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 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 23 trials | ||||||
| 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 | No outcome recorded |
| Phase 2 | NCT00425256 | Feb 2006 → May 2007 | sexual disorder | Palatin Technologies, Inc | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| 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 | No outcome recorded |
| Phase 3 | NCT02333071 | Dec 2014 → Jul 2016 | hypoactive sexual desire disorder | Palatin Technologies, Inc | Completed | No outcome recorded |
| 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 |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03973047 Comparator | Jun → Jul 2019 | — | AMAG Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06565611 Comparator | Aug 2024 → Feb 2025 overdue | obesity disorder | Palatin Technologies, Inc | Active not recruiting | No outcome recorded |
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 NCT05709444 ↗ |
| 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 |