Drugs / Irbesartan
last change Jul 2026 re-read 2 minutes ago

Irbesartan

Small molecule targets AGTR1 via inhibition

Developed for
hypertensive disorder · essential hypertension · diabetic kidney disease · type 2 diabetes mellitus · proteinuria · atrial fibrillation · chronic hepatitis C virus infection · chronic transplant rejection
+26 more · COVID-19 · Ebola hemorrhagic fever · end stage renal failure · glomerulonephritis · heart disorder · heart failure · hypertensive heart disease · IgA glomerulonephritis · infectious disease with sepsis · Marfan syndrome · metabolic syndrome X · myocardial infarction · myocardial ischemia · pneumonia · resistant hypertension · sickle cell disease · abdominal obesity-metabolic syndrome · acute kidney injury · chronic kidney disease · chronic renal failure syndrome · congestive heart failure · Ehlers-Danlos syndrome, vascular type · focal segmental glomerulosclerosis · hyperlipoproteinemia · obesity disorder · persistent atrial fibrillation
Investigated by
Sanofi · Bristol-Myers Squibb · Handok Inc. · Assistance Publique - Hôpitaux de Paris · Steno Diabetes Center Copenhagen · Technical University Dresden
+66 more · The Third Xiangya Hospital of Central South University · ANRS, Emerging Infectious Diseases · Affiliated Hospital of Jiaxing University · Alnylam Pharmaceuticals · Astellas Pharma Canada, Inc. · Astellas Pharma Inc · Australian and New Zealand Intensive Care Research Centre · Berry Consultants · Bill and Melinda Gates Foundation · Brigham and Women's Hospital · Canadian Institutes of Health Research (CIHR) · Charite University, Berlin, Germany · Clinical Research Management, Inc. · Connolly, Stuart, M.D. · Daiichi Sankyo · Damanhour University · Duke University · Federico II University · Global Coalition for Adaptive Research · Hangzhou Traditional Chinese Medicine Hospital · Hangzhou Xiaoshan First People's Hospital · Hanmi Pharmaceutical Company Limited · Hospital Authority, Hong Kong · Intensive Care National Audit & Research Centre · Jiangsu Famous Medical Technology Co., Ltd. · Jiangsu Province Hospital of Traditional Chinese Medicine · Karolinska Institutet · Keda Lu · LG Life Sciences · Maastricht University Medical Center · Martin Huelsmann · Medical Research Institute of New Zealand · Melbourne Health · Ministry of Health, France · Nat Intensive Care Surveillance - MORU · National Institute of Allergy and Infectious Diseases (NIAID) · National University Hospital, Singapore · Novartis · Ottawa Hospital Research Institute · Oxford University Hospitals NHS Trust · Red Cross Hospital, Hangzhou, China · Sanofi-Synthelabo · Shanghai 6th People's Hospital · Shanghai Jiao Tong University School of Medicine · Shao Yifu Hospital of Zhejiang Medical University · St. Marianna University School of Medicine · Swedish Heart Lung Foundation · Syneos Health · The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine · The First Affiliated Hospital of Zhejiang Chinese Medical University · The Second Affiliated Hospital of Zhejiang Chinese Medical University · UMC Utrecht · Unity Health · University of British Columbia · University of Campania Luigi Vanvitelli · University of Insubria · University of North Carolina · University of Oxford · University of Pittsburgh Medical Center · University of Salerno · University of Sierra Leone · University of Southern Denmark · Vital Strategies · Yuyao City Traditional Chinese Medicine Hospital · Zhejiang University · Zhenhai District Traditional Chinese Medicine Hospital

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (2) US (FDA) AVAPRO 2001-05-26 – 2002-09-17 fda.gov
Approved US (FDA) AVALIDE 1997-09-30 fda.gov
Approved EU (EMA) Aprovel 1997-08-26 europa.eu

Trials 68 · started per year

today
EU approved 1997
US approved 1997
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199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT03016832 Jan 2017 → May 2018 diabetic kidney disease Jiangsu Famous Medical Technology Co., Ltd. Unknown No outcome recorded
Phase 15 trials
Phase 1 NCT05688085 Oct → Dec 2022 Handok Inc. Completed No outcome recorded
Phase 1 NCT05688098 Sep → Nov 2022 Handok Inc. Completed No outcome recorded
Phase 1 NCT05663073 Sep → Dec 2022 Handok Inc. Completed No outcome recorded
Phase 1 NCT03934307 May 2019 → Apr 2022 hypertensive disorder Alnylam Pharmaceuticals Completed No outcome recorded
Phase 1 NCT01825850 Jun → Sep 2013 LG Life Sciences Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT02380625 Apr 2015 → Jan 2016 Ebola hemorrhagic fever Clinical Research Management, Inc. Unknown No outcome recorded
Phase 22 trials
Phase 2 NCT04488978 May 2020 → Nov 2021 essential hypertension Handok Inc. Completed No outcome recorded
Phase 2 NCT01949233 Oct 2013 → Oct 2015 Marfan syndrome University of Oxford Unknown No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT00106561 Jan 2002 → Sep 2004 diabetic kidney disease, glomerulonephritis, proteinuria Melbourne Health Completed No outcome recorded
Phase 2/3 NCT00389168 Apr 1995 → Apr 1997 hypertensive disorder Karolinska Institutet Completed No outcome recorded
Phase 320 trials
Phase 3 NCT05475665 Jul 2022 → Mar 2023 essential hypertension Handok Inc. Completed No outcome recorded
Phase 3 NCT04606563 Oct 2020 → Apr 2022 COVID-19 University of British Columbia Terminated No outcome recorded
Phase 3 NCT02735707 Apr 2016 → Feb 2026 overdue pneumonia UMC Utrecht Recruiting No outcome recorded
Phase 3 NCT01992796 Jan 2014 → Jan 2017 infectious disease with sepsis University of Salerno Unknown No outcome recorded
Phase 3 NCT01625494 May 2012 → Jan 2013 hypertensive disorder Sanofi Completed No outcome recorded
Phase 3 NCT01442987 May 2011 → Apr 2013 hyperlipidemia, hypertensive disorder Hanmi Pharmaceutical Company Limited Completed No outcome recorded
Phase 3 NCT00933231 Aug 2009 → May 2015 Astellas Pharma Inc Completed No outcome recorded
Phase 3 NCT00956644 Jul 2009 → Aug 2010 essential hypertension Sanofi Completed No outcome recorded
Phase 3 NCT00957554 Jul 2009 → Sep 2010 hypertensive disorder Sanofi Completed No outcome recorded
Phase 3 NCT00265642 Oct 2006 → Apr 2013 chronic hepatitis C virus infection ANRS, Emerging Infectious Diseases Completed No outcome recorded
Phase 428 trials
Phase 4 NCT05377203 Jul 2022 → Jul 2023 hypertensive disorder The Third Xiangya Hospital of Central South University Completed No outcome recorded
Phase 4 NCT03147677 Jul 2016 → Jul 2018 diabetic kidney disease The Third Xiangya Hospital of Central South University Completed No outcome recorded
Phase 4 NCT02817360 Feb 2016 → Dec 2025 overdue heart disorder, type 2 diabetes mellitus Martin Huelsmann Recruiting No outcome recorded
Phase 4 NCT02539810 Sep 2015 → Dec 2016 renal artery atheroma, resistant hypertension Assistance Publique - Hôpitaux de Paris Terminated No outcome recorded
Phase 4 NCT01500590 Nov 2011 → Aug 2018 hypertensive disorder, type 2 diabetes mellitus Hospital Authority, Hong Kong Unknown No outcome recorded
Phase 4 NCT00670566 Apr 2008 → Mar 2009 hypertensive disorder Sanofi Completed No outcome recorded
Phase 4 NCT00517322 Aug 2007 → Aug 2010 hypertensive heart disease University of Insubria Unknown No outcome recorded
Phase 4 NCT00500604 Jul 2007 → Jan 2010 hypertensive disorder Sanofi Completed No outcome recorded
Phase 4 NCT00443612 Sep 2006 → Oct 2008 hypertensive disorder Sanofi Completed No outcome recorded
Phase 4 NCT00334581 May 2006 → Jun 2008 hypertensive disorder Sanofi Completed No outcome recorded
Phase not applicable9 trials
NCT07360002 Jan → Dec 2026 expected IgA glomerulonephritis Keda Lu Not yet recruiting No outcome recorded
NCT06790927 Feb 2025 → Dec 2026 expected hypertensive disorder Shanghai Jiao Tong University School of Medicine Not yet recruiting No outcome recorded
NCT01858610 Mar → Apr 2013 Damanhour University Completed No outcome recorded
NCT01519297 May 2012 → Jul 2017 preeclampsia Brigham and Women's Hospital Suspended No outcome recorded
NCT01195818 Sep 2010 → Sep 2014 sickle cell disease Assistance Publique - Hôpitaux de Paris Completed No outcome recorded
NCT00742066 Mar 2008 → Jul 2009 essential hypertension Maastricht University Medical Center Unknown No outcome recorded
NCT00212901 Aug 2004 → Sep 2006 diabetic kidney disease Ottawa Hospital Research Institute Completed No outcome recorded
NCT00154024 Mar 2003 → Oct 2006 Technical University Dresden Completed No outcome recorded
NCT00180024 Jan 2002 → Sep 2005 Technical University Dresden Completed No outcome recorded
Also used as a comparator or background therapy in 44 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 28 trials
Phase 2 NCT07555054 Comparator May 2026 → Nov 2027 expected chronic kidney disease Jiangsu Hansoh Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 2 NCT06635772 Comparator Nov 2024 → Dec 2025 overdue IgA glomerulonephritis Hansoh BioMedical R&D Company Not yet recruiting No outcome recorded
Phase 2 NCT05670028 Background Jun 2023 → Jan 2026 ischemic stroke, vascular insufficiency disorder Beijing Tiantan Hospital Unknown No outcome recorded
Phase 2 NCT02386293 Comparator Apr 2014 → Nov 2019 hypertensive disorder, obesity disorder Augusta University Unknown No outcome recorded
Phase 2 NCT01613118 Comparator Mar 2014 → Jun 2016 focal segmental glomerulosclerosis Travere Therapeutics, Inc. Completed No outcome recorded
Phase 312 trials
Phase 3 NCT05272878 Comparator Nov 2022 → Jun 2025 overdue acute kidney injury Assistance Publique - Hôpitaux de Paris Active not recruiting No outcome recorded
Phase 3 NCT05476354 Comparator Jul 2022 → Apr 2023 essential hypertension Handok Inc. Completed No outcome recorded
Phase 3 NCT05056727 Background Sep 2021 → Feb 2024 chronic kidney disease AstraZeneca Terminated No outcome recorded
Phase 3 NCT03762850 Comparator Dec 2018 → Aug 2023 overdue IgA glomerulonephritis Travere Therapeutics, Inc. Active not recruiting No outcome recorded
Phase 3 NCT03660397 Background Aug 2018 → Jul 2019 hypertensive disorder Third Military Medical University Unknown No outcome recorded
Phase 419 trials
Phase 4 NCT07547878 Comparator Apr 2026 → Mar 2029 expected chronic kidney disease, type 2 diabetes mellitus Baylor Research Institute Not yet recruiting No outcome recorded
Phase 4 NCT06660940 Background Oct 2024 → Oct 2027 expected diabetic kidney disease, diabetic retinopathy Chinese PLA General Hospital Not yet recruiting No outcome recorded
Phase 4 NCT05243199 Comparator Aug 2020 → Mar 2023 end stage renal failure, heart failure Ruijin Hospital Completed No outcome recorded
Phase 4 NCT04394117 Comparator Jun 2020 → Nov 2021 COVID-19 The George Institute Completed No outcome recorded
Phase 4 NCT04330300 Comparator Apr 2020 → Jul 2021 COVID-19, essential hypertension National University of Ireland, Galway, Ireland Suspended No outcome recorded
Phase not applicable5 trials
NCT06208072 Comparator Sep 2023 → Dec 2024 essential hypertension, obesity disorder Hippocration General Hospital Unknown No outcome recorded
NCT04981613 Background Jul 2021 → Aug 2024 diabetic kidney disease First Affiliated Hospital Xi'an Jiaotong University Completed No outcome recorded
NCT02644486 Comparator Jan 2016 → Feb 2018 glomerular disorder Zhi-Hong Liu, M.D. Terminated No outcome recorded
NCT00794963 Background Nov 2008 → May 2010 metabolic syndrome X Northwell Health Terminated No outcome recorded
NCT00684489 Comparator Sep 2003 → Mar 2005 essential hypertension Medical University of South Carolina Completed No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2012-04-02 Teva Branded Pharmaceutical Products R&D, Inc. Teva Announces Launch of Generic Avapro® and Generic Avalide® in the United States; Awarded 180-Day Period of Marketing Exclusivity tevapharm.com

Evidence & citations 32 cited values

Every value below carries the sentence it was read from. 117 sources stand behind the page.

FieldValueCited text
Known as Irbesartan “Accordingly, we conducted studies in 17 subjects with untreated stage 1 hypertension, measuring sympathetic nerve activity at baseline and after 12 weeks of chlorthalidone...” PMID 22733474 Jun 2012
109

“Investigation of wheather addition of angiotensin receptor blocker (Irbesartan) to recommended doses of angiotensin converting enzyme inhibitor (trandolapril) is more effective...” NCT00212901

“Standardized antiproteinuric medication regimen includes an angiotensin receptor blocker (irbesartan 300mg), a diuretic (furosemide 40mg or indapamide LP 1.5mg according to the...” NCT01588795

“One of ARBs(Valsartan, Olmesartan, Candesartan, Telmisartan, Fimasartan, Losartan and Irbesartan) and one of statins(Rosuvastatin, Atorvastatin, Pitavastatin, Simvastatin,...” NCT04061824

“To manipulate the blood pressure within a certain range with hypotensive drugs (e.g. nifedipine, benidipine, captopril, benazepril, irbesartan, labetalol, urapidil) and/or...” NCT05670028

“Angiotensin II receptor antagonists ,these medicines have names that end in "sartan".For examples:losartan,candesartan,irbesartan,olmesartan,telmisartan,valsartan” NCT01377285

“amlodipine 5 mg + irbesartan 150mg is used for those who do not meet blood pressure targets after 4 weeks of treatment” NCT06790927

“ramipril 2.5mg to 10mg once daily if patient experience cough, we will use irbesartan 150 mg to 300mg once daily” NCT01500590

“participants will receive one table each of Irbesartan and Amlodipine High in a crossover design” NCT05688098

“Kunxian capsule (2# tid or 2# bid) + irbesartan tablet (150mg qd or 300mg qd) for 48 weeks” NCT04981613

“Candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, valsartan” NCT04330300

“In case of cough with Ramipril, the treatment may be change by Irbesartan.” NCT01195818

irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d” NCT03660397

“candesartan, eprosartan, irbesartan, losartan, olmesartan” NCT00684489

irbesartan tablets 75mg” NCT05377203

irbesartan 300 mg/d” NCT02539810

Irbesartan 300mg/d” NCT02817360

IrbesartanNCT02735707

IrbesartanNCT00741585

NCT00561964

NCT01613118

NCT05688085

NCT00657059

NCT00224549

NCT00320879

NCT05056727

NCT00249795

NCT00152698

NCT00742066

NCT03147677

NCT00263003

NCT05663073

NCT00791830

NCT00106561

NCT04488978

NCT00296218

NCT04394117

NCT01519297

NCT00389168

NCT01238705

NCT00950066

NCT02597361

NCT00635232

NCT00095550

NCT00264212

NCT01442987

NCT01625494

NCT06208072

NCT00957554

NCT05272878

NCT00334581

NCT00350038

NCT00660309

NCT00564187

NCT00987662

NCT05243199

NCT00670566

NCT06635772

NCT00171080

NCT00562809

NCT00708344

NCT00265642

NCT01968759

NCT01992796

NCT06660940

NCT00933231

NCT00517322

NCT00095394

NCT00125645

NCT00283036

NCT00180024

NCT02842359

NCT00352560

NCT00154024

NCT02386293

NCT01360710

NCT00335673

NCT03762850

NCT00956644

NCT00443612

NCT03934307

NCT00110422

NCT07555054

NCT03016832

NCT03493685

NCT00005010

NCT00500604

NCT04606563

NCT00613496

NCT00549133

NCT00535925

NCT00095290

NCT00265967

NCT00317915

NCT00185055

NCT01825850

NCT00529750

NCT00095238

NCT00794963

NCT02644486

NCT00362258

NCT05476354

NCT02380625

NCT01858610

NCT00362037

NCT01949233

NCT00847834

NCT05475665

NCT00225667

NCT00347087

Known as Aprovel “Irbesartan (Aprovel)” NCT00362258
2

“Irbesartan (Aprovel)” NCT00335673

“Irbesartan (Aprovel)” NCT00362037

Known as Avapro ClinicalTrials.gov intervention name — accepted as the source's own label NCT07547878
Known as BMS-186295 ChEMBL registry synonym — accepted as the source's own label CHEMBL1513
Known as I150 “irbesartan 150 mg [I150] monotherapy administered once daily” PMID 22853847 Jul 2012
Known as I300 “irbesartan (I300) monotherapy” PMID 22853847 Jul 2012
Known as Ifirmasta ChEMBL registry synonym — accepted as the source's own label CHEMBL1513
Known as Ifirmasta (previously irbesartan krka) ChEMBL registry synonym — accepted as the source's own label CHEMBL1513
Known as IRB “PURPOSE: To investigate the pharmacokinetic/pharmacodynamic (PK/PD) interaction between irbesartan (IRB) and hydrochlorothiazide (HCT) in normotensive subjects.” PMID 25545238 Feb 2015
2

“This study aimed to evaluate the efficacy and tolerability of irbesartan (IRB) and amlodipine (AML) combination therapy” PMID 38704294 May 2024

irbesartan (Irb) 150 mg” PMID 18538118 Jun 2008

Known as Irbesartan bms ChEMBL registry synonym — accepted as the source's own label CHEMBL1513
Known as Irbesartan component of avalide ChEMBL registry synonym — accepted as the source's own label CHEMBL1513
Known as Irbesartan component of coaprovel ChEMBL registry synonym — accepted as the source's own label CHEMBL1513
Known as Irbesartan component of ibersartan/hydrochlorothiazide ibersartan ChEMBL registry synonym — accepted as the source's own label CHEMBL1513
Known as Irbesartan component of ibersartan/hydrochlorothiazide teva ibersartan ChEMBL registry synonym — accepted as the source's own label CHEMBL1513
Known as Irbesartan component of ibersartan/hydrochlorothiazide zentiva ibersartan ChEMBL registry synonym — accepted as the source's own label CHEMBL1513
Known as Irbesartan component of ifirmacombi ChEMBL registry synonym — accepted as the source's own label CHEMBL1513
Known as IRBESARTAN HYDROCHLORIDE ChEMBL registry synonym — accepted as the source's own label CHEMBL1513
Known as Irbesartan teva ChEMBL registry synonym — accepted as the source's own label CHEMBL1513
Known as Irbesartan zentiva ChEMBL registry synonym — accepted as the source's own label CHEMBL1513
Known as Irbesartan zentiva (previously irbesartan winthrop) ChEMBL registry synonym — accepted as the source's own label CHEMBL1513
Known as Irbesartan/Amlodipine FDC ClinicalTrials.gov intervention name — accepted as the source's own label NCT05663073
Known as Karvea ChEMBL registry synonym — accepted as the source's own label CHEMBL1513
Known as NSC-758696 ChEMBL registry synonym — accepted as the source's own label CHEMBL1513
Known as Sabervel ChEMBL registry synonym — accepted as the source's own label CHEMBL1513
Known as Sarbevel ChEMBL registry synonym — accepted as the source's own label CHEMBL1513