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Overactive Bladder

87
Pipeline Programs
30
Companies
50
Clinical Trials
7
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
17
1
14
1
28
26
Early DiscoveryClinical DevelopmentMarket

On Market (7)

Approved therapies currently available

AbbVie
BOTOXApproved
onabotulinumtoxina
AbbVie
Acetylcholine Release Inhibitor [EPC]single-use1991
112M Part D
Pfizer
TOVIAZApproved
fesoterodine fumarate
Pfizer
oral2008
9M Part D
Astellas
VESICAREApproved
solifenacin succinate
Astellas
oral2004
6M Part D
Ipsen
DYSPORTApproved
botulinum toxin type a
Ipsen
Acetylcholine Release Inhibitor [EPC]injection2009
3M Part D
Astellas
VESICARE LSApproved
solifenacin succinate
Astellas
oral2020
32K Part D
TOLTERODINE TARTRATEApproved
tolterodine
Unknown Company
oral2015
AbbVie
BOTOX COSMETICApproved
onabotulinumtoxina
AbbVie
Acetylcholine Release Inhibitor [EPC]single-use1991

Competitive Landscape

39 companies ranked by most advanced pipeline stage

Pfizer
PfizerNEW YORK, NY
27 programs
2
5
7
7
DETRUSITOLPhase 41 trial
FesoterodinePhase 41 trial
FesoterodinePhase 41 trial
FesoterodinePhase 41 trial
TolterodinePhase 41 trial
+22 more programs
Active Trials
NCT02251054Completed47Est. Oct 2013
NCT00754260Terminated42Est. Jun 2009
NCT00465894Completed58Est. Dec 2011
+24 more trials
Astellas
AstellasChina - Shenyang
16 programs
2
2
3
SolifenacinPhase 45 trials
solifenacinPhase 41 trial
solifenacinPhase 41 trial
VesicarePhase 31 trial
VESICARE(solifenacin succinate)Phase 35 trials
+11 more programs
Active Trials
NCT01901120Completed1,263Est. Sep 2016
NCT01919047Completed10,711Est. Jul 2014
NCT00901251Completed50Est. May 2009
+25 more trials
AbbVie
AbbVieNORTH CHICAGO, IL
15 programs
2
1
8
4
Periprocedural AntibioticsPhase 41 trial
onabotulinumtoxinAPhase 41 trial
trospium chloridePhase 41 trial
trospium chloridePhase 41 trial
BOTOX®Phase 31 trial
+10 more programs
Active Trials
NCT00575016Terminated74Est. Jul 2010
NCT00168454Completed313Est. Jun 2008
NCT00479596Unknown40Est. May 2007
+12 more trials
Kyorin Pharmaceutical
1
1
ImidafenacinPhase 41 trial
imidafenacin, KRP-197/ONO-8025Phase 3
Active Trials
NCT01578304Completed207Est. Oct 2011
UNION therapeutics
UNION therapeuticsDenmark - Hellerup
2 programs
2
Solifenacin Succinate TabletsPhase 4
mirabegronPhase 41 trial
Active Trials
NCT05452434Unknown600Est. Jul 2023
Ipsen
IpsenChina - Tianjin
1 program
1
Botulinum toxin type APHASE_21 trial
Active Trials
NCT00578097Terminated81Est. Dec 2009
Sandoz
SandozAustria - Kundl
1 program
1
DarifenacinPhase 41 trial
Active Trials
NCT00171184Completed400Est. Jun 2006
Human BioSciences
1
Urgent PCPhase 41 trial
Active Trials
NCT06769854Not Yet Recruiting50Est. Oct 2029
Bayer
BayerLEVERKUSEN, Germany
4 programs
1
1
OxybutyninPhase 31 trial
Vardenafil HClPhase 21 trial
DarifenacinN/A1 trial
Darifenacin, EmselexN/A1 trial
Active Trials
NCT00921245Completed9Est. Feb 2009
NCT00786448Completed5,821Est. Feb 2006
NCT00478881Completed397Est. Nov 2008
+1 more trials
Ono Pharmaceutical
Ono PharmaceuticalJapan - Osaka
4 programs
2
2
ONO-8025Phase 31 trial
imidafenacin, KRP-197/ONO-8025Phase 31 trial
ONO-8025Phase 21 trial
ONO-8577Phase 21 trial
Active Trials
NCT00212706Completed400
NCT03106623Completed207Est. Sep 2017
NCT00212732Completed750
+1 more trials
Dong-A ST
3 programs
1
1
1
DA-8010 PlaceboPhase 31 trial
DA-8010 PlaceboPhase 21 trial
DA-8010Phase 11 trial
Active Trials
NCT02821312Unknown110Est. Apr 2017
NCT03566134Completed306Est. Dec 2019
NCT05282069Completed607Est. May 2024
Kissei Pharmaceutical
Kissei PharmaceuticalJapan - Matsumoto City
2 programs
2
KUC-7483Phase 31 trial
KUC-7483Phase 31 trial
Active Trials
NCT01004315Completed750
NCT01003405Withdrawn100
Apogepha
ApogephaGermany - Dresden
2 programs
2
Mictonetten 5 mg, coated tabletPhase 31 trial
propiverine hydrochloridePhase 33 trials
Active Trials
NCT00603343Completed303Est. Dec 2006
NCT01512004Completed324Est. Aug 2011
NCT01530620Completed66Est. Jul 2006
+1 more trials
Jeil Pharmaceutical
Jeil PharmaceuticalKorea - Seoul
1 program
1
JLP-2002 A mgPhase 31 trial
Active Trials
NCT04917315Completed210Est. Aug 2021
Boston Scientific
Boston ScientificCA - Valencia
1 program
1
bionPhase 31 trial
Active Trials
NCT00131573Completed118Est. Dec 2012
ViiV Healthcare
ViiV HealthcareNC - Durham
4 programs
3
1
SolabegronPhase 2
DETROL LAPhase 1
SolabegronPhase 1
solabegron and oxybutyninPhase 1
Oregon Therapeutics
Oregon TherapeuticsFrance - Paris
2 programs
1
Botox 50 Unit InjectionPhase 1/21 trial
Transcutaneous Tibial Nerve StimulationN/A1 trial
Active Trials
NCT07178314Recruiting38Est. Oct 2026
NCT05512039Active Not Recruiting376Est. Jan 2027
Sharp Therapeutics
Sharp TherapeuticsPA - Pittsburgh
4 programs
4
VibegronPhase 1
VibegronPhase 1
Vibegron 100 mgPhase 1
tolterodine tartratePhase 1
MSD
MSDIreland - Ballydine
4 programs
4
VibegronPhase 11 trial
VibegronPhase 11 trial
Vibegron 100 mgPhase 11 trial
tolterodine tartratePhase 11 trial
Active Trials
NCT01500382Terminated4Est. Jan 2013
NCT01737684Completed16Est. Jun 2013
NCT01628042Completed32Est. Jan 2013
+1 more trials
Neuspera Medical
1
AHLeveeS SystemPhase 11 trial
Active Trials
NCT03643380Completed6Est. Jan 2018
Hanmi Pharmaceutical
1 program
1
HIP1503Phase 11 trial
Active Trials
NCT02940314Completed36Est. May 2016
Channel Therapeutics
1
hMaxi-KPhase 11 trial
Active Trials
NCT00495053Terminated21Est. Nov 2009
Angeles Therapeutics
Noninvasive spinal cord stimulationN/A1 trial
SUFU Clinical Care Pathway for Overactive BladderN/A1 trial
iStim TENS unit and Transvaginal ProbeN/A1 trial
Active Trials
NCT03753750Withdrawn0Est. Jan 2022
NCT05117918Completed177Est. Aug 2023
NCT04957524Completed24Est. Feb 2025
TheraNova
3 programs
TENSN/A1 trial
TheraNova Neuromodulation DeviceN/A1 trial
TheraNova Neuromodulation SystemN/A1 trial
Active Trials
NCT03595215Completed18Est. Sep 2019
NCT05162833Completed3Est. Dec 2023
NCT04758247Completed12Est. Dec 2023
Valencia Technologies
3 programs
eCoin Tibial Nerve StimulationN/A1 trial
eCoin Tibial Nerve StimulationN/A1 trial
eCoin Tibial Nerve StimulationN/A1 trial
Active Trials
NCT03655054Completed23Est. Sep 2022
NCT05685433Recruiting200Est. Dec 2031
NCT03556891Completed133Est. Sep 2024
GSK
GSKLONDON, United Kingdom
3 programs
DETROL LAPHASE_11 trial
SolabegronPHASE_11 trial
solabegron and oxybutyninPHASE_11 trial
Active Trials
NCT00553657Completed55Est. Jan 2008
NCT00427596Completed18Est. Aug 2007
NCT00501267Completed24Est. Aug 2007
Amber Therapeutics
2 programs
Amber UI systemN/A2 trials
Picostim AmberN/A1 trial
Active Trials
NCT06597994Active Not Recruiting12Est. Jan 2026
NCT05241379Completed13Est. Apr 2024
NCT05256498Withdrawn0Est. Dec 2022
Avation Medical
2 programs
Avation SystemN/A1 trial
Wearable Bladder Modulation SystemN/A1 trial
Active Trials
NCT05381116Terminated125Est. Jul 2023
NCT04547920Completed96Est. Jun 2023
Axonics
2 programs
Axonics SNM SystemN/A1 trial
Sacral Neuromodulation SystemN/A3 trials
Active Trials
NCT06511141Recruiting150Est. Dec 2028
NCT05064384Completed272Est. Mar 2024
NCT03327948Completed129Est. Jun 2020
+1 more trials
Innovation Pharmaceuticals
2 programs
PTNS maintenanceN/A1 trial
Tibial nerve stimulationN/A1 trial
Active Trials
NCT03136601Completed37Est. May 2018
NCT07353944Completed70Est. Jun 2018

+9 more companies

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
Human BioSciencesUrgent PC
UNION therapeuticsmirabegron
AbbViePeriprocedural Antibiotics
PfizerFesoterodine
AbbVieonabotulinumtoxinA
PfizerToviaz
Astellassolifenacin
Astellassolifenacin succinate
AstellasSolifenacin
Kyorin PharmaceuticalImidafenacin
Astellassolifenacin succinate
AbbVietrospium chloride
AbbVietrospium chloride
AstellasSolifenacin
PfizerFesoterodine

Showing 15 of 47 trials with date data

Clinical Trials (50)

Total enrollment: 19,271 patients across 50 trials

Defining the Safety and Efficacy of POSterIor Tibial NeRve StimulatiON in Children

Start: Apr 2027Est. completion: Oct 202950 patients
Phase 4Not Yet Recruiting

Mirabegron Combined With Behavioral Intervention for Overactive Bladder:a Prospective Multicenter Randomized Controlled Clinical Study

Start: Jul 2022Est. completion: Jul 2023600 patients
Phase 4Unknown
NCT03508921AbbViePeriprocedural Antibiotics

Comparison of Methods for Prevention of Urinary Tract Infection Following Botox Injection

Start: Jul 2018Est. completion: Jun 202222 patients
Phase 4Terminated
NCT03946124PfizerFesoterodine

Fall Prevention in Older Adults With OAB

Start: Jul 2015Est. completion: Jul 201774 patients
Phase 4Completed
NCT01945489AbbVieonabotulinumtoxinA

OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder

Start: Oct 2013Est. completion: Jan 2017254 patients
Phase 4Completed

Premarin Versus Toviaz for Treatment of Overactive Bladder

Start: Apr 2012Est. completion: Dec 201890 patients
Phase 4Unknown

Therapy of the Overactive Bladder Syndrome

Start: Jan 2012Est. completion: Mar 201566 patients
Phase 4Completed
NCT01833663Astellassolifenacin succinate

Effectiveness and Safety Study of Solifenacin Succinate and Solifenacin Succinate + Estrogen to Treat OAB in Postmenopausal Women

Start: Oct 2011Est. completion: Oct 2013200 patients
Phase 4Completed

Pilot Trial Of Urinary Nerve Growth Factor (NGF) As Biomarker for Male Lower Urinary Tract Symptoms

Start: Oct 2011Est. completion: Jul 201410 patients
Phase 4Completed

Comparison of Efficacy and Safety Between Imidafenacin and Fesoterodine in Patients With Overactive Bladder

Start: Dec 2010Est. completion: Oct 2011207 patients
Phase 4Completed
NCT01381120Astellassolifenacin succinate

Therapeutic Merit of Solifenacin in the Mitigation of Ureteral Stent-induced Pain and Lower Urinary Tract Symptoms

Start: Oct 2010Est. completion: Jun 201284 patients
Phase 4Completed
NCT01178827AbbVietrospium chloride

Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART-II) Trial

Start: Aug 2010Est. completion: Mar 201120 patients
Phase 4Completed
NCT01089751AbbVietrospium chloride

Efficacy of Sanctura XR (Trospium Chloride) for Reducing Overactive Bladder Symptoms in Female Subjects Refractory to Detrol LA (Tolterodine Tartrate Extended Release) Daily

Start: Mar 2010Est. completion: Jun 2012322 patients
Phase 4Completed

Reproducibility Study of OABSS and Its Response to Treatment

Start: Sep 2009Est. completion: May 201350 patients
Phase 4Completed
NCT00928070PfizerFesoterodine

A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder

Start: Sep 2009Est. completion: Sep 2011566 patients
Phase 4Completed
NCT00911937PfizerFesoterodine

A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency

Start: Aug 2009Est. completion: Sep 2011963 patients
Phase 4Completed

A Study to Evaluate Add on Effect of Solifenacin in Men With Overactive Bladder Symptoms After Tamsulosin Monotherapy for 4 Weeks

Start: Mar 2009Est. completion: Dec 2010307 patients
Phase 4Completed
NCT00836381PfizerTolterodine extended-release

Assessment of Patient-reported Goal Attainment in the Treatment of Female Overactive Bladder

Start: Feb 2009Est. completion: Jan 201256 patients
Phase 4Completed
NCT00771394Astellassolifenacin succinate

Solifenacin as Add-on Therapy for Overactive Bladder Symptoms in Men Treated for Benign Prostatic Hyperplasia

Start: Oct 2008Est. completion: Jan 2010638 patients
Phase 4Completed

Study to Evaluate the Clinical Efficacy and Safety of Tamsulosin Alone or in Combination With Solifenacin for the Treatment in Men With Lower Urinary Tract Symptoms Including Overactive Bladder Symptoms

Start: Sep 2007Est. completion: Apr 201152 patients
Phase 4Completed
NCT00909428Astellassolifenacin succinate

Validation of a Real-time Urodynamic Measure of Urinary Urgency

Start: Jan 2007Est. completion: Feb 200951 patients
Phase 4Completed

Study to Compare the Safety and Efficacy of Solifenacin With Oxybutynin for the Treatment of Overactive Bladder (VECTOR)

Start: Dec 2006Est. completion: Feb 2008132 patients
Phase 4Completed

Exploring Predictors of Symptoms Relapse After Discontinuation of Treatment in Overactive Bladder (OAB) Patients

Start: Aug 2006Est. completion: Jul 2009173 patients
Phase 4Completed
NCT00337558Astellassolifenacin succinate

A Study of Solifenacin With Bladder Training Versus Solifenacin Alone in Patients With Overactive Bladder (SOLAR)

Start: May 2006Est. completion: May 2007643 patients
Phase 4Completed

Assessing the OAB-8 Questionnaire as a Tool to Measure Treatment Outcome

Start: Feb 2006Est. completion: Mar 2006100 patients
Phase 4Unknown

Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder

Start: Apr 2005Est. completion: Jun 2006400 patients
Phase 4Completed

Long-term Safety and Efficacy of KUC-7483 in Patients With Overactive Bladder

100 patients
Phase 3Withdrawn

A Confirmatory Study of KUC-7483 in Patients With Overactive Bladder

750 patients
Phase 3Completed
NCT00189800Astellassolifenacin succinate

A Study of Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder

Phase 3Completed
NCT05282069Dong-A STDA-8010 Placebo

A Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder

Start: May 2022Est. completion: May 2024607 patients
Phase 3Completed

To Evaluate the Efficacy and Safety of JLP-2002 on Symptoms of Overactive Bladder

Start: May 2020Est. completion: Aug 2021210 patients
Phase 3Completed
NCT02327936PfizerFesoterodine

Fesoterodine and Oxybutynin XL for Overactive Bladder Syndrome in Children

Start: Dec 2014Est. completion: Aug 201862 patients
Phase 3Completed
NCT01981954Astellassolifenacin succinate

A Clinical Study to Investigate How Solifenacin Fluid is Taken up, How Long it Stays in the Body and How Effective and Safe it is in Treating Children Aged From 6 Months to Less Than 5 Years With Symptoms of Neurogenic Detrusor Overactivity (NDO)

Start: Sep 2013Est. completion: Dec 201523 patients
Phase 3Completed

A Study Evaluating the Efficacy and Safety of BOTOX® or Solifenacin in Patients With Overactive Bladder and Urinary Incontinence

Start: Mar 2013Est. completion: Mar 2015356 patients
Phase 3Completed
NCT01655069Astellassolifenacin succinate

A Study to Investigate How Safe and Effective Solifenacin Solution is in Treating Children/Adolescents With Symptoms of Overactive Bladder (OAB) Who Completed Study 905-CL-076

Start: Oct 2012Est. completion: Oct 2014148 patients
Phase 3Completed
NCT01565694Astellassolifenacin succinate

A Study to Assess the Long Term Effect, Safety and Metabolism of a Solifenacin Liquid Suspension in Participants 5 to 18 Years of Age With Neurogenic Detrusor Overactivity

Start: Aug 2012Est. completion: Apr 201676 patients
Phase 3Completed
NCT01638000Astellassolifenacin succinate

A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment.

Start: Jun 2012Est. completion: Apr 20131,887 patients
Phase 3Completed

Study to Gather Information About the Actual Use of an Adhesive Patch Placed on the Skin to Deliver Oxytrol Through the Skin Into the Bloodstream.

Start: May 2010Est. completion: Jun 2011855 patients
Phase 3Completed
NCT01021332Astellassolifenacin succinate

Long Term Study of Solifenacin Succinate and Tamsulosin Hydrochloride Oral Controlled Absorption System (OCAS) in Males With Lower Urinary Tract Symptoms

Start: Apr 2010Est. completion: Dec 20111,067 patients
Phase 3Completed
NCT00915525AbbViebotulinum toxin Type A

Long Term Follow-up Study of Safety and Efficacy of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence

Start: Feb 2010Est. completion: Aug 2014829 patients
Phase 3Completed
NCT01512004Apogephapropiverine hydrochloride

Propiverine Hydrochloride Extended-Release Capsule for Overactive Bladder

Start: Jan 2010Est. completion: Aug 2011324 patients
Phase 3Completed
NCT00910520AbbVieonabotulinumtoxinA

Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence

Start: Sep 2009Est. completion: Aug 2011548 patients
Phase 3Completed
NCT00910845AbbVieonabotulinumtoxinA

Study of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence

Start: Sep 2009Est. completion: Jul 2011557 patients
Phase 3Completed
NCT00876447AbbVieBotulinum Toxin Type A 300U

A Long-term Follow-up Study of Botulinum Toxin Type A in Patients With Overactive Bladder as a Result of Spinal Injury or Multiple Sclerosis

Start: Jan 2009Est. completion: Sep 2013397 patients
Phase 3Completed

A Long-term Study of YM178 in Symptomatic Overactive Bladder Patients

Start: Dec 2008Est. completion: Mar 2010204 patients
Phase 3Completed
NCT00782769TevaOxybutinyn Vaginal Ring 4mg

A Safety Extension Study of DR-OXY-301

Start: Sep 2008Est. completion: Jul 2010240 patients
Phase 3Completed
NCT00658684Pfizerfesoterodine fumarate

Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder.

Start: Feb 2008Est. completion: Aug 2009153 patients
Phase 3Completed
NCT00611026PfizerTolterodine ER

Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder.

Start: Feb 2008Est. completion: Oct 20092,417 patients
Phase 3Completed
NCT00536484PfizerFesoterodine

Fesoterodine Flexible Dose Study

Start: Aug 2007Est. completion: Mar 2008896 patients
Phase 3Completed
NCT00512785Ono Pharmaceuticalimidafenacin, KRP-197/ONO-8025

Long-term Safety and Efficacy of Imidafenacin in Patients With Overactive Bladder

Start: Aug 2007435 patients
Phase 3Completed

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

28 late-stage (Phase 3) programs, potential near-term approvals
30 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.