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Drug

Irbesartan

Approved · FDA / EMA
Emerging researchLate-stage developmentCooling momentum

Also known as Avalide, Avapro, Hydrochlorothiazide-Irbesartan.

RxNorm83818ChEMBLCHEMBL1513UNIIJ0E2756Z7N
19
Research papers
6
Active clinical trials
60
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Label change: IRBESARTAN (NDA020757)

Regulatory2026-07-24FDA

Label change: IRBESARTAN (ANDA077205)

Regulatory2026-07-13FDA

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

Clinical trial2026-05-08Results expected Q1 2029 · ClinicalTrials.gov

A Randomized, Multicenter, Double-blind, Parallel Active-control Study of the Efficacy and Safety of HS-10390 for the Treatment of Participants With Chronic Kidney Disease

Clinical trial2026-04-28Results expected Q4 2027 · ClinicalTrials.gov

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

Clinical trial2026-04-20Results posted · ClinicalTrials.gov

A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients With Primary FSGS

Clinical trial2026-04-17Results posted · ClinicalTrials.gov

Label change: IRBESARTAN (NDA020757)

Regulatory2025-08-01FDA

Label change: IRBESARTAN (NDA020757)

Regulatory2021-09-10FDA

DUET: A Phase 2 Study Evaluating the Efficacy and Safety of Sparsentan in Patients with FSGS.

Research2018-11-01Journal of the American Society of Nephrology : JASN

Markers of inflammation, endothelial activation, and arterial stiffness in hypertensive heart disease and the effects of treatment: results from the SILVHIA study.

Research2013-12-01Journal of cardiovascular pharmacology

Mode of death in patients with heart failure and a preserved ejection fraction: results from the Irbesartan in Heart Failure With Preserved Ejection Fraction Study (I-Preserve) trial.

Research2010-03-15Circulation

Baseline plasma NT-proBNP and clinical characteristics: results from the irbesartan in heart failure with preserved ejection fraction trial.

Research2009-11-04Journal of cardiac failure

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Irbesartan
Aliases & brands
AvalideAvaproHydrochlorothiazide-Irbesartan
RxNorm CUI
83818
ChEMBL ID
CHEMBL1513
UNII
J0E2756Z7N
Regulatory jurisdictions
emafda

Regulatory timeline

60 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (1997-08-26 → 1999-03-16)
Approval / market entry confirmed across FDA and EMA (2007-01-19 → 2007-07-31)
Earliest approval
1997-08-26
Latest approval
2015-01-05
Authorities
FDA · EMA
Total events
60
fdaU.S. Food and Drug Administration· 56 events
2026-07-24Label change
Label change: IRBESARTAN (NDA020757)
Evidence ↗
2026-07-13Label change
Label change: IRBESARTAN (ANDA077205)
Evidence ↗
2025-08-01Label change
Label change: IRBESARTAN (NDA020757)
Evidence ↗
emaEuropean Medicines Agency· 4 events
2009-10-30Approval
Approval: Irbesartan Teva (EMA)

Indication: Treatment of essential hypertension. Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen.

Evidence ↗
2007-01-19ApprovalMulti-authority
Approval: Irbesartan Zentiva (previously Irbesartan Winthrop) (EMA)

Indication: Treatment of essential hypertension. Treatment of renal disease in patients with hypertension and type-2 diabetes mellitus as part of an antihypertensive medicinal-product regimen.

Evidence ↗
1997-08-26ApprovalMulti-authority
Approval: Aprovel (EMA)

Indication: Treatment of essential hypertension. Treatment of renal disease in patients with hypertension and type-2 diabetes mellitus as part of an antihypertensive medicinal-product regimen.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

79 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
79
registered trials across all phases
LATEST COMPLETION 2026
6
Active studies
4
Recruiting
67
Late-stage (III+)
57
Completed
16
Discontinued
PHASE DISTRIBUTIONn = 79
Early Phase 11Phase 15Phase 26Phase 2 / 32Phase 328Phase 428Phase N / A9

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

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

Not yet recruitingPH IVBaylor Research Instituten=642029

A Randomized, Double-blind, Multicenter Clinical Trial of Keluoxin Capsules in the Treatment of Diabetic Kidney Disease with Diabetic Retinopathy

Not yet recruitingPH IVChinese PLA General Hospitaln=4602027

Sacubitril/Valsartan for Dialysis Patients With CKD5 Stage Complicated With Hypertension- A Prospective, Randomized, Controlled Multicenter Study

CompletedPH IVRuijin Hospitaln=3302023

Nephropathy in Type 2 Diabetes: Effects of an Intensive Multifactorial Intervention Trial on Cardio-renal Events.

CompletedPH IVUniversity of Campania Luigi Vanvitellin=8502019

A Prospective, Multi-center, Randomized, Open-label, Parallel-arm Controlled Study of Treating Type 2 Diabetic Nephropathy (Stage II-IV) With Alfacalcidol and Irbesartan

CompletedPH IVThe Third Xiangya Hospital of Central South Universityn=602018

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients With Primary FSGS

CompletedPH IIITravere Therapeutics, Inc.n=3712026

Efficacy and Safety of Sparsentan (RE-021), a Dual Endothelin Receptor and Angiotensin Receptor Blocker, in Patients With Focal Segmental Glomerulosclerosis (FSGS): a Randomized, Double-Blind, Active-Control, Dose-Escalation Study

CompletedPH IITravere Therapeutics, Inc.n=1092024

A Randomized, Double-blind, Multicenter, Placebo-control, Parallel Group Phase 3 Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension Patients

CompletedPH IIIHandok Inc.n=2712023

A Randomized, Double-blind, Multicenter, Placebo-control, Parallel Group Phase # Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension Patients

CompletedPH IIIHandok Inc.n=1572023

A Randomized, Open-label, Crossover, Phase 1 Study to Evaluate Pharmacokinetics and Safety of Irbesartan/Amlodipine Fixed Dose Combination in Comparison With Co-administration of Mono Compounds in Healthy Volunteers

CompletedPH IHandok Inc.n=462023

A Randomized, Open-label, Crossover, Phase 1 Study to Evaluate Pharmacokinetics and Safety of Irbesartan/Amlodipine High Fixed Dose Combination in Comparison With Co-administration of Mono Compounds in Healthy Volunteers

CompletedPH IHandok Inc.n=442023

Research activity

19 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20012018
Most influential

Irbesartan in patients with heart failure and preserved ejection fraction.

The New England journal of medicine · 2008 · 1,406 cites

Mode of death in patients with heart failure and a preserved ejection fraction: results from the Irbesartan in Heart Failure With Preserved Ejection Fraction Study (I-Preserve) trial.

Circulation · 2010 · 244 cites

DUET: A Phase 2 Study Evaluating the Efficacy and Safety of Sparsentan in Patients with FSGS.

Journal of the American Society of Nephrology : JASN · 2018 · 155 cites

Heart failure with preserved ejection fraction: clinical characteristics of 4133 patients enrolled in the I-PRESERVE trial.

European journal of heart failure · 2008 · 151 cites

Regression of left ventricular hypertrophy in human hypertension with irbesartan.

Journal of hypertension · 2001 · 118 cites

The irbesartan in heart failure with preserved systolic function (I-PRESERVE) trial: rationale and design.

Journal of cardiac failure · 2005 · 92 cites
Recent papers

DUET: A Phase 2 Study Evaluating the Efficacy and Safety of Sparsentan in Patients with FSGS.

Journal of the American Society of Nephrology : JASN · 2018 · 155 cites

Markers of inflammation, endothelial activation, and arterial stiffness in hypertensive heart disease and the effects of treatment: results from the SILVHIA study.

Journal of cardiovascular pharmacology · 2013 · 25 cites

Mode of death in patients with heart failure and a preserved ejection fraction: results from the Irbesartan in Heart Failure With Preserved Ejection Fraction Study (I-Preserve) trial.

Circulation · 2010 · 244 cites

Baseline plasma NT-proBNP and clinical characteristics: results from the irbesartan in heart failure with preserved ejection fraction trial.

Journal of cardiac failure · 2010 · 45 cites

The effects of antihypertensive treatment on the doppler-derived myocardial performance index in patients with hypertensive left ventricular hypertrophy: results from the Swedish irbesartan in left ventricular hypertrophy investigation versus atenolol (SILVHIA).

Echocardiography (Mount Kisco, N.Y.) · 2009 · 2 cites

Irbesartan in patients with heart failure and preserved ejection fraction.

The New England journal of medicine · 2008 · 1,406 cites
Major research themes8
Angiotensin II Type 1 Receptor Blockers1Angiotensin II Type 2 Receptor Blockers1Angiotensin Receptor Antagonists1Cause of Death1Diastole1Echocardiography, Doppler1Polymorphism, Genetic1Polymorphism, Single Nucleotide1
Journals, researchers & institutions
Top journals
  • Journal of hypertension4
  • American journal of hypertension3
  • Journal of cardiac failure2
  • Journal of cardiovascular pharmacology2
  • Circulation1
  • Echocardiography (Mount Kisco, N.Y.)1
Leading researchers
  • Kahan T13
  • Malmqvist K11
  • Edner M6
  • Komajda M5
  • Lind L5
  • Massie BM5
  • Ptaszynska A5
  • McKelvie R4
Leading institutions
free-text, unnormalised
  • Karolinska Institutet Danderyd Hospital5
  • Department of Clinical Sciences2
  • Karolinska Institutet2
  • Uppsala University Hospital2
  • Arizona Kidney Disease and Hypertension Center1
  • Azienda Ospedaliero Universitaria Policlinico di Bari1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.