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Drug

Azilsartan medoxomil

Approved · EMA
Late-stage development

Also known as Edarbi, Edarbyclor, Azilsartán medoxomilo, Azilsartanum medoxomilum.

RxNorm1091642ChEMBLCHEMBL2028661UNIILL0G25K7I2
1
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Single Center, Open Label, Randomized, Four-period, Two-sequence, Fully Replicate, Cross-over Bioequivalence Study of Azilsartan Medoxomil 80 mg Tablets and Edarbi® 80 mg Tablets in Healthy Adult Subjects of Both Sexes Under Fasting Conditions

Clinical trial2025-07-01Primary completion · ClinicalTrials.gov

A Randomized, Double-Blind, Efficacy and Safety Study of AR 14 (AZILSARTAN MEDOXOMIL) Treatment and Withdrawal, Followed by an Open-Label Extension, in Children 6 to Less Than 18 Years of Age With Hypertension

Clinical trial2025-02-25Results posted · ClinicalTrials.gov

A Phase 3, Double-Blind, Randomized, Parallel-Group Study to Compare the Efficacy and Safety of TAK-491 With Valsartan in Chinese Subjects With Essential Hypertension

Clinical trial2019-03-05Results posted · ClinicalTrials.gov

A Prospective Study of Azilsartan Medoxomil in the Treatment of Patients With Essential Hypertension and Type 2 Diabetes in Asia

Clinical trial2019-03-01Results posted · ClinicalTrials.gov

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of TAK-491 in Korean Subjects With Essential Hypertension

Clinical trial2016-12-19Results posted · ClinicalTrials.gov

A Comparative Single-Dose Pharmacokinetic and Safety Study of TAK-491 Between Infants, Children, and Adolescents With Hypertension and Healthy Adults

Clinical trial2013-09-01Terminated · ClinicalTrials.gov

A Randomized, Double-Blind, Phase 3b Proof-of-Concept Study to Evaluate the Efficacy and Safety of TAK-491 Compared to Placebo When Used in Combination With Metformin in Subjects With Hypertension and Type 2 Diabetes

Clinical trial2013-05-01Terminated · ClinicalTrials.gov

A Double-Blind, Randomized, Parallel-Group Study to Compare the Efficacy and Safety of TAK-491 With Ramipril in Subjects With Essential Hypertension

Clinical trial2012-11-15Results posted · ClinicalTrials.gov

A Phase 3, Double-Blind, Randomized, Factorial, Efficacy and Safety Study of TAK 491 Plus Chlorthalidone Fixed-Dose Combination in Participants With Moderate to Severe Hypertension

Clinical trial2012-02-07Results posted · ClinicalTrials.gov

A Double-Blind, Randomized, Parallel-Group Study to Compare the Efficacy and Safety of TAK-491 With Valsartan in Subjects With Essential Hypertension

Clinical trial2012-02-02Results posted · ClinicalTrials.gov

An 8-Month Phase 3, Open-Label Study With a Blinded Reversal Phase to Evaluate the Safety and Tolerability of TAK-491 in Subjects With Essential Hypertension

Clinical trial2012-01-04Results posted · ClinicalTrials.gov

Approval: Edarbi (EMA)

Regulatory2011-12-07EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Azilsartan medoxomil
Aliases & brands
EdarbiEdarbyclorAzilsartán medoxomiloAzilsartanum medoxomilum
RxNorm CUI
1091642
ChEMBL ID
CHEMBL2028661
UNII
LL0G25K7I2
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2011-12-07
Latest approval
2011-12-07
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2011-12-07Approval
Approval: Edarbi (EMA)

Indication: Edarbi is indicated for the treatment of essential hypertension in adults.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

14 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
14
registered trials across all phases
LATEST COMPLETION 2019
1
Active studies
1
Recruiting
11
Late-stage (III+)
11
Completed
2
Discontinued
PHASE DISTRIBUTIONn = 14
Phase 12Phase 21Phase 310Phase 41

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Prospective Study of Azilsartan Medoxomil in the Treatment of Patients With Essential Hypertension and Type 2 Diabetes in Asia

CompletedPH IVTakedan=3802016

A Randomized, Double-Blind, Efficacy and Safety Study of AR 14 (AZILSARTAN MEDOXOMIL) Treatment and Withdrawal, Followed by an Open-Label Extension, in Children 6 to Less Than 18 Years of Age With Hypertension

CompletedPH IIIArbor Pharmaceuticals, Inc.n=3772019

A Phase 3, Double-Blind, Randomized, Parallel-Group Study to Compare the Efficacy and Safety of TAK-491 With Valsartan in Chinese Subjects With Essential Hypertension

CompletedPH IIITakedan=6122017

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of TAK-491 in Korean Subjects With Essential Hypertension

CompletedPH IIITakedan=3282016

A Randomized, Double-Blind, Phase 3b Proof-of-Concept Study to Evaluate the Efficacy and Safety of TAK-491 Compared to Placebo When Used in Combination With Metformin in Subjects With Hypertension and Type 2 Diabetes

TerminatedPH IIITakedan=1052013

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Randomized, Double-Blind, Efficacy and Safety Study of AR 14 (AZILSARTAN MEDOXOMIL) Treatment and Withdrawal, Followed by an Open-Label Extension, in Children 6 to Less Than 18 Years of Age With Hypertension

CompletedPH IIIArbor Pharmaceuticals, Inc.n=3772019

A Phase 3, Double-Blind, Randomized, Parallel-Group Study to Compare the Efficacy and Safety of TAK-491 With Valsartan in Chinese Subjects With Essential Hypertension

CompletedPH IIITakedan=6122017

A Prospective Study of Azilsartan Medoxomil in the Treatment of Patients With Essential Hypertension and Type 2 Diabetes in Asia

CompletedPH IVTakedan=3802016

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of TAK-491 in Korean Subjects With Essential Hypertension

CompletedPH IIITakedan=3282016

A Phase 3, Double-Blind, Randomized, Factorial, Efficacy and Safety Study of TAK 491 Plus Chlorthalidone Fixed-Dose Combination in Participants With Moderate to Severe Hypertension

CompletedPH IIIKey trialTakedan=1,7112010

A Double-Blind, Randomized, Parallel-Group Study to Compare the Efficacy and Safety of TAK-491 With Valsartan in Subjects With Essential Hypertension

CompletedPH IIITakedan=9842010
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.