety profile and modest clinical benefit.[1][4][7][9][5][10][8][2][6][11][3]

References

  1. Bremelanotide: First Approval. Dhillon S, Keam SJ. Drugs. 2019;79(14):1599-1606. doi:10.1007/s40265-019-01187-w.
  2. Vyleesi. Food and Drug Administration. Updated date: 2025-01-10.
  3. Sexual Dysfunction in Women. Davis SR. The New England Journal of Medicine. 2024;391(8):736-745. doi:10.1056/NEJMcp2313307.
  4. The Neurobiology of Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder in Premenopausal Women. Pfaus JG, Sadiq A, Spana C, Clayton AH. CNS Spectrums. 2022;27(3):281-289. doi:10.1017/S109285292100002X.
  5. Melanocortins in the Treatment of Male and Female Sexual Dysfunction. Shadiack AM, Sharma SD, Earle DC, Spana C, Hallam TJ. Current Topics in Medicinal Chemistry. 2007;7(11):1137-44. doi:10.2174/156802607780906681.
  6. PT-141: A Melanocortin Agonist for the Treatment of Sexual Dysfunction. Molinoff PB, Shadiack AM, Earle D, Diamond LE, Quon CY. Annals of the New York Academy of Sciences. 2003;994:96-102. doi:10.1111/j.1749-6632.2003.tb03167.x.
  7. Prespecified and Integrated Subgroup Analyses From the RECONNECT Phase 3 Studies of Bremelanotide. Simon JA, Kingsberg SA, Portman D, et al. Journal of Women's Health (2002). 2022;31(3):391-400. doi:10.1089/jwh.2021.0225.
  8. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Kingsberg SA, Clayton AH, Portman D, et al. Obstetrics and Gynecology. 2019;134(5):899-908. doi:10.1097/AOG.0000000000003500.
  9. Bremelanotide: New Drug Approved for Treating Hypoactive Sexual Desire Disorder. Mayer D, Lynch SE. The Annals of Pharmacotherapy. 2020;54(7):684-690. doi:10.1177/1060028019899152.
  10. An Evaluation of Bremelanotide Injection for the Treatment of Hypoactive Sexual Desire Disorder. Cipriani S, Alfaroli C, Maseroli E, Vignozzi L. Expert Opinion on Pharmacotherapy. 2023;24(1):15-21. doi:10.1080/14656566.2022.2132144.
  11. The Patient Experience of Premenopausal Women Treated With Bremelanotide for Hypoactive Sexual Desire Disorder: RECONNECT Exit Study Results. Koochaki P, Revicki D, Wilson H, et al. Journal of Women's Health (2002). 2021;30(4):587-595. doi:10.1089/jwh.2020.8460.

All information provided is for research purposes only.

ALL ARTICLES AND PRODUCT INFORMATION PROVIDED ON THIS WEBSITE ARE FOR INFORMATIONAL AND EDUCATIONAL PURPOSES ONLY. The products offered on this website are furnished for in-vitro studies only. In-vitro studies (Latin: in glass) are performed outside of the body. These products are not medicines or drugs and have not been approved by the FDA to prevent, treat or cure any medical condition, ailment or disease. Bodily introduction of any kind into humans or animals is strictly forbidden by law.