Vasotec

(Enalapril)

ApprovedSmall molecule

Enalapril is used to treat high blood pressure and heart failure by helping blood vessels relax and making it easier for the heart to pump blood.[2] Vasotec is currently approved and in use across 43 indications[4].[1]

Vasotec is one of 888 small molecule programs targeting Single ventricle. It is currently in Approved.

Indications

Total Trials

Active Trials

887

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Single VentricleActive, not recruiting

Metabolic SyndromeActive, not recruiting

Cardiovascular DiseaseActive, not recruiting

AlbuminuriaActive, not recruiting

Mitral RegurgitationActive, not recruiting

Essential HypertensionActive, not recruiting

Erectile DysfunctionActive, not recruiting

IschemiaActive, not recruiting

StrokeActive, not recruiting

Barrett's EsophagusApproved

Single VentriclePhase 3

Active, not recruiting

Metabolic SyndromeApproved

Active, not recruiting

Cardiovascular DiseaseApproved

Active, not recruiting

AlbuminuriaPreclinical

Active, not recruiting

Mitral RegurgitationPhase 3

Active, not recruiting

Essential HypertensionPhase 2

Active, not recruiting

Erectile DysfunctionPhase 3

Active, not recruiting

IschemiaPhase 1

Active, not recruiting

StrokePhase 2

Active, not recruiting

Barrett's EsophagusApproved

Approved

Showing 10 of 43 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Vasotec

BBausch Health Americas, Inc.

Approved

1 2

Tykerb

GSK

Preclinical

80 3

Avastin

BBio-Thera Solutions

Preclinical

153 4

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Preclinical

78 5

Prolia

Amgen

Preclinical

14 6

Voltaren

Novartis

Preclinical

1 7

Zolymbus

AbbVie

Preclinical

1 8

Lupron

EEastern Cooperative Oncology Group

Preclinical

5 9

Recentin

NNational Cancer Institute (NCI)

Preclinical

2 10

Tricor

JJagotec

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Recruiting

Obesity, Morbid

NCT03460366

Q4 2027

Phase 3Not yet recruiting

Preeclampsia

NCT07222852

Q4 2029

Phase 2Recruiting

C3 Glomerulopathy

NCT04183101

Q4 2030

Phase 2Recruiting

Venous Malformation

NCT06788314

Clinical

Trials by Indication[1]

Heart Failure9 trials

Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbidity-mortality in Patients With Chronic Heart Failure

Completed· Novartis logo

Novartis·Phase 3·NCT00853658·7,064 enrolled

Exercise Capacity Study of LCZ696 vs. Enalapril in Patients With Chronic Heart Failure and Reduced Ejection Fraction.

Completed· Novartis logo

Novartis·Phase 4·NCT02768298·201 enrolled

Study of Efficacy and Safety of LCZ696 in Japanese Patients With Chronic Heart Failure and Reduced Ejection Fraction

Completed· Novartis logo

Novartis·Phase 3·NCT02468232·225 enrolled

Show 6 more trials

Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode.

Completed· Novartis logo

Novartis·Phase 4·NCT02554890·887 enrolled

The Effect of Neprilysin (LCZ696) on Exercise Tolerance in Patients With Heart Failure

Completed·UUniversity of Sao Paulo General Hospital·Phase 4·NCT03190304·52 enrolled

Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 Followed by a 52-week, Double-blind Study of LCZ696 Compared With Enalapril in Pediatric Patients With Heart Failure

Completed· Novartis logo

Novartis·Phase 2/3·NCT02678312·393 enrolled

Evaluation of Heart Failure Treatment Guided by N-terminal Pro B-type Natriuretic Peptide (NTproBNP) vs Clinical Symptoms and Signs Alone

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00391846·252 enrolled

Pulmonary REsistance Modification Under Treatment With Sacubitril/valsartaN in paTients With Heart Failure With Reduced Ejection Fraction

Unknown status·—·Phase 4·NCT05487261·260 enrolled

randOmized stUdy Using acceleromeTry to Compare Sacubitril/valsarTan and Enalapril in Patients With Heart Failure

Completed· Novartis logo

Novartis·Phase 3·NCT02900378·621 enrolled

Hypertension5 trials

H-Type Hypertension Precision Medicine Trial

Unknown status·SShenzhen Ausa Pharmed Co.,Ltd·Phase 4·NCT03472508·3,600 enrolled

Extension Study to Assess Long Term Safety, Tolerability, and Efficacy of Valsartan and Enalapril Combined and Alone in Children With Hypertension

Completed· Novartis logo

Novartis·Phase 3·NCT00446511·250 enrolled

Telmisartan Compared With Enalapril in Elderly Patients With Blood Hypertension

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT02177461·374 enrolled

Show 2 more trials

Treatment of Mild Hypertension Study (TOMHS)

Completed·UUniversity of Minnesota·Phase 2·NCT00000522

Prevention of Diabetes and Hypertension

Terminated·IIstituto Auxologico Italiano·Phase 4·NCT00456963·3,000 enrolled

Cardiotoxicity3 trials

Prevention of Chemotherapy-induced Cardiotoxicity in High-risk Patients

Completed·EEuropean Institute of Oncology·Phase 4·NCT00292526·114 enrolled

Enalapril After Anthracycline Cardiotoxicity

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000547

Prevention of Anthracycline-induced Cardiotoxicity

Unknown status·EEuropean Institute of Oncology·Phase 3·NCT01968200·268 enrolled

Hypertensive2 trials

Anti-Hypertensive Agent (ACEi) and Heart Function Improvement in Association With Rho Kinase Activity Changes in Human

Unknown status·NNational Cheng-Kung University Hospital·Phase 4·NCT01069042·60 enrolled

An Extension Study to Evaluate the Long Term Safety, Tolerability and Efficacy of Aliskiren Compared to Enalapril in Pediatric Hypertensive Patients 6-17 Years of Age

Completed· Novartis logo

Novartis·Phase 3·NCT01151410·208 enrolled

High Blood Pressure2 trials

A Study to Determine the Effectiveness and Tolerability of MK8141 in Patients With High Blood Pressure (MK-8141-006)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT00543413·160 enrolled

Effect of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children With High Blood Pressure

Completed· Novartis logo

Novartis·Phase 3·NCT00433836·300 enrolled

44 more indications

Chagas cardiomyopathy1 trial

Angiotensin Receptor-Neprilysin Inhibition in Chagas Cardiomyopathy With Reduced Ejection Fraction: ANSWER-HF.

Recruiting·UUniversity of Sao Paulo General Hospital·Phase 3·NCT04853758·200 enrolled

Enzyme Inhibitors1 trial

Angiotensin-converting Enzyme Inhibitors and Early Sickle Cell Renal Disease in Children

Terminated·AAssistance Publique - Hôpitaux de Paris·N/A·NCT01096121·5 enrolled

Double-blind1 trial

A Randomized, Double-blind Controlled Study Comparing LCZ696 to Medical Therapy for Comorbidities in HFpEF Patients

Completed· Novartis logo

Novartis·Phase 3·NCT03066804·2,572 enrolled

ALS1 trial

Study of Effects of Sacubitril/Valsartan vs. Enalapril on Aortic Stiffness in Patients With Mild to Moderate HF With Reduced Ejection Fraction

Completed· Novartis logo

Novartis·Phase 4·NCT02874794·465 enrolled

ACE Inhibitors1 trial

The Use of ACE Inhibitors in the Early Renal Post-transplant Period

Completed·MMontefiore Medical Center·Phase 1·NCT00270153·110 enrolled

Tics1 trial

A Study to Assess the Effect of ASP1585 on Pharmacokinetics of Enalapril in Healthy Volunteers

Completed· Astellas logo

Astellas·Phase 1·NCT01115946·24 enrolled

Albuminuria1 trial

Chicken-Diet vs. Enalapril to Reduce Albuminuria

Completed·HHospital de Clinicas de Porto Alegre·N/A·NCT00484068·28 enrolled

Endothelial Function1 trial

Comparing ARNI With ACE Inhibitor on Endothelial Function

Withdrawn·—·Phase 4·NCT03119623

Diastolic Heart Failure1 trial

Evaluation of Enalapril Versus Placebo in Patients With Diastolic Heart Failure

Completed·WWake Forest University·Phase 3·NCT01411735·71 enrolled

Lupus Nephritis1 trial

Angiotensin-II Receptor Antibodies Blockade With Losartan in Patients With Lupus Nephritis

Unknown status·IInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran·N/A·NCT03526042·40 enrolled

Erectile Dysfunction1 trial

COmparing arNi and Ace For Improving Erectile Dysfunction in mEN With reduCed Ejection Fraction Heart Failure

Completed· Novartis logo

Novartis·Phase 3·NCT03917459·27 enrolled

Venous malformation1 trial

A Study of Enalapril in Treatment of Venous Malformations

Recruiting·OOslo University Hospital·Phase 2·NCT06788314·12 enrolled

C3 Glomerulopathy1 trial

Evaluation of a Renin Inhibitor, Aliskiren, Compared to Enalapril, in C3 Glomerulopathy

Recruiting·RRegion Skane·Phase 2·NCT04183101·30 enrolled

Metastatic Melanoma1 trial

Bevacizumab vs Dacarbazine in Metastatic Melanoma

Terminated·HHaukeland University Hospital·Phase 2·NCT01705392·2 enrolled

Stroke1 trial

Blood Pressure Management in Stroke Following Endovascular Treatment

Completed·HHamilton Health Sciences Corporation·Phase 2·NCT04484350·30 enrolled

Becker muscular dystrophy1 trial

Myocardial Fibrosis Progression in Duchenne and Becker Muscular Dystrophy - ACE Inhibitor Therapy Trial

Completed·IInCor Heart Institute·Phase 3·NCT02432885·76 enrolled

Metabolism1 trial

Metabolism of Methylphenidate and Enalapril Based on CES1 Genotype

Completed·—·Phase 4·NCT02135263·44 enrolled

Mitral regurgitation1 trial

Angiotensin Converting Enzyme Inhibition in Children With Mitral Regurgitation

Terminated·UUniversity of Utah·Phase 3·NCT00113698·5 enrolled

Drug1 trial

Genetic Determinants of ACEI Prodrug Activation

Completed·UUniversity of Michigan·Phase 4·NCT03051282·21 enrolled

Breast Cancer1 trial

PROACT: Can we Prevent Chemotherapy-related Heart Damage in Patients With Breast Cancer and Lymphoma?

Completed·SSouth Tees Hospitals NHS Foundation Trust·Phase 3·NCT03265574·111 enrolled

Postpartum Period1 trial

Comparing Nifedipine and Enalapril in Medical Resources Used in the Postpartum Period

Completed·—·Phase 4·NCT04236258·94 enrolled

Myocardial Infarction1 trial

The Effects of Sacubitril-Valsartan vs Enalapril on Left Ventricular Remodeling in ST-elevation Myocardial Infarction

Not yet recruiting·WWest China Hospital·Phase 3·NCT04912167·376 enrolled

Essential Hypertension1 trial

Efficacy and Safety of Lercanidipine and Enalapril in Patients With Essential Hypertension

Completed·RRECORDATI GROUP·Phase 2·NCT01093807·1,039 enrolled

Cardiovascular Disease1 trial

Early Detection of Atherosclerosis: a Randomized Trial in the Primary Prevention of Cardiovascular Diseases.

Unknown status·HHospital Arnau de Vilanova·Phase 4·NCT00734123·2,948 enrolled

Pseudohypoaldosteronism1 trial

Phase II Study of the Pathophysiology and Treatment With Enalapril and Polystyrene Sulfonate for Pseudohypoaldosteronism, Type I

Completed·NNational Center for Research Resources (NCRR)·Phase 2·NCT00004328·1 enrolled

Function1 trial

Expression and Function of the Renin-Angiotensin System in the Esophagus

Completed·GGöteborg University·Phase 1·NCT02879721·33 enrolled

IgA Nephropathy1 trial

Pilot Study of Enalapril and Renal Function in Patients With IgA Nephropathy

Completed·NNational Center for Research Resources (NCRR)·N/A·NCT00006137·43 enrolled

Peritoneal Dialysis1 trial

The Effect of Enalapril and Losartan on Peritoneal Membrane in Continuous Ambulatory Peritoneal Dialysis Patients

Unknown status·—·Phase 4·NCT01041963·90 enrolled

Left Ventricular Dysfunction1 trial

Studies of Left Ventricular Dysfunction (SOLVD)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000516

Chronic Kidney Disease1 trial

Renal Effects of an Angiotensin Converting Enzyme Inhibitor in Adults With Chronic Kidney Disease of Uncertain Aetiology

Unknown status·MMinistry of Health, Sri Lanka·Phase 1/2·NCT01624064·200 enrolled

Single ventricle1 trial

Trial of Angiotensin Converting Enzyme Inhibition in Infants With Single Ventricle--Pediatric Heart Network

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00113087·230 enrolled

Diabetes1 trial

DETAIL Study: Diabetes Exposed to Telmisartan and Enalapril

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00274118·250 enrolled

Radiation Pneumonitis1 trial

Mitigation of Radiation Pneumonitis and Fibrosis

Completed·VVA Office of Research and Development·Phase 2·NCT01754909·50 enrolled

Type 2 Diabetes Mellitus1 trial

Effect of Enalapril and Losartan Association Therapy on Proteinuria and Inflammatory Biomarkers in Diabetic Nephropathy: a Clinical Trial on Type 2 Diabetes Mellitus

Completed·UUniversity of Sao Paulo·Phase 4·NCT00419835·80 enrolled

Mortality1 trial

Efficacy and Safety of Sacubitril/Valsartan Compared With Enalapril on Morbidity, Mortality, and NT-proBNP Change in Patients With CCC

Completed· Novartis logo

Novartis·Phase 4·NCT04023227·918 enrolled

Angiotensin Converting Enzyme1 trial

Impact of Angiotensin Converting Enzyme Activity on Exercise Training Sensitivity

Completed·UUniversity of Copenhagen·N/A·NCT03949075·52 enrolled

Physical Activity1 trial

Study on the Effects of Sacubitril/Valsartan on Physical Activity and Sleep in Heart Failure With Reduced Ejection Fraction Patients.

Completed· Novartis logo

Novartis·Phase 4·NCT02970669·140 enrolled

Preeclampsia1 trial

Cardiovascular Protection After Preeclampsia With Enalapril

Not yet recruiting·WWomen and Infants Hospital of Rhode Island·Phase 3·NCT07222852·60 enrolled

Efficacy and Safety1 trial

A Study to Investigate the Efficacy and Safety of Different Doses of Losartan Potassium (MK0954-011)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00882440·576 enrolled

Nephropathy1 trial

Efficacy of Antioxidant Therapy Compared With Enalapril in Sickle Nephropathy

Unknown status·TThe University of The West Indies·N/A·NCT01891292·30 enrolled

Ischemia1 trial

Evaluation of the Effects of Oxygen Therapy and Enalapril for Diabetic Macular Ischemia

Unknown status·SShahid Beheshti University of Medical Sciences·Phase 1·NCT00899587

Metabolic Syndrome1 trial

Effect of Sitagliptin and an ACE Inhibitor on Blood Pressure in Metabolic Syndrome

Completed·VVanderbilt University·Phase 4·NCT00666848·24 enrolled

Obesity, Morbid1 trial

Bariatric Surgery and Pharmacokinetics Enalapril: BAR-MEDS Enalapril

Recruiting·NNorwegian University of Science and Technology··NCT03460366·12 enrolled

Unspecified2 trials

Renin Angiotensin System Study (RASS/B-RASS)

Completed·—·Phase 2·NCT00143949·285 enrolled

Relative Bioavailability Study With Enalapril in Healthy Volunteers

Unknown status·EEthicare GmbH·Phase 1·NCT02252692·24 enrolled

Regulatory

FDA Approval Timeline[5]

Jul 26, 1988

VASOTEC

NDA NDA018998

Aug 13, 2013

EPANED KIT

NDA NDA204308

Sep 20, 2016

EPANED

NDA NDA208686

Sources

References

[1]
ClinicalTrials.gov — 66 trial records for Enalapril. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Vasotec drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Enalapril compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Enalapril. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA208686). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Vasotec. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Bausch Health Americas, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Angiotensin-Converting Enzyme Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: BBausch Health Americas, Inc.

Patent Landscape[6]

Patent Cliff

Nov 6, 2032

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9855214Nov 6, 2032

9968553Nov 6, 2032

8568747Nov 6, 2032

8778366Nov 6, 2032

9669008Mar 25, 2036

8 more patents

10772868Mar 25, 2036

10786482Mar 25, 2036

10039745Mar 25, 2036

11173141Mar 25, 2036

11141405Mar 25, 2036

9808442Mar 25, 2036

10154987Mar 25, 2036

11040023Mar 25, 2036

Vasotec

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Q4 2029

Q4 2030

Trials by Indication[1]

Heart Failure9 trials

Hypertension5 trials

Cardiotoxicity3 trials

Hypertensive2 trials

High Blood Pressure2 trials

Chagas cardiomyopathy1 trial

Enzyme Inhibitors1 trial

Double-blind1 trial

ALS1 trial

ACE Inhibitors1 trial

Tics1 trial

Albuminuria1 trial

Endothelial Function1 trial

Diastolic Heart Failure1 trial

Lupus Nephritis1 trial

Erectile Dysfunction1 trial

Venous malformation1 trial

C3 Glomerulopathy1 trial

Metastatic Melanoma1 trial

Stroke1 trial

Becker muscular dystrophy1 trial

Metabolism1 trial

Mitral regurgitation1 trial

Drug1 trial

Breast Cancer1 trial

Postpartum Period1 trial

Myocardial Infarction1 trial

Essential Hypertension1 trial

Cardiovascular Disease1 trial

Pseudohypoaldosteronism1 trial

Function1 trial

IgA Nephropathy1 trial

Peritoneal Dialysis1 trial

Left Ventricular Dysfunction1 trial

Chronic Kidney Disease1 trial

Single ventricle1 trial

Diabetes1 trial

Radiation Pneumonitis1 trial

Type 2 Diabetes Mellitus1 trial

Mortality1 trial

Angiotensin Converting Enzyme1 trial

Physical Activity1 trial

Preeclampsia1 trial

Efficacy and Safety1 trial

Nephropathy1 trial

Ischemia1 trial

Metabolic Syndrome1 trial

Obesity, Morbid1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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