Overview
Tamsulosin is a selective alpha-1A and alpha-1B adrenoceptor antagonist that exerts its greatest effect in the prostate and bladder, where these receptors are most common. It is indicated for the treatment of signs and symptoms of benign prostatic hypertrophy. Antagonism of these receptors leads to relaxation of smooth muscle in the prostate and detrusor muscles in the bladder, allowing for better urinary flow. Other alpha-1 adrenoceptor antagonists developed in the 1980s were less selective and more likely to act on the smooth muscle of blood vessels, resulting in hypotension. Tamsulosin was first approved by the FDA on April 15, 1997.
Indication
Tamsulosin is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Tamsulosin is also used off label for the treatment of ureteral stones, prostatitis, and female voiding dysfunction.
Associated Conditions
- Benign Prostatic Hyperplasia (BPH)
- Benign Prostatic Hypertrophy
- Bladder Outlet Obstruction
- Ureteral Calculus
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/03/08 | Not Applicable | Active, not recruiting | |||
2023/03/03 | Phase 3 | Completed | |||
2022/12/20 | Early Phase 1 | Recruiting | |||
2022/10/06 | Phase 3 | Recruiting | Princess Margaret Hospital, Hong Kong | ||
2022/09/22 | Phase 4 | Recruiting | Xintian Pharmaceutical | ||
2022/09/13 | Phase 4 | ENROLLING_BY_INVITATION | University Hospital of Split | ||
2022/09/07 | Phase 2 | Completed | REMD Medical Technology | ||
2022/08/10 | Phase 4 | UNKNOWN | |||
2022/06/30 | Not Applicable | Recruiting | Centre Hospitalier Universitaire de Nīmes | ||
2022/06/13 | Phase 4 | UNKNOWN |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Ascend Laboratories, LLC | 67877-450 | ORAL | 0.4 mg in 1 1 | 11/16/2021 | |
| STAT RX USA LLC | 16590-298 | ORAL | 0.4 mg in 1 1 | 7/11/2011 | |
| Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd. | 60723-056 | ORAL | 0.4 mg in 1 1 | 5/26/2020 | |
| PD-Rx Pharmaceuticals, Inc. | 43063-947 | ORAL | 0.4 mg in 1 1 | 10/18/2023 | |
| Physicians Total Care, Inc. | 54868-6328 | ORAL | 0.4 mg in 1 1 | 5/16/2012 | |
| Denton Pharma, Inc. DBA Northwind Pharmaceuticals | 70934-092 | ORAL | 0.4 mg in 1 1 | 1/1/2023 | |
| RedPharm Drug, Inc. | 67296-1739 | ORAL | 0.4 mg in 1 1 | 1/21/2022 | |
| EXELAN PHARMACEUTICALS, INC. | 76282-744 | ORAL | 0.4 mg in 1 1 | 2/1/2025 | |
| NuCare Pharmaceuticals,Inc. | 68071-4872 | ORAL | 0.4 mg in 1 1 | 2/17/2021 | |
| RPK Pharmaceuticals, Inc. | 53002-1663 | ORAL | 0.4 mg in 1 1 | 9/9/2021 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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