EPANED (enalapril maleate)
Epaned treats high blood pressure in both adults and children older than one month. It also helps patients with symptomatic heart failure and those with asymptomatic left ventricular dysfunction. By lowering blood pressure, this medication helps reduce the risk of cardiovascular events like strokes and heart attacks, while also working to prevent the progression of heart failure and related hospitalizations.
How EPANED Works
Enalapril maleate is a prodrug that, following oral administration, is hydrolyzed to its active metabolite, enalaprilat. Enalaprilat is a potent, competitive inhibitor of angiotensin-converting enzyme (ACE), the peptidyl dipeptidase responsible for converting angiotensin I to the vasoconstrictor angiotensin II. By inhibiting ACE, the medication reduces plasma angiotensin II levels, leading to decreased vasopressor activity and diminished aldosterone secretion from the adrenal cortex. This suppression of the renin-angiotensin-aldosterone system (RAAS) results in systemic vasodilation and blood pressure reduction. Additionally, because ACE is identical to kininase II, the enzyme that degrades the vasodilator bradykinin, ACE inhibition may lead to increased levels of bradykinin, potentially contributing to the drug's antihypertensive effects.
Details
- Status
- Prescription
- First Approved
- 2016-09-20
- Patent Cliff
- 2036
- Routes
- ORAL
- Dosage Forms
- SOLUTION
EPANED Approval History
What EPANED Treats
3 indicationsEPANED is approved for 3 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
- Heart Failure
- Left Ventricular Dysfunction
EPANED Boxed Warning
FETAL TOXICITY When pregnancy is detected, discontinue EPANED ® as soon as possible. [See Warnings and Precautions ( 5.1 )] Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. [See Warnings and Precautions ( 5.1 )] WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue EPANED as soon as possible ( 5.1 ). Drugs that act directly on the renin-angiotensin system can cause in...
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue EPANED ® as soon as possible. [See Warnings and Precautions ( 5.1 )] Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. [See Warnings and Precautions ( 5.1 )] WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue EPANED as soon as possible ( 5.1 ). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.1 ).
EPANED 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 EPANED's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications EPANED treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to EPANED
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.
EPANED FDA Label Details
Indications & Usage
FDA Label (PDF)EPANED is indicated for the treatment of Hypertension; Heart Failure; Left Ventricular Dysfunction.
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue EPANED ® as soon as possible. [See Warnings and Precautions ( 5.1 )] Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. [See Warnings and Precautions ( 5.1 )] WARNING: FETAL TOXIC...
EPANED Patents & Exclusivity
Patents (9 active)
Pro Intelligence Preview
Deep insights for EPANED
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 17 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.