Overview
Enalapril is a prodrug belonging to the angiotensin-converting enzyme (ACE) inhibitor drug class that works on the renin-angiotensin-aldosterone system, which is responsible for the regulation of blood pressure and fluid and electrolyte homeostasis. Enalapril is an orally-active and long-acting nonsulphydryl antihypertensive agent that suppresses the renin-angiotensin-aldosterone system to lower blood pressure. It was developed from a targeted research programmed using molecular modelling. Being a prodrug, enalapril is rapidly biotransformed into its active metabolite, enalaprilat, which is responsible for the pharmacological actions of enalapril. The active metabolite of enalapril competitively inhibits the ACE to hinder the production of angiotensin II, a key component of the renin-angiotensin-aldosterone system that promotes vasoconstriction and renal reabsorption of sodium ions in the kidneys. Ultimately, enalaprilat works to reduce blood pressure and blood fluid volume. Commonly marketed under the trade name Vasotec, enalapril was first approved by the FDA in 1985 for the management of hypertension, heart failure, and asymptomatic left ventricular dysfunction. It is also found in a combination product containing hydrochlorothiazide that is used for the management of hypertension. The active metabolite enalaprilat is also available in oral tablets and intravenous formulations for injection.
Indication
Indicated for the management of essential or renovascular hypertension as monotherapy or in combination with other antihypertensive agents, such as thiazide diuretics, for an additive effect. Indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. Indicated for the management of asymptomatic left ventricular dysfunction in patients with an ejection fraction of ≤ to 35 percent to decrease the rate of development of overt heart failure and the incidence of hospitalization for heart failure.
Associated Conditions
- Diabetic Nephropathy
- Hypertension
- Symptomatic Congestive Heart Failure
- Asymptomatic Left ventricular dysfunction
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/03/25 | Phase 2 | Recruiting | Oslo University Hospital | ||
2024/01/02 | Not Applicable | Not yet recruiting | |||
2023/02/03 | Phase 4 | Completed | Yang I. Pachankis | ||
2022/08/04 | Phase 4 | Recruiting | Clinical Hospital Heliodor Swiecicki of the Medical University of Karol Marcinkowski in Poznań | ||
2022/05/13 | Phase 2 | UNKNOWN | Omar Tarek Elfarargi | ||
2021/07/07 | Phase 3 | Completed | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2021/06/03 | Phase 3 | Not yet recruiting | |||
2021/04/21 | Phase 3 | Recruiting | |||
2020/07/23 | Phase 2 | Completed | |||
2020/01/22 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
State of Florida DOH Central Pharmacy | 53808-0833 | ORAL | 2.5 mg in 1 1 | 9/11/2013 | |
Aurobindo Pharma Limited | 59651-529 | ORAL | 1 mg in 1 mL | 1/18/2024 | |
Ranbaxy Pharmaceuticals Inc. | 63304-525 | ORAL | 20 mg in 1 1 | 4/26/2016 | |
NuCare Pharmaceuticals, Inc. | 68071-3303 | ORAL | 20 mg in 1 1 | 2/12/2021 | |
Preferred Pharmaceuticals Inc. | 68788-7967 | ORAL | 10 mg in 1 1 | 5/22/2023 | |
St. Mary's Medical Park Pharmacy | 60760-777 | ORAL | 5 mg in 1 1 | 11/12/2018 | |
Wockhardt USA LLC. | 64679-923 | ORAL | 2.5 mg in 1 1 | 12/7/2021 | |
A-S Medication Solutions | 50090-6712 | ORAL | 10 mg in 1 1 | 7/27/2023 | |
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-772 | ORAL | 10 mg in 1 1 | 5/2/2023 | |
Legacy Pharmaceutical Packaging, LLC | 68645-607 | ORAL | 20 mg in 1 1 | 12/12/2023 |
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 |
---|---|---|---|---|---|
INVORIL-5 TABLETS 5 mg | SIN11063P | TABLET | 5.00 mg | 8/4/1999 | |
GLIOTEN 10 TABLET 10 mg | SIN12412P | TABLET | 10 mg | 8/30/2003 | |
GLIOTEN 20 TABLET 20 mg | SIN12413P | TABLET | 20 mg | 8/30/2003 | |
ENAP TABLET 10 mg | SIN11371P | TABLET | 10 mg | 8/15/2000 | |
KORANDIL 10 TABLET 10 mg | SIN07658P | TABLET | 10 mg | 3/10/1994 | |
GLIOTENZIDE 20 TABLET | SIN12641P | TABLET | 20 mg | 1/14/2005 | |
ANAPRIL 5 TABLET 5 mg | SIN09877P | TABLET | 5 mg | 7/9/1998 | |
INVORIL-10 TABLETS 10 mg | SIN11064P | TABLET | 10.00 mg | 8/4/1999 | |
ENAPRIL- 5 TABLET 5 mg | SIN11572P | TABLET | 5.000 mg | 6/21/2001 | |
ENAP TABLET 20 mg | SIN11370P | TABLET | 20 mg | 8/15/2000 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Enalapril Maleate Oral Solution | 国药准字H20223438 | 化学药品 | 口服溶液剂 | 6/28/2022 | |
Enalapril Maleate Oral Solution | 国药准字H20234397 | 化学药品 | 口服溶液剂 | 10/27/2023 | |
Enalapril Maleate Orally Disintegrating Tablets | 国药准字H20080813 | 化学药品 | 片剂 | 6/8/2023 | |
Enalapril Maleate Disperible Tablets | 国药准字H20051002 | 化学药品 | 片剂 | 8/1/2020 | |
Enalapril Maleate Capsules | 国药准字H10930088 | 化学药品 | 胶囊剂 | 5/14/2024 | |
Enalapril Maleate Capsules | 国药准字H10930089 | 化学药品 | 胶囊剂 | 5/14/2024 | |
Enalapril Maleate Capsules | 国药准字H20000221 | 化学药品 | 胶囊剂 | 5/22/2020 | |
Enalapril Maleate Capsules | 国药准字H10960145 | 化学药品 | 胶囊剂 | 5/11/2020 | |
Enalapril Maleate Tablets | 国药准字H32026568 | 化学药品 | 片剂 | 8/17/2020 | |
Enalapril Maleate Tablets | 国药准字HJ20170297 | 化学药品 | 片剂 | 9/25/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
ENACORD 5 TABLETS 5MG | N/A | N/A | N/A | 10/10/2024 | |
SYNBOT TABLETS 5MG | N/A | N/A | N/A | 11/1/2024 | |
SYNBOT TABLETS 20MG | N/A | N/A | N/A | 11/1/2024 | |
ENACORD 20 TABLETS 20MG | N/A | N/A | N/A | 10/10/2024 | |
ENACORD 10 TABLETS 10MG | N/A | N/A | N/A | 10/10/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
ENMALEATE enalapril maleate 10mg tablet blister pack | 196486 | Medicine | A | 5/28/2013 | |
ENPRIL enalapril maleate 20mg tablet blister pack | 196463 | Medicine | A | 5/28/2013 | |
RENITEC PLUS 20/6 tablet blister pack | 73359 | Medicine | A | 3/8/2000 | |
ENALAPRIL GH enalapril maleate 5mg tablet blister pack | 142936 | Medicine | A | 12/23/2008 | |
ENMALEATE enalapril maleate 5mg tablet blister pack | 196496 | Medicine | A | 5/28/2013 | |
APO-ENALAPRIL enalapril maleate 5 mg tablet blister pack | 196472 | Medicine | A | 5/28/2013 | |
ENALAPRIL-WGR enalapril maleate 5mg tablet blister pack | 196507 | Medicine | A | 5/28/2013 | |
ACETEC 10 enalapril maleate 10mg tablet blister pack | 75498 | Medicine | A | 8/18/2000 | |
AUSPRIL enalapril maleate 5 mg tablet blister pack | 121758 | Medicine | A | 9/6/2006 | |
ENALAPRIL-WGR enalapril maleate 10mg tablet blister pack | 196498 | Medicine | A | 5/28/2013 |
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