Overview
Doxazosin is an alpha-1 antagonist used for the treatment of benign prostatic hypertrophy (BPH) symptoms and hypertension. Other members of this drug class include Prazosin, Terazosin, Tamsulosin, and Alfuzosin. Because of its long-lasting effects, doxazosin can be administered once a day. It is marketed by Pfizer and was initially approved by the FDA in 1990.
Indication
Doxazosin is indicated to treat the symptoms of benign prostatic hypertrophy, which may include urinary frequency, urgency, and nocturia, among other symptoms. In addition, doxazosin is indicated alone or in combination with various antihypertensive agents for the management of hypertension. Off-label uses of doxazosin include the treatment of pediatric hypertension and the treatment of ureteric calculi.
Associated Conditions
- Benign Prostatic Hyperplasia (BPH)
- Hypertension
- Ureteric calculus
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/05/04 | Phase 2 | Recruiting | |||
2019/10/23 | Phase 2 | Recruiting | |||
2018/01/12 | Phase 1 | Withdrawn | |||
2017/11/13 | Phase 2 | Active, not recruiting | San Francisco Veterans Affairs Medical Center | ||
2017/06/05 | Phase 3 | Completed | |||
2016/12/12 | Phase 2 | Completed | |||
2016/09/15 | Phase 4 | Completed | |||
2016/05/27 | Phase 1 | Completed | |||
2015/09/30 | Phase 2 | UNKNOWN | First Affiliated Hospital of Harbin Medical University | ||
2015/09/02 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| State of Florida DOH Central Pharmacy | 53808-1017 | ORAL | 2 mg in 1 1 | 1/3/2015 | |
| DOH CENTRAL PHARMACY | 53808-1107 | ORAL | 4 mg in 1 1 | 1/15/2019 | |
| ROERIG | 0049-2760 | ORAL | 2 mg in 1 1 | 1/20/2022 | |
| Accord Healthcare Inc. | 16729-414 | ORAL | 2 mg in 1 1 | 3/15/2023 | |
| NuCare Pharmaceuticals, Inc. | 66267-377 | ORAL | 4 mg in 1 1 | 1/6/2023 | |
| A-S Medication Solutions | 50090-3143 | ORAL | 8 mg in 1 1 | 11/30/2021 | |
| Apotex Corp. | 60505-0096 | ORAL | 8 mg in 1 1 | 5/25/2023 | |
| Aurobindo Pharma Limited | 59651-892 | ORAL | 1 mg in 1 1 | 3/22/2024 | |
| Aidarex Pharmaceuticals LLC | 33261-658 | ORAL | 4 mg in 1 1 | 12/30/2013 | |
| A-S Medication Solutions | 50090-6298 | ORAL | 4 mg in 1 1 | 7/31/2021 |
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 |
|---|---|---|---|---|---|
| CARDURA TABLET 2 mg | SIN05014P | TABLET | 2 mg | 8/16/1990 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Doxazosin Mesylate Extended Release Tablets | 国药准字H20253807 | 化学药品 | 片剂 | 4/1/2025 | |
| Doxazosin Mesylate Extended Release Tablets | 国药准字H20244353 | 化学药品 | 片剂 | 6/28/2024 | |
| Doxazosin Mesylate Extended Release Tablets | 国药准字H20233964 | 化学药品 | 片剂 | 9/28/2023 | |
| Doxazosin Mesylate Extended Release Tablets | 国药准字H20103571 | 化学药品 | 片剂(缓释片) | 8/5/2020 | |
| Doxazosin Mesylate Extended Release Tablets | 国药准字H20233967 | 化学药品 | 片剂 | 7/25/2023 | |
| Doxazosin Mesylate Extended Release Tablets | 国药准字H20243226 | 化学药品 | 片剂 | 2/23/2024 | |
| Doxazosin Mesylate Extended Release Tablets | 国药准字HJ20170175 | 化学药品 | 片剂 | 7/4/2023 | |
| Doxazosin Mesylate Extended Release Tablets | 国药准字HJ20170174 | 化学药品 | 片剂 | 7/4/2023 | |
| Doxazosin Mesylate Tablets | 国药准字H20070220 | 化学药品 | 片剂 | 7/30/2020 | |
| Doxazosin Mesylate Tablets | 国药准字H20052636 | 化学药品 | 片剂 | 7/30/2020 |
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 |
|---|---|---|---|---|---|
| Doxazosin mesilate Tablets 4 mg | 238897 | Medicine | A | 5/25/2015 | |
| Doxazosin mesilate Tablets 1 mg | 238895 | Medicine | A | 5/25/2015 | |
| Doxazosin mesilate Tablets 8 mg | 238898 | Medicine | A | 5/25/2015 | |
| Doxazosin mesilate Tablets 2 mg | 238896 | Medicine | A | 5/25/2015 |
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