Last reviewed 2026-04-20 · How we verify

Vasotec (ENALAPRIL MALEATE)

Vasotec works by blocking the conversion of angiotensin I to angiotensin II, a potent vasoconstrictor.

Vasotec (Enalapril Maleate) is an Angiotensin Converting Enzyme Inhibitor (ACE inhibitor) developed by Valeant Pharms North and currently owned by Azurity. It targets the angiotensin-converting enzyme to treat asymptomatic left ventricular systolic dysfunction, congestive heart failure, and hypertensive disorders. Vasotec is a small molecule modality, FDA-approved in 1985, with 21 generic manufacturers. The commercial status of Vasotec is off-patent, and its bioavailability is 64%. Key safety considerations include monitoring renal function and potassium levels.

At a glance

Mechanism of action

Mechanism of ActionEnalapril, after hydrolysis to enalaprilat, inhibits angiotensin-converting enzyme (ACE) in human subjects and animals. ACE is peptidyl dipeptidase that catalyzes the conversion of angiotensin to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. The beneficial effects of enalapril in hypertension and heart failure appear to result primarily from suppression of the renin-angiotensin-aldosterone system. Inhibition of ACE results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and to decreased aldosterone secretion. Although the latter decrease is small, it results in small increases of serum potassium. In hypertensive patients treated with VASOTEC alone for up to 48 weeks, mean increases in serum potassium of approximately 0.2 mEq/L were observed. In patients treated with VASOTEC plus thiazide diuretic, there was essentially no change in serum potassium (see PRECA

Approved indications

• Hypertension
• Symptomatic Congestive Heart Failure
• Asymptomatic Left Ventricular Dysfunction

Boxed warnings

• 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 .)

Common side effects

• Hypotension
• Dizziness
• Headache
• Fatigue
• Diarrhea
• Cough
• Orthostatic Effects
• Nausea
• Asthenia
• Abdominal Pain
• Rash
• Syncope

Drug interactions

• neprilysin inhibitors
• angiotensin receptor blockers, ACE inhibitors, or aliskiren
• diuretics
• agents causing renin release (e.g., diuretics)
• NSAIDs, including selective COX-2 inhibitors
• beta adrenergic-blocking agents, methyldopa, nitrates, calcium-blocking agents, hydralazine, prazosin, and digoxin
• agents increasing serum potassium

Key clinical trials

• Study of Hydroxychloroquine in Patients With X-linked Alport Syndrome in China (CHXLAS) (PHASE2)
• Mortality Control Program for Economically Productive Age Group in Tribal Area of Melghat. (PHASE4)
• Genetic Determinants of ACEI Prodrug Activation (PHASE4)
• The COVID-RASi Trial (COVID-19) (PHASE3)
• Nifedipine and Enalapril vs Nifedipine and Labetalol for the Treatment of Postpartum Hypertension Study (NA)
• Mineralocorticoid Receptor, Coronary Microvascular Function, and Cardiac Efficiency in Hypertension (PHASE4)
• Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Post-Stroke Pneumonia: A Real-World Retrospective Cohort Study
• Efficacy and Safety of Sacubitril/Valsartan Compared With Enalapril on Morbidity, Mortality, and NT-proBNP Change in Patients With CCC (PHASE4)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Vasotec CI brief — competitive landscape report
• Vasotec updates RSS · CI watch RSS
• Azurity portfolio CI