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darifenacin

Trade name: enablex

Small moleculeapproved

Approved

Dec 22, 2004

Darifenacin is a selective muscarinic receptor M3 antagonist which was approved by FDA for the treatment of overactive bladder. — NCATS

Clinical trial activity

21 trials · 19 clinical orgs · 16 marketing orgs

Phase 1
5
Phase 2
8
Phase 3
3
Phase 4
6

Earliest trial started Apr 1, 2002 (NCT00170755)

Timeline

2000s

  1. Jan 1, 2002

    Novartis — Earliest Phase 3 Sponsor(trial)

  2. Dec 22, 2004

    Novartis — Earliest FDA Approval

  3. Dec 22, 2004

    Novartis — NDA Organization

  4. Dec 22, 2004

    Allergan — NDA Secondary Org

  5. Dec 22, 2004

    AbbVie — Marketing Organization

  6. Dec 22, 2004

    AbbVie — NDA Secondary Org

  7. Jan 1, 2005

    Novartis — Earliest Phase 2 Sponsor(trial)

  8. Jan 1, 2006

    Novartis — Earliest Phase 1 Sponsor(trial)

2010s

  1. Mar 13, 2015

    Endo Pharmaceuticals — Marketing Organization

  2. Mar 13, 2015

    Anchen Pharmaceuticals, Inc — Marketing Organization

  3. Mar 13, 2015

    Par Pharmaceuticals — Marketing Organization

  4. Sep 1, 2016

    Cipla — Marketing Organization

  5. Sep 19, 2016

    Aurobindo Pharma — Marketing Organization

  6. Oct 12, 2016

    Jubilant Innovation Ltd. — Marketing Organization

  7. Nov 17, 2016

    Torrent Pharmaceuticals Limited — Marketing Organization

  8. Jul 28, 2017

    Macleods Pharmaceuticals, Ltd — Marketing Organization

  9. Jul 28, 2017

    Neogen — Marketing Organization

  10. Dec 8, 2017

    Alembic — Marketing Organization

  11. Oct 22, 2019

    Alan Labs Inc — Marketing Organization

  12. Oct 22, 2019

    Exeltis — Marketing Organization

2020s

  1. Jan 6, 2020

    Polygen Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedDec 22, 2004

Chemistry & pharmacology

Loading structure…

SMILES

NC(=O)C(c1ccccc1)(c1ccccc1)[C@@H]1CCN(CCc2ccc3c(c2)CCO3)C1
Mol. weight
426.56 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • darifenacin
  • darifenacin
  • darifenacin
  • darifenacin
  • darifenacin
  • darifenacin
  • darifenacin
  • darifenacin
  • darifenacin
  • darifenacina
  • darifenacina
  • darifenacine
  • darifénacine
  • darifénacine
  • darifenacin hydrobromide
  • darifenacin hydrobromide
  • darifenacin hydrobromide
  • darifenacin hydrobromide
  • darifenacin hydrobromide
  • darifenacin hydrobromide
  • darifenacin hydrochloride
  • darifenacinum
  • darifenacinum
  • darifenicin
  • emselex
  • emselex
  • emselex
  • emselex
  • enablex
  • enablex
  • enablex
  • enablex
  • enablex
  • enablex
  • enablex
  • enablex
  • oxybutynin darifenacin
  • (s)-1-(2-(2,3-dihydro-5-benzofuranyl)ethyl)-alpha,alpha-diphenyl-3-pyrrolidineacetamide
  • (s)-1-(2-(2,3-dihydro-5-benzofuranyl)ethyl)-alpha,alpha-diphenyl-3-pyrrolidineacetamide
  • (s)-1-(2-(2,3-dihydro-5-benzofuranyl)ethyl)-alpha,alpha-diphenyl-3-pyrrolidineacetamide
  • uk-88525
  • uk-88525
  • uk-88525
  • uk-88525-04
  • uk-88525-04

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06249867Phase 2Mar 31, 2024McGill University, University of Montreal
NCT07206706Phase 1/Phase 2 (Phase 2)May 1, 2022Ain Shams University
NCT03662893N/AJan 1, 2015Government of Turkey, University of Ankara
NCT02143570Phase 3May 1, 2014Abbott, Universidad de Valparaiso
NCT01229280Phase 1Dec 1, 2010Center for Clinical Pharmacology Research Bdbeq S.A., Laboratorio Elea S.A.C.I.F. y A., University of Montevideo
NCT01227811Phase 1Nov 1, 2010Center for Clinical Pharmacology Research Bdbeq S.A., Laboratorio Elea S.A.C.I.F. y A., University of Montevideo
NCT01018225Phase 4Nov 1, 2009Cognitive Research Corporation, Novartis
NCT01189071N/AAug 1, 2009University of Missouri
NCT00892450N/AMay 1, 2009Department of Veteran Affairs
NCT00712322Phase 2Oct 1, 2008Warner Chilcott
NCT00703703Phase 1May 1, 2008Novartis, Procter and Gamble
NCT00800462Phase 4Mar 1, 2008Ontario Neurotrauma Foundation, University of Toronto
NCT00845338Phase 2Feb 1, 2007Bayer
NCT00413790Phase 4Nov 1, 2006Novartis, Procter and Gamble
NCT00366002Phase 4Jun 1, 2006Novartis, Procter and Gamble
NCT00413426Phase 1Jun 1, 2006Novartis, Procter and Gamble
NCT00127270Phase 4May 1, 2005Novartis, Procter and Gamble
NCT00171184Phase 4Apr 1, 2005Novartis, Procter and Gamble
NCT00170768Phase 2Feb 1, 2005Novartis
NCT00171145Phase 3Apr 1, 2004Novartis
Showing 20 of 21 trials
Page 1 / 2

Organizations

Research & Development (19)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
NovartisFor profit10942002
Procter and GambleFor profit6022005
Center for Clinical Pharmacology Research Bdbeq S.A.Academic/Hospital2212010
Laboratorio Elea S.A.C.I.F. y A.For profit2012010
University of MontevideoAcademic/Hospital2012010
AbbottFor profit1012014
Ain Shams UniversityAcademic/Hospital1112022
BayerFor profit1112007
Cognitive Research CorporationFor profit1112009
Department of Veteran AffairsGovernment1112009
Government of TurkeyGovernment1012015
McGill UniversityAcademic/Hospital1112024
Ontario Neurotrauma FoundationAcademic/Hospital1012008
Universidad de ValparaisoAcademic/Hospital1112014
University of AnkaraAcademic/Hospital1112015
University of MissouriAcademic/Hospital1112009
University of MontrealAcademic/Hospital1012024
University of TorontoAcademic/Hospital1112008
Warner ChilcottFor profit1112008
19 organizations
Page 1 / 1

Marketing (19)

OrganizationOrg typeRelationshipDate
AbbVieFor profitMKTGDec 22, 2004
AbbVieFor profitNDA2Dec 22, 2004
Alan Labs IncFor profitMKTGOct 22, 2019
AlembicFor profitMKTGDec 8, 2017
AlembicFor profitSYNDec 8, 2017
AllerganFor profitNDA2Dec 22, 2004
Anchen Pharmaceuticals, IncFor profitMKTGMar 13, 2015
Aurobindo PharmaFor profitSYNSep 19, 2016
Aurobindo PharmaFor profitMKTGSep 19, 2016
CiplaFor profitMKTGSep 1, 2016
Endo PharmaceuticalsFor profitMKTGMar 13, 2015
ExeltisFor profitMKTGOct 22, 2019
Jubilant Innovation Ltd.For profitMKTGOct 12, 2016
Macleods Pharmaceuticals, LtdFor profitMKTGJul 28, 2017
NeogenFor profitMKTGJul 28, 2017
NovartisFor profitNDADec 22, 2004
Par PharmaceuticalsFor profitMKTGMar 13, 2015
Polygen PharmaceuticalsFor profitMKTGJan 6, 2020
Torrent Pharmaceuticals LimitedFor profitMKTGNov 17, 2016