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Overactive Bladder

Urology 2 original drugs
2
Novel Drugs
6
Reformulations
40
Active Trials
15
Drug Targets

Urology indication. Overactive Bladder has 2 FDA-approved novel treatments, led by SUMITOMO PHARMA AM, with 40 active industry clinical trials across 15 drug targets. Explore market leaders, treatments by mechanism, the clinical pipeline, and drug targets below.

Overactive Bladder Market Leaders

Companies with the most FDA-approved novel Overactive Bladder drugs.

Phase 3 Readouts Pro

2 active Phase 3 trials with confidence-graded completion dates.

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Q1 2027
Vibegron
Urovant Sciences GmbH
Estimated · stale NCT05491525
Q1 2026
mirabegron
Astellas
Completed · awaiting NCT05621616

Anchored on CT.gov primary completion date. Topline announcements typically precede this by 3–9 months. Confidence labels combine date type (ACTUAL/ESTIMATED) with last-update freshness.

Overactive Bladder Treatments by Mechanism

Top 7 mechanisms across 34 industry trials with a known mechanism of action.

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beta3-Adrenergic Agonist
18 trials 2 active 3 sponsors
Muscarinic receptor
7 trials 3 sponsors
Acetylcholine Release Inhibitor
3 trials 1 sponsor
Cholinergic Muscarinic Agonist
3 trials 1 sponsor
alpha 1A adrenergic receptor/alpha 1B adrenergic receptor/alpha 1D adrenergic receptor
1 trials 1 sponsor
Cholinergic Muscarinic Antagonist
1 trials 1 sponsor
M1 muscarinic receptor/M2 muscarinic receptor/M3 muscarinic receptor/M4 muscarinic receptor/M5 muscarinic receptor
1 trials 1 sponsor

MoA derived from FDA pharmClassEpc when intervention matches an approved drug. Codenamed clinical-stage assets without an approved counterpart show "—" and aren't grouped here — they're still in the phase tables below.

Overactive Bladder Clinical Pipeline by Phase

112 industry-sponsored trials across 41 sponsors

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Novel Overactive Bladder Drugs by Company (New molecular entities)

2 companies have an FDA-approved novel drug for Overactive Bladder.

Reformulations (6 drugs) Click to expand

Reformulations are FDA-approved versions of existing molecules in new dosage forms (e.g., oral solution vs tablet, extended-release vs immediate-release). They require a new NDA but use an already-proven active ingredient.

Generic Drugs (6 ANDA approved) Click to expand

Generic drugs contain the same active ingredient as the brand-name drug and are approved via ANDA (Abbreviated New Drug Application).

Related Indications

Other Urology indications

Drug Categories:

  • Novel Drugs: NDA Type 1/2 (new molecular entity) or original BLA
  • Reformulations: NDA Type 3/5 (new dosage form of existing molecule)
  • Biosimilars: BLA-approved biologics highly similar to reference products
  • Generics: ANDA-approved copies of small molecule drugs

View data sources and methodology