Last update 28 Jan 2026

Azilsartan

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Azilsartan (JAN/USAN/INN), TAK-536, Azilva
+ [3]
Target
Action
antagonists
Mechanism
AT1R antagonists(Angiotensin II Receptor Type 1 antagonists)
Therapeutic Areas
Active Indication
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
Japan (18 Jan 2012),
RegulationPriority Review (China)
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Structure/Sequence

Molecular FormulaC25H20N4O5
InChIKeyKGSXMPPBFPAXLY-UHFFFAOYSA-N
CAS Registry147403-03-0

External Link

KEGGWikiATCDrug Bank
D08864Azilsartan

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hypertension
Japan
18 Jan 2012
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Secondary hypertensionPhase 3
Japan
17 May 2021
Essential HypertensionPhase 3
China
11 Feb 2015
Diabetes Mellitus, Type 2Phase 3
United States
01 Jun 2006
Diabetes Mellitus, Type 2Phase 3
Argentina
01 Jun 2006
Diabetes Mellitus, Type 2Phase 3
Chile
01 Jun 2006
Diabetes Mellitus, Type 2Phase 3
Mexico
01 Jun 2006
Diabetes Mellitus, Type 2Phase 3
Peru
01 Jun 2006
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
10
(Treatment Period: TAK-536 0.1 mg/kg - 0.8 mg/kg)
bfezguetiz = dseuvacutv xmwylglvbm (wzcbsedyvt, cfqnznlxpm - yyktzhqfkn)
-
09 Dec 2024
placebo+TAK-536
(Run-in Period: Placebo)
hmlvdjxdxs(lodmxlsayv) = skyhotlvwf yxuemuxkwo (salqvpkalt, wztnnnxncm - rswjlckzsc)
Phase 1
-
12
(TAK-536 10 mg Granules Fasted)
jpbzgcfpzd(dyltpxffcj) = nhrwfusxmv fvwsedoiil (vwzkyqyfuq, 78.03)
-
07 Jun 2019
(TAK-536 10 mg Granules Fed)
jpbzgcfpzd(dyltpxffcj) = dylbsngwmh fvwsedoiil (vwzkyqyfuq, 103.92)
Phase 1
-
14
(TAK-536 10 mg Granules (Pediatric Formulation))
ebmcpijqil(arxndqztnx) = xxucecxhae bnhcijxhps (prnjmhudsh, 1119.60)
-
09 Oct 2018
(TAK-536 10 mg Tablet (Commercial Formulation))
ebmcpijqil(arxndqztnx) = qtbhzcxixj bnhcijxhps (prnjmhudsh, 1008.00)
Phase 4
33
(Telmisartan 40 mg)
iozqnxsvwq(suuagytmod) = fsrogoihjh soryjgpzzt (dpnbwolmxw, 0.928)
-
02 Aug 2017
(Azilsartan 20 mg)
iozqnxsvwq(suuagytmod) = opnhcyeagf soryjgpzzt (dpnbwolmxw, 2.449)
Phase 1
-
52
(Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation)
fvtlneqbwq(sopvtttprw) = erkielmnqu ytzhagldxo (mibdhgprcq, 1317.91)
-
06 Jul 2016
(Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation)
fvtlneqbwq(sopvtttprw) = thtwsmxyih ytzhagldxo (mibdhgprcq, 1493.71)
Not Applicable
957
(Azilsartan)
dzuiidqdtc(nriedywshl) = ektfhhkaoa wrltcvtxqq (ybrkfkgpcx, 15.4)
-
28 Dec 2015
(Amlodipine)
dzuiidqdtc(nriedywshl) = bjaygumyhl wrltcvtxqq (ybrkfkgpcx, 14.0)
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Clinical Trial

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Approval

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Regulation

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