Drugs / Bremelanotide
Bremelanotide
also known as
BMT · Bremelanotida · BREMELANOTIDE ACETATE · PT 141 · PT-141 FREE BASE · Vyleesi · Vyleesi (autoinjector)
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | VYLEESI (AUTOINJECTOR) | — | 2019-06-21 | fda.gov ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 23 trials · 1 met primary | ||||||
| Phase 2 | NCT05709444 | Dec 2022 → Apr 2024 | kidney disorder | Palatin Technologies, Inc | Completed | No outcome recorded |
| Phase 2 | NCT01382719 | Jun 2011 → Sep 2012 | hypoactive sexual desire disorder | Palatin Technologies, Inc | Completed | Met primary |
| Phase 2 | NCT00425256 | Feb 2006 → May 2007 | sexual disorder | Palatin Technologies, Inc | Completed | No outcome recorded |
| Phase 33 trials · 2 met primary | ||||||
| Phase 3 | NCT04943068 | May 2021 → May 2023 | hypoactive sexual desire disorder | Kwang Dong Pharmaceutical co., ltd. | Completed | No outcome recorded |
| Phase 3 | NCT02338960 | Jan 2015 → Aug 2016 | hypoactive sexual desire disorder | Palatin Technologies, Inc | Completed | Met primary |
| Phase 3 | NCT02333071 | Dec 2014 → Jul 2016 | hypoactive sexual desire disorder | Palatin Technologies, Inc | Completed | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT06867835 | Jul → Nov 2025 | lactation disease | Cosette Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT04179734 | Oct 2019 → Oct 2020 | hypoactive sexual desire disorder | Imperial College Healthcare NHS Trust | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT03973047 Comparator | Jun → Jul 2019 | — | AMAG Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT06565611 Comparator | Aug 2024 → Feb 2025 overdue | obesity disorder | Palatin Technologies, Inc | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2025-11-06 | Palatin Technologies, Inc | Results Palatin Presents Data at ObesityWeek® 2025 Highlighting Promise of Melanocortin-Based Therapies for Obesity palatin.com ↗
Adding a low dose of an MC4R agonist led to greater weight loss compared to tirzepatide alone. |
| 2025-04-17 | Palatin Technologies, Inc | Results Palatin Reports Positive Appetite Suppression Results From Phase 2 Obesity Study of MC4R Agonist Bremelanotide and Tirzepatide palatin.com ↗
Using a validated daily appetite questionnaire, the study showed that patients receiving co-administered bremelanotide + tirzepatide, tirzepatide alone, and bremelanotide alone, experienced significant improvements in appetite suppression, fullness, and satiety. |
| 2025-04-10 | Palatin Technologies, Inc | Results Palatin to Present Positive Phase 2b Data for Melanocortin Agonist in Diabetic Kidney Disease at the National Kidney Foundation Spring Meeting palatin.com ↗
Six-month open-label study showed clinically meaningful improvements in kidney function and disease in patients with Type 2 diabetic nephropathy. |
| 2025-03-31 | Palatin Technologies, Inc | Results Palatin Announces MC4R Agonist Bremelanotide Co-Administered with GLP-1/GIP Tirzepatide Meets Primary Endpoint in Phase 2 Obesity Study palatin.com ↗
Primary endpoint met in the 8-week treatment study (highly statistically significant). |
| 2024-12-19 | Palatin Technologies, Inc | Results Palatin Announces Positive Phase IIb BREAKOUT Study Results in Patients with Type 2 Diabetic Nephropathy palatin.com ↗
The study showed that bremelanotide therapy for six months, in patients with established Type II diabetic nephropathy, resulted in positive and beneficial results for the majority of patients related to worsening kidney function and disease progression. |
| 2024-05-02 | Palatin Technologies, Inc | Regulatory Palatin Announces FDA Clearance of IND Application for the Co-Administration of Bremelanotide with Tirzepatide (GLP-1) for the Treatment of Obesity palatin.com ↗ |
| 2022-10-17 | Palatin Technologies, Inc | Results Palatin Announces Publication of Vyleesi® (bremelanotide) fMRI Study in Women with Hypoactive Sexual Desire Disorder (HSDD) palatin.com ↗
The important findings in the double-blinded, placebo controlled, crossover study showed that bremelanotide enhanced sexual brain processing, including a significant increase in sexual desire for up to 24 hours after administration compared with placebo (statistically significant P ≤ 0.01). |
| 2020-05-25 | Kwang Dong Pharmaceutical co., ltd. | Regulatory 광동제약, 여성 성욕저하장애 치료제 ‘바이리시’ 임상 3상 IND 승인 ekdp.com ↗
광동제약(대표이사 최성원)이 국내 독점 판권을 보유하고 있는 여성 성욕저하장애 치료 신약 ‘바이리시(Vyleesi, Bremelanotide Injection)’의 국내 가교 임상 3상에 대한 임상시험계획(IND)을 식품의약품안전처로부터 승인 받았다. |
| 2019-10-16 | Palatin Technologies, Inc | Results Vyleesi™ Phase 3 Data To Be Presented At The 13th European Society Of Gynecology Congress palatin.com ↗
Both randomized, placebo-controlled clinical trials of Vyleesi met the pre-specified co-primary efficacy endpoints of improvement in desire, and reduction in associated distress, as measured by validated patient-reported outcome instruments. |
| 2019-06-21 | Palatin Technologies, Inc | Regulatory FDA Approves New Drug Application for Vyleesi™ (bremelanotide injection) palatin.com ↗ |
| 2018-06-04 | Palatin Technologies, Inc | Regulatory Palatin Technologies Announces FDA Acceptance for Review of Bremelanotide NDA palatin.com ↗
Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical needs and commercial potential, announced today that the U.S. Food and Drug Administration (FDA) has accepted the bremelanotide New Drug Application (NDA) for filing. |
| 2016-02-26 | Palatin Technologies, Inc | Results Palatin Technologies Presents Bremelanotide Alcohol Interaction Study at International Society for the Study of Women’s Sexual Health Annual Meeting palatin.com ↗
The presentation concluded that, in a Phase 1 study, bremelanotide and ethanol can be safely co-administered and are generally well tolerated with no reports of drug-related serious adverse events. |
| 2013-10-28 | Palatin Technologies, Inc | Results Palatin Technologies Reports Successful Completion Of Device Bioequivalence Trial palatin.com ↗
Bioequivalence was achieved in this clinical trial. |
| 2012-11-08 | Palatin Technologies, Inc | Results Palatin Technologies Reports Positive Results for Phase 2B Bremelanotide Female Sexual Dysfunction Trial palatin.com ↗
The data demonstrate that women taking bremelanotide showed statistically significant increases in the number of Satisfying Sexual Events (SSEs) and also showed statistically significant improved measures of overall sexual functioning and distress related to sexual dysfunction, compared with placebo. |
| 2010-08-17 | Palatin Technologies, Inc | Results Palatin Technologies, Inc. Announces Positive Safety Results in Subcutaneous Bremelanotide Trial in Men palatin.com ↗
The results demonstrate that with subcutaneous administration consistent therapeutic blood plasma levels can be obtained without sustained clinically significant blood pressure effects and support the continued development of bremelanotide. |
All press releases naming this drug 52 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Bremelanotide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03973047 ↗ |
| Known as | BMT | “AIM: Evaluate efficacy/safety of bremelanotide (BMT), a melanocortin-receptor-4 agonist, to treat female sexual dysfunctions in premenopausal women.” PMID 27181790 ↗ May 20164“bremelanotide (BMT) sterile aqueous solution for subcutaneous injection, provided as autoinjectors containing 0.3 mL volume” NCT06565611 ↗ “Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector.” NCT04943068 ↗ “efficacy of melanocortin receptor agonist bremelanotide (BMT) when administered with RAAS inhibition therapy” NCT05709444 ↗ “Bremelanotide (BMT) is secreted in breast milk” NCT06867835 ↗ |
| Known as | Bremelanotida | ChEMBL registry synonym — accepted as the source's own label CHEMBL2070241 ↗ |
| Known as | BREMELANOTIDE ACETATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2070241 ↗ |
| Known as | PT 141 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2070241 ↗ |
| Known as | PT-141 FREE BASE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2070241 ↗ |
| Known as | Vyleesi | “Vyleesi (Bremelanotide Injection)” NCT06867835 ↗ |
| Known as | Vyleesi (autoinjector) | ChEMBL registry synonym — accepted as the source's own label CHEMBL2070241 ↗ |
| Action | Activate | “a melanocortin-receptor-4 agonist” PMID 27181790 ↗ May 2016 |
| Modality | Peptide | “A melanocortin agonist and synthetic peptide analog” NCT02333071 ↗ |
| Route | Intranasal | “evaluate the safety of intranasal Bremelanotide in women with Female Sexual Arousal Disorder” NCT00425256 ↗ |
| Target | MC4R | “MC4R agonism significantly increased sexual desire” PMID 36189794 ↗ Oct 2022 |