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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2015/07/16 | Phase 2 | Completed | |||
2015/02/23 | Phase 4 | UNKNOWN | |||
2014/12/04 | Phase 1 | Completed | |||
2014/10/17 | Phase 1 | Completed | |||
2013/10/09 | Phase 4 | Completed | San Francisco Veterans Affairs Medical Center | ||
2013/10/01 | Phase 2 | Completed | |||
2013/09/19 | Phase 4 | Completed | |||
2012/11/21 | Phase 2 | Completed | |||
2012/09/05 | Phase 2 | Completed | Buddhist Tzu Chi General Hospital | ||
2012/08/09 | Phase 4 | Completed | Buddhist Tzu Chi General Hospital |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Greenstone LLC | 59762-2310 | ORAL | 1 mg in 1 1 | 1/20/2022 | |
| Mylan Pharmaceuticals Inc. | 59762-2310 | ORAL | 1 mg in 1 1 | 1/20/2022 | |
| Rebel Distributors Corp | 42254-075 | ORAL | 2 mg in 1 1 | 8/7/2009 | |
| Unichem Pharmaceuticals (USA), Inc. | 29300-353 | ORAL | 4 mg in 1 1 | 1/23/2024 | |
| Aphena Pharma Solutions - Tennessee, LLC | 43353-646 | ORAL | 8 mg in 1 1 | 9/28/2017 | |
| Physicians Total Care, Inc. | 54868-4802 | ORAL | 4 mg in 1 1 | 2/28/2011 | |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-095 | ORAL | 8 mg in 1 1 | 4/4/2022 | |
| AvPAK | 50268-222 | ORAL | 1 mg in 1 1 | 5/9/2022 | |
| A-S Medication Solutions | 50090-6401 | ORAL | 2 mg in 1 1 | 11/30/2021 | |
| ROERIG | 0049-2780 | ORAL | 8 mg in 1 1 | 1/20/2022 |
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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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Doxazosin Mesylate Tablets | 国药准字H20020336 | 化学药品 | 片剂 | 4/30/2020 | |
| Doxazosin Mesylate Tablets | 国药准字H20000444 | 化学药品 | 片剂 | 3/17/2020 | |
| Doxazosin Mesylate Tablets | 国药准字H20031308 | 化学药品 | 片剂 | 1/9/2020 | |
| Doxazosin Mesylate Tablets | 国药准字H20010721 | 化学药品 | 片剂 | 9/14/2024 | |
| Doxazosin Mesylate Tablets | 国药准字H20020111 | 化学药品 | 片剂 | 9/3/2019 | |
| Doxazosin Mesylate Tablets | 国药准字H20050083 | 化学药品 | 片剂 | 1/9/2020 | |
| Doxazosin Mesylate Tablets | 国药准字H20020335 | 化学药品 | 片剂 | 4/30/2020 | |
| Doxazosin Mesylate Tablets | 国药准字H20030832 | 化学药品 | 片剂 | 7/30/2020 | |
| Doxazosin Mesylate Tablets | 国药准字H20031084 | 化学药品 | 片剂 | 6/15/2020 | |
| Doxazosin Mesylate Capsules | 国药准字H20051158 | 化学药品 | 胶囊剂 | 11/20/2019 |
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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