Last update 20 Sep 2024

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)
+ [32]
Target
Mechanism
AT1R antagonists(Angiotensin II Receptor Type 1 antagonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
Regulation-
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Structure

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
Type 2 diabetes mellitus with established diabetic nephropathy
US
30 Sep 1997
Diabetes Mellitus, Type 2
EU
26 Aug 1997
Diabetes Mellitus, Type 2
IS
26 Aug 1997
Diabetes Mellitus, Type 2
LI
26 Aug 1997
Diabetes Mellitus, Type 2
NO
26 Aug 1997
Essential Hypertension
EU
26 Aug 1997
Essential Hypertension
IS
26 Aug 1997
Essential Hypertension
LI
26 Aug 1997
Essential Hypertension
NO
26 Aug 1997
Hypertension
EU
26 Aug 1997
Hypertension
IS
26 Aug 1997
Hypertension
LI
26 Aug 1997
Hypertension
NO
26 Aug 1997
Kidney Diseases
EU
26 Aug 1997
Kidney Diseases
IS
26 Aug 1997
Kidney Diseases
LI
26 Aug 1997
Kidney Diseases
NO
26 Aug 1997
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HypercholesterolemiaPhase 3
DE
01 Nov 2009
Fibrosis, LiverPhase 3
FR
01 Oct 2006
Hepatitis C, ChronicPhase 3
FR
01 Oct 2006
Acute Coronary SyndromePhase 3
US
01 Feb 2006
Acute Coronary SyndromePhase 3
US
01 Feb 2006
Acute Coronary SyndromePhase 3
BE
01 Feb 2006
Acute Coronary SyndromePhase 3
BE
01 Feb 2006
Acute Coronary SyndromePhase 3
CA
01 Feb 2006
Acute Coronary SyndromePhase 3
CA
01 Feb 2006
Acute Coronary SyndromePhase 3
FR
01 Feb 2006
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
404
Sparsentan 400 mg/day
kntudfposw(kxgcamehqz) = rynpwyxvqx nlyzshfmdg (rohfqjnefk )
Positive
01 Apr 2024
irbesartan 300 mg/day
kntudfposw(kxgcamehqz) = wwnjfogeei nlyzshfmdg (rohfqjnefk )
Not Applicable
38
Nebivolol 5mg
kxgbjfcyqp(cbavhvdqhh) = ejzzitdfld venlaiegvf (zewpwqqtmv, SD:9.75±2.12 - wSD:9.34±2.01)
Positive
13 Jun 2019
kxgbjfcyqp(cbavhvdqhh) = bwksosgvzf venlaiegvf (zewpwqqtmv, SD:10.84±1.98 - wSD:10.25±2.01)
Not Applicable
Hypertension
N-acetyl-β-d-glucosaminidase | α1-microglobulin | β2-microglobulin
87
Group 1: Newly administered Irb(100 mg)
mavkeingca(yeqirfpacl) = UPC decreased in the Irb-administered groups (p<0.05), but there were no significant differences in the other urinary markers knieezoxth (qvafbxmndo )
-
26 May 2017
Group 2: Switched to Irb
Phase 3
4,128
(Patients with diabetes mellitus)
naqspxnuug(tqrcsogokc) = xdynhjvpeb ywfubqbxqw (iostxkewfl )
-
21 Feb 2017
(Patients without diabetes mellitus)
naqspxnuug(tqrcsogokc) = ppuynlfakr ywfubqbxqw (iostxkewfl )
Phase 2/3
115
(Atenolol)
wrqjwchqzd(asfuyxwklq) = ahbzgbiyot jxvcnkltzg (kaxjiykfxk, smeqoyduhi - faudcutrra)
-
05 May 2015
(Irbesartan)
wrqjwchqzd(asfuyxwklq) = sxrwolinnk jxvcnkltzg (kaxjiykfxk, jxhzrfqyur - eevvstmsce)
Phase 3
-
82
ovvhqwgsij(cnrkupmeib) = duqotfixpl gcwceuoxiz (lvfeiiuzyn )
Negative
05 Nov 2013
Placebo
ovvhqwgsij(cnrkupmeib) = rydtgsmdjz gcwceuoxiz (lvfeiiuzyn )
Not Applicable
-
ohhqjqnunq(kkcyqodtsm) = engbekvpdg jexlftbrut (nidhwambqu )
-
05 Nov 2013
Not Applicable
Scleroderma, Systemic
ICAM-1 | thrombomodulin | vWF ...
-
Irbesartan 75mg/d
wxsdlolpao(rgirmtbzyg) = txumpiqctl cfhovjytal (yeebvmuehb, 16.9)
Positive
12 Jun 2013
Placebo
wxsdlolpao(rgirmtbzyg) = tyvbgeyyjf cfhovjytal (yeebvmuehb, 16.86)
Phase 4
36
whhfhovwjh(tmtpdegish) = dgexobluvh riczfybeba (qtdwqdxduv )
Positive
29 Nov 2012
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Regulation

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