Sexual health
PT-141 (Bremelanotide)
Also known as Bremelanotide, Vyleesi
Melanocortin receptor agonist studied for hypoactive sexual desire disorder (HSDD).
Where the evidence comes from
58 verified records from 15 countries. The number of studies or countries is not proof that PT-141 (Bremelanotide) works or is safe.
Systematic review / meta-analysis: 4 · Animal study: 3 · Narrative review: 27 · Human clinical trial: 19 · Randomized clinical trial: 5
What is known
Editorial summary not yet written.
What remains uncertain
Editorial summary not yet written.
Conflicting findings
Editorial summary not yet written.
U.S. regulatory status (FDA)
Compound
Product or formulation
FDA status
FDA-approved branded drug
Approved indication
Metara availability (compounded formulation)
Research material (research use only)
Source
Last verified
Notes
Approval applies only to the exact finished drug, formulation and indication. A shared active ingredient does not make a compounded version, blend or other use FDA-approved. Pharmacy or research-material availability is not FDA approval.
International regulatory status
Kept separate from U.S. status. The regulator's country is not the same as where studies took place.
No sourced international decisions recorded yet.
Continue your research
These are two different pathways, not two ways to get the same thing. Neither changes the FDA status shown above.
Clinical care
Available through Metara Health
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EXPLORE BIONEX →Limitations
Approved for premenopausal women only. Nausea common in trials. Use in men is not an approved indication.
Human clinical evidence (24)
A Phase 4, Open-Label Study of a Single Dose of Vyleesi® (Bremelanotide Injection) in Healthy, Premenopausal Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast Milk
Cosette Pharmaceuticals, Inc. · ClinicalTrials.gov · NCT06867835
This completed, open-label human trial investigated whether bremelanotide passes into breast milk in healthy, premenopausal lactating women and how its concentration changes over time. The abstract reports no results.
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Clinical Study Investigating the Safety, Tolerability, and Effectiveness of the Co-Administration of Bremelanotide With Tirzepatide (GLP-1/GIP) for the Treatment of Obesity
Palatin Technologies, Inc · ClinicalTrials.gov · NCT06565611
This human trial is assessing the safety, tolerability, and effectiveness of bremelanotide combined with tirzepatide in people with obesity, using a randomized, placebo-controlled design. It is active but not recruiting, and no results are reported.
Safety Profile of Bremelanotide Across the Clinical Development Program.
Clayton AH, Kingsberg SA, Portman D, Sadiq A, Krop J, Jordan R, Lucas J, Simon JA · Journal of women's health (2002) · DOI 10.1089/jwh.2021.0191
This review assessed bremelanotide’s safety across human clinical studies, including studies in premenopausal women with low sexual desire. Side effects were mostly mild to moderate, most commonly nausea, flushing, headache, and injection-site reactions; nausea was the main reason for stopping treatment. Small, temporary blood pressure increases were also observed.
Prespecified and Integrated Subgroup Analyses from the RECONNECT Phase 3 Studies of Bremelanotide
Simon JA, Kingsberg SA, Portman D, Jordan R, Lucas J, Sadiq A, Krop J, Clayton AH · Journal of women's health (2002) · DOI 10.1089/jwh.2021.0225
This analysis examined bremelanotide versus placebo across subgroups of premenopausal women with distressing low sexual desire in the RECONNECT trials. Bremelanotide was associated with statistically significant improvements in desire and reduced distress across age, weight, body mass index, and testosterone subgroups, with few exceptions.
A Phase IIb, Multicenter, Open-Label, Prospective Study of Bremelanotide in Diabetic Kidney Disease to Assess the Efficacy in Reducing Urinary Protein and Maintaining Podocyte Density and Function
Palatin Technologies, Inc · ClinicalTrials.gov · NCT05709444
This completed, open-label human trial studied bremelanotide alongside therapy targeting the renin-angiotensin-aldosterone system in people with type 2 diabetic kidney disease. It aimed to assess urinary protein, kidney filtering-cell function, and kidney tissue changes, but the abstract reports no results.
The Patient Experience of Premenopausal Women Treated with Bremelanotide for Hypoactive Sexual Desire Disorder: RECONNECT Exit Study Results
Koochaki P, Revicki D, Wilson H, Pokrzywinski R, Jordan R, Lucas J, Williams LA, Sadiq A, Krop J · Journal of women's health (2002) · DOI 10.1089/jwh.2020.8460
This human study used exit surveys and interviews with premenopausal women who completed bremelanotide trials for distressing low sexual desire. Women receiving bremelanotide described increased desire, physical arousal, and improved quality of sexual activities with their partners. Placebo recipients reported benefits such as better partner communication, but not the physiological responses described by bremelanotide recipients.
A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (With or Without Decreased Arousal)
Kwang Dong Pharmaceutical co., ltd. · ClinicalTrials.gov · NCT04943068
This completed human trial evaluated the effectiveness and safety of injected bremelanotide in premenopausal women with hypoactive sexual desire disorder, with or without decreased arousal. The abstract reports no results.
A Phase 1, Randomized Study to Evaluate the Rate of Nausea in Healthy Premenopausal Female Subjects Treated With a Single Dose of Bremelanotide Alone or With Zofran
AMAG Pharmaceuticals, Inc. · ClinicalTrials.gov · NCT03973047
This completed, randomized human trial studied how often nausea occurred in healthy premenopausal women receiving bremelanotide alone or with Zofran beforehand. The abstract reports no results.
Systematic & narrative reviews (31)
Female Sexual Desire, Arousal, and Orgasmic Dysfunctions: A Systematic Review and Meta-Analysis of Treatment Options.
Toledo RG, Winkelman WD, Reyes-Gonzalez D, Bergeron S, Fladger A, Hacker MR, Anand M · Journal of minimally invasive gynecology · DOI 10.1016/j.jmig.2025.06.004
This systematic review and meta-analysis examined treatments for women with sexual desire, arousal, or orgasm difficulties without sexual pain conditions. Bremelanotide improved overall sexual function, desire, and arousal, and reduced distress. Mindfulness-based cognitive behavioral therapy improved desire, arousal, and orgasm, while flibanserin improved desire; both also reduced distress.
2024 SOGC, 2024 NCCN, 2022 ESO-ESMO, and 2018 ASCO: a comparison of female cancer survivorship guidelines for the management of sexual health concerns.
Bhinder JK, Kennedy SKF, Faouk Al Aadah C, Al-Khaifi M · Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · DOI 10.1007/s00520-025-09640-1
This review compared sexual-health guidelines for female cancer survivors. The guidelines agreed on several aspects of care but differed on others, and evidence for medicines addressing low sexual desire, including bremelanotide, was limited. The authors identified a need for more research on drug treatments and types of counselling.
Practical considerations and emerging approaches for the management of vasomotor and sexual symptoms in breast cancer patients on endocrine therapies.
Fuhrman J, Yun J, Indorf A · Expert review of clinical pharmacology · DOI 10.1080/17512433.2025.2573780
This review examined medicines for hot flashes and reduced sexual desire in breast cancer patients receiving endocrine therapy. It discussed newer agents, including flibanserin and bremelanotide, but noted that their clinical trials excluded breast cancer patients. Evidence specific to this population was still awaited from ongoing research.
Polymorphism of Melanocortin Receptor Genes-Association with Inflammatory Traits and Diseases.
Bardhan M, Anand A, Javed A, Chilo MA, Khan N, Garg T, Surana A, Huang H, Samim MM, Suresh V, Khare A, Menon B et al. · Diseases (Basel, Switzerland) · DOI 10.3390/diseases13090305
This review examined melanocortin receptor gene variations, immune-cell functions, and links to human diseases rather than reporting a new clinical trial. It described associations between receptor gene changes and several diseases, alongside evidence that these receptors help regulate inflammation. Drugs targeting these receptors were discussed as having potential uses in inflammatory diseases.
Novel Pharmacologic Treatments of Female Sexual Dysfunction.
How A, Jowdy C, Novatcheva E, Clayton AH · Clinical obstetrics and gynecology · DOI 10.1097/GRF.0000000000000922
This review evaluated medications for sexual dysfunction in women, focusing on low sexual desire and including bremelanotide, flibanserin, and investigational therapies. It discusses study outcomes, safety, and clinical management, but the abstract does not report specific efficacy or safety findings.
Pharmacotherapy of Hypoactive Sexual Desire Disorder in Premenopausal Women.
Barakeh D, Mdaihly H, Karaoui LR · The Annals of pharmacotherapy · DOI 10.1177/10600280241253273
This review examined medicines for distressing low sexual desire in premenopausal women, focusing on flibanserin and bremelanotide. It highlighted limited efficacy, potential side effects, and concerns about transparency in reporting. The authors concluded that further research using suitable measures of clinical benefit is needed before widespread adoption.
Understanding the Interplay Between Premenstrual Dysphoric Disorder (PMDD) and Female Sexual Dysfunction (FSD).
Gollapudi M, Thomas A, Yogarajah A, Ospina D, Daher JC, Rahman A, Santistevan L, Patel RV, Abraham J, Oommen SG, Siddiqui HF · Cureus · DOI 10.7759/cureus.62788
This review examined sexual function in women with premenstrual dysphoric disorder or premenstrual syndrome. Studies reported frequent, debilitating sexual distress before menstruation, but the evidence was understudied and had methodological limitations. Although flibanserin and bremelanotide were described as effective for female sexual dysfunction, their effects when both conditions occur together remained inconclusive.
Small Effects, Questionable Outcomes: Bremelanotide for Hypoactive Sexual Desire Disorder
Spielmans GI, Ellefson EM · Journal of sex research · DOI 10.1080/00224499.2023.2175192
This review examined how benefits were measured in bremelanotide trials involving women with hypoactive sexual desire disorder. Previously unpublished outcomes showed effects ranging from none to small. Overall benefits were statistically modest and limited to measures with little evidence that they validly assess outcomes in these women.
Laboratory, animal & other research (3)
Female Syrian hamster analyses of bremelanotide, a US FDA approved drug for the treatment of female hypoactive sexual desire disorder
Borland JM, Kohut-Jackson AL, Peyla AC, Hall MA, Mermelstein PG, Meisel RL · Neuropharmacology · DOI 10.1016/j.neuropharm.2025.110299
This animal study examined bremelanotide’s effects on brain receptor gene activity and sexual reward in female Syrian hamsters. Bremelanotide did not change melanocortin receptor gene activity in the dopamine reward system or enhance the rewarding effects of sexual interactions in the behavioral test.
Ultra-sensitive quantification of the therapeutic cyclic peptide bremelanotide utilizing UHPLC-MS/MS for evaluation of its oral plasma pharmacokinetics
Sauter M, Uhl P, Burhenne J, Haefeli WE · Journal of pharmaceutical and biomedical analysis · DOI 10.1016/j.jpba.2020.113276
This laboratory and animal study developed a sensitive blood test to measure bremelanotide and examined its absorption after oral administration in beagle dogs. The test was validated, and the dog experiments indicated minimal oral absorption.
Bremelanotide: an overview of preclinical CNS effects on female sexual function
Pfaus J, Giuliano F, Gelez H · The journal of sexual medicine · DOI 10.1111/j.1743-6109.2007.00610.x
This animal research review examined bremelanotide’s effects on sexual behavior and brain activity in female rats. Bremelanotide selectively increased behaviors that invite sexual activity, without changing how rats paced encounters or their mating posture. The findings suggest it may act by activating dopamine signaling in a brain region involved in sexual behavior.
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Profile last reviewed September 26, 2026. Educational content only. Not medical advice, a dosing protocol or a treatment recommendation.