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.
Background
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
View More Clinical Trials
Sign in to access the complete clinical trial database with detailed study information.
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/09/19 | Phase 3 | Recruiting | Karuna Therapeutics | ||
2024/08/27 | Phase 3 | Completed | Karuna Therapeutics | ||
2024/04/04 | Phase 4 | Completed | |||
2023/11/13 | Phase 3 | Active, not recruiting | Karuna Therapeutics | ||
2023/08/08 | Phase 3 | Recruiting | Karuna Therapeutics | ||
2023/05/30 | Early Phase 1 | Active, not recruiting | |||
2022/08/23 | Phase 3 | Recruiting | Karuna Therapeutics | ||
2020/01/13 | Phase 4 | Recruiting | Becky Clarkson | ||
2018/10/17 | Not Applicable | Suspended | |||
2018/07/27 | N/A | Completed |
FDA Drug Approvals
View More FDA Approvals
Sign in to access additional FDA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Aphena Pharma Solutions - Tennessee, LLC | 71610-812 | ORAL | 20 mg in 1 1 | 4/2/2024 | |
Bryant Ranch Prepack | 63629-8457 | ORAL | 20 mg in 1 1 | 12/11/2021 | |
Padagis US LLC | 0574-0118 | ORAL | 60 mg in 1 1 | 11/22/2021 | |
35573 | 35573-446 | ORAL | 60 mg in 1 1 | 1/31/2023 | |
Actavis Pharma, Inc. | 0591-3636 | ORAL | 60 mg in 1 1 | 8/1/2014 | |
Granules Pharmaceuticals Inc. | 70010-027 | ORAL | 60 mg in 1 1 | 7/28/2023 | |
Bryant Ranch Prepack | 72162-1108 | ORAL | 20 mg in 1 1 | 10/9/2023 | |
Bryant Ranch Prepack | 63629-8458 | ORAL | 60 mg in 1 1 | 11/22/2021 | |
Exelan Pharmaceuticals Inc. | 76282-336 | ORAL | 20 mg in 1 1 | 12/3/2018 | |
Chartwell RX, LLC | 62135-742 | ORAL | 20 mg in 1 1 | 8/25/2023 |
EMA Drug Approvals
View More EMA Approvals
Sign in to access additional EMA-approved drug information with detailed regulatory data.
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
View More HSA Approvals
Sign in to access additional HSA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
View More NMPA Approvals
Sign in to access additional NMPA-approved drug information with detailed regulatory data.
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
View More PPB Approvals
Sign in to access additional PPB-approved drug information with detailed regulatory data.
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
View More TGA Approvals
Sign in to access additional TGA-approved drug information with detailed regulatory data.
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
No TGA approvals found for this drug. |