Drugs / Darifenacin
Darifenacin
also known as
darifenacin hydrobromide · ENABLEX · BAY79-4998 · DAR328 · Darifenacin extended release · Darifenacin hbr · Darifenacin Hydrogen Bromide (HBr) · Darifenacina · +5 more
Small molecule targets CHRM2, CHRM3 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ENABLEX | — | 2004-12-22 | fda.gov ↗ |
| Approved | EU (EMA) | Emselex | — | 2004-10-22 | europa.eu ↗ |
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT00703703 | May → Oct 2008 | — | Novartis | Completed | No outcome recorded |
| Phase 1 | NCT00413426 | Jun 2006 → Sep 2007 | — | Novartis | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07206706 | May → Dec 2022 | — | Ain Shams University | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT06249867 | Nov 2024 → Oct 2027 expected | amyotrophic lateral sclerosis | Oliver Blanchard | Recruiting | No outcome recorded |
| Phase 2 | NCT00712322 | Oct 2008 → May 2013 | overactive bladder | Warner Chilcott | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00845338 | Feb → Oct 2007 | multiple sclerosis, overactive bladder | Bayer | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00170768 | Feb → May 2005 | — | Novartis | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT02143570 | May 2014 → Apr 2016 | overactive bladder | Universidad de Valparaiso | Completed | No outcome recorded |
| Phase 3 | NCT00171145 | Apr → Dec 2004 | overactive bladder | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00170755 | Apr 2002 → Jan 2005 | overactive bladder | Novartis | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT01018225 | Nov 2009 → Jul 2010 | — | Cognitive Research Corporation | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00413790 | Nov 2006 → Sep 2007 | — | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00366002 | Jun 2006 → Sep 2007 | overactive bladder | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00127270 | May 2005 → Feb 2006 | — | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00171184 | Apr 2005 → Jun 2006 | overactive bladder | Novartis | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00892450 | May 2009 → Sep 2014 | Parkinson disease, overactive bladder | US Department of Veterans Affairs | Completed | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 0 | NCT07016451 Background | Apr 2024 → Sep 2025 | radiation cystitis | Ramathibodi Hospital | Completed | No outcome recorded |
| Phase 4 | NCT06616675 Comparator | Mar 2022 → Dec 2023 | human T-lymphotropic virus 1 infectious disease, overactive bladder | Hospital Universitário Professor Edgard Santos | Completed | No outcome recorded |
| Phase 4 | NCT00800462 Comparator | Mar 2008 → Jun 2012 | overactive bladder, spinal cord injury | Toronto Rehabilitation Institute | Completed | No outcome recorded |
| Phase 4 | NCT00547378 Comparator | Oct 2007 → Aug 2016 | overactive bladder | MedtronicNeuro | Completed | No outcome recorded |
| — | NCT03662893 Comparator | Jan 2015 → Dec 2017 | overactive bladder | Ankara Training and Research Hospital | Completed | No outcome recorded |
| — | NCT01189071 Comparator | Aug 2009 → Jul 2011 | overactive bladder, urinary tract obstruction | University of Missouri-Columbia | Terminated | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-05-05 | Xiromed LLC | Xiromed LLC Launches Darifenacin ER Tablets xiromed.com ↗ |
| 2020-10-01 | Norgine | Norgine B.V. enters into an agreement to dispose of its rights to EMSELEX® (darifenacin) in Europe to pharma& norgine.com ↗ |
Evidence & citations 19 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Darifenacin | “Antimuscarinic drugs (Tolterodine, solifenacin, propiverine, darifenacin,fesoterodine)” NCT03662893 ↗ |
| Known as | BAY79-4998 | “Darifenacin (BAY79-4998)” NCT00845338 ↗ |
| Known as | DAR328 | “Darifenacin (DAR328)” NCT00413426 ↗ |
| Known as | Darifenacin extended release | ChEMBL registry synonym — accepted as the source's own label CHEMBL1346 ↗ |
| Known as | Darifenacin hbr | ChEMBL registry synonym — accepted as the source's own label CHEMBL1346 ↗ |
| Known as | darifenacin hydrobromide | “This is a phase IV, double-blind, multicenter, randomized trial evaluating the efficacy and safety of two M3 receptors antagonists (Trospium Chloride and Darifenacin...” NCT00800462 ↗1“ENABLEX (Darifenacin Extended Release Tablets), or darifenacin hydrobromide, is a known active substance with the chemical name:...” NCT06249867 ↗ |
| Known as | Darifenacin Hydrogen Bromide (HBr) | “Drug: Darifenacin Hydrogen Bromide (HBr)” NCT00800462 ↗ |
| Known as | Darifenacina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1346 ↗ |
| Known as | Darifenacine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1346 ↗ |
| Known as | Emselex | ChEMBL registry synonym — accepted as the source's own label CHEMBL1346 ↗ |
| Known as | ENABLEX | “ENABLEX (Darifenacin Extended Release Tablets), or darifenacin hydrobromide, is a known active substance with the chemical name:...” NCT06249867 ↗1“Preoperative Use of Darifenacin (Enablex) to Alleviate Postoperative Ureteral Stent Pain” NCT01189071 ↗ |
| Known as | UK-88525 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1346 ↗ |
| Known as | Uk-88525-04 (hbr) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1346 ↗ |
| Known as | UK-88525-04 (HYDROBROMIDE) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1346 ↗ |
| Action | Inhibit | “M(3)-selective muscarinic receptor antagonist darifenacin over 2 years” PMID 18663723 ↗ 20082“Muscarinic acetylcholine receptor M2 antagonist” CHEMBL1346 ↗ “Muscarinic acetylcholine receptor M3 antagonist” CHEMBL1346 ↗ |
| Modality | Small molecule | — CHEMBL1346 ↗ |
| Route | Oral | “Darifenacin 7,5 mg tablets, Darifenacin 15 mg tablets administered once daily” NCT00170755 ↗ |
| Target | CHRM2 | “Muscarinic acetylcholine receptor M2 antagonist” CHEMBL1346 ↗ |
| Target | CHRM3 | “Muscarinic acetylcholine receptor M3 antagonist” CHEMBL1346 ↗ |