Overview
Terazosin is a quinazoline derivative alpha-1-selective adrenergic blocking agent indicated for benign prostatic hyperplasia and hypertension. Terazosin blocks adrenaline's action on alpha-1 adrenergic receptors, causing relaxation of smooth muscle in blood vessels and the prostate.
Indication
Terazosin is indicated for use in treating symptomatic benign prostatic hyperplasia and hypertension.
Associated Conditions
- Benign Prostatic Hyperplasia (BPH)
- Hypertension
- Ureteral Calculus
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/13 | Phase 3 | Recruiting | Penang Hospital, Malaysia | ||
2023/05/11 | Phase 4 | Not yet recruiting | I.R.C.C.S. Fondazione Santa Lucia | ||
2021/11/05 | Phase 2 | Recruiting | |||
2021/02/18 | Phase 1 | Not yet recruiting | Qiang Zhang | ||
2020/09/16 | Phase 1 | Active, not recruiting | |||
2020/05/13 | Phase 2 | Recruiting | |||
2019/04/05 | Phase 1 | Completed | |||
2017/06/22 | Phase 2 | UNKNOWN | Capital Medical University | ||
2012/02/09 | Phase 2 | Completed | |||
2012/01/12 | Not Applicable | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Golden State Medical Supply, Inc. | 51407-734 | ORAL | 5 mg in 1 1 | 8/8/2023 | |
| REMEDYREPACK INC. | 70518-0342 | ORAL | 1 mg in 1 1 | 8/12/2025 | |
| Bryant Ranch Prepack | 63629-2439 | ORAL | 10 mg in 1 1 | 12/7/2017 | |
| Aphena Pharma Solutions - Tennessee, LLC | 71610-762 | ORAL | 10 mg in 1 1 | 12/15/2023 | |
| Chartwell RX, LLC | 62135-459 | ORAL | 2 mg in 1 1 | 2/9/2023 | |
| AvPAK | 50268-766 | ORAL | 5 mg in 1 1 | 5/6/2022 | |
| Bryant Ranch Prepack | 72162-2183 | ORAL | 5 mg in 1 1 | 12/11/2023 | |
| State of Florida DOH Central Pharmacy | 53808-1056 | ORAL | 1 mg in 1 1 | 1/19/2015 | |
| A-S Medication Solutions | 50090-0659 | ORAL | 10 mg in 1 1 | 2/28/2019 | |
| Northwind Pharmaceuticals, LLC | 51655-676 | ORAL | 5 mg in 1 1 | 3/19/2015 |
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 |
|---|---|---|---|---|---|
| HYTRIN TABLET 5 mg | SIN11676P | TABLET | 5 mg | 9/21/2001 | |
| TERASIN TABLET 2 mg | SIN11600P | TABLET | 2 mg | 7/31/2001 | |
| HYTRIN TABLET 1 mg | SIN11674P | TABLET | 1 mg | 9/21/2001 | |
| HYTRIN TABLET 2 mg | SIN11675P | TABLET | 2 mg | 9/21/2001 | |
| APO-TERAZOSIN TABLET 2 mg | SIN12672P | TABLET | 2 mg | 9/21/2005 |
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 |
|---|---|---|---|---|---|
| APO-TERAZOSIN TAB 2MG | N/A | N/A | N/A | 3/28/2001 | |
| RASINOL TABLETS 2MG | N/A | N/A | N/A | 7/28/2023 |
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 |
|---|---|---|---|---|---|
| HYTRIN | BGP Pharma ULC | 00818674 | Tablet - Oral | 10 MG | 12/31/1992 |
| MYLAN-TERAZOSIN | Mylan Pharmaceuticals ULC | 02396289 | Tablet - Oral | 1 MG | 11/9/2012 |
| HYTRIN | BGP Pharma ULC | 00818682 | Tablet - Oral | 2 MG | 12/31/1989 |
| RATIO-TERAZOSIN - TAB 5MG | ratiopharm inc division of teva canada limited | 02218976 | Tablet - Oral | 5 MG | 10/31/1997 |
| RATIO-TERAZOSIN - TAB 10MG | ratiopharm inc division of teva canada limited | 02218984 | Tablet - Oral | 10 MG | 10/31/1997 |
| HYTRIN | BGP Pharma ULC | 00818666 | Tablet - Oral | 5 MG | 12/31/1989 |
| MYLAN-TERAZOSIN | Mylan Pharmaceuticals ULC | 02396319 | Tablet - Oral | 10 MG | 11/9/2012 |
| RATIO-TERAZOSIN - TAB 1MG | ratiopharm inc division of teva canada limited | 02218941 | Tablet - Oral | 1 MG | 10/31/1997 |
| RATIO-TERAZOSIN - TAB 2MG | ratiopharm inc division of teva canada limited | 02218968 | Tablet - Oral | 2 MG | 10/31/1997 |
| MYLAN-TERAZOSIN | Mylan Pharmaceuticals ULC | 02396297 | Tablet - Oral | 2 MG | 11/9/2012 |
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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