Drug

Azilsartan

Approved medicine

ClassType-1 angiotensin II receptor antagonistResearchOngoing clinical research

Also known as Edarbi, Edarbyclor.

RxNorm1091643 ChEMBLCHEMBL57242UNIIF9NUX55P23

Type-1 angiotensin II receptor

Primary target

Latest activity

beta

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

The Effect of Azilsartan in Patients With Diabetic Kidney Disease and Hypertension

Clinical trial2024-10-30Primary completion · ClinicalTrials.gov

Host Response Mediators in Coronavirus (COVID-19) Infection - Is There a Protective Effect of Losartan and Other ARBs on Outcomes of Coronavirus Infection?

Clinical trial2022-04-22Terminated · ClinicalTrials.gov

A Phase 3, Open-label, Multicenter, Long-term Study to Evaluate the Safety, Efficacy and Pharmacokinetics of TAK-536 in Pediatric Patients 6 to Less Than 16 Years of Age With Hypertension

Clinical trial2020-02-07Results posted · ClinicalTrials.gov

A Multi-center, Randomized, Double-blind, Double-dummy, With Olmesartan Medoxomil as Positive Control Parallel Clinical Study to Evaluate the the Safety and Efficacy of Azilsartan in Chinese Patients With Primary Mild and Moderate Hypertension

Clinical trial2018-08-01Completed · ClinicalTrials.gov

Single-Dose, Randomized, Open-Label, Two-Way Crossover Study to Evaluate the Bioequivalence of Azilsartan Tablets in Chinese Healthy Volunteers

Clinical trial2018-07-05Completed · ClinicalTrials.gov

Single Center, Randomized, Open Labeled Pharmacokinetics Study of Azilsartan Tablets in Chinese Healthy Volunteers

Clinical trial2017-11-30Completed · ClinicalTrials.gov

A Study to Explore the Effects of Azilsartan Compared to Telmisartan on Insulin Resistance of Patients With Essential Hypertension on Type 2 Diabetes Mellitus by HOMA-R

Clinical trial2017-08-02Results posted · ClinicalTrials.gov

An Open-label, Phase 3, Multicenter Study to Evaluate the Pharmacokinetics Following a Single Oral Dose of TAK-536 in Pediatric Patients 6 to Less Than 16 Years of Age With Hypertension

Clinical trial2016-04-07Results posted · ClinicalTrials.gov

A Study to Evaluate the Effects of Azilsartan on Coronary Artery Plaque in Essential Hypertensive Patients With Stable Angina and Dyslipidemia.

Clinical trial2016-04-01Withdrawn · ClinicalTrials.gov

Azilsartan Circadian and Sleep Pressure - the 1st Study

Clinical trial2015-12-28Results posted · ClinicalTrials.gov

A Phase 3, Double-Blind, Randomized, Parallel-Group Study to Evaluate the Efficacy and Safety of Azilsartan Compared to Olmesartan Medoxomil in Chinese Participants With Grade I or II Essential Hypertension

Clinical trial2015-10-01Primary completion · ClinicalTrials.gov

A Randomized, Open Label Study to Evaluate the Pleiotropic Effects of Azilsartan Medoxomil 40 and 80 mg for 12 Weeks Over Metabolic Markers in Patients With Hypertension, Obesity or Type 2 Diabetes Mellitus

Clinical trial2015-06-01Primary completion · ClinicalTrials.gov

Profile

Identifiers & mechanism

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

Canonical name

Azilsartan

Aliases & brands

EdarbiEdarbyclor

RxNorm CUI

1091643

ChEMBL ID

CHEMBL57242

UNII

F9NUX55P23

Primary mechanism

Type-1 angiotensin II receptor antagonist

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Type-1 angiotensin II receptor

AGTR1 · P30556

ANTAGONISTType-1 angiotensin II receptor antagonist

Clinical trials

15 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

registered trials across all phases

LATEST COMPLETION 2019

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 15

Phase 12Phase 22Phase 2 / 31Phase 35Phase 43Phase N / A2

Late-stage studies

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

A Study to Explore the Effects of Azilsartan Compared to Telmisartan on Insulin Resistance of Patients With Essential Hypertension on Type 2 Diabetes Mellitus by HOMA-R

CompletedPH IVTakedan=332016

A Study to Evaluate the Effects of Azilsartan on Coronary Artery Plaque in Essential Hypertensive Patients With Stable Angina and Dyslipidemia.

WithdrawnPH IVTakeda2016

Effects of the New Angiotensin II Receptor Blocker Azilsartan Versus Valsartan on Blood Pressure in Japanese Patients With Hypertension

CompletedPH IVNara Medical Universityn=702013

Host Response Mediators in Coronavirus (COVID-19) Infection - Is There a Protective Effect of Losartan and Other ARBs on Outcomes of Coronavirus Infection?

TerminatedPH IIIUniversity of British Columbian=3412022

A Phase 3, Open-label, Multicenter, Long-term Study to Evaluate the Safety, Efficacy and Pharmacokinetics of TAK-536 in Pediatric Patients 6 to Less Than 16 Years of Age With Hypertension

CompletedPH IIITakedan=272019

Recent completions

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

A Phase 3, Open-label, Multicenter, Long-term Study to Evaluate the Safety, Efficacy and Pharmacokinetics of TAK-536 in Pediatric Patients 6 to Less Than 16 Years of Age With Hypertension

CompletedPH IIITakedan=272019

CompletedPH IIILee's Pharmaceutical Limitedn=3042018

Single-Dose, Randomized, Open-Label, Two-Way Crossover Study to Evaluate the Bioequivalence of Azilsartan Tablets in Chinese Healthy Volunteers

CompletedPH ILee's Pharmaceutical Limitedn=602018

Single Center, Randomized, Open Labeled Pharmacokinetics Study of Azilsartan Tablets in Chinese Healthy Volunteers

CompletedPH ILee's Pharmaceutical Limitedn=292017

A Study to Explore the Effects of Azilsartan Compared to Telmisartan on Insulin Resistance of Patients With Essential Hypertension on Type 2 Diabetes Mellitus by HOMA-R

CompletedPH IVTakedan=332016

An Open-label, Phase 3, Multicenter Study to Evaluate the Pharmacokinetics Following a Single Oral Dose of TAK-536 in Pediatric Patients 6 to Less Than 16 Years of Age With Hypertension

CompletedPH IIITakedan=62015

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
ClinicalTrials.gov — clinical trials