VASERETIC (enalapril maleate)
VASERETIC is indicated for the treatment of Hypertension; Renal Impairment; Angioedema.
How VASERETIC Works
Vaseretic combines two antihypertensive mechanisms. Enalapril maleate is a prodrug that, after hydrolysis to enalaprilat, inhibits angiotensin-converting enzyme (ACE). This inhibition prevents the conversion of angiotensin I to angiotensin II, a potent vasoconstrictor, leading to decreased vasopressor activity and reduced aldosterone secretion. Hydrochlorothiazide is a thiazide diuretic that promotes the excretion of water and electrolytes. While ACE inhibitors alone can cause small increases in serum potassium, the addition of hydrochlorothiazide helps attenuate this effect. The combination effectively lowers blood pressure through both the suppression of the renin-angiotensin-aldosterone system and the reduction of plasma volume.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1986-10-31
- Routes
- ORAL
- Dosage Forms
- TABLET
VASERETIC Approval History
What VASERETIC Treats
3 indicationsVASERETIC is approved for 3 conditions since its original approval in 1986. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
- Renal Impairment
- Angioedema
VASERETIC Boxed Warning
FETAL TOXICITY See full prescribing information for complete boxed warning. • When pregnancy is detected, discontinue VASERETIC ® 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 VASERETIC ® 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
VASERETIC 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 VASERETIC's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications VASERETIC treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to VASERETIC
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.
VASERETIC FDA Label Details
Indications & Usage
FDA Label (PDF)VASERETIC is indicated for the treatment of Hypertension; Renal Impairment; Angioedema.
WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. • When pregnancy is detected, discontinue VASERETIC ® 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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment