DARIFENACIN (darifenacin hydrobromide)
DARIFENACIN is indicated for the treatment of Overactive Bladder; Urge Urinary Incontinence.
How DARIFENACIN Works
Darifenacin is a competitive muscarinic receptor antagonist with a high affinity for the $M_3$ receptor subtype. $M_3$ receptors are the primary mediators of cholinergic-induced contractions of the bladder's detrusor smooth muscle. By selectively binding to these receptors, darifenacin inhibits the stimulatory effects of acetylcholine, reducing the frequency and severity of involuntary bladder contractions and increasing the volume threshold for voiding.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2017-07-28
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
DARIFENACIN Approval History
What DARIFENACIN Treats
2 indicationsDARIFENACIN is approved for 2 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Overactive Bladder
- Urge Urinary Incontinence
DARIFENACIN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06616675 | CAAE: 59171022.9.0000.0049 | Ph 4 | completed | Darifenacin x Parasacral Transcutaneous Electric Nerve Stimulation for OAB in Patients Infected With Human T-Lymphotropic Virus 1 |
| NCT00712322 results posted | CDAR328B2201 | Ph 2 | terminated | A Two-week Open-label Pharmacodynamic and Pharmacokinetic Study of Multiple Doses of a Darifenacin Liquid Oral Suspension in Children (2 - 15 Years) With Neurogenic Detrusor Overactivity |
| NCT02143570 | 635 | Ph 3 | completed | Efficacy of Darifenacin and Physiotherapy for the Treatment of Overactive Bladder in Women |
| NCT01018225 | CRC090001 | Ph 4 | withdrawn | Exploratory Study Evaluating the Effects of Darifenacin on Nocturia, Sleep and Daytime Wakefulness |
| NCT00703703 | CDAR328A2414 | Ph 1 | completed | Pharmacologic Effects of Darifenacin and Tolterodine on Cardiovascular Parameters in Healthy Subjects |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DARIFENACIN FDA Label Details
Indications & Usage
DARIFENACIN is indicated for the treatment of Overactive Bladder; Urge Urinary Incontinence.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment