Drugs / Irbesartan
last change Jul 2026 re-read 9 days 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 · 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 · IgA glomerulonephritis · 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
+52 more · The Third Xiangya Hospital of Central South University · ANRS, Emerging Infectious Diseases · 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 · Hanmi Pharmaceutical Company Limited · Hospital Authority, Hong Kong · Intensive Care National Audit & Research Centre · Jiangsu Famous Medical Technology Co., Ltd. · Karolinska Institutet · 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 · Sanofi-Synthelabo · Shanghai Jiao Tong University School of Medicine · St. Marianna University School of Medicine · Swedish Heart Lung Foundation · Syneos Health · 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

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 67 · started per year

today
EU approved 1997
US approved 1997
1
3
6
10
8
7
2
2
3
1
2
2
3
1
2
3
1
1
2
5
1
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 · 3 met primary · 4 missed
Phase 3 NCT05475665 Jul 2022 → Mar 2023 essential hypertension Handok Inc. Completed Met primary
Phase 3 NCT04606563 Oct 2020 → Apr 2022 COVID-19 University of British Columbia Terminated Missed primary
Phase 3 NCT02735707 Apr 2016 → Feb 2026 overdue pneumonia UMC Utrecht Recruiting Mixed
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 Missed primary
Phase 3 NCT00957554 Jul 2009 → Sep 2010 hypertensive disorder Sanofi Completed Met primary
Phase 3 NCT00956644 Jul 2009 → Aug 2010 essential hypertension Sanofi Completed Met primary
Phase 3 NCT00265642 Oct 2006 → Apr 2013 chronic hepatitis C virus infection ANRS, Emerging Infectious Diseases Completed No outcome recorded
Phase 428 trials · 2 met primary · 1 missed
Phase 4 NCT05377203 Jul 2022 → Jul 2023 hypertensive disorder The Third Xiangya Hospital of Central South University Completed Met primary
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 applicable8 trials
— 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 Stop: Business
— 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
Comparator or background therapy44 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 Met primary

News releases announcing trial results or a regulatory action · 7

DateIssuerRelease
2021-11-13 Alnylam Pharmaceuticals Results Alnylam Presents New Data for Zilebesiran, an Investigational RNAi Therapeutic for the Treatment of Hypertension, at the American Heart Association Scientific Sessions 2021 alnylam.com ↗
Additional results demonstrated that zilebesiran was safe and well tolerated in the Phase 1 study during salt restriction and when administered concomitantly with irbesartan, an oral renin-angiotensin-aldosterone system inhibitor (RAASi).
2019-03-05 Hanmi Pharmaceutical Company Limited Results <보도자료> 한미약품 ‘로벨리토’ 4상 결과 국제학술지 등재 hanmi.co.kr ↗
연구 결과에 따르면, 로벨리토를 투여한 환자의 약 86%가 목표혈압과 LDL-C 목표수치에 각각 도달했다.
2018-06-12 Hanmi Pharmaceutical Company Limited Results <보도자료> 한미약품, 아모잘탄·로벨리토 임상 결과 유럽고혈압학회 발표 hanmi.co.kr ↗
로벨리토를 투여한 환자군의 약 75%에서 혈압과 LDL-C 목표치를 동시에 달성했다
2016-11-10 Hanmi Pharmaceutical Company Limited Results <보도자료> ‘로벨리토’ 3상 결과 국제학술지 등재 hanmi.co.kr ↗
연구 결과, 병용 투여군은 최대 용량 투여시 93.1%가 LDL-콜레스테롤 목표에, 55.2%가 목표혈압에 도달했다.
2012-09-28 Sumitomo Pharma America, Inc. Regulatory Dainippon Sumitomo Pharma obtains manufacturing and marketing approval for "AIMIX Combination Tablets LD/HD" sumitomo-pharma.com ↗
2012-04-02 Teva Branded Pharmaceutical Products R&D, Inc. Regulatory Teva Announces Launch of Generic Avapro® and Generic Avalide® in the United States; Awarded 180-Day Period of Marketing Exclusivity tevapharm.com ↗
As the first company to file Abbreviated New Drug Applications (ANDA) containing paragraph IV certifications for both of these products, Teva has been awarded a 180-day period of marketing exclusivity.
2011-11-30 Sumitomo Pharma America, Inc. Regulatory Dainippon Sumitomo Pharma announces application for manufacturing and marketing approval for "DSP-8153", combination product of irbesartan and amlodipine besilate sumitomo-pharma.com ↗
it submitted an application for manufacturing and marketing approval for "DSP-8153" (product code)

All press releases naming this drug 9 releases

DateIssuerRelease

Evidence & citations 30 cited values

Every value below carries the sentence it was read from. 116 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 ↗

Show 99 more sources

Known as Aprovel “Irbesartan (Aprovel)” NCT00362037 ↗
2

“Irbesartan (Aprovel)” NCT00335673 ↗

“Irbesartan (Aprovel)” NCT00362258 ↗

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 ↗