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.
Background
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 |
|---|---|---|---|---|---|
2017/03/08 | Phase 3 | Completed | |||
2016/01/05 | Phase 4 | UNKNOWN | |||
2011/04/27 | Not Applicable | Completed | China-Japan Friendship Hospital | ||
2009/11/17 | Phase 4 | Completed | |||
2008/10/23 | Not Applicable | Completed | |||
2008/10/23 | Not Applicable | Completed | |||
2008/10/21 | Not Applicable | Completed | |||
2008/10/21 | Not Applicable | Completed | |||
2007/11/30 | Not Applicable | UNKNOWN | Shanghai Municipal Health Bureau | ||
2006/04/17 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Unit Dose Services | 50436-3138 | ORAL | 20 mg in 1 1 | 1/25/2011 | |
| Physicians Total Care, Inc. | 54868-5064 | ORAL | 10 mg in 1 1 | 2/5/2013 | |
| Aurobindo Pharma Limited | 65862-473 | ORAL | 40 mg in 1 1 | 11/8/2022 | |
| Chartwell RX, LLC | 62135-041 | ORAL | 10 mg in 1 1 | 6/6/2023 | |
| Physicians Total Care, Inc. | 54868-5346 | ORAL | 10 mg in 1 1 | 9/7/2010 | |
| Bryant Ranch Prepack | 71335-0187 | ORAL | 20 mg in 1 1 | 5/17/2019 | |
| A-S Medication Solutions | 50090-4743 | ORAL | 40 mg in 1 1 | 10/1/2017 | |
| Bryant Ranch Prepack | 71335-0726 | ORAL | 10 mg in 1 1 | 10/1/2017 | |
| Preferred Pharmaceuticals, Inc. | 68788-7717 | ORAL | 20 mg in 1 1 | 6/15/2023 | |
| 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 |
|---|---|---|---|---|---|
| Fosinopril Sodium Capsules | 国药准字H20080311 | 化学药品 | 胶囊剂 | 3/8/2023 | |
| Fosinopril Sodium Tablets | 国药准字H19980197 | 化学药品 | 片剂 | 3/27/2020 | |
| Fosinopril Sodium Tablets | 国药准字H20064148 | 化学药品 | 片剂 | 4/28/2020 |
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 |
|---|---|---|---|---|---|
| APO-FOSINOPRIL fosinopril sodium 10mg tablet bottle | 119875 | Medicine | A | 8/31/2006 | |
| MONOPRIL fosinopril sodium 10mg tablet | 46751 | Medicine | A | 10/26/1993 | |
| APO-FOSINOPRIL fosinopril sodium 20mg tablet bottle | 119877 | Medicine | A | 8/31/2006 | |
| FOSIPRIL 20 fosinopril sodium 20 mg tablet blister pack | 100060 | Medicine | A | 11/16/2004 | |
| Fosinopril Sodium Tablets 10 mg | 174954 | Medicine | A | 8/19/2010 | |
| APO-FOSINOPRIL fosinopril sodium 10mg tablet blister pack | 119874 | Medicine | A | 8/31/2006 | |
| Fosinopril Sodium Tablets 20 mg | 174955 | Medicine | A | 8/19/2010 | |
| FOSINOPRIL HCTZ AN 10/12.5 fosinopril sodium 10 mg and hydrochlorothiazide12.5 mg tablet blister pack | 151947 | Medicine | A | 8/19/2008 | |
| APO-FOSINOPRIL fosinopril sodium 20mg tablet blister pack | 119876 | Medicine | A | 8/31/2006 | |
| FOSINOPRIL HCTZ AN 20/12.5 fosinopril sodium 20 mg and hydrochlorothiazide12.5 mg tablet blister pack | 151948 | Medicine | A | 8/19/2008 |