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
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Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2017/06/16 | Phase 4 | Completed | |||
2017/06/07 | Phase 1 | Terminated | |||
2017/04/18 | Phase 4 | Withdrawn | |||
2017/02/28 | Phase 3 | Completed | |||
2017/02/13 | Phase 4 | Recruiting | |||
2016/12/29 | Phase 2 | Withdrawn | |||
2016/11/22 | Phase 4 | Completed | |||
2016/09/14 | Phase 3 | Completed | |||
2016/08/26 | Early Phase 1 | Completed | Göteborg University | ||
2016/08/22 | Phase 4 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Sandoz Inc | 0781-5443 | ORAL | 10 mg in 1 1 | 8/18/2015 | |
Rebel Distributors Corp | 21695-780 | ORAL | 10 mg in 1 1 | 11/14/2008 | |
Bryant Ranch Prepack | 71335-0305 | ORAL | 5 mg in 1 1 | 12/1/2020 | |
Sandoz Inc | 0781-5442 | ORAL | 5 mg in 1 1 | 8/18/2015 | |
A-S Medication Solutions | 50090-5292 | ORAL | 5 mg in 1 1 | 12/1/2020 | |
Med Health Pharma, LLC | 51138-033 | ORAL | 2.5 mg in 1 1 | 1/1/2011 | |
NuCare Pharmaceuticals,Inc. | 68071-2618 | ORAL | 10 mg in 1 1 | 1/18/2022 | |
Bausch Health US, LLC | 0187-0146 | ORAL | 10 mg in 1 1 | 8/31/2020 | |
Blenheim Pharmacal, Inc. | 10544-632 | ORAL | 10 mg in 1 1 | 2/19/2015 | |
Northstar RxLLC | 16714-442 | ORAL | 2.5 mg in 1 1 | 10/20/2017 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Enalapril Maleate Tablets | 国药准字H20055812 | 化学药品 | 片剂 | 8/19/2020 | |
Enalapril Maleate Tablets | 国药准字H20083533 | 化学药品 | 片剂 | 2/6/2023 | |
Enalapril Maleate Tablets | 国药准字H20244880 | 化学药品 | 片剂 | 9/10/2024 | |
Enalapril Maleate Tablets | 国药准字H20066383 | 化学药品 | 片剂 | 12/18/2020 | |
Enalapril Maleate Tablets | 国药准字H10930062 | 化学药品 | 片剂 | 6/30/2020 | |
Enalapril Maleate Tablets | 国药准字H10930061 | 化学药品 | 片剂 | 6/30/2020 | |
Enalapril Maleate Tablets | 国药准字H20244881 | 化学药品 | 片剂 | 9/10/2024 | |
Enalapril Maleate Tablets | 国药准字H14023578 | 化学药品 | 片剂 | 8/6/2020 | |
Enalapril Maleate Tablets | 国药准字H20083534 | 化学药品 | 片剂 | 2/6/2023 | |
Enalapril Maleate Tablets | 国药准字H14023577 | 化学药品 | 片剂 | 8/6/2020 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
APO-ENALAPRIL enalapril maleate 20 mg tablet blister pack | 196504 | Medicine | A | 5/28/2013 | |
IPCA-ENALAPRIL enalapril maleate 20mg tablet blister pack | 196506 | Medicine | A | 5/28/2013 | |
MALEAN enalapril maleate 20mg tablet blister pack | 196489 | Medicine | A | 5/28/2013 | |
IPCA-ENALAPRIL enalapril maleate 5mg tablet blister pack | 196473 | Medicine | A | 5/28/2013 | |
ENALAPRIL GH enalapril maleate 10mg tablet blister pack | 142940 | Medicine | A | 12/23/2008 | |
ENALAPRIL/HCT SANDOZ 20mg/6mg enalapril maleate 20mg and hydrochlorothiazide 6mg tablet blister pack | 126490 | Medicine | A | 7/11/2007 | |
LERCANIDIPINE ENALAPRIL MYLAN 10/10 lercanidipine hydrochloride 10mg and enalapril maleate 10mg film coated tablets blister pack | 295923 | Medicine | A | 12/6/2017 | |
NOUMED ENALAPRIL enalapril maleate 20 mg tablet blister pack | 284364 | Medicine | A | 6/6/2017 | |
ENMALEATE enalapril maleate 20mg tablet blister pack | 196464 | Medicine | A | 5/28/2013 | |
ENPRIL enalapril maleate 5mg tablet blister pack | 196475 | Medicine | A | 5/28/2013 |
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