ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE (enalapril maleate)
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE is indicated for the treatment of Hypertension; Angioedema.
How ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE Works
Enalapril, converted to enalaprilat, inhibits angiotensin-converting enzyme (ACE), preventing the conversion of angiotensin I to the vasoconstrictor angiotensin II. This results in decreased vasopressor activity and reduced aldosterone secretion. While ACE inhibition typically increases serum potassium, the concomitant use of the thiazide diuretic hydrochlorothiazide offsets this effect, maintaining potassium balance. The combination provides broad efficacy across various patient populations, including those with low-renin hypertension.
Details
- Status
- Discontinued
- First Approved
- 2001-09-18
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE Approval History
What ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE Treats
2 indicationsENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE is approved for 2 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
- Angioedema
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE Boxed Warning
FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue enalapril maleate and hydrochlorothiazide 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 and hydrochlorothiazide 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 AND HYDROCHLOROTHIAZIDE 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 AND HYDROCHLOROTHIAZIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE treats. First-in-class if their pivotal trials read out positive.
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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 AND HYDROCHLOROTHIAZIDE FDA Label Details
Indications & Usage
FDA Label (PDF)ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE is indicated for the treatment of Hypertension; Angioedema.
WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue enalapril maleate and hydrochlorothiazide as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.