Drugs / Solifenacin
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Solifenacin

Small molecule targets CHRM2, CHRM3 via inhibition

Developed for
overactive bladder · benign prostatic hyperplasia · Alzheimer disease · enuresis · female stress incontinence · nocturnal enuresis · urinary tract infection · urinary tract obstruction
+4 more · cystitis · disorder of neck of urinary bladder · urethral syndrome · urinary bladder disorder
Investigated by
Astellas Pharma Inc · Astellas Pharma Europe B.V. · Astellas Pharma Inc · Astellas Pharma US, Inc. · Jeil Pharmaceutical Co., Ltd. · Loyola University
+46 more · National Taiwan University Hospital · Astellas Pharma Canada, Inc. · Beni-Suef University · Chase Pharmaceuticals Corporation, an affiliate of Allergan plc · Far Eastern Memorial Hospital · KYU-SUNG LEE · Mansoura University · University of Aarhus · University of California, Irvine · University of South Florida · Asan Medical Center · Astellas Pharma Europe Ltd. · Astellas Pharma Inc · Astellas Pharma Indonesia Inc. · Astellas Pharma Taiwan, Inc. · Barrie Urology Associates · Beijing CAT Science Co., Ltd. · Beijing Children's Hospital · Benha University · Brigham and Women's Hospital · Buddhist Tzu Chi General Hospital · Cantonal Hospital, Frauenfeld · Center Eugene Marquis · Children's Hospital of Soochow University · Cleveland Clinic Florida · Dr Cipto Mangunkusumo General Hospital · Guizhou Provincial People's Hospital · Hartford Hospital · IlDong Pharmaceutical Co Ltd · Jeong Gu Lee · Mackay Medical College · Mackay Memorial Hospital · Medical University of Silesia · NYU Langone Health · Peking Union Medical College Hospital · Pharos Life Corporation · Samsung Biomedical Research Institute · Samsung Medical Center · Seattle Urology Research Center · Shanghai Children's Hospital · Stamford Hospital · Timothy Boone, MD, PhD · Unidade Local de Saúde São João · University of Arkansas · University of Porto · Xing Liu

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) VESICARE 2004-11-19 fda.gov

Trials 91 · started per year

today
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20032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 114 trials
Phase 1 NCT02494349 Aug → Nov 2015 benign prostatic hyperplasia, overactive bladder Jeil Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 1 NCT02180997 Jul 2014 → Mar 2015 benign prostatic hyperplasia, overactive bladder Jeil Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 1 NCT02169713 May → Aug 2014 Astellas Pharma Europe B.V. Completed No outcome recorded
Phase 1 NCT02127034 Mar → Jun 2014 Astellas Pharma Europe B.V. Completed No outcome recorded
Phase 1 NCT02010944 Sep → Nov 2012 Astellas Pharma Europe B.V. Completed No outcome recorded
Phase 1 NCT01539707 Mar → Aug 2012 overactive bladder Astellas Pharma Inc Completed No outcome recorded
Phase 1 NCT01406158 May → Jul 2011 Astellas Pharma Inc Completed No outcome recorded
Phase 1 NCT01262391 Oct 2010 → Aug 2011 overactive bladder Astellas Pharma Inc Completed No outcome recorded
Phase 1 NCT01953861 Apr → Jun 2010 Astellas Pharma Europe B.V. Completed No outcome recorded
Phase 1 NCT01953848 Apr → Jul 2010 Astellas Pharma Europe B.V. Completed No outcome recorded
Phase 28 trials
Phase 2 NCT07617922 May 2026 → Apr 2027 expected ureterolithiasis Beni-Suef University Recruiting No outcome recorded
Phase 2 NCT03632772 Aug 2018 → Jul 2019 overactive bladder Buddhist Tzu Chi General Hospital Unknown No outcome recorded
Phase 2 NCT02860065 Sep 2016 → Jun 2017 Alzheimer disease Chase Pharmaceuticals Corporation, an affiliate of Allergan plc Withdrawn No outcome recorded
Phase 2 NCT02549196 Oct 2015 → Sep 2017 Alzheimer disease Chase Pharmaceuticals Corporation, an affiliate of Allergan plc Completed No outcome recorded
Phase 2 NCT01642277 Jul 2012 → Jul 2014 overactive bladder Loyola University Completed No outcome recorded
Phase 2 NCT01530373 Feb 2012 → Jul 2027 expected breast cancer University of Arkansas Recruiting No outcome recorded
Phase 2 NCT01340027 Mar 2011 → Jun 2012 overactive bladder Astellas Pharma Europe B.V. Completed No outcome recorded
Phase 2 NCT00507455 Jun 2007 → Aug 2008 urinary tract obstruction Astellas Pharma Inc Completed No outcome recorded
Phase 322 trials
Phase 3 NCT07429734 Feb → Oct 2026 expected overactive bladder Mansoura University Not yet recruiting No outcome recorded
Phase 3 NCT07199894 Dec 2024 → Dec 2025 overdue nocturnal enuresis Mansoura University Recruiting No outcome recorded
Phase 3 NCT06551246 Jun 2024 → Oct 2027 expected enuresis University of Aarhus Recruiting No outcome recorded
Phase 3 NCT04023253 Aug 2019 → Dec 2024 overactive bladder Far Eastern Memorial Hospital Unknown No outcome recorded
Phase 3 NCT02805452 Jul 2016 → May 2017 overactive bladder Center Eugene Marquis Terminated No outcome recorded
Phase 3 NCT02972268 Feb 2016 → Nov 2017 benign prostatic hyperplasia Jeil Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 3 NCT02827578 Jan 2016 → Aug 2017 benign prostatic hyperplasia IlDong Pharmaceutical Co Ltd Unknown No outcome recorded
Phase 3 NCT02045862 Mar 2014 → Sep 2016 overactive bladder Astellas Pharma Europe B.V. Completed No outcome recorded
Phase 3 NCT01972841 Nov 2013 → Oct 2015 overactive bladder Astellas Pharma Europe B.V. Completed No outcome recorded
Phase 3 NCT01981954 Sep 2013 → Dec 2015 overactive bladder Astellas Pharma Europe B.V. Completed No outcome recorded
Phase 436 trials
Phase 4 NCT07711808 Jul 2026 → Jul 2027 expected overactive bladder University of Porto Not yet recruiting No outcome recorded
Phase 4 NCT06465576 May 2024 → Dec 2027 expected enuresis University of Aarhus Active not recruiting No outcome recorded
Phase 4 NCT05968885 Oct 2021 → Jun 2026 overdue overactive bladder Mackay Memorial Hospital Recruiting No outcome recorded
Phase 4 NCT04090190 Oct 2019 → May 2021 overactive bladder Brigham and Women's Hospital Completed No outcome recorded
Phase 4 NCT02294396 Oct 2014 → Sep 2016 overactive bladder Astellas Pharma Inc Completed No outcome recorded
Phase 4 NCT01876186 May 2013 → Dec 2015 overactive bladder National Taiwan University Hospital Unknown No outcome recorded
Phase 4 NCT02094703 Apr 2013 → Nov 2014 urinary tract infection Dr Cipto Mangunkusumo General Hospital Unknown No outcome recorded
Phase 4 NCT01747577 Dec 2012 → Oct 2013 benign prostatic hyperplasia, overactive bladder Astellas Pharma Inc Completed No outcome recorded
Phase 4 NCT01559389 Mar 2012 → Jun 2017 overactive bladder Loyola University Completed No outcome recorded
Phase 4 NCT01314781 Jan 2012 → Jan 2014 overactive bladder Cantonal Hospital, Frauenfeld Completed No outcome recorded
Phase not applicable11 trials
NCT07025642 Jul 2025 → May 2026 overdue overactive bladder Mackay Medical College Recruiting No outcome recorded
NCT06489951 Dec 2024 → Jun 2025 overactive bladder Xing Liu Completed No outcome recorded
NCT05911594 Feb 2022 → Feb 2023 Benha University Completed No outcome recorded
NCT04064619 Jan 2018 → Aug 2019 overactive bladder Beni-Suef University Completed No outcome recorded
NCT04477265 Jun 2016 → Dec 2021 overactive bladder Far Eastern Memorial Hospital Completed No outcome recorded
NCT01627145 Aug 2012 → Jan 2015 overactive bladder National Taiwan University Hospital Unknown No outcome recorded
NCT01215721 Oct 2010 → May 2013 University of California, Irvine Completed No outcome recorded
NCT01499069 Feb 2010 → Nov 2015 overactive bladder Samsung Medical Center Completed No outcome recorded
NCT01503580 Aug 2008 → Jul 2010 National Taiwan University Hospital Completed No outcome recorded
NCT00581061 Jun 2008 → Feb 2009 University of California, Irvine Terminated No outcome recorded
Also used as a comparator or background therapy in 53 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT07016451 Background Apr 2024 → Sep 2025 radiation cystitis Ramathibodi Hospital Completed No outcome recorded
Phase 12 trials
Phase 1 NCT00832650 Comparator Apr → Dec 2009 Pfizer Terminated No outcome recorded
Phase 1 NCT02634489 Comparator Mar → Jul 2009 benign prostatic hyperplasia Astellas Pharma Europe B.V. Completed No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT05240456 Comparator Feb → Jul 2022 overactive bladder Mansoura University Unknown No outcome recorded
Phase 1/2 NCT01737918 Comparator Jan 2013 → Dec 2017 disorder of neck of urinary bladder University Hospital of Cologne Unknown No outcome recorded
Phase 1/2 NCT01737411 Comparator Jan 2013 → Dec 2017 urinary bladder disorder University Hospital of Cologne Unknown No outcome recorded
Phase 23 trials
Phase 2 NCT03566134 Comparator Jul 2018 → Dec 2019 overactive bladder Dong-A ST Co., Ltd. Completed No outcome recorded
Phase 2 NCT03106623 Comparator Apr → Aug 2017 overactive bladder Ono Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 2 NCT00510406 Comparator Jan → Sep 2007 benign prostatic hyperplasia Astellas Pharma Inc Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT01486706 Comparator Oct 2010 → Oct 2014 overactive bladder Michael E. Chua Completed No outcome recorded
Phase 310 trials
Phase 3 NCT06803030 Comparator Aug → Dec 2025 overdue Bir Hospital Recruiting No outcome recorded
Phase 3 NCT07114640 Comparator Aug 2025 → Dec 2028 expected overactive bladder Far Eastern Memorial Hospital Not yet recruiting No outcome recorded
Phase 3 NCT05282069 Comparator May 2022 → Nov 2023 overactive bladder Dong-A ST Co., Ltd. Completed No outcome recorded
Phase 3 NCT05490082 Comparator Mar 2022 → Mar 2023 urinary bladder disorder Mansoura University Unknown No outcome recorded
Phase 3 NCT04325880 Comparator Dec 2021 → Jun 2022 ureteral disorder Mansoura University Unknown No outcome recorded
Phase 419 trials
Phase 4 NCT07473310 Comparator Nov 2025 → Jun 2027 expected overactive bladder Mansoura University Recruiting No outcome recorded
Phase 4 NCT07416968 Comparator Sep 2025 → Sep 2026 expected overactive bladder Mansoura University Recruiting No outcome recorded
Phase 4 NCT07114848 Comparator Jun → Dec 2024 ureterolithiasis Liaquat National Hospital & Medical College Completed No outcome recorded
Phase 4 NCT06479720 Comparator Jun 2022 → Jun 2026 overdue overactive bladder Mackay Memorial Hospital Recruiting No outcome recorded
Phase 4 NCT06197295 Background Jun 2022 → Jun 2026 overdue overactive bladder Mackay Memorial Hospital Recruiting No outcome recorded
Phase not applicable14 trials
NCT06201013 Comparator Apr → Sep 2026 expected overactive bladder Children's Hospital of Chongqing Medical University Recruiting No outcome recorded
NCT07312955 Comparator May → Nov 2025 overactive bladder Ain Shams University Completed No outcome recorded
NCT06955533 Comparator Apr → Aug 2024 Ain Shams University Completed No outcome recorded
NCT05798403 Comparator Jul 2023 → Aug 2025 overdue overactive bladder Yin Ping Recruiting No outcome recorded
NCT06024005 Comparator Apr → May 2023 overactive bladder Ege University Completed No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2019-04-22 Teva Branded Pharmaceutical Products R&D, Inc. Teva Announces Launch of a Generic Version of VESIcare® (solifenacin succinate) Tablets in the United States tevapharm.com

Evidence & citations 19 cited values

Every value below carries the sentence it was read from. 148 sources stand behind the page.

FieldValueCited text
Known as solifenacin Solifenacin (sold under the name Vesicare) is used for the treatment of patients suffering from problems related to overactive bladder, such as needing to go to the toilet...” NCT01953848
128

“Patients will receive solifenacin succinate 5 mg, an oral selective M3 antimuscarinic, taken once daily for 2 months. Solifenacin reduces overactive bladder symptoms by...” NCT07711808

Solifenacin reduced mean urgency episodes/day versus placebo in the severe subgroup (-4.6 vs. -3.1, p = 0.1150), similar to the significant reduction observed in the FAS (-3.9...” PMID 20707767 Oct 2010

“A Randomized Controlled Trial Comparing Mirabegron and Solifenacin Combination Therapy Versus Desmopressin Monotherapy in Treatment of Children With Primary Mono-Symptomatic...” NCT07199894

“This study investigates the effect of the co-administration of verapamil on the steady-state pharmacokinetics (PK) of solifenacin succinate and tamsulosin given as a...” NCT01943487

“the other group receiving the standard anticholinergic treatment (solifenacin succinate, Vesicare®).” NCT04819360

solifenacin 10 mg, 6 hours after IVI of BCG and continue for another 2 days post instillation” NCT03038321

“combination of solifenacin (SOLI) and tamsulosin oral controlled absorption system (TOCAS)” PMID 22831853 Jul 2012

“Antimuscarinic drugs (Tolterodine, solifenacin, propiverine, darifenacin,fesoterodine)” NCT03662893

“single dose of solifenacin and tamsulosin administered as combination tablet EC905.” NCT01953861

Solifenacin 5 mg tablet orally once daily for 30 days” NCT03817931

solifenacin and donepezil” NCT02860065

Solifenacin 5mg, 10mg” NCT00547378

“* SolifenacinNCT07016451

NCT02127034

NCT06955533

NCT02549196

NCT01530373

NCT00979472

NCT02180997

NCT04477265

NCT00699049

NCT02094703

NCT07617922

NCT01297192

NCT03787654

NCT03632772

NCT03468465

NCT00826527

NCT00801944

NCT06201013

NCT07114640

NCT06551246

NCT01833663

NCT01470001

NCT01381120

NCT01018264

NCT07025642

NCT02715024

NCT01505439

NCT01953887

NCT02972268

NCT01015040

NCT03558919

NCT01876186

NCT01028014

NCT07114848

NCT01642277

NCT00771394

NCT06024005

NCT01499069

NCT07416968

NCT00759577

NCT01655069

NCT01166438

NCT02827578

NCT00573508

NCT00463541

NCT01747577

NCT01972841

NCT01539707

NCT01880619

NCT05968885

NCT02494349

NCT01767519

NCT00584090

NCT05911594

NCT01559389

NCT00510406

NCT04437108

NCT06197295

NCT05494567

NCT02294396

NCT03566134

NCT01092624

NCT01777217

NCT05240456

NCT03149809

NCT01457573

NCT04090190

NCT07473310

NCT02805452

NCT02540707

NCT01908829

NCT02169713

NCT01745094

NCT01638000

NCT04064619

NCT01093534

NCT01981954

NCT01737918

NCT01565694

NCT00832650

NCT01565707

NCT06479720

NCT01314781

NCT01627145

NCT00189800

NCT06803030

NCT03106623

NCT05490082

NCT01340027

NCT04023253

NCT01262391

NCT01503580

NCT06465576

NCT06489951

NCT02667470

NCT07429734

NCT02634489

NCT04325880

NCT00884104

NCT01737411

NCT00852696

NCT00909428

NCT00431041

NCT02010944

NCT05282069

NCT05709990

NCT04909255

NCT02047032

NCT01318837

NCT01533597

NCT00821184

NCT07312955

NCT01126424

NCT01021332

NCT00629642

NCT01423838

Known as NSC-759144 ChEMBL registry synonym — accepted as the source's own label CHEMBL1734
Known as Sofenacin “Group A included 32 patients with stent related symptoms receiving double doses of tamsulosin (Tamsulin® 0.4 mg 2 capsules taken together per day) and Solifenacin 10mg...” NCT06955533
Known as SOLI “combination of solifenacin (SOLI) and tamsulosin oral controlled absorption system (TOCAS)” PMID 22831853 Jul 2012
Known as solifenacin free base “Blood samples for pharmacokinetic (PK) analysis of tamsulosin HCl and solifenacin free base are collected” NCT01953848
Known as Solifenacin succinate “Patients will receive solifenacin succinate 5 mg, an oral selective M3 antimuscarinic, taken once daily for 2 months. Solifenacin reduces overactive bladder symptoms by...” NCT07711808
37

“Phase 4, multi-center, randomized, double-blind, placebo-controlled, parallel group study. All subjects that meet the baseline criteria will be randomized in a 1:1 ratio into...” NCT00573508

“The purpose of this study was to evaluate long term efficacy and safety of treatment with solifenacin succinate (the study drug) in children with neurogenic detrusor...” NCT01981954

“The purpose of this study is to examine how well two medicines in combination (solifenacin succinate and mirabegron) work in the treatment of bladder problems over a 12-week period.” NCT01340027

“The purpose of this study is to evaluate blood levels of solifenacin succinate (the study drug) in children with neurogenic detrusor overactivity after taking a single oral dose.” NCT01539707

“This study will assess the effectiveness of solifenacin succinate (VESIcare) in reducing symptoms of overactive bladder in Parkinson's disease (PD) patients.” NCT01018264

“Efficacy and safety of solifenacin succinate in Korean patients with overactive bladder: a randomised, prospective, double-blind, multicentre study.” PMID 19143854 Nov 2008

“In Period 1, subjects are randomized to receive one of the two final combination tablet formulations of tamsulosin HCl and solifenacin succinate.” NCT01953848

“the other group receiving the standard anticholinergic treatment (solifenacin succinate, Vesicare®).” NCT04819360

“tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)” NCT01021332

solifenacin succinate 5 mg orally once daily for the duration of 12 weeks” NCT07416968

“The medicine being tested in this study is called solifenacin succinate.” NCT01565694

Solifenacin Succinate 5 MG Oral Tablet [Vesicare]” NCT05709990

“Drug: Solifenacin succinate treatment” NCT01381120

Solifenacin Succinate 5mg/tab daily” NCT04477265

Solifenacin Succinate (VESIcare)” NCT00584090

“Drug: solifenacin succinateNCT01297192

“Drug: Solifenacin SuccinateNCT00909428

“Drug: Solifenacin succinateNCT01972841

“Drug: solifenacin succinateNCT00463541

“Drug: solifenacin succinateNCT00510406

“Drug: Solifenacin SuccinateNCT02634489

“Drug: Solifenacin succinateNCT02169713

“Drug: Solifenacin succinateNCT00771394

NCT00507455

NCT01595152

NCT02045862

NCT01486706

NCT02452879

NCT01406158

NCT00802373

NCT00773552

NCT00337558

NCT00454740

NCT01371994

NCT00368706

NCT00333112

NCT05798403

Known as Solifenacina ChEMBL registry synonym — accepted as the source's own label CHEMBL1734
Known as Solifenacine ChEMBL registry synonym — accepted as the source's own label CHEMBL1734
Known as Succinate of Solifenacin “Drug: Succinate of SolifenacinNCT02805452
Known as VESIcare “Experimental arm = pts. with Solifenacin succinate 5 mg - Vesicare® All patients with an OAB sub-score using the USP scale greater to 5 during prostate cancer radiotherapy will...” NCT02805452
7

“Solifenacin (sold under the name Vesicare) is used for the treatment of patients suffering from problems related to overactive bladder, such as needing to go to the toilet...” NCT01953848

“This study will assess the effectiveness of solifenacin succinate (VESIcare) in reducing symptoms of overactive bladder in Parkinson's disease (PD) patients.” NCT01018264

“Solifenacin Succinate 5 MG Oral Tablet [Vesicare]” NCT05709990

“Solifenacin Succinate (VESIcare)” NCT00584090

Vesicare (solifenacin)” NCT00821184

NCT00581061

NCT01215721

Known as Vesicare (Solifenacin) Vesicare (Solifenacin)NCT01215721
Known as Vesicare ls ChEMBL registry synonym — accepted as the source's own label CHEMBL1734
Known as YM-67905 ChEMBL registry synonym — accepted as the source's own label CHEMBL1734
Known as YM-905 ChEMBL registry synonym — accepted as the source's own label CHEMBL1734
Action Inhibit “We compared the effects of non-selective (fesoterodine) and M(3)-selective (solifenacin) antimuscarinics on gastrointestinal transit in healthy women.” PMID 23171069 Nov 2012
2

“Muscarinic acetylcholine receptor M3 antagonist” CHEMBL1734

“Muscarinic acetylcholine receptor M2 antagonist” CHEMBL1734

Modality Small molecule CHEMBL1734
Route Oral OralNCT00333112
Target CHRM2 “Muscarinic acetylcholine receptor M2 antagonist” CHEMBL1734
Target CHRM3 “Muscarinic acetylcholine receptor M3 antagonist” CHEMBL1734