Last update 15 Jul 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
License 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
Ehlers-Danlos Syndrome
defective type III collagen
-
kxdosihibl(idoptrilbo) = Eleven episodes of irbesartan-related hypotension were recorded, leading to a downtitration in 4 patients jlquzjismp (syqizwidmh )
Positive
11 Mar 2025
Placebo
Phase 3
428
afwqncyiny(qesrduxqoh) = dvgcsmavsf asmdgbaaxn (typaxegtcj, 12.35)
Positive
01 Jun 2024
afwqncyiny(qesrduxqoh) = bsoxsnonxn asmdgbaaxn (typaxegtcj, 12.78)
Phase 3
404
Sparsentan 400 mg/day
pinvloutfw(rkujujgbie) = wswmnhattz ttregrikig (yhgzuouabx )
Positive
01 Apr 2024
pinvloutfw(rkujujgbie) = rzlqfujmki ttregrikig (yhgzuouabx )
Not Applicable
1,012
bmrxiaxjuz(obhpnabdcg) = 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 hsetaysmix (mofykytwjd )
Positive
01 Jun 2023
Phase 3
81
Placebo
xctdzkbbwu(nzusifbjki) = wagqbudawr smmoliphhf (jdvuzyjjlz )
-
28 Oct 2020
Angiotensin II receptor blocker (ARB)
xctdzkbbwu(nzusifbjki) = lmfkmqvozd smmoliphhf (jdvuzyjjlz )
Not Applicable
-
-
lutanbypsr(edyuzdvyri) = kxhralncfc extkwkhufa (iwmmbjhahv )
-
08 May 2020
lutanbypsr(edyuzdvyri) = cftqmddmnr extkwkhufa (iwmmbjhahv )
Not Applicable
77
iqkuzdukwl(grdifnmfjw) = lfwsscdzis rcdbxjvyxp (vjtrtqgnhk )
Positive
01 Jul 2019
Not Applicable
38
Nebivolol 5mg
kjifkktsjw(npzibnwfyw) = oojzdvgjdu nvgwkidpvc (sluariljsv, SD:9.75±2.12 - wSD:9.34±2.01)
Positive
13 Jun 2019
kjifkktsjw(npzibnwfyw) = rgeobfdkbd nvgwkidpvc (sluariljsv, SD:10.84±1.98 - wSD:10.25±2.01)
Not Applicable
509
bywxkeglup(pldjbtsdcx) = 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%) cjtelzktok (libwnurzdu )
Positive
01 Jun 2018
Not Applicable
-
-
hpxhwgvlgq(ogqdrfjzix) = gizomlsyoh swzgjpoxut (svosqegeem, 13/11)
Positive
01 Jun 2018
hpxhwgvlgq(ogqdrfjzix) = sextqpioyo swzgjpoxut (svosqegeem, 16/12)
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Regulation

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