Avapro

(Irbesartan)

ApprovedSmall molecule

Irbesartan is used to treat high blood pressure and to protect the kidneys in patients with type 2 diabetes who have high blood pressure.[2] Avapro is currently approved and in use across 21 indications[4].[1]

Avapro is one of 476 small molecule programs targeting Cardiovascular Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

475

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Cardiovascular DiseaseActive, not recruiting

Endothelial DysfunctionCompleted

Ehlers-Danlos Syndrome, Vascular TypeApproved

Left Ventricular HypertrophyCompleted

Ebola Hemorrhagic FeverApproved

Diabetic NephropathyCompleted

Acute Myocardial InfarctionCompleted

Type 2 Diabetes MellitusActive, not recruiting

Congestive Heart FailureApproved

Myocardial IschemiaApproved

Cardiovascular DiseaseApproved

Active, not recruiting

Endothelial DysfunctionApproved

Completed

Ehlers-Danlos Syndrome, Vascular TypeApproved

Approved

Left Ventricular HypertrophyApproved

Completed

Ebola Hemorrhagic FeverApproved

Approved

Diabetic NephropathyApproved

Completed

Acute Myocardial InfarctionApproved

Completed

Type 2 Diabetes MellitusApproved

Active, not recruiting

Congestive Heart FailureApproved

Approved

Myocardial IschemiaApproved

Approved

Showing 10 of 21 indications

Competition

Competitive Landscape

198 competitors in Heart Failure

#DrugCompanyPhaseTrials

Avapro

Sanofi

Approved

2 2

Bayer Aspirin

Bayer

Preclinical

2 3

Brethine

Sanofi

Preclinical

1 4

Amidate

Pfizer

Preclinical

1 5

Activase

Zemplar

Adriamycin

Savaysa

Xifaxan

2 10

Xylocaine

MMEDRx USA, Inc.

Preclinical

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

Timeline

Expected Milestones

Q4 2027

Post-ApprovalNot yet recruiting

Diabetic Retinopathy

NCT06660940

Clinical

Trials by Indication[1]

Hypertension11 trials

The Efficacy and Safety of Irbesartan 150/12.5 mg and 300/25 mg in Patients With Mild Hypertension

Completed· Sanofi logo

Sanofi·Phase 4·NCT00562809·1,005 enrolled

The Effect of Moxonidine on Blood Pressure and Regression of Early Target Organ Damage in Young Subjects With Abdominal Obesity and Hypertension

Unknown status·BBaker Heart and Diabetes Institute·Phase 4·NCT01360710·100 enrolled

A Study to Evaluate ALN-AGT01 in Patients With Hypertension

Completed· Alnylam Pharmaceuticals logo

Alnylam Pharmaceuticals·Phase 1·NCT03934307·124 enrolled

Show 8 more trials

Irbesartan in Hypertension

Completed· Sanofi logo

Sanofi·Phase 4·NCT00265967·88 enrolled

A Study To Evaluate The Dose-Related Efficacy and Safety of PS433540 in Subjects With Hypertension

Completed·LLigand Pharmaceuticals·Phase 2·NCT00635232·261 enrolled

VALID: Study to Compare the Reduction of Predialysis Systolic Blood Pressure With Valsartan Compared to Irbesartan in Patients With Mild to Moderate Hypertension on Long-term Hemodialysis

Completed· Novartis logo

Novartis·Phase 3·NCT00171080·86 enrolled

Irbesartan/Hydrochlorothiazide and Irbesartan in the Treatment of Mild to Moderate Hypertension

Completed· Sanofi logo

Sanofi·Phase 3·NCT00263003·40 enrolled

Irbesartan-Hydrochlorothiazide Phase IV Study: Treatment of Hypertension in Chinese Population

Completed· Sanofi logo

Sanofi·Phase 4·NCT00847834·968 enrolled

APROVE : Irbesartan in Hypertension

Completed· Sanofi logo

Sanofi·Phase 4·NCT00283036·200 enrolled

Irbesartan for the Prevention of Atrial Arrhythmias and Cardiac Electrical Remodeling in Patients With Hypertension and Permanent Pacemakers

Unknown status·—·Phase 3·NCT00225667·200 enrolled

Left Atrial Remodelling in Hypertension: Effects of Ramipril or Irbesartan

Unknown status·UUniversità degli Studi dell'Insubria·Phase 4·NCT00517322·80 enrolled

ART5 trials

Irbesartan Versus Amlodipine: The OBI Study

Withdrawn·—·Phase 4·NCT00987662

Irbesartan and Adhesion Molecules in AF

Unknown status·UUniversity of Magdeburg·Phase 4·NCT00613496·60 enrolled

Irbesartan/Hydrochlorothiazide National Taiwan University Hospital Listing

Completed· Sanofi logo

Sanofi·Phase 4·NCT00443612·60 enrolled

Show 2 more trials

Crossover Bioequivalence Study of Irbesartan 300 mg Tablets Under Fed Conditions

Completed·RRoxane Laboratories·N/A·NCT01712100·34 enrolled

Crossover Bioequivalence Study of Irbesartan 300 mg Tablets Under Fasted Conditions

Completed·RRoxane Laboratories·N/A·NCT01712113·33 enrolled

Hypertensive3 trials

Irbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Irbesartan 150 mg Monotherapy

Completed· Sanofi logo

Sanofi·Phase 3·NCT00957554·435 enrolled

I SAVE - Irbesartan in Mild to Moderate Hypertensive Patients

Completed· Sanofi logo

Sanofi·Phase 4·NCT00335673·1,630 enrolled

I PREVENT - Irbesartan In Hypertensive Diabetic Patients

Completed· Sanofi logo

Sanofi·Phase 4·NCT00362258·797 enrolled

Albuminuria3 trials

Randomized, Parallel, Comparison, Double-Blind Efficacy & Safety Study of APROVEL Versus Placebo in Chinese Patients With Hypertensive Type II Diabetic Patients With Microalbuminuria

Completed· Sanofi logo

Sanofi·Phase 3·NCT00561964·241 enrolled

Irbesartan in Chinese Hypertensive Diabetics With Microalbuminuria

Completed· Sanofi logo

Sanofi·Phase 4·NCT00334581·192 enrolled

Optimal Dose of Irbesartan for Renoprotection in Type 2 Diabetic Patients With Persistent Microalbuminuria

Completed·SSteno Diabetes Center Copenhagen·Phase 4·NCT00320879·52 enrolled

Blood Pressure3 trials

The Relative Effects of Olmesartan Medoxomil, Irbesartan and Valsartan on the Activity of the Blood Pressure Control System in Healthy Subjects

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 4·NCT00185055·20 enrolled

Irbesartan and Amlodipine Combination in Controlling Blood Pressure

Completed· Sanofi logo

Sanofi·Phase 2·NCT00950066·270 enrolled

The Predictive Role of Urinary Proteomics in Blood Pressure Response of Obese Hypertensive Treated With Irbesartan or Eplerenone.

Unknown status·HHippocration General Hospital·N/A·NCT06208072·50 enrolled

40 more indications

Chronic Kidney Disease2 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

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

Dialysis Patients2 trials

Sacubitril/Valsartan for CKD5 Stage Dialysis Patients

Completed·RRuijin Hospital·Phase 4·NCT05243199·330 enrolled

Saving Residual Renal Function Among Haemodialysis Patients Receiving Irbesartan

Completed·UUniversity of Aarhus·Phase 3·NCT00791830·82 enrolled

Tics2 trials

Pharmacokinetics of Irbesartan/Amlodipine High FDC and Co-administration of Irbesartan and Amlodipine High in Healthy Volunteers

Completed·HHandok Inc.·Phase 1·NCT05688098·44 enrolled

Pharmacokinetics of Irbesartan/Amlodipine FDC and Co-administration of Irbesartan and Amlodipine in Healthy Volunteers

Completed·HHandok Inc.·Phase 1·NCT05663073·46 enrolled

Hyperlipidemia2 trials

Efficacy and Safety of Irbesartan and Atorvastatin in Hypertension and Hyperlipidemia

Completed· Hanmi Pharmaceutical Company Limited logo

Hanmi Pharmaceutical Company Limited·Phase 3·NCT01442987·230 enrolled

Evaluation of the Fixed-dose Combination of Irbesartan/Atorvastatin in Type 2 Diabetic Patients Diagnosed With Hyperlipidemia and Hypertension

Completed· Sanofi logo

Sanofi·Phase 4·NCT02842359·11 enrolled

Essential Hypertension2 trials

Clinical Efficacy and Safety Evaluation of Irbesartan High and Amlodipine Combined Therapy in Essential Hypertension Patients

Completed·HHandok Inc.·Phase 3·NCT05475665·157 enrolled

Clinical Efficacy and Safety Evaluation of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension Patients

Completed·HHandok Inc.·Phase 3·NCT05476354·271 enrolled

IgA Nephropathy2 trials

A Study of the Effect and Safety of HS-10390 in the Treatment of Patients with Primary IgA Nephropathy

Not yet recruiting·HHansoh BioMedical R&D Company·Phase 2·NCT06635772·90 enrolled

Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN)

Completed·SSun Yat-sen University·Phase 3·NCT00657059·151 enrolled

Focal Segmental Glomerulosclerosis2 trials

Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)

Active, not recruiting·TTravere Therapeutics, Inc.·Phase 3·NCT03493685·371 enrolled

Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental Glomerulosclerosis

Completed·TTravere Therapeutics, Inc.·Phase 2·NCT01613118·109 enrolled

Heart Failure2 trials

Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00095238·4,128 enrolled

Effect of Irbesartan on Insulin Sensitivity in Chronic Heart Failure

Completed·—·Phase 4·NCT00347087·36 enrolled

Interaction2 trials

Drug Interaction Between Irbesartan and Hydrochlorothiazide

Completed·—·N/A·NCT01858610·18 enrolled

Pharmacokinetic Drug Interaction Study Between Gemigliptin and Irbesartan After Oral Administration in Healthy Male Subjects

Completed·LLG Life Sciences·Phase 1·NCT01825850·30 enrolled

Endothelial Dysfunction2 trials

Effect of the Angiotensin II Receptor Antagonist Irbesartan on Biochemical and Functional Markers of Endothelial Dysfunction in Patients With Hypertension

Completed· Sanofi logo

Sanofi·Phase 4·NCT00529750·108 enrolled

Irbesartan Effects on Endothelial Dysfunction in Hypertensive Type II Diabetic Patients Comparing Atenolol

Completed· Sanofi logo

Sanofi·Phase 4·NCT00549133·44 enrolled

Preeclampsia1 trial

Preeclampsia: A Marker for Future Cardiovascular Risk in Women

Suspended·—·N/A·NCT01519297·150 enrolled

COVID-191 trial

Host Response Mediators in Coronavirus (COVID-19) Infection - Is There a Protective Effect of Losartan and Other ARBs on Outcomes of Coronavirus Infection?

Terminated·UUniversity of British Columbia·Phase 3·NCT04606563·341 enrolled

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00352560·44 enrolled

Efficacy and Safety1 trial

Evaluation of Efficacy and Safety of the Dosage Adjustment of Aprovel® (Irbesartan) in Hypertensive Outpatients in Current Clinical Practice

Completed· Sanofi logo

Sanofi·Phase 4·NCT00564187·115 enrolled

Spironolactone1 trial

Using the Drug Spironolactone to Test If It Reduces Protein Leakage From the Kidney

Completed·MMelbourne Health·Phase 2/3·NCT00106561·60 enrolled

Type 2 Diabetes Mellitus1 trial

A Clinical Study to Evaluate Renal Hemodynamic Responses to Aliskiren in Patients With Type 2 Diabetes Mellitus

Completed· Novartis logo

Novartis·Phase 4·NCT00660309·45 enrolled

Hypercholesterolemia1 trial

Effect of Irbesartan on Endothelial Function of the Retinal Vasculature in Patients With Hypercholesterolemia

Withdrawn·UUniversity of Erlangen-Nürnberg Medical School·Phase 3·NCT00152698

Effectiveness1 trial

Effectiveness of Avapro in Obese Normotensive/Hypertensive African Americans

Unknown status·—·Phase 2·NCT02386293·30 enrolled

Allograft1 trial

Comparison of Standard Versus Low Dose Advagraf® With or Without Angiotensin-converting Enzyme Inhibitor (ACEi)/Angiotensin Receptor Blocker (ARB) on Histology and Function of Renal Allografts

Completed· Astellas logo

Astellas·Phase 3·NCT00933231·281 enrolled

Obesity1 trial

A Prospective, Single-center, Randomized, Controlled Study of Sevelamer Carbonate in the Lipid Metabolism and Uric Acid Treatment of Obesity-Related Glomerulopathy

Terminated·ZZhi-Hong Liu, M.D.·N/A·NCT02644486·4 enrolled

Heart Disease1 trial

Irbesartan and Atenolol in Hypertensive Heart Disease

Completed·KKarolinska Institutet·Phase 2/3·NCT00389168·115 enrolled

Endothelial Function1 trial

Irbesartan, Ciprofibrate and Their Combination Onto the Endothelial Functions

Completed· Sanofi logo

Sanofi·Phase 4·NCT00350038·60 enrolled

Kidney Disease1 trial

Clinical Trial of HuangKui Capsule to Treat Diabetic Kidney Disease

Unknown status·JJiangsu Famous Medical Technology Co., Ltd.·Phase 1·NCT03016832·414 enrolled

Acute Myocardial Infarction1 trial

Left Ventricular Function After Acute Myocardial Infarction (AMI). Treatment With Angiotensin 2-Receptor Blockade (GLOBAL-Study)

Completed·UUniversity of Southern Denmark·Phase 4·NCT00125645·200 enrolled

Trial1 trial

A Bioequivalence Trial of Irbesartan Tablets（0.15g） in Healthy Chinese Subjects

Unknown status·TThe Affiliated Hospital of Qingdao University·Phase 1·NCT05297929·54 enrolled

Left Ventricular Hypertrophy1 trial

I SELECT - Irbesartan In Hypertensive Patients With Left Ventricular Hypertrophy

Completed· Sanofi logo

Sanofi·Phase 4·NCT00362037·281 enrolled

Metabolic Syndrome1 trial

Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT00110422·400 enrolled

Sepsis1 trial

Angiotensin II Antagonist in Severe Sepsis

Unknown status·UUniversity of Salerno·Phase 3·NCT01992796·300 enrolled

Vasodilation1 trial

Role of AT1-receptor Blockers in Insulin-induced Vasodilation.

Unknown status·MMaastricht University Medical Center·N/A·NCT00742066·32 enrolled

Chronic Hepatitis1 trial

Evaluation of Irbesartan on Hepatic Fibrosis in Chronic Hepatitis C

Completed·AANRS, Emerging Infectious Diseases·Phase 3·NCT00265642·166 enrolled

Acute Coronary Syndrome1 trial

ARCHIPELAGO: Irbesartan in Patients With Acute Coronary Syndrome Without ST Segment Elevation

Completed· Sanofi logo

Sanofi·Phase 3·NCT00296218·440 enrolled

Atrial Fibrillation1 trial

Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE I)

Completed· Sanofi logo

Sanofi·Phase 3·NCT00249795·9,016 enrolled

Type 2 Diabetes1 trial

Nephropathy In Type 2 Diabetes and Cardio-renal Events

Completed·UUniversity of Campania Luigi Vanvitelli·Phase 4·NCT00535925·850 enrolled

Diabetic Retinopathy1 trial

Clinical Trial of Keluoxin Capsules in the Treatment of Diabetic Kidney Disease with Diabetic Retinopathy

Not yet recruiting·—·Phase 4·NCT06660940·460 enrolled

Immunoglobulin A Nephropathy1 trial

A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy

Completed·TTravere Therapeutics, Inc.·Phase 3·NCT03762850·406 enrolled

Obesity, Morbid1 trial

Bariatric Surgery and Pharmacokinetics Irbesartan: BAR-MEDS Irbesartan

Recruiting·NNorwegian University of Science and Technology··NCT03476603·12 enrolled

Unspecified2 trials

Angiotensin II Receptor Blockade in Vascular Ehlers Danlos Syndrome (ARCADE)

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT02597361·61 enrolled

Characterization of Vascular Effects of Angiotensin II in Dorsal Human Hand Veins.

Completed·TTechnische Universität Dresden·N/A·NCT00180024

Regulatory

FDA Approval Timeline[5]

Sep 30, 1997

AVAPRO

NDA NDA020757

Sep 30, 1997

AVAPRO

NDA NDA020757

Jan 30, 1998

AVAPRO

NDA NDA020757

Jan 30, 1998

AVAPRO

NDA NDA020757

Apr 6, 1998

AVAPRO

NDA NDA020757

Sep 3, 1998

AVAPRO

NDA NDA020757

Dec 8, 1998

AVAPRO

NDA NDA020757

Mar 16, 1999

AVAPRO

NDA NDA020757

Mar 16, 1999

AVAPRO

NDA NDA020757

Nov 2, 1999

AVAPRO

NDA NDA020757

Apr 28, 2000

AVAPRO

NDA NDA020757

May 9, 2000

AVAPRO

NDA NDA020757

May 10, 2000

AVAPRO

NDA NDA020757

Aug 1, 2000

AVAPRO

NDA NDA020757

Aug 23, 2000

AVAPRO

NDA NDA020757

Sep 20, 2000

AVAPRO

NDA NDA020757

Feb 2, 2001

AVAPRO

NDA NDA020757

Mar 6, 2001

AVAPRO

NDA NDA020757

May 26, 2001

AVAPRO

NDA NDA020757

Jun 7, 2001

AVAPRO

NDA NDA020757

Sep 26, 2001

AVAPRO

NDA NDA020757

Jul 19, 2002

AVAPRO

NDA NDA020757

Sep 17, 2002

AVAPRO

NDA NDA020757

Mar 21, 2003

AVAPRO

NDA NDA020757

Mar 21, 2003

AVAPRO

NDA NDA020757

May 1, 2003

AVAPRO

NDA NDA020757

May 21, 2003

AVAPRO

NDA NDA020757

Sep 9, 2003

AVAPRO

NDA NDA020757

Oct 9, 2003

AVAPRO

NDA NDA020757

Jan 2, 2004

AVAPRO

NDA NDA020757

May 20, 2004

AVAPRO

NDA NDA020757

Jul 21, 2004

AVAPRO

NDA NDA020757

Oct 29, 2004

AVAPRO

NDA NDA020757

Nov 21, 2005

AVAPRO

NDA NDA020757

Mar 16, 2006

AVAPRO

NDA NDA020757

Apr 21, 2006

AVAPRO

NDA NDA020757

Jul 31, 2007

AVAPRO

NDA NDA020757

Aug 1, 2011

AVAPRO

NDA NDA020757

Dec 8, 2011

AVAPRO

NDA NDA020757

Jan 18, 2012

AVAPRO

NDA NDA020757

Sep 12, 2012

AVAPRO

NDA NDA020757

Feb 28, 2013

AVAPRO

NDA NDA020757

Oct 10, 2013

AVAPRO

NDA NDA020757

May 28, 2014

AVAPRO

NDA NDA020757

Jan 5, 2015

AVAPRO

NDA NDA020757

Feb 5, 2016

AVAPRO

NDA NDA020757

Feb 5, 2016

AVAPRO

NDA NDA020757

Jul 20, 2018

AVAPRO

NDA NDA020757

Dec 15, 2020

AVAPRO

NDA NDA020757

May 11, 2021

AVAPRO

NDA NDA020757

Sep 10, 2021

AVAPRO

NDA NDA020757

Aug 1, 2025

AVAPRO

NDA NDA020757

Jul 24, 2026

AVAPRO

NDA NDA020757

Sources

References

[1]
ClinicalTrials.gov — 76 trial records for Irbesartan. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Avapro drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Irbesartan compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Irbesartan. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020757). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Sanofi company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Type-1 Angiotensin II Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Sanofi

Avapro

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2027

Trials by Indication[1]

Hypertension11 trials

ART5 trials

Hypertensive3 trials

Albuminuria3 trials

Blood Pressure3 trials

Chronic Kidney Disease2 trials

Dialysis Patients2 trials

Tics2 trials

Hyperlipidemia2 trials

Essential Hypertension2 trials

IgA Nephropathy2 trials

Focal Segmental Glomerulosclerosis2 trials

Heart Failure2 trials

Interaction2 trials

Endothelial Dysfunction2 trials

Preeclampsia1 trial

COVID-191 trial

Diabetic Nephropathy1 trial

Kidney Transplant1 trial

Atorvastatin1 trial

Paroxysmal atrial fibrillation1 trial

Efficacy and Safety1 trial

Spironolactone1 trial

Type 2 Diabetes Mellitus1 trial

Hypercholesterolemia1 trial

Effectiveness1 trial

Allograft1 trial

Obesity1 trial

Heart Disease1 trial

Endothelial Function1 trial

Kidney Disease1 trial

Acute Myocardial Infarction1 trial

Trial1 trial

Left Ventricular Hypertrophy1 trial

Metabolic Syndrome1 trial

Sepsis1 trial

Vasodilation1 trial

Chronic Hepatitis1 trial

Acute Coronary Syndrome1 trial

Atrial Fibrillation1 trial

Type 2 Diabetes1 trial

Diabetic Retinopathy1 trial

Immunoglobulin A Nephropathy1 trial

Obesity, Morbid1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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