Overview
Trospium is an antispasmodic agent used to treat the symptoms of overactive bladder, a condition that causes the bladder muscles to contract uncontrollably. An overactive bladder leads to an increased urge to urinate, frequent urination, and sometimes, loss of control over urination. Trospium is manufactured by Indevus Pharmaceutical Inc. and was granted FDA approval in 2007.
Indication
For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency, detrusor instability and frequency of micturition.
Associated Conditions
- Overactive Bladder Syndrome (OABS)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/08/12 | Not Applicable | Not yet recruiting | Karuna Therapeutics | ||
2025/07/14 | Not Applicable | Recruiting | |||
2025/07/11 | Not Applicable | Not yet recruiting | |||
2025/05/16 | Phase 3 | Recruiting | |||
2025/05/16 | Phase 3 | Recruiting | |||
2025/04/30 | Phase 3 | Recruiting | |||
2025/04/30 | Phase 3 | Recruiting | |||
2025/04/27 | Phase 3 | Not yet recruiting | |||
2025/04/22 | Phase 3 | Not yet recruiting | |||
2025/04/16 | Phase 3 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Padagis US LLC | 0574-0145 | ORAL | 20 mg in 1 1 | 12/11/2021 | |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-530 | ORAL | 20 mg in 1 1 | 8/21/2023 | |
| Bryant Ranch Prepack | 63629-9279 | ORAL | 20 mg in 1 1 | 12/11/2021 | |
| Glenmark Pharmaceuticals Inc., USA | 68462-461 | ORAL | 20 mg in 1 1 | 12/28/2023 | |
| CIPLA USA INC., | 69097-912 | ORAL | 20 mg in 1 1 | 12/21/2018 | |
| Proficient Rx LP | 71205-917 | ORAL | 60 mg in 1 1 | 4/1/2022 | |
| Slate Run Pharmaceuticals, LLC | 70436-174 | ORAL | 60 mg in 1 1 | 12/6/2023 | |
| BIOMES PHARMACEUTICALS LLC | 69150-258 | ORAL | 20 mg in 1 1 | 10/25/2017 | |
| Major Pharmaceuticals | 0904-7059 | ORAL | 20 mg in 1 1 | 5/19/2020 | |
| Bluepoint Laboratories | 68001-427 | ORAL | 60 mg in 1 1 | 7/8/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Spasmolyt Tablet 20mg | SIN13312P | TABLET, COATED | 20mg | 7/6/2007 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| ACCEL-TROSPIUM | accel pharma inc | 02492717 | Tablet - Oral | 20 MG | N/A |
| MAR-TROSPIUM | marcan pharmaceuticals inc | 02488353 | Tablet - Oral | 20 MG | 6/21/2019 |
| SANCTURA XR | 02339706 | Capsule (Extended Release) - Oral | 60 MG | 1/20/2010 | |
| TROSEC | sunovion pharmaceuticals canada inc | 02275066 | Tablet - Oral | 20 MG | 4/4/2006 |
| JAMP TROSPIUM | 02506661 | Tablet - Oral | 20 MG | 11/21/2023 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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