Fosinopril

Overview

Fosinopril is a phosphinic acid-containing ester prodrug that belongs to the angiotensin-converting enzyme (ACE) inhibitor class of medications. It is rapidly hydrolyzed to fosinoprilat, its principle active metabolite. Fosinoprilat inhibits ACE, the enzyme responsible for the conversion of angiotensin I (ATI) to angiotensin II (ATII). ATII regulates blood pressure and is a key component of the renin-angiotensin-aldosterone system (RAAS). Fosinopril may be used to treat mild to moderate hypertension, as an adjunct in the treatment of congestive heart failure, and to slow the rate of progression of renal disease in hypertensive individuals with diabetes mellitus and microalbuminuria or overt nephropathy.

Indication

For treating mild to moderate hypertension, use as an adjunct in treating congestive heart failure, and may be used to slow the rate of progression of renal disease in hypertensive individuals with diabetes mellitus and microalbuminuria or overt nephropathy.

Associated Conditions

Heart Failure
Hypertension

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Prevention of Renal and Vascular Endstage Disease Intervention Trial	2017/03/08	NCT03073018	Phase 3	Completed	University Medical Center Groningen
Benidipine and Hydrochlorothiazide in Fosinopril Treated Chronic Kidney Disease Patients With Hypertension	2016/01/05	NCT02646397	Phase 4	UNKNOWN	Shanghai Changzheng Hospital
The Effect of Metformin on the Correlation Between Hyperinsulinemia and Hypertension	2011/04/27	NCT01342614	Not Applicable	Completed	China-Japan Friendship Hospital
Angiotensin-converting Enzyme (ACE)-Inhibition and Mechanisms of Skeletal Muscle Weakness in Chronic Obstructive Pulmonary Disease (COPD)	2009/11/17	NCT01014338	Phase 4	Completed	Imperial College London
Bioequivalence Study of Fosinopril Sodium/ Hydrochlorothiazide 20/ 12.5 mg Tablets Under Fasting Conditions	2008/10/23	NCT00777972	Not Applicable	Completed	Ranbaxy Laboratories Limited
Bioequivalence Study of Fosinopril Sodium / Hydrochlorothiazide 20/ 12.5 mg Tablets Under Fed Conditions	2008/10/23	NCT00778713	Not Applicable	Completed	Ranbaxy Laboratories Limited
Bioequivalence Study of Fosinopril 40mg Tablets Under Fed Conditions	2008/10/21	NCT00776672	Not Applicable	Completed	Ranbaxy Laboratories Limited
Bioequivalence Study of Fosinopril 40mg Tablets Under Fasting Conditions	2008/10/21	NCT00776334	Not Applicable	Completed	Ranbaxy Laboratories Limited
Effectiveness Study on Fosinopril and/or Losartan in Patients With Chronic Kidney Disease Stage 3	2007/11/30	NCT00565396	Not Applicable	UNKNOWN	Shanghai Municipal Health Bureau
Eplerenone, ACE Inhibition and Albuminuria	2006/04/17	NCT00315016	Phase 2	Completed	Radboud University Medical Center

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Fosinopril Sodium	Unit Dose Services	50436-3138	ORAL	20 mg in 1 1	1/25/2011
Fosinopril Sodium	Physicians Total Care, Inc.	54868-5064	ORAL	10 mg in 1 1	2/5/2013
Fosinopril Sodium	Aurobindo Pharma Limited	65862-473	ORAL	40 mg in 1 1	11/8/2022
Fosinopril Sodium	Chartwell RX, LLC	62135-041	ORAL	10 mg in 1 1	6/6/2023
Fosinopril Sodium and Hydrochlorothiazide	Physicians Total Care, Inc.	54868-5346	ORAL	10 mg in 1 1	9/7/2010
Fosinopril Sodium	Bryant Ranch Prepack	71335-0187	ORAL	20 mg in 1 1	5/17/2019
Fosinopril sodium	A-S Medication Solutions	50090-4743	ORAL	40 mg in 1 1	10/1/2017
Fosinopril sodium	Bryant Ranch Prepack	71335-0726	ORAL	10 mg in 1 1	10/1/2017
Fosinopril Sodium	Preferred Pharmaceuticals, Inc.	68788-7717	ORAL	20 mg in 1 1	6/15/2023
Fosinopril Sodium	Physicians Total Care, Inc.	54868-5055	ORAL	20 mg in 1 1	2/5/2013

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
APO-FOSINOPRIL fosinopril sodium 10mg tablet bottle	119875	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/31/2006
MONOPRIL fosinopril sodium 10mg tablet	46751	Bristol-Myers Squibb Australia Pty Ltd	Medicine	A	10/26/1993
APO-FOSINOPRIL fosinopril sodium 20mg tablet bottle	119877	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/31/2006
FOSIPRIL 20 fosinopril sodium 20 mg tablet blister pack	100060	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	11/16/2004
Fosinopril Sodium Tablets 10 mg	174954	Alphapharm Pty Ltd	Medicine	A	8/19/2010
APO-FOSINOPRIL fosinopril sodium 10mg tablet blister pack	119874	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/31/2006
Fosinopril Sodium Tablets 20 mg	174955	Alphapharm Pty Ltd	Medicine	A	8/19/2010
FOSINOPRIL HCTZ AN 10/12.5 fosinopril sodium 10 mg and hydrochlorothiazide12.5 mg tablet blister pack	151947	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/19/2008
APO-FOSINOPRIL fosinopril sodium 20mg tablet blister pack	119876	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/31/2006
FOSINOPRIL HCTZ AN 20/12.5 fosinopril sodium 20 mg and hydrochlorothiazide12.5 mg tablet blister pack	151948	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/19/2008

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
NU-FOSINOPRIL	nu-pharm inc	02335263	Tablet - Oral	10 MG	N/A
MONOPRIL TAB 10MG	bristol-myers squibb canada	01907107	Tablet - Oral	10 MG	12/31/1992
FOSINOPRIL TABLETS	ranbaxy pharmaceuticals canada inc.	02332566	Tablet - Oral	10 MG	N/A
RAN-FOSINOPRIL	ranbaxy pharmaceuticals canada inc.	02294532	Tablet - Oral	20 MG	8/15/2007
APO-FOSINOPRIL	Apotex Inc	02266016	Tablet - Oral	20 MG	4/27/2005
MYLAN-FOSINOPRIL	Mylan Pharmaceuticals ULC	02262401	Tablet - Oral	10 MG	12/21/2004
FOSINOPRIL	sanis health inc	02459396	Tablet - Oral	20 MG	4/11/2017
PHL-FOSINOPRIL	pharmel inc	02256061	Tablet - Oral	20 MG	N/A
NU-FOSINOPRIL	nu-pharm inc	02335271	Tablet - Oral	20 MG	N/A
FOSINOPRIL-10	PRO DOC LIMITEE	02303000	Tablet - Oral	10 MG	10/23/2008

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
FOSITENS PLUS 20 mg / 12,5 mg COMPRIMIDOS	Bausch Health Ireland Limited	61529	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized
FOSITENS 20 mg COMPRIMIDOS	Bausch Health Ireland Limited	59716	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	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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