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Enalapril

Generic Name
Enalapril
Brand Names
Epaned, Vaseretic, Vasotec, Aqumeldi
Drug Type
Small Molecule
Chemical Formula
C20H28N2O5
CAS Number
75847-73-3
Unique Ingredient Identifier
69PN84IO1A

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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Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approval Number
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Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Company
Approval Number
Drug Type
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Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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Company
Licence No.
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Registration Date
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Health Canada Drug Approvals

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Approved Product
Company
DIN
Dosage Form
Strength
Market Date
NU-ENALAPRIL
nu-pharm inc
02338157
Tablet - Oral
20 MG
N/A
AVA-ENALAPRIL
avanstra inc
02363453
Tablet - Oral
2.5 MG
10/11/2011
APO-ENALAPRIL
02020025
Tablet - Oral
2.5 MG
12/31/1993
AVA-ENALAPRIL
avanstra inc
02363488
Tablet - Oral
10.0 MG
10/11/2011
AVA-ENALAPRIL
avanstra inc
02363461
Tablet - Oral
5.0 MG
10/11/2011
NU-ENALAPRIL
nu-pharm inc
02338149
Tablet - Oral
10 MG
N/A
PRIVA-ENALAPRIL
pharmapar inc
02512718
Tablet - Oral
10 MG
N/A
MAR-ENALAPRIL
marcan pharmaceuticals inc
02444771
Tablet - Oral
10 MG
3/20/2019
JAMP ENALAPRIL
02474816
Tablet - Oral
20 MG
2/25/2019
JAMP ENALAPRIL
02474786
Tablet - Oral
2.5 MG
2/25/2019

CIMA AEMPS Drug Approvals

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Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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UK EMC Drug Information

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MA Holder
MA Number
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Active Ingredient
Authorization Date
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