TROSPIUM CHLORIDE
Trospium chloride helps patients with overactive bladder manage symptoms such as urinary frequency and a sudden, strong need to urinate. It is also used for individuals experiencing urge urinary incontinence. This medication is prescribed to improve bladder control by targeting the smooth muscle within the organ.
How TROSPIUM CHLORIDE Works
This drug works by blocking the action of acetylcholine on muscarinic receptors in the bladder. This process reduces the tone of the bladder's smooth muscle, which helps alleviate overactive symptoms. It specifically targets these muscarinic receptors with minimal impact on nicotinic receptors at therapeutic levels.
Details
- Status
- Prescription
- First Approved
- 2010-08-13
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE, EXTENDED RELEASE
Companies
TROSPIUM CHLORIDE Approval History
What TROSPIUM CHLORIDE Treats
4 indicationsTROSPIUM CHLORIDE is approved for 4 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Overactive bladder
- Urge urinary incontinence
- Urinary urgency
- Urinary frequency
TROSPIUM CHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
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.
Drugs Similar to TROSPIUM CHLORIDE
3 of 12FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07063342 | CN012-0043 U1111-1321-3511 | Ph 1 | recruiting | A Study to Evaluate Novel KarX and KarT Prototypes Versus the KarXT and KarX-EC Reference Following Single Doses, and to Explore the Effect of Food After Multiple Doses of Selected Prototypes in Healthy Adult Participants |
| NCT01166438 ABC results posted | PFDN 17 2U01HD041249, 2U10HD041250 | Ph 3 | completed | Anticholinergic vs. Botox Comparison Study |
| NCT02831231 | KAR-001 | Ph 1 | completed | Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium |
| NCT01922115 ACE results posted | 13-1352 | Ph 4 | completed | The Effect of Anticholinergics on Cognitive Function in the Elderly |
| NCT01178827 results posted | MA-SXR-09-005 | Ph 4 | completed | Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART-II) Trial |
| NCT00863551 results posted | MA-SXR-09-001 SMART Trial | Ph 4 | completed | Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial |
| NCT01089751 results posted | GMA-SXR-09-004 | Ph 4 | completed | Efficacy of Sanctura XR (Trospium Chloride) for Reducing Overactive Bladder Symptoms in Female Subjects Refractory to Detrol LA (Tolterodine Tartrate Extended Release) Daily |
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.
TROSPIUM CHLORIDE FDA Label Details
Indications & Usage
TROSPIUM CHLORIDE is indicated for the treatment of Overactive bladder; Urge urinary incontinence; Urinary urgency; Urinary frequency.
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COBENFY
Full clinical data, patents, trials, and competitive landscape for trospium chloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.