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Urinary Bladder, Overactive

21
Pipeline Programs
9
Companies
28
Clinical Trials
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
3
1
4
0
3
10
Early DiscoveryClinical DevelopmentMarket

On Market (2)

Approved therapies currently available

AbbVie
BOTOXApproved
onabotulinumtoxina
AbbVie
Acetylcholine Release Inhibitor [EPC]single-use1991
112M Part D
AbbVie
BOTOX COSMETICApproved
onabotulinumtoxina
AbbVie
Acetylcholine Release Inhibitor [EPC]single-use1991

Competitive Landscape

9 companies ranked by most advanced pipeline stage

Pfizer
PfizerNEW YORK, NY
9 programs
3
1
4
FesoterodinePhase 41 trial
FesoterodinePhase 41 trial
Fesoterodine 8 mgPhase 41 trial
tolterodine extended releasePhase 41 trial
UK-369,003Phase 22 trials
+4 more programs
Active Trials
NCT00795509Completed374Est. Mar 2011
NCT01566760Completed24Est. Jul 2012
NCT01521767Completed16Est. Nov 2011
+7 more trials
Astellas
AstellasChina - Shenyang
7 programs
1
3
Alpha blockerPhase 42 trials
Pubovaginal sling procedurePhase 41 trial
SolifenacinPhase 41 trial
VESIcare®Phase 31 trial
Pre- and postoperative evaluationsN/A1 trial
+2 more programs
Active Trials
NCT01540214Unknown100Est. Dec 2014
NCT02087098Completed2,000Est. Mar 2016
NCT00985387Completed1,215Est. Aug 2011
+5 more trials
AbbVie
AbbVieNORTH CHICAGO, IL
5 programs
1
1
onabotulinumtoxinAPhase 41 trial
AGN-214868Phase 21 trial
botulinum toxin Type AN/A1 trial
onabotulinumtoxinAN/A1 trial
onabotulinumtoxinAN/A1 trial
Active Trials
NCT02673047Completed474Est. Aug 2016
NCT02557971Completed315Est. Jul 2016
NCT03043287Completed420Est. Sep 2019
+2 more trials
ViiV Healthcare
ViiV HealthcareNC - Durham
2 programs
2
GSK1358820Phase 3
GSK1358820Phase 3
Sharp Therapeutics
Sharp TherapeuticsPA - Pittsburgh
1 program
1
VibegronPhase 2
MSD
MSDIreland - Ballydine
1 program
1
VibegronPhase 21 trial
Active Trials
NCT01314872Completed1,395Est. Oct 2013
EG 427
EG 427France - Paris
1 program
1
UrodynamicsPhase 1/21 trial
Active Trials
NCT07227285Not Yet Recruiting16Est. Apr 2031
Fempulse
3 programs
FemPulse SystemN/A1 trial
The FemPulse SystemN/A1 trial
TreamentN/A1 trial
Active Trials
NCT03784170Completed21Est. Dec 2019
NCT04001426Completed2Est. Dec 2019
NCT03874637Completed15Est. May 2017
Francis Medical
Francis MedicalMN - Maple Grove
1 program
MirabegronPHASE_2

Trial Timeline

Clinical trial activity over time

2021
2022
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2024
2025
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2027
2028
2029
2030
2031
AbbVieonabotulinumtoxinA
AstellasAlpha blocker
PfizerFesoterodine 8 mg
AstellasPubovaginal sling procedure
PfizerFesoterodine
AstellasSolifenacin
PfizerFesoterodine
AstellasAlpha blocker
Pfizertolterodine extended release
AstellasVESIcare®
MSDVibegron
AbbVieAGN-214868
PfizerUK-369,003
PfizerUK-369,003
EG 427Urodynamics

Showing 15 of 28 trials with date data

Clinical Trials (28)

Total enrollment: 11,055 patients across 28 trials

NCT03052764AbbVieonabotulinumtoxinA

Evaluation of an Alternative Injection Paradigm for OnabotulinumtoxinA (BOTOX®) in the Treatment of Overactive Bladder in Patients With Urinary Incontinence

Start: Dec 2016Est. completion: Dec 2018120 patients
Phase 4Completed
NCT02656173AstellasAlpha blocker

A Phase 4 Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Male Subjects With Overactive Bladder (OAB) Symptoms, While Taking the Alpha Blocker for Benign Prostatic Hypertrophy (BPH)

Start: Jan 2016Est. completion: Jul 2017568 patients
Phase 4Completed
NCT01302054PfizerFesoterodine 8 mg

A Clinical Study in Patients With Overactive Bladder With Leakage of Urine, to Find Out if the Medicine, Fesoterodine, Works in Those Patients Who Did Not Have Enough Response to the Medicine, Tolterodine.

Start: May 2011Est. completion: May 2012990 patients
Phase 4Completed
NCT01194999AstellasPubovaginal sling procedure

Evaluating the Change of Overactive Bladder Symptoms in Women Post Pubovaginal Sling Procedure for Stress Incontinence

Start: Oct 2010Est. completion: Jun 2012132 patients
Phase 4Completed
NCT01054222PfizerFesoterodine

Local, Open-Label, Extension Trial Of The Efficacy And Safety Of Fesoterodine In Elderly Patients With Overactive Bladder

Start: May 2010Est. completion: Jan 201231 patients
Phase 4Completed

Solifenacin Flexible Dosing Study in Frequent Micturition Patients With and Without Urgency

Start: Apr 2009Est. completion: Jun 2010291 patients
Phase 4Completed
NCT00806494PfizerFesoterodine

UK Study Assessing Flexible Dose Fesoterodine in Adults

Start: Feb 2009Est. completion: Jan 2010331 patients
Phase 4Completed
NCT00699049AstellasAlpha blocker

A Study Comparing the Efficacy of an Alpha Blocker Versus an Alpha Blocker Plus Solifenacin in Men With Overactive Bladder

Start: Jun 2008Est. completion: Mar 201094 patients
Phase 4Completed
NCT00645281Pfizertolterodine extended release

A Study to Evaluate the Efficacy of Tolterodine on Specific Symptoms in Adult Patients With Overactive Bladder.

Start: Mar 2004Est. completion: Jan 2005896 patients
Phase 4Completed

A Multicenter VESIcare® Efficacy and Safety Study for the Treatment of Urgency Associated With Overactive Bladder (OAB)

Start: May 2004Est. completion: Sep 2005739 patients
Phase 3Completed

A Study of the Efficacy and Safety of Vibegron (MK-4618) in Participants With Overactive Bladder (OAB) (MK-4618-008)

Start: Mar 2011Est. completion: Oct 20131,395 patients
Phase 2Completed

Safety and Efficacy Study of AGN-214868 in Patients With Idiopathic Overactive Bladder and Urinary Incontinence

Start: Oct 2010Est. completion: May 2013160 patients
Phase 2Completed

Study The Effects Of Different Doses Of UK-369,003 In Men With Overactive Bladder

Start: Jun 2007Est. completion: Jun 2008275 patients
Phase 2Completed

Urodynamic Effects of UK-369,003 in Men With Lower Urinary Tract Symptoms

Start: Mar 2007Est. completion: Jun 200827 patients
Phase 2Completed

Long-term Follow-up Study of Patients Who Received EG110A, a Non-replicative Herpes Simplex Virus 1-derived Gene Therapy

Start: Apr 2026Est. completion: Apr 203116 patients
Phase 1/2Not Yet Recruiting
NCT01566760Pfizerfesoterodine fumarate

A Study To Estimate The Effects Of Food On Drug Fesoterodine Fumarate And The Pharmacokinetics Of 5-Hydroxymethyl Tolterodine (5-HMT) In Healthy Volunteers

Start: May 2012Est. completion: Jul 201224 patients
Phase 1Completed
NCT01521767Pfizertolterodine tartrate

Pharmacokinetics and Relative Bioavailability Study

Start: Oct 2011Est. completion: Nov 201116 patients
Phase 1Completed

The Effect Of Fesoterodine On Pharmacokinetics And Pharmacodynamics Of Warfarin In Healthy Subjects

Start: Jul 2009Est. completion: Aug 200914 patients
Phase 1Completed
NCT04001426FempulseThe FemPulse System

Pilot Phase for an Acute Evaluation of a Non-Implantable Electrical Continence Device

Start: Apr 2019Est. completion: Dec 20192 patients
N/ACompleted
NCT03784170FempulseFemPulse System

FemPulse Therapy for Overactive Bladder in Women

Start: Dec 2018Est. completion: Dec 201921 patients
N/ACompleted
NCT03043287AbbVieonabotulinumtoxinA

Voiding Efficiency, a Predictor of Clean Intermittent Catheterization (CIC)

Start: May 2017Est. completion: Sep 2019420 patients
N/ACompleted

FemPulse Therapy First-in-Human Experience

Start: Feb 2017Est. completion: May 201715 patients
N/ACompleted
NCT02673047AbbViebotulinum toxin Type A

Observational Study of Botulinum Toxin Type A in Patients With Urinary Incontinence Associated With Overactive Bladder

Start: Feb 2016Est. completion: Aug 2016474 patients
N/ACompleted
NCT02557971AbbVieonabotulinumtoxinA

Urinary Retention Rates in Clinical Practice After Treatment With OnabotulinumtoxinA for Idiopathic Overactive Bladder

Start: Aug 2015Est. completion: Jul 2016315 patients
N/ACompleted

A Study to Evaluate Quality of Life in Patients Switched to Solifenacin From Other Antimuscarinics

Start: Jun 2014Est. completion: Mar 20162,000 patients
N/ACompleted
NCT01540214AstellasPre- and postoperative evaluations

Study of Overactive Bladder in Women With Prolapse

Start: Feb 2012Est. completion: Dec 2014100 patients
N/AUnknown

Evaluation of Adherence to Solifenacin Treatment in Overactive Bladder Patients

Start: Aug 2009Est. completion: Aug 20111,215 patients
N/ACompleted
NCT00795509PfizerTolterodine tartrate

Special Investigation For Long Term Use Of Tolterodine (Regulatory Post Marketing Commitment Plan).

Start: Aug 2007Est. completion: Mar 2011374 patients
N/ACompleted

Phase Legend

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

Key Insights

3 late-stage (Phase 3) programs, potential near-term approvals
9 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.