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.
Background
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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/13 | Phase 3 | Not yet recruiting | Penang Hospital, Malaysia | ||
2025/03/25 | Phase 4 | Completed | |||
2025/03/10 | Not Applicable | Recruiting | First Affiliated Hospital of Zhejiang University | ||
2025/03/07 | Not Applicable | Recruiting | Ankara Training and Research Hospital | ||
2025/02/25 | Phase 3 | Recruiting | |||
2025/02/05 | Phase 4 | Completed | |||
2025/01/31 | Phase 3 | Not yet recruiting | Bir Hospital | ||
2024/12/31 | Phase 3 | Completed | |||
2024/12/17 | Phase 3 | Recruiting | |||
2024/08/23 | Not Applicable | Completed | NPO Petrovax |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| DirectRX | 61919-298 | ORAL | 0.4 mg in 1 1 | 1/21/2020 | |
| Zydus Pharmaceuticals USA Inc. | 68382-640 | ORAL | 0.4 mg in 1 1 | 10/6/2022 | |
| WOCKHARDT LIMITED | 55648-516 | ORAL | 0.4 mg in 1 1 | 6/23/2010 | |
| Major Pharmaceuticals | 0904-7383 | ORAL | 0.4 mg in 1 1 | 10/9/2023 | |
| MedVantx, Inc. | 66116-435 | ORAL | 0.4 mg in 1 1 | 7/20/2012 | |
| Rising Pharma Holdings, Inc. | 57237-014 | ORAL | 0.4 mg in 1 1 | 11/17/2023 | |
| XLCare Pharmaceuticals, Inc | 72865-282 | ORAL | 0.4 mg in 1 1 | 1/27/2025 | |
| AvKARE | 42291-031 | ORAL | 0.4 mg in 1 1 | 11/15/2023 | |
| Proficient Rx LP | 63187-371 | ORAL | 0.4 mg in 1 1 | 1/1/2023 | |
| Proficient Rx LP | 63187-469 | ORAL | 0.4 mg in 1 1 | 1/1/2021 |
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 |
|---|---|---|---|---|---|
| TAMSIN PROLONGED RELEASE TABLET 0.4MG | SIN15476P | TABLET, FILM COATED, EXTENDED RELEASE | 0.4mg | 5/3/2018 | |
| Harnal OCAS Prolonged Release Film-coated Tablet 400mcg | SIN13696P | TABLET, FILM COATED, EXTENDED RELEASE | 0.4 mg | 8/21/2009 | |
| TAMSULOSIN-TEVA PROLONGED RELEASE FILM-COATED TABLET 400MCG | SIN16191P | TABLET, FILM COATED, EXTENDED RELEASE | 0.40 mg | 5/11/2021 | |
| TASULOSE PROLONGED-RELEASE FILM-COATED TABLETS 400 mcg | SIN15573P | TABLET, FILM COATED, EXTENDED RELEASE | 0.4mg | 11/1/2018 | |
| DUTABIT PLUS 0.5/0.4 CAPSULES 0.5MG/0.4MG | SIN16633P | CAPSULE | 0.4mg | 11/1/2022 | |
| Duodart Capsules 0.5mg/0.4mg | SIN14181P | CAPSULE | 0.4 mg | 7/2/2012 | |
| DUOFLOW CAPSULE 0.5mg/0.4mg | SIN16558P | CAPSULE | 0.4mg | 7/20/2022 | |
| LOTUFLO-D CAPSULES 0.5 MG/0.4 MG | SIN16678P | CAPSULE | 0.4 mg | 1/17/2023 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Tamsulosin Hydrochloride Sustained-release Capsules | 国药准字H20080063 | 化学药品 | 胶囊剂 | 9/29/2022 | |
| Tamsulosin Hydrochloride Sustained-release Tablets | 国药准字H20051461 | 化学药品 | 缓释制剂 | 6/23/2020 | |
| Tamsulosin Hydrochloride Sustained-release Capsules | 国药准字H20253938 | 化学药品 | 胶囊剂 | 4/15/2025 | |
| Tamsulosin Hydrochloride Sustained-release Capsules | 国药准字H20223698 | 化学药品 | 胶囊剂 | 9/30/2022 | |
| Tamsulosin Hydrochloride Sustained-release Capsules | 国药准字H20050285 | 化学药品 | 胶囊剂（缓释） | 8/15/2024 | |
| Tamsulosin Hydrochloride Sustained-release Capsules | 国药准字H20020623 | 化学药品 | 缓释制剂 | 5/12/2020 | |
| Tamsulosin Hydrochloride Sustained-release Capsules | 国药准字H20000681 | 化学药品 | 胶囊剂(缓释) | 6/4/2020 | |
| Tamsulosin Hydrochloride Sustained-release Capsules | 国药准字H20249588 | 化学药品 | 胶囊剂 | 12/1/2024 | |
| Tamsulosin Hydrochloride Sustained-release Capsules | 国药准字H20213991 | 化学药品 | 胶囊剂 | 12/31/2021 | |
| Tamsulosin Hydrochloride Sustained-release Capsules | 国药准字H20050392 | 化学药品 | 胶囊剂 | 8/31/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| DUTASTERIDE/TAMSULOSIN HYDROCHLORIDE SANDOZ CAPSULES 0.5MG/0.4MG | N/A | N/A | N/A | 7/11/2024 | |
| DUTABIT PLUS 0.5/0.4 CAPSULES 0.5MG/0.4MG | N/A | hang lung trading (h.k.) co | N/A | N/A | 9/13/2024 |
| DUODART CAPSULE 0.5MG/0.4MG | N/A | glaxosmithkline limited | N/A | N/A | 3/22/2012 |