TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

VASOTEC

ENALAPRIL MALEATE
Cardiovascular Approved 1985-12-24
7
Indications
--
Phase 3 Trials
1
Priority Reviews
40
Years on Market

Details

Status
Prescription
First Approved
1985-12-24
Routes
ORAL, INJECTION
Dosage Forms
TABLET, INJECTABLE

Companies

Active Ingredient: ENALAPRIL MALEATE

VASOTEC Approval History

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What VASOTEC Treats

3 indications

VASOTEC is approved for 3 conditions since its original approval in 1985. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypertension
  • Heart Failure
  • Left Ventricular Dysfunction
Source: FDA Label

VASOTEC Boxed Warning

FETAL TOXICITY See full prescribing information for complete boxed warning. • When pregnancy is detected, discontinue VASOTEC ® as soon as possible. • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (see WARNINGS, Fetal Toxicity )....

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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

VASOTEC FDA Label Details

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Indications & Usage

FDA Label (PDF)

Hypertension VASOTEC is indicated for the treatment of hypertension. VASOTEC is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of VASOTEC and thiazides are approximately additive. Heart Failure VASOTEC is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients VASOTEC improves symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL PHARMACOLOGY , Heart Failure , Mortality Trials for ...

⚠️ BOXED WARNING

WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. • When pregnancy is detected, discontinue VASOTEC ® as soon as possible. • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (see WARNINGS, Fetal Toxicity )....

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.