9 completed, 1 active not recruiting. 4 Phase 2, 3 Phase 3, 2 Phase 4, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 4 | Completed 3, Active not recruiting 1 |
| Phase 3 | 3 | Completed 3 |
| Phase 4 | 2 | Completed 2 |
| Phase 1 | 1 | Completed 1 |
Follow bremelanotide: new trials by email Literature Review of bremelanotide trials Research Report on bremelanotide
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Single Dose of Vyleesi in Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast Milk Vyleesi (Bremelanotide Injection) - Lactating Mother | Phase 4 | Completed | Cosette Pharmaceuticals, Inc. | 10 | 2025-07-11 | 2026-01-13 |
| A Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of Obesity bremelanotide, tirzepatide - Obesity | Phase 2 | Active not recruiting | Palatin Technologies, Inc | 108 | 2024-08-05 | 2025-03-06 |
| A Phase IIb, Multicenter, Open-Label, Prospective Study of Bremelanotide in Diabetic Kidney Disease Bremelanotide, RAAS inhibition therapy - Kidney Disease | Phase 2 | Completed | Palatin Technologies, Inc | 16 | 2022-12-26 | 2024-10-17 |
| 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) Bremelanotide, Placebo - Hypoactive Sexual Desire Disorder | Phase 3 | Completed | Kwang Dong Pharmaceutical co., ltd. | 193 | 2021-05-10 | 2024-11-13 |
| Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder Bremelanotide, Placebo - Hypoactive Sexual Desire Disorder | Phase 4 | Completed | Imperial College Healthcare NHS Trust | 40 | 2019-10-07 | 2024-08-09 |
| Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With Zofran Bremelanotide, Zofran, Placebo - Nausea | Phase 1 | Completed | AMAG Pharmaceuticals, Inc. | 228 | 2019-06-17 | 2022-04-04 |
| 2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder Bremelanotide, Placebo - Hypoactive Sexual Desire Disorder | Phase 3 | Completed | Palatin Technologies, Inc | 714 | 2015-01-01 | 2021-01-28 |
| 1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder Bremelanotide, Placebo - Hypoactive Sexual Desire Disorder | Phase 3 | Completed | Palatin Technologies, Inc | 723 | 2014-12-01 | 2021-04-09 |
| Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder bremelanotide - Female Sexual Arousal Disorder, Hypoactive Sexual Desire Disorder | Phase 2 | Completed | Palatin Technologies, Inc | 612 | 2011-06-01 | 2014-12-18 |
| Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD) Bremelanotide - Sexual Arousal Disorder | Phase 2 | Completed | Palatin Technologies, Inc | 2006-02-01 | 2011-02-23 |
Sexual Dysfunctions, Psychological (6) · Kidney Diseases (1) · Nausea (1) · Obesity (1)
Palatin Technologies, Inc (6) · AMAG Pharmaceuticals, Inc. (1) · Cosette Pharmaceuticals, Inc. (1) · Imperial College Healthcare NHS Trust (1) · Kwang Dong Pharmaceutical co., ltd. (1)
United States (8) · Canada (3) · South Korea (1) · United Kingdom (1)
Robert Jordan (4) · James Tumlin, MD (1) · Jeffrey Edelson, MD, FRCPC (1) · Soo Woong Kim, Dr (1) · Tak Kim, Dr (1) · Waljit S Dhillo, MBBS PhD (1)
PMID 10782451, PMID 28189361, PMID 31599840, PMID 31599847, PMID 33033885, PMID 33538638, PMID 35147466, PMID 36809187, PMID 27181790, PMID 34559353, PMID 36189794