VASOTEC (enalapril maleate) · BAUSCH
Vasotec is indicated for the treatment of hypertension, effective both as monotherapy and in combination with other antihypertensive agents, particularly thiazide-type diuretics. It is also indicated for the management of symptomatic congestive heart failure (usually in combination with diuretics and digitalis) to improve symptoms, increase survival, and decrease hospitalization. Additionally, in clinically stable patients with asymptomatic left ventricular dysfunction (ejection fraction ≤35%), Vasotec is used to reduce the incidence of hospitalization and slow the progression to overt heart failure.
How VASOTEC Works
Enalapril is a prodrug that, following hydrolysis to its active metabolite enalaprilat, inhibits angiotensin-converting enzyme (ACE). ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the potent vasoconstrictor angiotensin II. By inhibiting this process, enalaprilat decreases plasma angiotensin II levels, leading to reduced vasopressor activity and decreased aldosterone secretion. This suppression of the renin-angiotensin-aldosterone system lowers blood pressure and reduces the hemodynamic workload on the heart.
Details
- Status
- Prescription
- First Approved
- 1985-12-24
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, INJECTABLE
VASOTEC Approval History
What VASOTEC Treats
3 indicationsVASOTEC 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
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 )....
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 ).
VASOTEC Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in VASOTEC's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications VASOTEC treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to VASOTEC
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03466333 PICk-UP | R04725 | Ph 2 | completed | Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia |
| NCT03667131 | EEVA | Ph 2 | completed | Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis. |
| NCT01871740 CSPPT-CKD | Ausa-CSPPT-CKD | Ph 4 | withdrawn | CSPPT- Chronic Kidney Diseases Study |
| NCT00794885 CSPPT | Ausa-CSPPT | Ph 4 | completed | China Stroke Primary Prevention Trial |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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
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 ...
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.