Drugs / flibanserin
flibanserin
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | ADDYI | — | 2025-12-13 | fda.gov ↗ |
| Approved | US (FDA) | ADDYI | — | 2015-08-18 | fda.gov ↗ |
Trials 17
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01188603 | Jul → Oct 2010 | psychosexual disorder | Sprout Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 1 | NCT01134965 | Jun → Jul 2010 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT04743934 | Jul 2021 → Mar 2025 | prostate adenocarcinoma | Andrew McDonald | Completed | No outcome recorded |
| Phase 2 | NCT03707340 | Sep 2018 → Oct 2026 expected | breast cancer, hypoactive sexual desire disorder | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 312 trials · 1 met primary | ||||||
| Phase 3 | NCT01103362 | Apr 2010 → Jan 2011 | hypoactive sexual desire disorder | Sprout Pharmaceuticals, Inc | Terminated | No outcome recorded |
| Phase 3 | NCT01057901 | Jan 2010 → Jan 2011 | psychosexual disorder | Sprout Pharmaceuticals, Inc | Terminated | No outcome recorded |
| Phase 3 | NCT01040208 | Jan 2010 → Jan 2011 | depressive disorder, psychosexual disorder | Sprout Pharmaceuticals, Inc | Terminated | No outcome recorded |
| Phase 3 | NCT00996372 | Oct 2009 → Mar 2011 | hypoactive sexual desire disorder | Sprout Pharmaceuticals, Inc | Completed | Met primary |
| Phase 3 | NCT00996164 | Oct 2009 → Dec 2010 | psychosexual disorder | Sprout Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 3 | NCT00601367 | Jan 2008 → Oct 2009 | hypoactive sexual desire disorder | Sprout Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 3 | NCT00491829 | Jun 2007 → Mar 2009 | hypoactive sexual desire disorder | Sprout Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 3 | NCT00441558 | Feb 2007 → Aug 2009 | hypoactive sexual desire disorder | Sprout Pharmaceuticals, Inc | Terminated | No outcome recorded |
| Phase 3 | NCT00360529 | Jul 2006 → Apr 2008 | psychosexual disorder | Sprout Pharmaceuticals, Inc | Completed | Mixed |
| Phase 3 | NCT00360243 | Jul 2006 → Apr 2008 | hypoactive sexual desire disorder | Sprout Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 3 | NCT00360555 | Jul 2006 → Mar 2008 | hypoactive sexual desire disorder | Sprout Pharmaceuticals, Inc | Completed | Mixed |
| Phase 3 | NCT00277914 | Jan 2006 → Jul 2007 | psychosexual disorder | Sprout Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT02714049 | Jan 2017 → Jan 2019 | hypoactive sexual desire disorder | San Diego Sexual Medicine | Terminated | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT04002661 Comparator | May 2020 → Oct 2025 | hypoactive sexual desire disorder | Mohit Khera | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT02770768 Comparator | Oct 2016 → Dec 2021 | hypoactive sexual desire disorder | University of Chicago | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2010-06-18 | Boehringer Ingelheim | Regulatory Boehringer Ingelheim Comments on June 18th FDA Advisory Committee Meeting prnewswire.com ↗
Members of the committee advised that additional data are necessary to further support the efficacy and safety profile of flibanserin and recommended that clinical development of the drug continue. |
| 2010-05-18 | Boehringer Ingelheim | Results Boehringer Ingelheim Announces New Data on Flibanserin in Pre-Menopausal Women with Hypoactive Sexual Desire Disorder prnewswire.com ↗
Data from pivotal Phase III clinical trials demonstrate that a higher proportion of pre-menopausal women with Hypoactive Sexual Desire Disorder (HSDD) receiving flibanserin 100mg reported both an improvement in their condition and a meaningful benefit from their treatment, compared to placebo. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2010-06-18 | Boehringer Ingelheim | Boehringer Ingelheim Comments on June 18th FDA Advisory Committee Meeting prnewswire.com ↗ |
| 2010-05-18 | Boehringer Ingelheim | Boehringer Ingelheim Announces New Data on Flibanserin in Pre-Menopausal Women with Hypoactive Sexual Desire Disorder prnewswire.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | flibanserin | “To evaluate safety and tolerability of flibanserin in such patients.” NCT00491829 ↗ |
| Known as | Addyi | ChEMBL registry synonym — accepted as the source's own label CHEMBL231068 ↗ |
| Known as | BIMT 17 | ChEMBL registry synonym — accepted as the source's own label CHEMBL231068 ↗ |
| Known as | BIMT 17 BS | ChEMBL registry synonym — accepted as the source's own label CHEMBL231068 ↗ |
| Known as | Ectris | ChEMBL registry synonym — accepted as the source's own label CHEMBL231068 ↗ |
| Known as | Flibanserina | ChEMBL registry synonym — accepted as the source's own label CHEMBL231068 ↗ |
| Known as | Flibanserine | ChEMBL registry synonym — accepted as the source's own label CHEMBL231068 ↗ |
| Modality | Small molecule | — CHEMBL231068 ↗ |
| Route | Oral | “Flibanserin (100 Milligrams) Administered Orally Once Daily” NCT00996164 ↗ |