Prazosin

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.

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
Brain Blood Vessel Responses to Changes in Blood Flow: Younger Cohort	2024/10/08	NCT06629090	Phase 2	Not yet recruiting	University of Wisconsin, Madison
Brain Blood Vessel Responses to Changes in Blood Flow	2024/10/08	NCT06629077	Phase 2	Not yet recruiting	University of Wisconsin, Madison
A Comparative Study of Using Scorpion Antivenom Versus Scorpion Antivenom and Prazosin	2024/03/01	NCT06287905	Phase 4	Recruiting	Sohag University
A Study to Assess the Pharmacokinetic Profile of Prazosin and Cyproheptadine	2023/11/27	NCT06147622	Phase 1	Completed	Kinnov Therapeutics
A Trial to Assess the Effects of Prazosin or Propranolol on Blood Pressure in the Presence of Brexpiprazole/Sertraline	2022/01/13	NCT05189977	Phase 1	Terminated	Otsuka Pharmaceutical Development & Commercialization, Inc.
Pivotal Bioequivalence Study to Qualify Manufacturing Site Transfer for Prazosin Hydrochloride Capsules	2021/07/19	NCT04967443	Phase 1	Completed	Pfizer
Prazosin for Alcohol Use Disorder with Withdrawal Symptoms	2021/03/11	NCT04793685	Phase 2	Recruiting	Yale University
Reducing Cannabis Overuse With Prazosin	2021/01/22	NCT04721353	Phase 4	Completed	VA Puget Sound Health Care System
Prazosin to Prevent COVID-19 (PREVENT-COVID Trial)	2020/04/28	NCT04365257	Phase 2	Terminated	Johns Hopkins University
Administration of Prazosin to Prevent PTSD in Adult Women After Sexual Assault	2019/06/25	NCT03997864	Phase 4	Withdrawn	University of Colorado, Denver

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Prazosin Hydrochloride	REMEDYREPACK INC.	70518-2177	ORAL	1 mg in 1 1	2/27/2024
Prazosin Hydrochloride	Contract Pharmacy Services-PA	67046-209	ORAL	1 mg in 1 1	9/21/2017
Prazosin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	43353-868	ORAL	2 mg in 1 1	4/3/2014
prazosin hydrochloride	Novadoz Pharmaceuticals LLC	72205-275	ORAL	1 mg in 1 1	4/16/2025
Prazosin Hydrochloride	Exelan Pharmaceuticals	76282-723	ORAL	5 mg in 1 1	1/26/2023
Prazosin hydrochloride	Biocon Pharma Inc.	70377-068	ORAL	5 mg in 1 1	1/4/2023
Prazosin Hydrochloride	Quality Care Products, LLC	55700-492	ORAL	1 mg in 1 1	3/1/2023
PRAZOSIN HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	62332-692	ORAL	2 mg in 1 1	5/12/2023
Prazosin Hydrochloride	Mylan Institutional Inc.	51079-631	ORAL	2 mg in 1 1	4/3/2023
Prazosin Hydrochloride	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	APOTEX INC	SIN07260P	TABLET	2 mg	11/25/1992
MINISON TABLET 1MG	Y.S.P. Industries (M) Sdn. Bhd.	SIN16122P	TABLET	1mg	3/18/2021
APO-PRAZO TABLET 1 mg	APOTEX INC	SIN07264P	TABLET	1 mg	11/25/1992
APO-PRAZO TABLET 5 mg	APOTEX INC	SIN07263P	TABLET	5 mg	11/25/1992
ATODEL 1 TABLET 1 mg	REMEDICA LTD	SIN07529P	TABLET	1 mg	10/26/1993

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
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
Minipress 2mg tablets	10757	Pfizer Australia Pty Ltd	Medicine	A	7/19/1991
APO-PRAZOSIN prazosin (as hydrochloride) 2mg tablet blister pack	73862	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/19/2000
Minipress 5mg tablets	10758	Pfizer Australia Pty Ltd	Medicine	A	7/19/1991
Minipress 1mg tablets	10756	Pfizer Australia Pty Ltd	Medicine	A	7/19/1991
APO-PRAZOSIN prazosin (as hydrochloride) 5mg tablet blister pack	73866	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/19/2000
APO-PRAZOSIN prazosin (as hydrochloride) 1mg tablet blister pack	73858	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/19/2000

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
NU-PRAZO TAB 2MG	nu-pharm inc	01913808	Tablet - Oral	2 MG	12/31/1992
NU-PRAZO TAB 5MG	nu-pharm inc	01913816	Tablet - Oral	5 MG	12/31/1992
NU-PRAZO TAB 1MG	nu-pharm inc	01913794	Tablet - Oral	1 MG	12/31/1992

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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