{"id":"azilsartan","rwe":[{"n":671468,"pmid":"40468725","year":"2025","title":"Safety of combination therapy of azilsartan medoxomil and amlodipine: a population-based cohort study.","finding":"In this population-based cohort study, azilsartan medoxomil combined with amlodipine was not associated with an increased risk of adverse outcomes compared to other ARBs combined with amlodipine. DOI: 10.4178/epih.e2025029 PMCID: PMC12425867 PMID: 40468725 [Indexed for MEDLINE] Conflict of interest ","journal":"Epidemiology and health","studyType":"Cohort"},{"n":null,"pmid":"28290827","year":"2016","title":"[Azilsartan Medoxomil Capabilities in Arterial Hypertension and Obesity].","finding":"","journal":"Kardiologiia","studyType":"Observational"},{"n":null,"pmid":"40416031","year":"2025","title":"Enhancing Home Blood Pressure Management: Implementation of the Sacubitril/Valsartan Treatment in Practical Clinical Settings.","finding":"","journal":"JMA journal","studyType":"Observational"},{"n":null,"pmid":"38512445","year":"2024","title":"Angiotensin Receptor Blockers and the Risk of Suspected Drug-Induced Liver Injury: A Retrospective Cohort Study Using Electronic Health Record-Based Common Data Model in South Korea.","finding":"","journal":"Drug safety","studyType":"Retrospective"},{"n":null,"pmid":"30848243","year":"2019","title":"Use of azilsartan medoxomil in the primary-care setting in Germany: A real-world evidence study .","finding":"","journal":"International journal of clinical pharmacology and therapeutics","studyType":"Observational"}],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":["WARNING: FETAL TOXICITY When pregnancy is detected, discontinue Edarbyclor as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. WARNING: FETAL TOXICITY See full prescribing"],"safetySignals":[],"drugInteractions":[{"drug":"Renal clearance of lithium is reduced by diuretics","severity":"Monitor closely","mechanism":"","management":"","clinicalEffect":", such as chlorthalidone increasing the risk of lithium toxicity ( 7 ) NSAIDS increase risk of renal dysfunction and interfere with antihypertensive effect ( 7 ) Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hyp"},{"drug":"Non-Steroidal Anti-Inflammatory Agents including","severity":"Monitor closely","mechanism":"","management":"","clinicalEffect":"Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) In patients who are elderly, volume-depleted (including those on diuretic therapy), or who have compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, wi"},{"drug":"Lithium Increases in serum lithium concentrations and","severity":"Monitor closely","mechanism":"","management":"","clinicalEffect":"lithium toxicity have been reported during concomitant admin"}],"commonSideEffects":[{"notes":"","effect":"continuation because of adverse reactions","severity":"mild","placeboRate":null,"incidenceRate":"8.3%"}],"contraindications":["Hyponatremia","Hypovolemia","Impaired renal function disorder","Low blood pressure","Pregnancy, function","Renal artery stenosis"],"specialPopulations":{"Pregnancy":"8.1 Pregnancy Risk Summary Edarbyclor can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death ( see Clinical Considerations ). Most epidemiologic studies examining fetal abnormalities after exposure to antihy","Paediatric use":"8.4 Pediatric Use Safety and effectiveness of Edarbyclor in pediatric patients under 18 years of age have not been established.","Elderly (≥65 years)":"8.5 Geriatric Use Edarbyclor No dose adjustment with Edarbyclor is necessary in elderly patients. Of the total patients in clinical studies with Edarbyclor, 24% were elderly (65 years of age or older); 5.7% were 75 years and older. No overall differences in safety or effectiveness were observed between elderly patients and younger patients, but greater sensitivity of some older individuals cannot "},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"discontinued","trials":["NCT06618079","NCT02235909","NCT00847626","NCT03042299","NCT00362115","NCT07262710","NCT02407210","NCT05841654","NCT03539627","NCT01609959","NCT05107960","NCT02517866","NCT01124656","NCT02401464","NCT01985152","NCT02092025","NCT02480764","NCT02541669","NCT05498675","NCT02400775","NCT06990204","NCT01762501","NCT02609490","NCT01456169","NCT00376181","NCT04470830","NCT04467931","NCT04470817","NCT03006796","NCT00591578","NCT03652792","NCT00846365","NCT04606563","NCT00762736","NCT02072330","NCT00591266","NCT00818883","NCT02791438","NCT00696384","NCT02235519","NCT02100319","NCT05002244","NCT01309828","NCT02203916","NCT02181816","NCT05753696","NCT00591773","NCT00760214","NCT04743063","NCT01496430"],"aliases":[],"patents":[],"pricing":[],"offLabel":[],"timeline":[{"date":"2006","type":"neutral","milestone":"Phase 2 Initiated","description":"Safety and Efficacy of Azilsartan Medoxomil in Participants With Mild to Moderate Hypertension — Hypertension"},{"date":"2008","type":"neutral","milestone":"Phase 3 Initiated","description":"Efficacy and Safety of Azilsartan Medoxomil in Participants With Essential Hypertension — Hypertension"},{"date":"2013","type":"neutral","milestone":"Phase 4 Initiated","description":"New Angiotensin II Receptor Blocker Azilsartan Study for Stronger Blood Pressure Lowering — Hypertension"},{"date":"2015","type":"neutral","milestone":"Phase 1 Initiated","description":"A Phase 1 Food Effect Study of TAK-536TCH Final Formulation Tablet — Hypertension"}],"aiSummary":"AZILSARTAN was discontinued before reaching advanced clinical trials. The drug was intended to treat high blood pressure. Its clinical significance is limited as it never progressed to a stage where it could be used to treat patients.","brandName":"AZILSARTAN","companyId":"unknown","ecosystem":[],"mechanism":{"target":"Type-1 angiotensin II receptor, Type-1 angiotensin II receptor","novelty":"","modality":"Small molecule","drugClass":"","explanation":"12.1 Mechanism of Action The active ingredients of Edarbyclor target two separate mechanisms involved in blood pressure regulation. Azilsartan medoxomil Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzymes (ACE, kinase II). Angiotensin II is the principle pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodi","oneSentence":"12.1 Mechanism of Action The active ingredients of Edarbyclor target two separate mechanisms involved in blood pressure regulation.","oneSentence_ai":"AZILSARTAN works by blocking the action of angiotensin II, a hormone that narrows blood vessels.","technicalDetail":"12.1 Mechanism of Action The active ingredients of Edarbyclor target two separate mechanisms involved in blood pressure regulation. Azilsartan medoxomil Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzymes (ACE, kinase II). Angiotensin II is the principle pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Azilsartan medoxomil is an orally administered prodrug that is rapidly converted by esterases during absorption to the active moiety, azilsartan. Azilsartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT 1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is, therefore, independent of the pathway for angiotensin II synthesis. An AT 2 receptor is also found"},"commercial":null,"references":[],"ai_enriched":true,"biosimilars":[],"companyName":"","competitors":[],"dataSources":[{"url":"https://clinicaltrials.gov","name":"ClinicalTrials.gov","fields":["trialDetails","trials"],"retrievedDate":"2026-04-07"},{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"genericName":"AZILSARTAN","indications":{"approved":[{"name":"Hypertensive disorder","diseaseId":"hypertensive-disorder","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06618079","phase":"Phase 1","title":"A Two Cohort, Single-sequence, Parallel, Open Label, Multiple Oral Dosing Phase 1 Clinical Trial to Evaluate the Safety and the Pharmacokinetic Drug-drug Interaction of HUC2-565-A and HUC2-565-B in He","status":"ACTIVE_NOT_RECRUITING","sponsor":"Huons Co., Ltd.","isPivotal":false,"enrollment":46,"indication":"Hypertension","completionDate":"2024-10-01"},{"nctId":"NCT02235909","phase":"Phase 3","title":"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 Hyp","status":"COMPLETED","sponsor":"Arbor Pharmaceuticals, Inc.","isPivotal":true,"enrollment":377,"indication":"Hypertension","completionDate":"2019-11-11"},{"nctId":"NCT00847626","phase":"Phase 3","title":"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","status":"COMPLETED","sponsor":"Takeda","isPivotal":true,"enrollment":1711,"indication":"Hypertension","completionDate":"2010-07"},{"nctId":"NCT03042299","phase":"Phase 1","title":"A Randomized, Open 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Tianjin University of Traditional Chinese Medicine","isPivotal":false,"enrollment":13656,"indication":"Post-stroke Pneumonia","completionDate":"2026-08-19"},{"nctId":"NCT02407210","phase":"Phase 3","title":"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 Hypert","status":"UNKNOWN","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","isPivotal":true,"enrollment":304,"indication":"Essential Hypertension","completionDate":""},{"nctId":"NCT05841654","phase":"Phase 4","title":"Effect of Azilsartan on the Incidence of Atrial Fibrillation in Patients With Hypertension Combined With Left Ventricular Hypertrophy","status":"UNKNOWN","sponsor":"Beijing Tsinghua Chang Gung Hospital","isPivotal":false,"enrollment":400,"indication":"Hypertension, Atrial Fibrillation","completionDate":"2025-10-01"},{"nctId":"NCT03539627","phase":"N/A","title":"One-center, 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the Effects of Azilsartan on Coronary Artery Plaque in Essential Hypertensive Patients With Stable Angina and Dyslipidemia.","status":"WITHDRAWN","sponsor":"Takeda","isPivotal":false,"enrollment":0,"indication":"Essential Hypertension With Stable Angina and Dyslipidemia","completionDate":"2016-04"},{"nctId":"NCT06990204","phase":"Phase 1","title":"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 Su","status":"NOT_YET_RECRUITING","sponsor":"Gedeon Richter Plc.","isPivotal":false,"enrollment":56,"indication":"Hypertension","completionDate":"2025-07-01"},{"nctId":"NCT01762501","phase":"NA","title":"Azilsartan Circadian and Sleep Pressure - the 1st Study","status":"COMPLETED","sponsor":"Sogo Rinsho Médéfi Co., Ltd.","isPivotal":false,"enrollment":957,"indication":"Hypertension","completionDate":"2013-12"},{"nctId":"NCT02609490","phase":"Phase 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Treatment of Adult Patients With Essential Hypertension in South Korea","status":"COMPLETED","sponsor":"Celltrion Pharm, Inc.","isPivotal":false,"enrollment":3438,"indication":"Essential Hypertension","completionDate":"2023-05-25"},{"nctId":"NCT03006796","phase":"N/A","title":"Observational Prospective stUdy of aZilsartan Medoxomil/ Chlorthalidone Compared With Irbesartan/hydrochlorothiaZide Combination Therapy in Patients With arteriaL Hypertension and obEsity in Routine C","status":"COMPLETED","sponsor":"Russian Heart Failure Society","isPivotal":false,"enrollment":94,"indication":"Arterial Hypertension","completionDate":"2020-03-31"},{"nctId":"NCT00591578","phase":"Phase 3","title":"A Double-Blind, Randomized, Parallel-Group Study to Compare the Efficacy and Safety of TAK-491 With Valsartan in Subjects With Essential Hypertension","status":"COMPLETED","sponsor":"Takeda","isPivotal":true,"enrollment":984,"indication":"Hypertension","completionDate":"2010-03"},{"nctId":"NCT03652792","phase":"Phase 1","title":"Single-Dose, Randomized, Open-Label, Two-Way Crossover Study to Evaluate the Bioequivalence of Azilsartan Tablets in Chinese Healthy Volunteers","status":"COMPLETED","sponsor":"Lee's Pharmaceutical Limited","isPivotal":false,"enrollment":60,"indication":"Bioequivalence of Two Azilsartan Formulations","completionDate":"2018-07-05"},{"nctId":"NCT00846365","phase":"Phase 3","title":"A Phase 3, Double-Blind, Randomized, Efficacy and Safety Study Comparing the TAK-491 Plus Chlorthalidone Fixed-Dose Combination vs Benicar HCT® (Olmesartan Medoxomil-Hydrochlorothiazide) in Subjects W","status":"COMPLETED","sponsor":"Takeda","isPivotal":true,"enrollment":1085,"indication":"Essential Hypertension","completionDate":"2010-06"},{"nctId":"NCT04606563","phase":"Phase 3","title":"Host Response Mediators in 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Hydrochlorothiazide Fixed-","status":"COMPLETED","sponsor":"Takeda","isPivotal":true,"enrollment":153,"indication":"Safety","completionDate":"2012-10"},{"nctId":"NCT02203916","phase":"Phase 3","title":"A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of TAK-491 in Korean Subjects With Essential Hypertension","status":"COMPLETED","sponsor":"Takeda","isPivotal":true,"enrollment":328,"indication":"Hypertension","completionDate":"2016-02"},{"nctId":"NCT02181816","phase":"N/A","title":"Azilsartan/Amlodipine (Zacras) Combination Tablets LD & HD Specified Drug-use Survey \"Long-term Use Survey\"","status":"COMPLETED","sponsor":"Takeda","isPivotal":false,"enrollment":1090,"indication":"Hypertension","completionDate":"2017-01-31"},{"nctId":"NCT05753696","phase":"NA","title":"The Effect of Azilsartan in Patients With Diabetic Kidney Disease and Hypertension","status":"UNKNOWN","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","isPivotal":false,"enrollment":106,"indication":"Proteinuria, Kidney Dysfunction","completionDate":"2024-12-30"},{"nctId":"NCT00591773","phase":"Phase 3","title":"A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-491 When Co-administered With Chlorthalidone in Subjects With Essential Hypertension","status":"COMPLETED","sponsor":"Takeda","isPivotal":true,"enrollment":551,"indication":"Hypertension","completionDate":"2009-03"},{"nctId":"NCT00760214","phase":"Phase 3","title":"A Double-Blind, Randomized, Parallel-Group Study to Compare the Efficacy and Safety of TAK-491 With Ramipril in Subjects With Essential Hypertension","status":"COMPLETED","sponsor":"Takeda","isPivotal":true,"enrollment":885,"indication":"Hypertension","completionDate":"2009-04"},{"nctId":"NCT04743063","phase":"N/A","title":"Prospective Monitoring of Angiotensin Receptor Neprilysin Inhibitor in Older Adults With Heart Failure and Frailty","status":"UNKNOWN","sponsor":"Brigham and Women's Hospital","isPivotal":false,"enrollment":40000,"indication":"Heart Failure, Systolic, Frailty","completionDate":"2022-12-31"},{"nctId":"NCT01496430","phase":"Phase 3","title":"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","status":"TERMINATED","sponsor":"Takeda","isPivotal":true,"enrollment":105,"indication":"Hypertension, Diabetes","completionDate":"2013-05"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"Oral","frequency":"Once daily","formulation":"Film-coated tablet"},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Cardiovascular"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Small molecule","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}