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Disease

Urinary Bladder, Overactive

Late-stage therapeutic developmentEmerging research
MeSHUrinary Bladder, Overactive
1
Publications
16
Clinical trials
2020
Latest publication
Current focus
Therapeutic developmentDiagnosis & biomarkersMetabolic & lifestyle factors
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this disease.

Approval: Obgemsa (EMA)

Regulatory2024-06-27EMA

Chronic mirabegron treatment increases human brown fat, HDL cholesterol, and insulin sensitivity.

Research2020-05-01The Journal of clinical investigation

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: Low
Key developments
  • 1 clinical trial expected to report results, the earliest in Q3 2026.
Upcoming Milestones
Clinical Milestones4View
Results expected 1
Recently completed 3
Activity timeline4

Therapeutic landscape

Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.

Approved & established therapies
Fesoterodine fumarateapproved

Approval — Treatment of the symptoms (increased urinary frequency and / or urgency and / or urgency… (2007)

Darifenacin hydrobromideapproved

Approval — Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency… (2004)

Clinical trials

11 sponsors · 1 new · 0 completed in the last 12 months (net +1)

The current development programme across all trial phases.

Clinical programme
16
All trials
5
Active
11
Late-stage
6
Completed
Late-stage studies

Evaluation of the Efficacy and Urodynamic Outcomes Between Intradetrusor onabotulinumtoxinA Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity

Phase 4 · Recruiting · Mackay Memorial Hospital

Efficacy and Safety of Solifenacin Combined With Mirabegron Versus Solifenacin With Vaginal Estrogen Cream for the Treatment of Detrusor Overactivity

Phase 4 · Recruiting · Mackay Memorial Hospital

Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A for Treatment of Overactive Bladder: a Multi-center Randomized Controlled Trial

Phase 4 · Recruiting · University of South Florida

Efficacy and Safety of Solifenacin or Mirabegron With Local Estrogen Versus Combination Treatment With Mirabegron and Solifenacin for Refractory Overactive Bladder

Phase 4 · Recruiting · Mackay Memorial Hospital

A Phase III Study to Evaluate the Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity

Phase 3 · Completed · GlaxoSmithKline

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate an Alternative Injection Paradigm for OnabotulinumtoxinA (BOTOX®) in the Treatment of Overactive Bladder in Patients With Urinary Incontinence (LO-BOT)

Phase 4 · Completed · Allergan
Recruiting

Evaluation of the Efficacy and Urodynamic Outcomes Between Intradetrusor onabotulinumtoxinA Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity

Phase 4 · Recruiting · Mackay Memorial Hospital

Efficacy and Safety of Solifenacin Combined With Mirabegron Versus Solifenacin With Vaginal Estrogen Cream for the Treatment of Detrusor Overactivity

Phase 4 · Recruiting · Mackay Memorial Hospital

Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A for Treatment of Overactive Bladder: a Multi-center Randomized Controlled Trial

Phase 4 · Recruiting · University of South Florida

Efficacy, Neural Repair Mechanism, and Health Economics of a Multimodal Treat-to-Target Strategy Incorporating Vitamin D for Pediatric Overactive Bladder-Wet: A Randomized Controlled Trial

N/A · Recruiting · Children's Hospital of Chongqing Medical University

Efficacy and Safety of Solifenacin or Mirabegron With Local Estrogen Versus Combination Treatment With Mirabegron and Solifenacin for Refractory Overactive Bladder

Phase 4 · Recruiting · Mackay Memorial Hospital
Recently completed

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate an Alternative Injection Paradigm for OnabotulinumtoxinA (BOTOX®) in the Treatment of Overactive Bladder in Patients With Urinary Incontinence (LO-BOT)

Phase 4 · Completed · Allergan

A Phase III Study to Evaluate the Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity

Phase 3 · Completed · GlaxoSmithKline

An Open-Label, Long-Term Extension, Multi-center, Sequential Dose Titration Study to Assess Safety and Efficacy of Solifenacin Succinate Suspension in Pediatric Subjects With Overactive Bladder (OAB)

Phase 3 · Completed · Astellas Pharma Europe B.V.

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

Phase 4 · Completed · Barrie Urology Associates

A 14 Week Randomized Parallel Group Placebo-Controlled Double-Blind Multicentre Study Of Fesoterodine 8 Mg In Overactive Bladder Patients With Sub-Optimal Response To Tolterodine 4 Mg Extended Release (ER).

Phase 4 · Completed · Pfizer

NK1 Receptor Antagonist vs Placebo in the Treatment of Overactive Bladder Symptoms

Phase 2 · Completed · GlaxoSmithKline

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

First approvals
2007emaApproval — Fesoterodine fumarate· Treatment of the symptoms (increased urinary frequency and / or urgency and / or urgency incontinence) that may occur in patients with overactive-bladder syndrome. source ↗
2004emaApproval — Darifenacin hydrobromide· Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with overactive bladder syndrome. source ↗

European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.

Research activity

1 papers

Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.

Most influential

Chronic mirabegron treatment increases human brown fat, HDL cholesterol, and insulin sensitivity.

The Journal of clinical investigation · 2020 · 293 cites
Recent publications

Chronic mirabegron treatment increases human brown fat, HDL cholesterol, and insulin sensitivity.

The Journal of clinical investigation · 2020 · 293 cites
Major themes5
  • Acetanilides1
  • Adipose Tissue, Brown1
  • Insulin Resistance1
  • Positron Emission Tomography Computed Tomography1
  • Thiazoles1
Leading journals1
  • The Journal of clinical investigation1
Leading researchers8
  • Ader M1
  • Baskin AS1
  • Bergman RN1
  • Brychta RJ1
  • Cai H1
  • Cassimatis TM1
  • Cero C1
  • Chen KY1
Affiliations (unnormalised)5
  • Clinical Laboratory Core1
  • Clinical Mass Spectrometry Core1
  • Diabetes and Obesity Research Institute1
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)1
  • NYU School of Medicine1

Reference

Authoritative identity, definition & identifiers.

Defined in MeSH

Symptom of overactive detrusor muscle of the URINARY BLADDER that contracts with abnormally high frequency and urgency. Overactive bladder is characterized by the frequent feeling of needing to urinate during the day, during the night, or both. URINARY INCONTINENCE may or may not be present.

Identifiers
MeSHUrinary Bladder, Overactive
References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.