CDEK
← All drugs Report issue

solifenacin

Trade name: vesicare

Small moleculeapproved

Approved

Nov 19, 2004

Solifenacin is a competitive muscarinic acetylcholine receptor antagonist. The binding of acetylcholine to these receptors, particularly the M3 receptor subtype, plays a critical role in the contraction of smooth muscle. By preventing the binding of acetylcholine to these receptors, solifenacin reduces smooth muscle tone in the bladder, allowing the bladder to retain larger volumes of urine. It is FDA approved for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Common adverse reactions include constipation, Xerostomia. Inhibitors of CYP3A4 may increase the concentration of Solifenacin. Vice versa, CYP3A4 Inducers decrease concentration. — NCATS

Clinical trial activity

142 trials · 105 clinical orgs · 31 marketing orgs

Phase 1
22
Phase 2
47
Phase 3
33
Phase 4
47

Earliest trial started Jul 1, 2003 (NCT00802373)

Timeline

2000s

  1. Jan 1, 2003

    Astellas — Earliest Phase 3 Sponsor(trial)

  2. Nov 19, 2004

    Yamanouchi Pharmaceuticals — Earliest FDA Approval

  3. Nov 19, 2004

    Astellas — NDA Secondary Org

  4. Nov 19, 2004

    Yamanouchi Pharmaceuticals — NDA Organization

  5. Jan 1, 2007

    Astellas — Earliest Phase 2 Sponsor(trial)

  6. Jan 1, 2009

    Astellas — Earliest Phase 1 Sponsor(trial)

2010s

  1. Apr 2, 2014

    Teva — Marketing Organization

  2. Jun 2, 2015

    Watson Pharmaceuticals — Marketing Organization

  3. Sep 11, 2017

    Zydus Discovery DMCC — Marketing Organization

  4. Nov 15, 2017

    Alkem Labs Ltd — Marketing Organization

  5. Mar 26, 2018

    Amneal Pharmaceuticals — Marketing Organization

  6. Sep 14, 2018

    MSN Laboratories — Marketing Organization

  7. Dec 21, 2018

    Qilu Pharmaceutical Co., Ltd. — Marketing Organization

  8. May 20, 2019

    Ajanta Pharma Ltd — Marketing Organization

  9. May 20, 2019

    Alembic — Marketing Organization

  10. May 20, 2019

    Esteve Labs — Marketing Organization

  11. May 20, 2019

    Celltrion — Marketing Organization

  12. May 20, 2019

    Austarpharma — Marketing Organization

  13. May 20, 2019

    Cipla — Marketing Organization

  14. May 20, 2019

    Glenmark Pharmaceuticals — Marketing Organization

  15. May 20, 2019

    Jiangxi Boya Seehot — Marketing Organization

  16. May 20, 2019

    Sciegen Pharmaceticals — Marketing Organization

  17. May 20, 2019

    Chartwell Pharmaceuticals — Marketing Organization

  18. May 20, 2019

    Allergan PLC (2015) — Marketing Organization

  19. Aug 27, 2019

    Unichem — Marketing Organization

  20. Sep 26, 2019

    Strides Pharma Science — Marketing Organization

  21. Dec 11, 2019

    Graviti Pharmaceuticals — Marketing Organization

  22. Dec 11, 2019

    Shijiazhuang Pharma Group (CSPC) — Marketing Organization

  23. Dec 11, 2019

    Rising Pharmaceuticals — Marketing Organization

2020s

  1. Apr 13, 2020

    Sunshine Lake Pharma Co., Ltd. — Marketing Organization

  2. May 26, 2020

    Leo Pharma — NDA Secondary Org

  3. Jan 4, 2022

    Accord Research — Marketing Organization

  4. Jun 15, 2022

    Annora Pharma — Marketing Organization

  5. Dec 27, 2022

    Aurobindo Pharma — Marketing Organization

  6. Jun 6, 2023

    Lannett Company, Inc. — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedNov 19, 2004

Chemistry & pharmacology

Loading structure…

SMILES

O=C(O[C@H]1CN2CCC1CC2)N1CCc2ccccc2[C@@H]1c1ccccc1
Mol. weight
362.47 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

  • sofenacin
  • solifenacin
  • solifenacin
  • solifenacin
  • solifenacin
  • solifenacin
  • solifenacin
  • solifenacin
  • solifenacin
  • solifenacin hydrochloride
  • solifenacin succinate
  • solifenacin succinate
  • solifenacin succinate
  • solifenacin succinate
  • solifenacin succinate
  • vesicare
  • vesicare
  • vesicare
  • vesicare
  • vesicare
  • ym-67905
  • ym-67905
  • ym-67905
  • ym-67905
  • ym-67905
  • ym-67905
  • ym-905
  • ym-905
  • ym-905

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06546735Phase 3Nov 30, 2026Eurofarma Laboratorios S.A.
NCT07305298Phase 3Jan 1, 2026Medical University of Lublin, University of Naples Frederico II
NCT07025642N/AJul 1, 2025Mackay Medical College
NCT07312955N/AMay 15, 2025Ain Shams University
NCT06803030Phase 3Feb 1, 2025Government of Nepal, NAMS Bir Hospital
NCT06489951N/ADec 31, 2024Capital Medical University, Chongqing Medical University, Guizhou Medical University, Jiao Tong University, Soochow University
NCT06551246Phase 3Jun 27, 2024Aarhus University, Gødstrup Hospital
NCT07114848Phase 4Jun 13, 2024Liaquat University of Medical & Health Sciences
NCT06465576Phase 4May 27, 2024Aarhus University, Gødstrup Hospital
NCT06955533N/AApr 1, 2024Ain Shams University
NCT06201013N/ASep 3, 2023Chongqing Medical University
NCT05798403N/AJul 7, 2023Shanghai University, Shanghai University of Traditional Chinese Medicine
NCT06024005N/AApr 18, 2023Ege University
NCT05709990N/AJan 15, 2023Chongqing Medical University
NCT06184334N/ASep 14, 2022Kafrelsheikh University
NCT06479720Phase 4Jun 16, 2022Mackay Medical College
NCT05767632Phase 1May 30, 2022Genuine Research Center, Egypt, Hikma
NCT05282069Phase 3May 12, 2022Dong-A Pharmaceutical
NCT05490082Phase 3Mar 1, 2022Mansoura University
NCT05240456Phase 1/Phase 2 (Phase 2)Feb 28, 2022Mansoura University
Showing 20 of 142 trials
Page 1 / 8

Organizations

Research & Development (105)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AstellasFor profit674852003
Mansoura UniversityAcademic/Hospital7742013
Chase Pharmaceuticals CorporationFor profit4412014
Jeil Pharmaceutical Co., Ltd.For profit4422014
National Taiwan UniversityAcademic/Hospital4422008
Seoul National UniversityAcademic/Hospital4022010
China Academy of Chinese Medical SciencesAcademic/Hospital3312014
Chongqing Medical UniversityAcademic/Hospital3312023
Loyola UniversityAcademic/Hospital3332007
Mackay Medical CollegeAcademic/Hospital3322021
Sungkyunkwan UniversityAcademic/Hospital3122008
Aarhus UniversityAcademic/Hospital2222024
Ain Shams UniversityAcademic/Hospital2212024
Capital Medical UniversityAcademic/Hospital2012014
Dong-A PharmaceuticalFor profit2222018
Far Eastern Memorial HospitalAcademic/Hospital2222016
Gødstrup HospitalAcademic/Hospital2022024
Kangbuk Samsung HospitalAcademic/Hospital2212008
Korea UniversityAcademic/Hospital2122005
Peking UniversityAcademic/Hospital2022006
105 organizations
Page 1 / 6

Marketing (38)

OrganizationOrg typeRelationshipDate
Accord ResearchFor profitMKTGJan 4, 2022
Ajanta Pharma LtdFor profitMKTGMay 20, 2019
AlembicFor profitMKTGMay 20, 2019
AlembicFor profitSYNMay 20, 2019
Alkem Labs LtdFor profitMKTGNov 15, 2017
Allergan PLC (2015)For profitMKTGMay 20, 2019
Amneal PharmaceuticalsFor profitMKTGMar 26, 2018
Annora PharmaFor profitMKTGJun 15, 2022
AstellasFor profitNDA2Nov 19, 2004
Aurobindo PharmaFor profitMKTGDec 27, 2022
AustarpharmaFor profitMKTGMay 20, 2019
CelltrionFor profitMKTGMay 20, 2019
Chartwell PharmaceuticalsFor profitMKTGMay 20, 2019
CiplaFor profitMKTGMay 20, 2019
Esteve LabsFor profitMKTGMay 20, 2019
Esteve LabsFor profitSYNMay 20, 2019
Glenmark PharmaceuticalsFor profitMKTGMay 20, 2019
Graviti PharmaceuticalsFor profitMKTGDec 11, 2019
Jiangxi Boya SeehotFor profitMKTGMay 20, 2019
Lannett Company, Inc.For profitMKTGJun 6, 2023
Leo PharmaFor profitNDA2May 26, 2020
MSN LaboratoriesFor profitMKTGSep 14, 2018
MSN LaboratoriesFor profitSYNMay 20, 2019
Qilu Pharmaceutical Co., Ltd.For profitMKTGDec 21, 2018
Qilu Pharmaceutical Co., Ltd.For profitSYNMay 20, 2019
Rising PharmaceuticalsFor profitMKTGDec 11, 2019
Sciegen PharmaceticalsFor profitMKTGMay 20, 2019
Shijiazhuang Pharma Group (CSPC)For profitMKTGDec 11, 2019
Strides Pharma ScienceFor profitMKTGSep 26, 2019
Sunshine Lake Pharma Co., Ltd.For profitMKTGApr 13, 2020
Sunshine Lake Pharma Co., Ltd.For profitSYNApr 13, 2020
TevaFor profitMKTGApr 2, 2014
UnichemFor profitMKTGAug 27, 2019
UnichemFor profitSYNAug 27, 2019
Watson PharmaceuticalsFor profitMKTGJun 2, 2015
Yamanouchi PharmaceuticalsFor profitNDANov 19, 2004
Zydus Discovery DMCCFor profitMKTGSep 11, 2017
Zydus Discovery DMCCFor profitSYNOct 19, 2020