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irbesartan

Trade name: avapro

Small moleculeapproved

Approved

Sep 30, 1997

Irbesartan is an angiotensin receptor blocker (ARB) used mainly for the treatment of hypertension. It was developed by Sanofi Research (now part of Sanofi-Aventis). It is marketed under the trade names Aprovel, Karvea, and Avapro. AVAPRO is an angiotensin II receptor blocker (ARB) indicated for: • Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. • Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. Irbesartan is a specific competitive antagonist of AT1 receptors with a much greater affinity (more than 8500-fold) for the AT1 receptor than for the AT2 receptor and no agonist activity. — NCATS

Clinical trial activity

103 trials · 91 clinical orgs · 39 marketing orgs

Phase 1
10
Phase 2
39
Phase 3
32
Phase 4
39

Earliest trial started Apr 1, 1995 (NCT00389168)

Timeline

1990s

  1. Jan 1, 1995

    Earliest Phase 2 Sponsor(trial)

  2. Sep 30, 1997

    Earliest FDA Approval

  3. Sep 30, 1997

    Sanofi-Aventis — NDA Secondary Org

2000s

  1. Jan 1, 2000

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Jan 1, 2011

    Earliest Phase 1 Sponsor(trial)

  2. Feb 16, 2011

    Zydus Discovery DMCC — Marketing Organization

  3. Mar 30, 2012

    Teva — Marketing Organization

  4. Sep 27, 2012

    Appco Pharma — Marketing Organization

  5. Sep 27, 2012

    Dr. Reddy's Laboratories — Marketing Organization

  6. Sep 27, 2012

    Hetero Labs Ltd — Marketing Organization

  7. Sep 27, 2012

    Macleods Pharmaceuticals, Ltd — Marketing Organization

  8. Sep 27, 2012

    Mylan — Marketing Organization

  9. Sep 27, 2012

    Neopharma — Marketing Organization

  10. Sep 27, 2012

    Prinston Inc — Marketing Organization

  11. Sep 27, 2012

    Sandoz — Marketing Organization

  12. Sep 27, 2012

    US Antibiotics — Marketing Organization

  13. Sep 27, 2012

    Aurobindo Pharma — Marketing Organization

  14. Sep 27, 2012

    Picket Pharms — Marketing Organization

  15. Sep 27, 2012

    Novartis — Marketing Organization

  16. Sep 27, 2012

    Upsher-Smith Laboratories — Marketing Organization

  17. Sep 27, 2012

    PHARMOBEDIENT — Marketing Organization

  18. Sep 27, 2012

    Yiling Pharmaceutical Inc. — Marketing Organization

  19. Sep 28, 2012

    Cipla — Marketing Organization

  20. Oct 3, 2012

    Neogen — Marketing Organization

  21. Oct 12, 2012

    Watson Pharmaceuticals — Marketing Organization

  22. Oct 12, 2012

    Actavis — Marketing Organization

  23. Oct 15, 2012

    Apotex — Marketing Organization

  24. Oct 15, 2012

    Lupin — Marketing Organization

  25. Oct 15, 2012

    West-Ward Pharmaceutical — Marketing Organization

  26. Oct 15, 2012

    Hikma — Marketing Organization

  27. Oct 15, 2012

    Alembic — Marketing Organization

  28. Nov 14, 2012

    Chartwell Pharmaceuticals — Marketing Organization

  29. Feb 23, 2015

    Jubilant Innovation Ltd. — Marketing Organization

  30. Dec 7, 2015

    Sciegen Pharmaceticals — Marketing Organization

  31. Dec 7, 2015

    Unichem — Marketing Organization

  32. Dec 10, 2015

    Ajanta Pharma Ltd — Marketing Organization

  33. Jan 15, 2016

    Atlas Chemical Industries — Marketing Organization

  34. Jan 15, 2016

    AkzoNobel — Marketing Organization

  35. Jun 14, 2016

    Zhejiang Hisun Pharmaceutical Co. Ltd. — Marketing Organization

  36. Apr 17, 2018

    Amneal Pharmaceuticals — Marketing Organization

2020s

  1. May 22, 2024

    IPCA Laboratories Ltd. — Marketing Organization

  2. Nov 4, 2025

    MSN Laboratories — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedSep 30, 1997

Chemistry & pharmacology

Loading structure…

SMILES

CCCCC1=NC2(CCCC2)C(=O)N1CC3=CC=C(C=C3)C4=CC=CC=C4C5=NN=NN5
Mol. weight
428.5294 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • 1,3-diazaspiro(4.4)non-1-en-4-one, 2-butyl-3-((2'-(1h-tetrazol-5-yl)(1,1'-biphenyl)-4-yl)methyl)-
  • 2-butyl-3-{[2'-(1h-tetrazol-5-yl)biphenyl-4-yl]methyl}-1,3-diazaspiro[4.4]non-1-en-4-one
  • 2-butyl-3-{[2'-(1h-tetrazol-5-yl)biphenyl-4-yl]methyl}-1,3-diazaspiro[4.4]non-1-en-4-one
  • 2-n-butyl-3-((2'-(1h-tetrazol-5-yl)biphenyl-4-yl)methyl)-1,3-diazaspiro(4,4)non-1-en-4-one
  • aprovel
  • aprovel
  • aprovel
  • aprovel
  • avapro
  • avapro
  • avapro
  • avapro
  • bms 186295
  • bms 186295
  • bms 186295
  • bms-186295
  • bms-186295
  • bms-186295
  • ibesartan
  • ifirmasta
  • ifirmasta
  • ifirmasta
  • irbesartan
  • irbesartan
  • irbesartan
  • irbesartan
  • irbesartan
  • irbesartan
  • irbesartan
  • irbesartan
  • irbesartan
  • irbesartan
  • irbesartan
  • irbesartan
  • irbesartan
  • irbesartan hcl
  • irbesartan hydrochloride
  • irbesartan hydrochloride
  • irbesartan / hydrochlorothiazide
  • irbesartan: hydrochlorothiazide
  • karvea
  • karvea
  • karvea
  • karvea
  • sabervel
  • sr 47436
  • sr-47436
  • sr-47436
  • sr-47436

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06635772Phase 2Nov 30, 2024Jiangsu Hansoh Pharmaceutical Co., Ltd.
NCT06660940Phase 4Oct 31, 2024People's Liberation Army of China
NCT06208072N/ASep 1, 2023Aristotle University of Thessaloniki, University of Athens
NCT05272878Phase 3Nov 22, 2022Assistance Publique - Hôpitaux de Paris, Hôpital Lariboisière, University of California, San Francisco
NCT05688085Phase 1Oct 18, 2022Handok Pharmaceuticals Co., Ltd.
NCT05552300N/AOct 1, 2022Sichuan University
NCT05688098Phase 1Sep 23, 2022Handok Pharmaceuticals Co., Ltd.
NCT05663073Phase 1Sep 13, 2022Handok Pharmaceuticals Co., Ltd.
NCT05476354Phase 3Aug 31, 2022Handok Pharmaceuticals Co., Ltd.
NCT05475665Phase 3Jul 14, 2022Handok Pharmaceuticals Co., Ltd.
NCT05297929Phase 1Feb 17, 2022Qingdao University
NCT05056727Phase 3Sep 30, 2021AstraZeneca, Stanford University
NCT05243199Phase 4Aug 1, 2020Jiao Tong University
NCT04488978Phase 2May 21, 2020Handok Pharmaceuticals Co., Ltd.
NCT03934307Phase 1May 1, 2019Alnylam Pharmaceuticals
NCT03762850Phase 3Dec 20, 2018Travere
NCT05786339Phase 1Nov 17, 2018Qingdao University
NCT03660397Phase 3Aug 1, 2018People's Liberation Army of China
NCT03493685Phase 3Apr 3, 2018Travere
NCT03016832Early Phase 1 (Phase 1)Jan 1, 2017Guangzhou Pharmaceucal Company Limited
Showing 20 of 103 trials
Page 1 / 6

Organizations

Research & Development (91)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
SanofiFor profit362631995
Bristol-Myers SquibbFor profit25621995
Handok Pharmaceuticals Co., Ltd.For profit6632020
Roxane LaboratoriesFor profit4412007
Worldwide Clinical TrialsFor profit4012007
TravereFor profit3322013
University of ParisAcademic/Hospital3322005
Aristotle University of ThessalonikiAcademic/Hospital2222012
Government of FranceGovernment2022015
Hanmi PharmaceuticalFor profit2222011
NovartisFor profit2222004
People's Liberation Army of ChinaGovernment2222018
Qingdao UniversityAcademic/Hospital2212018
Steno Diabetes Center CopenhagenAcademic/Hospital2222003
Technical University of DresdenAcademic/Hospital2212002
Aalborg UniversityAcademic/Hospital1012009
Aarhus UniversityAcademic/Hospital1112009
Alnylam PharmaceuticalsFor profit1112019
Anhui Medical UniversityAcademic/Hospital1012007
Assistance Publique - Hôpitaux de ParisAcademic/Hospital1112022
91 organizations
Page 1 / 5

Marketing (44)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGOct 12, 2012
Ajanta Pharma LtdFor profitMKTGDec 10, 2015
AkzoNobelFor profitMKTGJan 15, 2016
AlembicFor profitSYNOct 15, 2012
AlembicFor profitMKTGOct 15, 2012
Amneal PharmaceuticalsFor profitMKTGApr 17, 2018
ApotexFor profitMKTGOct 15, 2012
Appco PharmaFor profitMKTGSep 27, 2012
Atlas Chemical IndustriesFor profitMKTGJan 15, 2016
Aurobindo PharmaFor profitMKTGSep 27, 2012
Chartwell PharmaceuticalsFor profitMKTGNov 14, 2012
Chartwell PharmaceuticalsFor profitSYNSep 27, 2012
CiplaFor profitMKTGSep 28, 2012
Dr. Reddy's LaboratoriesFor profitMKTGSep 27, 2012
Hetero Labs LtdFor profitMKTGSep 27, 2012
HikmaFor profitMKTGOct 15, 2012
HikmaFor profitSYNOct 15, 2012
IPCA Laboratories Ltd.For profitMKTGMay 22, 2024
Jubilant Innovation Ltd.For profitMKTGFeb 23, 2015
LupinFor profitMKTGOct 15, 2012
MSN LaboratoriesFor profitMKTGNov 4, 2025
Macleods Pharmaceuticals, LtdFor profitMKTGSep 27, 2012
MylanFor profitMKTGSep 27, 2012
NeogenFor profitMKTGOct 3, 2012
NeopharmaFor profitMKTGSep 27, 2012
NovartisFor profitMKTGSep 27, 2012
PHARMOBEDIENTFor profitMKTGSep 27, 2012
Picket PharmsFor profitMKTGSep 27, 2012
Prinston IncFor profitMKTGSep 27, 2012
SandozFor profitMKTGSep 27, 2012
SanofiFor profitNDA—
Sanofi-AventisFor profitNDA2Sep 30, 1997
Sciegen PharmaceticalsFor profitMKTGDec 7, 2015
TevaFor profitMKTGMar 30, 2012
TevaFor profitSYNMar 30, 2012
US AntibioticsFor profitMKTGSep 27, 2012
UnichemFor profitMKTGDec 7, 2015
UnichemFor profitSYNDec 7, 2015
Upsher-Smith LaboratoriesFor profitMKTGSep 27, 2012
Watson PharmaceuticalsFor profitMKTGOct 12, 2012
West-Ward PharmaceuticalFor profitMKTGOct 15, 2012
Yiling Pharmaceutical Inc.For profitMKTGSep 27, 2012
Zhejiang Hisun Pharmaceutical Co. Ltd.For profitMKTGJun 14, 2016
Zydus Discovery DMCCFor profitMKTGFeb 16, 2011