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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
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

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