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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

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
No NMPA approvals found for this drug.

PPB Drug Approvals

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
APO-ENALAPRIL
02019906
Tablet - Oral
20 MG
12/31/1993
PRO-ENALAPRIL - 5
PRO DOC LIMITEE
02311410
Tablet - Oral
5 MG
7/4/2008
PRO-ENALAPRIL - 20
PRO DOC LIMITEE
02311437
Tablet - Oral
20 MG
7/4/2008
ENALAPRIL MALEATE/HCTZ
aa pharma inc
02352923
Tablet - Oral
5 MG
2/24/2011
AVA-ENALAPRIL
avanstra inc
02363496
Tablet - Oral
20.0 MG
10/11/2011
ENALAPRIL MALEATE/HCTZ
aa pharma inc
02352931
Tablet - Oral
10 MG
2/24/2011
PRIVA-ENALAPRIL
pharmapar inc
02512696
Tablet - Oral
5 MG
N/A
PRIVA-ENALAPRIL
pharmapar inc
02512726
Tablet - Oral
20 MG
N/A
MAR-ENALAPRIL
marcan pharmaceuticals inc
02444798
Tablet - Oral
20 MG
3/20/2019
JAMP ENALAPRIL
02474794
Tablet - Oral
5 MG
2/25/2019

CIMA AEMPS Drug Approvals

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

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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