Last update 30 Mar 2025

Irbesartan

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
2-butyl-3-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-1,3-diazaspiro[4.4]non-1-en-4-one, Aprovel, Irbesartan (JP17/USP/INN)
+ [31]
Target
Action
antagonists
Mechanism
AT1R antagonists(Angiotensin II Receptor Type 1 antagonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
European Union (26 Aug 1997),
Regulation-
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Structure/Sequence

Molecular FormulaC25H28N6O
InChIKeyYOSHYTLCDANDAN-UHFFFAOYSA-N
CAS Registry138402-11-6

External Link

KEGGWikiATCDrug Bank
D00523Irbesartan

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Diabetes Mellitus, Type 2
Australia
18 May 2005
Hypertension
United States
30 Sep 1997
Type 2 diabetes mellitus with established diabetic nephropathy
United States
30 Sep 1997
Essential Hypertension
European Union
26 Aug 1997
Essential Hypertension
Iceland
26 Aug 1997
Essential Hypertension
Liechtenstein
26 Aug 1997
Essential Hypertension
Norway
26 Aug 1997
Kidney Diseases
European Union
26 Aug 1997
Kidney Diseases
Iceland
26 Aug 1997
Kidney Diseases
Liechtenstein
26 Aug 1997
Kidney Diseases
Norway
26 Aug 1997
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HypercholesterolemiaPhase 3
Germany
01 Nov 2009
Fibrosis, LiverPhase 3
France
01 Oct 2006
Hepatitis C, ChronicPhase 3
France
01 Oct 2006
Acute Coronary SyndromePhase 3
United States
01 Feb 2006
Acute Coronary SyndromePhase 3
United States
01 Feb 2006
Acute Coronary SyndromePhase 3
Belgium
01 Feb 2006
Acute Coronary SyndromePhase 3
Belgium
01 Feb 2006
Acute Coronary SyndromePhase 3
Canada
01 Feb 2006
Acute Coronary SyndromePhase 3
Canada
01 Feb 2006
Acute Coronary SyndromePhase 3
France
01 Feb 2006
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
404
Sparsentan 400 mg/day
ccfurxmhgp(yryudwjqxt) = shxbgyppmc uftrwydjza (wioxaowmsp )
Positive
01 Apr 2024
ccfurxmhgp(yryudwjqxt) = xreuagpkmg uftrwydjza (wioxaowmsp )
Not Applicable
1,012
dhbaimhqwp(ulpsbasfzo) = Adverse events were reported in 22.3 % of patients mainly oedema in 11 % of cases. None of the patients in the study reported a serious adverse event that would have led to discontinuation of treatment tyuxellrfe (zqltmxobeq )
Positive
01 Jun 2023
Not Applicable
77
sxjsczwonv(vzsbfbskjl) = hkquvuynjb upoxnncpxe (nleecdcdld )
Positive
01 Jul 2019
Not Applicable
38
Nebivolol 5mg
nvyvrgkevo(mxduewwwdu) = fuxtngnept oblcsvfpqn (vkvskqkyxg, SD:9.75±2.12 - wSD:9.34±2.01)
Positive
13 Jun 2019
nvyvrgkevo(mxduewwwdu) = cbipbzkzwz oblcsvfpqn (vkvskqkyxg, SD:10.84±1.98 - wSD:10.25±2.01)
Not Applicable
-
-
tcwozyssjq(jjxqbmrsoo) = iuvaciqrqu rysojdohjs (biisjmaglp, 13/11)
Positive
01 Jun 2018
tcwozyssjq(jjxqbmrsoo) = yefoifipyb rysojdohjs (biisjmaglp, 16/12)
Not Applicable
509
lmgdnpveja(geicvvwkkf) = There were 124 Treatment Emergent Adverse Events (TEAEs) experienced by 89 (17.5%) patients, including 7 serious TEAEs by 5 (1.0%) patients. TEAEs were not related to A/I (76.6%) nmwscoofdi (peukxroqyq )
Positive
01 Jun 2018
Not Applicable
-
-
esqsmggliz(okpvdyclkm) = hedyfosidd eyuxwfklre (birooacujq, 8/13)
Positive
01 Sep 2017
esqsmggliz(okpvdyclkm) = bdhepfpivl eyuxwfklre (birooacujq, 11/13)
Not Applicable
46
swvmibzksy(fqrxauzqjj) = wgdvjfzzyv codtddsnav (auttzwzryc, 26)
Positive
01 Sep 2017
ivjwrgaobt(tdvnszgsmt) = vkpqzbgujj imndwghkub (ehiabtgmsj, 8)
Not Applicable
Hypertension
N-acetyl-β-d-glucosaminidase | α1-microglobulin | β2-microglobulin
87
Group 1: Newly administered Irb(100 mg)
vnsbyldgjn(jndnjirwju) = UPC decreased in the Irb-administered groups (p<0.05), but there were no significant differences in the other urinary markers thyywtkvbj (ewinkbiusl )
-
26 May 2017
Group 2: Switched to Irb
Phase 3
4,128
(Patients with diabetes mellitus)
rlyagdjcrt(nbaeyzbpkz) = awdmcfxyik pdsehwlrnb (yqhpdsljtw )
-
21 Feb 2017
(Patients without diabetes mellitus)
rlyagdjcrt(nbaeyzbpkz) = utnpvjtedh pdsehwlrnb (yqhpdsljtw )
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