Prinivil

(lisinopril)

ApprovedSmall molecule

Lisinopril is used to treat high blood pressure and heart failure by helping your blood vessels relax so blood can flow more easily through your body.[2] Prinivil is currently approved and in use across 16 indications[4].[1]

Prinivil is one of 423 small molecule programs targeting Cardiovascular Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

422

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Cardiovascular DiseaseActive, not recruiting

Essential HypertensionActive, not recruiting

Diabetic NephropathyActive, not recruiting

Chest PainActive, not recruiting

Diastolic Heart FailureActive, not recruiting

Kidney DiseaseActive, not recruiting

FibrosisActive, not recruiting

Myocardial InfarctionActive, not recruiting

Congestive Heart FailureActive, not recruiting

Diabetes MellitusActive, not recruiting

Cardiovascular DiseaseApproved

Active, not recruiting

Essential HypertensionPreclinical

Active, not recruiting

Diabetic NephropathyApproved

Active, not recruiting

Chest PainPreclinical

Active, not recruiting

Diastolic Heart FailurePreclinical

Active, not recruiting

Kidney DiseasePreclinical

Active, not recruiting

FibrosisApproved

Active, not recruiting

Myocardial InfarctionApproved

Active, not recruiting

Congestive Heart FailureApproved

Active, not recruiting

Diabetes MellitusApproved

Active, not recruiting

Showing 10 of 16 indications

Competition

Competitive Landscape

314 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Prinivil

TTwinpig Biolab, Inc.

Approved

1 2

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Phase 3

7 3

Lipitor

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Phase 3

4 4

Fluciclovine

UUniversity of Utah

Phase 3

3 5

Piflufolastat F 18

Novartis

Phase 3

1 6

Fuzuloparib

JJiangsu HengRui Medicine Co., Ltd.

Phase 3

1 7

HC-1119

HHinova Pharmaceuticals Inc.

Phase 3

2 8

Trexall

Jazz Pharmaceuticals

Preclinical

—9

Jatenzo

GGrupo Espanol de Tumores Neuroendocrinos

Preclinical

2 10

Botox

VVitae Pharmaceuticals Inc., an Allergan affiliate

Preclinical

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

Timeline

Expected Milestones

Q1 2028

Phase 1Recruiting

Prostate Cancer

NCT05530655

Clinical

Trials by Indication[1]

Hypertension11 trials

COREG MR Versus TOPROL-XL On Reduction Of Microalbuminuria In Patients With Hypertension And Microalbuminuria

Terminated· GSK logo

GSK·Phase 3·NCT00123903·1,220 enrolled

Evaluation of Periop Biochemical Stress Factors in Craniotomy Neurosurgical Procedure With Respect to Preop Hypertension

Completed·MMilton S. Hershey Medical Center·Phase 4·NCT02441842·85 enrolled

Blood Pressure Effects of Nebivolol Versus Lisinopril in New Onset or Worsening Hypertension Induced by Bevacizumab

Withdrawn·UUniversity of Mississippi Medical Center·N/A·NCT01076140

Show 8 more trials

N-of-1 Trials In Children With Hypertension

Completed·TThe University of Texas Health Science Center, Houston·Phase 4·NCT03461003·49 enrolled

Genetics of Hypertension Associated Treatments (GenHAT)

Completed·DDonna Arnett, 257-5678··NCT00006294·37,939 enrolled

Non-invasive Haemodynamic Assessment in Hypertension

Completed·MMilitary Institute od Medicine National Research Institute·N/A·NCT01996085·144 enrolled

A Pilot Study of Plasma Renin Activity Guided vs Generic Combination Therapy for Hypertension

Completed·UUniversity of North Carolina, Chapel Hill·N/A·NCT01658657·17 enrolled

Benazepril Hydrochloride, Lisinopril, Ramipril, or Losartan Potassium in Treating Hypertension in Patients With Solid Tumors

Terminated·WWake Forest University Health Sciences·Phase 2·NCT01234922·6 enrolled

Black Education and Treatment of Hypertension (BEAT HTN)

Completed·—·Phase 4·NCT00661895·99 enrolled

Hypertension in Hemodialysis Patients (Aim 3)

Terminated·IIndiana University·Phase 3·NCT00582114·200 enrolled

Comparison of Optimal Hypertension Regimens

Completed·—·Phase 4·NCT02847338·940 enrolled

Chronic Kidney Disease3 trials

A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia

Terminated· AstraZeneca logo

AstraZeneca·Phase 3·NCT05056727·1,112 enrolled

Effect of ACE-inhibitors on Aortic Stiffness in Elderly Patients With Chronic Kidney Disease

Completed·UUniversity of Wisconsin, Madison·Phase 2·NCT00874432·43 enrolled

A Pilot Randomized Clinical Trial to Assess Feasibility, Safety, and Efficacy of Rapid, Simultaneous Therapy Initiation in Chronic Kidney Disease and Type 2 Diabetes: RAPID-CKD

Enrolling by invitation·BBaylor Research Institute·Approved·NCT07547878·64 enrolled

Cardiomyopathy3 trials

Cardiomyopathy in DMD: Lisinopril vs. Losartan

Completed·NNationwide Children's Hospital·N/A·NCT01982695·23 enrolled

Autophagy Activation for the Alleviation of Cardiomyopathy Symptoms After Anthracycline Treatment, ATACAR Trial

Withdrawn·MMayo Clinic·Phase 2·NCT04190433

Prophylactic Lisinopril to Prevent Anthracycline Cardiomyopathy.

Withdrawn·AAscension Health·Phase 4·NCT03392740

MPA2 trials

Comparative Bioavailability Study of Lisinopril Tablets, 10 mg

Completed·PPar Pharmaceutical, Inc.·Phase 1·NCT01375244·36 enrolled

A Comparative Bioavailability Study of Lisinopril Tablets, 40 mg - Effect of Food Study

Completed·PPar Pharmaceutical, Inc.·Phase 1·NCT01380431·18 enrolled

Polycystic Kidney Disease2 trials

HALT Progression of Polycystic Kidney Disease Study B

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 3·NCT01885559·486 enrolled

HALT Progression of Polycystic Kidney Disease Study A

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 3·NCT00283686·558 enrolled

46 more indications

Type 2 Diabetes2 trials

Effect of Angiotensin Converting Enzyme Inhibitor, Lisinopril, on Renal Blood Flow and Its Correlation With Proteinuria Reduction in Subjects With Type 2 Diabetes and Kidney Disease

Terminated·UUniversity of Virginia·N/A·NCT01101269·6 enrolled

Drugs for High Blood Pressure and High Cholesterol in American Indians With Type 2 Diabetes

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 3·NCT00004266·160 enrolled

Essential Hypertension2 trials

Series of N-of-1 Crossover Trials of Antihypertensive Therapy in Adolescents With Essential Hypertension

Completed·TThe University of Texas Health Science Center, Houston·N/A·NCT02412761·42 enrolled

Dose-finding Study With ACT-132577 (Aprocitentan) in Participants With Essential Hypertension

Completed· Idorsia Pharmaceuticals Ltd. logo

Idorsia Pharmaceuticals Ltd.·Phase 2·NCT02603809·1,659 enrolled

Fasting Conditions2 trials

To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablets Under Fasting Conditions

Completed· Novartis logo

Novartis·Phase 1·NCT00883064·32 enrolled

Bioequivalence Study of Two Formulations of Lisinopril Tablet 20 mg in Healthy Volunteers Under Fasting Conditions

Completed·PPharmtechnology LLC·Phase 1·NCT05061901·38 enrolled

Kidney Transplant1 trial

Safety Study of Lisinopril in Children and Adolescents With a Kidney Transplant

Completed·UUptal Patel·Phase 1·NCT01491919·26 enrolled

Kidney Disease1 trial

Maximal Dose of Angiotensin Converting Enzyme (ACE) Inhibitor for Treatment of Diabetic Kidney Disease

Completed·SSteno Diabetes Center Copenhagen·N/A·NCT00118976·60 enrolled

Stroke1 trial

Paramedic Initiated Lisinopril For Acute Stroke Treatment

Completed·NNewcastle-upon-Tyne Hospitals NHS Trust·Phase 1·NCT01066572·14 enrolled

AIN1 trial

CAndesartan vs LIsinopril Effects on the BRain

Completed·EEmory University·Phase 2·NCT01984164·176 enrolled

Renal Protection1 trial

Lisinopril for Renal Protection in Postpartum Preeclamptic Women

Withdrawn·—·N/A·NCT05016440

Albuminuria1 trial

VALERIA: Valsartan in Combination With Lisinopril in Hypertensive Patients With Microalbuminuria

Completed· Novartis logo

Novartis·Phase 3·NCT00171067·134 enrolled

Orthopedic Surgery1 trial

Risk Factor Control Before Orthopedic Surgery

Terminated·NNYU Langone Health·Phase 4·NCT01837069·198 enrolled

Cardiovascular Function1 trial

Efficacy of Coreg CR and Lisinopril on Markers for Cardiovascular Functional and Structural Disease

Completed·UUniversity of Minnesota·Phase 1/2·NCT00553969·101 enrolled

Fibrosis1 trial

ACE Inhibitors to Decrease Lymphoid Fibrosis in Antiretroviral-Treated, HIV-infected Patients: A Pilot Study

Completed·UUniversity of California, San Francisco·Phase 4·NCT01535235·31 enrolled

Acute Coronary Syndrome1 trial

Renal Denervation in Patients After Acute Coronary Syndrome

Unknown status·MMeshalkin Research Institute of Pathology of Circulation·Phase 2·NCT01901549·80 enrolled

Complication1 trial

Optimal Management of HIV Infected Adults at Risk for Kidney Complications in Nigeria

Terminated·VVanderbilt University Medical Center·Phase 2·NCT03201939·66 enrolled

Diabetic Nephropathy1 trial

Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy

Completed·SSteno Diabetes Center Copenhagen·Phase 4·NCT00311870·52 enrolled

ALS1 trial

Antiproteinuric Effect of Valsartan and Lisinopril

Completed· Novartis logo

Novartis·Phase 4·NCT00171574·124 enrolled

Glomerulonephritis1 trial

ACE-inhibitors in Extracapillary Glomerulonephritis

Unknown status·MMonia Lorini·Phase 2·NCT02682459·22 enrolled

Heart Failure1 trial

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

Heart Attack1 trial

Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000542

Diabetes1 trial

Comparison Of Morning And Evening Dosing Of Valsartan And Lisinopril In Patients With Diabetes

Completed· Novartis logo

Novartis·Phase 4·NCT00241124·1,099 enrolled

Cardiovascular Prevention1 trial

Cardiovascular Prevention for Persons With HIV

Completed·HHennepin Healthcare Research Institute·N/A·NCT00982189·37 enrolled

Gastrointestinal1 trial

Effect of Liraglutide on Gastrointestinal Absorption of Several Drugs and Potential Influence of Liraglutide on Intragastric pH

Completed· Novo Nordisk logo

Novo Nordisk·Phase 1·NCT01518166·70 enrolled

Fed1 trial

Bioequivalence Study of Lisinopril Tablets 40 mg Under Fed Condition

Completed·IIPCA Laboratories Ltd.·Phase 1·NCT01735344·40 enrolled

Type 1 Diabetes1 trial

The Effect of Amlodipine and Lisinopril on Retinal Autoregulation in Type 1 Diabetes

Completed·UUniversity of Aarhus·N/A·NCT00337298·25 enrolled

Elderly Patients1 trial

Effect of RAS Blockers on CKD Progression in Elderly Patients With Non Proteinuric Nephropathies (PROERCAN01)

Unknown status·HHospital General Universitario Gregorio Marañon·Phase 4·NCT03195023·106 enrolled

Blood Pressure1 trial

A Study of the Effect of LY2189265 on Two Blood Pressure Drugs

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01324388·51 enrolled

Lung Cancer1 trial

Lisinopril in Reducing Shortness of Breath Caused by Radiation Therapy in Patients With Lung Cancer

Completed·MMayo Clinic·Phase 2·NCT01880528·23 enrolled

Hypertensive1 trial

Hypertensive Ambulatory Trial to Compare the Efficacy of HCTZ and Lisinopril

Completed·SScripps Translational Science Institute·N/A·NCT01258764·2 enrolled

Semaglutide1 trial

A Trial Investigating the Influence of Oral Semaglutide on the Pharmacokinetics of Lisinopril and Warfarin in Healthy Subjects

Completed· Novo Nordisk logo

Novo Nordisk·Phase 1·NCT02070510·52 enrolled

Pilot Study1 trial

A Pilot Study: Preventing Adverse Remodelling Following Pacemaker Implantation

Unknown status·UUniversity of Leeds·Phase 2·NCT03422705·75 enrolled

Chest pain1 trial

Women With Chest Pain and Normal Coronary Arteries Study

Terminated·NNorthwestern University·N/A·NCT00743197·3 enrolled

Orthostatic Hypotension1 trial

Evaluation of Potential for Orthostatic Hypotension in Elderly Hypertensives

Completed· GSK logo

GSK·Phase 1·NCT00508365·62 enrolled

Nephropathy1 trial

VA NEPHRON-D: Diabetes iN Nephropathy Study

Terminated·UUS Department of Veterans Affairs·Phase 3·NCT00555217·1,448 enrolled

Infertility1 trial

The Effect and Safety of Lisinopril in Non-hypertensive Men With Infertility From Low Sperm Count

Completed·—·Phase 2·NCT01409837·33 enrolled

Combination Therapy1 trial

The COREG And Lisinopril Combination Therapy In Hypertensive Subjects (COSMOS) Trial

Completed· GSK logo

GSK·Phase 3·NCT00347360·654 enrolled

Carvedilol1 trial

Vascular Benefits of Adding CarvedilolCR to Type2 Diabetic Patients on ACEI.

Terminated·UUniversity at Buffalo·Phase 4·NCT00430040·14 enrolled

Type 2 Diabetes Mellitus1 trial

A Pharmacodynamic/Pharmacokinetic Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus on Treatment With Lisinopril

Completed· Roche logo

Roche·Phase 1·NCT01398267·55 enrolled

Thyroid1 trial

The Renin-Angiotensin-Aldosterone System and Parathyroid Hormone Control: The RAAS-PARC Study

Completed·—·N/A·NCT01691781·41 enrolled

Gastric Emptying1 trial

Study of the Effects of ITCA 650 on Gastric Emptying and Interaction of ITCA 650 on 4 Commonly Studied Drugs

Completed·IIntarcia Therapeutics·Phase 1·NCT02641899·33 enrolled

Breast Cancer1 trial

Lisinopril or Coreg CR® in Reducing Side Effects in Women With Breast Cancer Receiving Trastuzumab

Completed·UUniversity of South Florida·Phase 2·NCT01009918·468 enrolled

Cognitive Function1 trial

The Antihypertensives and Vascular, Endothelial and Cognitive Function Trial

Completed·UUniversity of Southern California·Phase 2·NCT00605072·53 enrolled

Regression1 trial

The CLEVER Study - Coreg And Left Ventricular Mass Regression

Completed· GSK logo

GSK·Phase 3·NCT00108082·287 enrolled

Adult1 trial

A Study of Enlicitide Decanoate (MK-0616), Warfarin, and Lisinopril in Healthy Adult Participants (MK-0616-026)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06772779·36 enrolled

Hepatocellular Carcinoma1 trial

Role of Lisinopril in Preventing The Progression of Non-Alcoholic Fatty Liver Disease (NAFLD): Relief-NAFLD

Active, not recruiting·NNorthwestern University·Phase 2·NCT04550481·35 enrolled

Prostate Cancer1 trial

A Phase I Study to Determine the Preferred Dose of the Angiotensin Converting Enzyme Inhibitor Lisinopril for Preventing Urinary Toxicity Following Radiotherapy for Prostate Cancer

Recruiting·UUniversity of Rochester·Phase 1·NCT05530655·30 enrolled

Unspecified3 trials

Bioequivalence Study of Lisinopril Tablets 40 mg Under Fasting Condition

Completed·IIPCA Laboratories Ltd.·Phase 1·NCT01735318·40 enrolled

A Study Investigating the Bioequivalence of the Fixed Dose Combination of COREG CR to COREG CR and ZESTRIL.

Completed· GSK logo

GSK·Phase 1·NCT00552708·55 enrolled

Modulation of Heme Oxygenase 1 by Nizatidine and Lisinopril in Healthy Subjects

Completed·AAdil Bharucha·Phase 1·NCT02232308·24 enrolled

Regulatory

FDA Approval Timeline[5]

Apr 29, 1993

ZESTRIL

NDA NDA019777

Jan 28, 1994

PRINIVIL

NDA NDA019558

Jul 29, 2016

QBRELIS

NDA NDA208401

Sources

References

[1]
ClinicalTrials.gov — 72 trial records for lisinopril. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Prinivil drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — lisinopril compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for lisinopril. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA208401). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Prinivil. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Twinpig Biolab, 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: TTwinpig Biolab, Inc.

Patent Landscape[6]

Patent Cliff

Nov 6, 2035

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9616096Nov 6, 2035

10039800Nov 6, 2035

10406199Nov 6, 2035

12433931Nov 6, 2035

10265370Nov 6, 2035

7 more patents

9463183Nov 6, 2035

11179434Nov 6, 2035

9814751Nov 6, 2035

10940177Nov 6, 2035

11771733Nov 6, 2035

12186360Nov 6, 2035

12128083Nov 6, 2035

Prinivil

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2028

Trials by Indication[1]

Hypertension11 trials

Chronic Kidney Disease3 trials

Cardiomyopathy3 trials

MPA2 trials

Polycystic Kidney Disease2 trials

Type 2 Diabetes2 trials

Essential Hypertension2 trials

Fasting Conditions2 trials

Kidney Transplant1 trial

Kidney Disease1 trial

Stroke1 trial

AIN1 trial

Renal Protection1 trial

Albuminuria1 trial

Orthopedic Surgery1 trial

Cardiovascular Function1 trial

Fibrosis1 trial

Acute Coronary Syndrome1 trial

Complication1 trial

Diabetic Nephropathy1 trial

ALS1 trial

Glomerulonephritis1 trial

Heart Failure1 trial

Heart Attack1 trial

Diabetes1 trial

Cardiovascular Prevention1 trial

Gastrointestinal1 trial

Fed1 trial

Type 1 Diabetes1 trial

Elderly Patients1 trial

Blood Pressure1 trial

Lung Cancer1 trial

Hypertensive1 trial

Semaglutide1 trial

Pilot Study1 trial

Chest pain1 trial

Orthostatic Hypotension1 trial

Nephropathy1 trial

Infertility1 trial

Combination Therapy1 trial

Carvedilol1 trial

Type 2 Diabetes Mellitus1 trial

Thyroid1 trial

Gastric Emptying1 trial

Breast Cancer1 trial

Cognitive Function1 trial

Regression1 trial

Adult1 trial

Hepatocellular Carcinoma1 trial

Prostate Cancer1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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