ENALAPRIL MALEATE
Enalapril maleate treats high blood pressure and is used to manage symptomatic congestive heart failure, often in combination with other medications like diuretics. It helps patients with heart failure by improving symptoms, increasing survival rates, and reducing the frequency of hospitalizations. The drug also helps patients with asymptomatic left ventricular dysfunction by slowing the progression to overt heart failure.
How ENALAPRIL MALEATE Works
After converting to its active form, enalaprilat, this drug works by inhibiting the angiotensin-converting enzyme (ACE) to prevent the production of angiotensin II, a substance that constricts blood vessels. This reduction in angiotensin II leads to decreased blood vessel constriction and lower aldosterone secretion, which helps lower blood pressure and reduce the workload on the heart.
Details
- Status
- Prescription
- First Approved
- 2000-08-22
- Routes
- ORAL
- Dosage Forms
- TABLET, SOLUTION
Companies
ENALAPRIL MALEATE Approval History
What ENALAPRIL MALEATE Treats
3 indicationsENALAPRIL MALEATE is approved for 3 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
- Heart Failure
- Left Ventricular Dysfunction
ENALAPRIL MALEATE Boxed Warning
FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue enalapril maleate 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 enalapril maleate 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 .)
ENALAPRIL MALEATE 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 ENALAPRIL MALEATE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ENALAPRIL MALEATE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ENALAPRIL MALEATE
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.
ENALAPRIL MALEATE FDA Label Details
Indications & Usage
ENALAPRIL MALEATE is indicated for the treatment of Hypertension; Heart Failure; Left Ventricular Dysfunction.
WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue enalapril maleate 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 Toxicit...
Looking for the branded version?
EPANED
Full clinical data, patents, trials, and competitive landscape for enalapril maleate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.