Quinapril

Overview

Quinapril is the ethyl ester prodrug of the non-sulfhydryl angiotensin converting enzyme inhibitor quinaprilat. It is used to treat hypertension and heart failure. ACE inhibitors are commonly used as a first line therapy in the treatment of hypertension, along with thiazide diuretics or beta blockers. Quinapril was granted FDA approval on 19 November 1991. A combination tablet with hydrochlorothiazide was also approved on 28 December 1999.

Indication

Quinapril is indicated for the treatment of hypertension and as an adjunct therapy in the treatment of heart failure. Quinapril in combination with hydrochlorothiazide is indicated for the treatment of hypertension.

Associated Conditions

Congestive Heart Failure (CHF)
Diabetic Nephropathy
Hypertension
Left Ventricular Dysfunction

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Diabetic Autonomic Neuropathy and Left Ventricular Function	2023/02/06	NCT05713396	Phase 4	Completed	AHEPA University Hospital
Efficacy of Administration of ACE-Inhibition on Autonomic and Peripheral Neuropathy in Patients With Diabetes Mellitus	2017/01/26	NCT03031834	Phase 4	Completed	Aristotle University Of Thessaloniki
A Non Interventional Study To Asses The Safety, Effectiveness And Tolerability Of Quinapril (Acupil®) In An Indian Population	2009/06/30	NCT00930722	N/A	Completed	Pfizer
Effects of Quinapril 40 mg With Alpha Lipoic Acid or Placebo on Diabetes and Hypertension	2008/11/21	NCT00795262	Not Applicable	Completed	InVasc Therapeutics, Inc.
A Study to Evaluate the Efficacy and Safety of Quinapril or Quinapril Plus Hydrochlorothiazide in Patients With Mild to Moderate Hypertension	2008/04/02	NCT00651287	Phase 4	Completed	Pfizer
Food Study of Quinapril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Accuretic™ Tablets 20 mg/25 mg	2008/04/01	NCT00648011	Phase 1	Completed	Mylan Pharmaceuticals Inc
Food Study of Quinapril Hydrochloride Tablets 40 mg and Accupril® Tablets 40 mg	2008/04/01	NCT00649649	Phase 1	Completed	Mylan Pharmaceuticals Inc
Fasting Study of Quinapril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Accuretic™ Tablets 20 mg/25 mg	2008/04/01	NCT00649441	Phase 1	Completed	Mylan Pharmaceuticals Inc
Fasting Study of Quinapril Hydrochloride Tablets 40 mg and Accupril® Tablets 40 mg	2008/04/01	NCT00649103	Phase 1	Completed	Mylan Pharmaceuticals Inc
High-Dose Quinapril Versus Low-Dose Quinapril Plus Amlodipine in the Treatment of High-Risk Hypertensive Patients	2006/04/12	NCT00313547	Phase 4	Terminated	Montreal Heart Institute

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Quinapril Hydrochloride	Carilion Materials Management	68151-1021	ORAL	10 mg in 1 1	6/13/2014
Quinapril Hydrochloride	Carilion Materials Management	68151-1020	ORAL	5 mg in 1 1	6/13/2014
Quinapril Hydrochloride	Carilion Materials Management	68151-1022	ORAL	20 mg in 1 1	6/13/2014

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
No HSA approvals found for this drug.

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
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
BICETIL 20 mg / 12,5 mg COMPRIMIDOS RECUBIERTOS CON PELÍCULA	Laboratorios Menarini S.A.	60455	COMPRIMIDO RECUBIERTO	Medicamento Sujeto A Prescripción Médica	Not Commercialized
ACUPREL 20 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Pfizer S.L.	59082	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Not Commercialized
ACUPREL 5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Pfizer S.L.	59081	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Not Commercialized

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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