SANCTURA (trospium chloride) · AbbVie
SANCTURA is FDA-approved to treat 4 conditions (same as TROSPIUM CHLORIDE).
Details
- Status
- Discontinued
- First Approved
- 2004-05-28
- Routes
- ORAL
- Dosage Forms
- TABLET
SANCTURA Approval History
What SANCTURA Treats
4 indicationsSANCTURA is approved for 4 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Overactive bladder
- Urge urinary incontinence
- Urinary urgency
- Urinary frequency
Same approved indications as TROSPIUM CHLORIDE (same active ingredient).
AbbVie's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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.
SANCTURA FDA Label Details
Indications & Usage
FDA Label (PDF)SANCTURA is FDA-approved to treat 4 conditions — same approved indications as TROSPIUM CHLORIDE.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.