Overview
Prazosin is a drug used to treat hypertension. Prazosin is marketed by Pfizer and was initially approved by the FDA in 1988. It belongs to the class of drugs known as alpha-1 antagonists. Recently, many studies have evaluated the benefits of this drug in controlling the symptoms of post-traumatic stress disorder (PTSD) and associated nightmares.
Background
Prazosin is a drug used to treat hypertension. Prazosin is marketed by Pfizer and was initially approved by the FDA in 1988. It belongs to the class of drugs known as alpha-1 antagonists. Recently, many studies have evaluated the benefits of this drug in controlling the symptoms of post-traumatic stress disorder (PTSD) and associated nightmares.
Indication
This drug is indicated for the treatment of hypertension (high blood pressure). Prazosin can be given alone or given with other blood pressure-lowering drugs, including diuretics or beta-adrenergic blocking agents . Prazosin does not negatively impact lung function, and therefore may be used to manage hypertension in patients who are asthmatic or patients with chronic obstructive lung disease (COPD).
Associated Conditions
- Agitation
- Benign Prostatic Hyperplasia (BPH)
- Hypertension
- Raynaud's Phenomenon
- Disturbed sleep/nightmares
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/10/08 | Phase 2 | Not yet recruiting | |||
2024/10/08 | Phase 2 | Not yet recruiting | |||
2024/03/01 | Phase 4 | Recruiting | |||
2023/11/27 | Phase 1 | Completed | |||
2022/01/13 | Phase 1 | Terminated | |||
2021/07/19 | Phase 1 | Completed | |||
2021/03/11 | Phase 2 | Recruiting | |||
2021/01/22 | Phase 4 | Completed | |||
2020/04/28 | Phase 2 | Terminated | |||
2019/06/25 | Phase 4 | Withdrawn |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| REMEDYREPACK INC. | 70518-2177 | ORAL | 1 mg in 1 1 | 2/27/2024 | |
| Contract Pharmacy Services-PA | 67046-209 | ORAL | 1 mg in 1 1 | 9/21/2017 | |
| Aphena Pharma Solutions - Tennessee, LLC | 43353-868 | ORAL | 2 mg in 1 1 | 4/3/2014 | |
| Novadoz Pharmaceuticals LLC | 72205-275 | ORAL | 1 mg in 1 1 | 4/16/2025 | |
| Exelan Pharmaceuticals | 76282-723 | ORAL | 5 mg in 1 1 | 1/26/2023 | |
| Biocon Pharma Inc. | 70377-068 | ORAL | 5 mg in 1 1 | 1/4/2023 | |
| Quality Care Products, LLC | 55700-492 | ORAL | 1 mg in 1 1 | 3/1/2023 | |
| Alembic Pharmaceuticals Inc. | 62332-692 | ORAL | 2 mg in 1 1 | 5/12/2023 | |
| Mylan Institutional Inc. | 51079-631 | ORAL | 2 mg in 1 1 | 4/3/2023 | |
| Aphena Pharma Solutions - Tennessee, LLC | 71610-694 | ORAL | 2 mg in 1 1 | 3/20/2023 |
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 |
|---|---|---|---|---|---|
| APO-PRAZO TABLET 2 mg | SIN07260P | TABLET | 2 mg | 11/25/1992 | |
| MINISON TABLET 1MG | SIN16122P | TABLET | 1mg | 3/18/2021 | |
| APO-PRAZO TABLET 1 mg | SIN07264P | TABLET | 1 mg | 11/25/1992 | |
| APO-PRAZO TABLET 5 mg | SIN07263P | TABLET | 5 mg | 11/25/1992 | |
| ATODEL 1 TABLET 1 mg | SIN07529P | TABLET | 1 mg | 10/26/1993 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Prazosin Hydrochloride Tablets | 国药准字H34021255 | 化学药品 | 片剂 | 6/8/2020 | |
| Prazosin Hydrochloride Tablets | 国药准字H32022662 | 化学药品 | 片剂 | 7/14/2020 | |
| Prazosin Hydrochloride Tablets | 国药准字H31021553 | 化学药品 | 片剂 | 12/25/2019 | |
| Prazosin Hydrochloride Tablets | 国药准字H44021754 | 化学药品 | 片剂 | 3/15/2024 | |
| Prazosin Hydrochloride Tablets | 国药准字H44021502 | 化学药品 | 片剂 | 3/16/2020 | |
| Prazosin Hydrochloride Tablets | 国药准字H22022282 | 化学药品 | 片剂 | 2/17/2020 | |
| Prazosin Hydrochloride Tablets | 国药准字H22021803 | 化学药品 | 片剂 | 5/6/2020 | |
| Prazosin Hydrochloride Tablets | 国药准字H22021832 | 化学药品 | 片剂 | 5/6/2020 | |
| Prazosin Hydrochloride Tablets | 国药准字H32024235 | 化学药品 | 片剂 | 5/11/2020 | |
| Prazosin Hydrochloride Tablets | 国药准字H32024234 | 化学药品 | 片剂 | 5/11/2020 |
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 |
|---|---|---|---|---|---|
| Minipress 2mg tablets | 10757 | Medicine | A | 7/19/1991 | |
| APO-PRAZOSIN prazosin (as hydrochloride) 2mg tablet blister pack | 73862 | Medicine | A | 6/19/2000 | |
| Minipress 5mg tablets | 10758 | Medicine | A | 7/19/1991 | |
| Minipress 1mg tablets | 10756 | Medicine | A | 7/19/1991 | |
| APO-PRAZOSIN prazosin (as hydrochloride) 5mg tablet blister pack | 73866 | Medicine | A | 6/19/2000 | |
| APO-PRAZOSIN prazosin (as hydrochloride) 1mg tablet blister pack | 73858 | Medicine | A | 6/19/2000 |