{"id":"irbesartan-oral-tablet","safety":{"commonSideEffects":[{"rate":"9","effect":"Dizziness"},{"rate":"3","effect":"Fatigue"},{"rate":"7","effect":"Musculoskeletal pain"},{"rate":"2","effect":"Hyperkalemia"},{"rate":"1","effect":"Elevated creatinine"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Irbesartan is an angiotensin II receptor blocker (ARB) that selectively antagonizes AT1 receptors on vascular smooth muscle and adrenal tissue. By blocking angiotensin II signaling, it causes vasodilation and reduces sodium and water retention, thereby decreasing blood pressure and reducing cardiac workload. This mechanism also provides renal protection in patients with hypertension and diabetes.","oneSentence":"Irbesartan blocks angiotensin II type 1 (AT1) receptors, preventing vasoconstriction and aldosterone release to lower blood pressure.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:33:33.660Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypertension"},{"name":"Diabetic nephropathy in patients with type 2 diabetes and hypertension"}]},"trialDetails":[{"nctId":"NCT05056727","phase":"PHASE3","title":"A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia","status":"TERMINATED","sponsor":"AstraZeneca","startDate":"2021-09-30","conditions":"Renal Insufficiency, Chronic, Hyperkalemia","enrollment":1112},{"nctId":"NCT05272878","phase":"PHASE3","title":"Impact of a Treatment With Angiotensin Receptor Blocker on Outcome After Acute Kidney Injury in Patients Discharged From the ICU.","status":"ACTIVE_NOT_RECRUITING","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2022-11-22","conditions":"Acute Kidney Injury","enrollment":508},{"nctId":"NCT03493685","phase":"PHASE3","title":"Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Travere Therapeutics, Inc.","startDate":"2018-04-17","conditions":"Focal Segmental Glomerulosclerosis","enrollment":371},{"nctId":"NCT03762850","phase":"PHASE3","title":"A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy","status":"ACTIVE_NOT_RECRUITING","sponsor":"Travere Therapeutics, Inc.","startDate":"2018-12-11","conditions":"Immunoglobulin A Nephropathy","enrollment":406},{"nctId":"NCT05498675","phase":"","title":"Effect of Sacubitril/Valsartan on Cardiac Function in Hypertensive Patients Stratified by BMI: A Real World Study","status":"RECRUITING","sponsor":"Beijing Friendship Hospital","startDate":"2021-09-01","conditions":"Sacubitril/Valsartan, Hypertension, Obesity","enrollment":180},{"nctId":"NCT06635772","phase":"PHASE2","title":"A Study of the Effect and Safety of HS-10390 in the Treatment of Patients with Primary IgA Nephropathy","status":"NOT_YET_RECRUITING","sponsor":"Hansoh BioMedical R&D Company","startDate":"2024-11","conditions":"Immunoglobulin a Nephropathy","enrollment":90},{"nctId":"NCT02597361","phase":"PHASE3","title":"Angiotensin II Receptor Blockade in Vascular Ehlers Danlos Syndrome (ARCADE)","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2016-01","conditions":"Ehlers-Danlos Syndrome, Vascular Type","enrollment":61},{"nctId":"NCT05377203","phase":"PHASE4","title":"Low-dose Quadruple Combination Therapy in Patients With Hypertension","status":"COMPLETED","sponsor":"The Third Xiangya Hospital of Central South University","startDate":"2022-07-13","conditions":"Hypertension, Arterial Hypertension","enrollment":90},{"nctId":"NCT05297929","phase":"PHASE1","title":"A Bioequivalence Trial of Irbesartan Tablets（0.15g） in Healthy Chinese Subjects","status":"UNKNOWN","sponsor":"The Affiliated Hospital of Qingdao University","startDate":"2022-02-17","conditions":"Irbesartan Tablets (0.15g/Tablet), Under Fasted Condition, Under Fed Condition","enrollment":54},{"nctId":"NCT00125645","phase":"PHASE4","title":"Left Ventricular Function After Acute Myocardial Infarction (AMI). Treatment With Angiotensin 2-Receptor Blockade (GLOBAL-Study)","status":"COMPLETED","sponsor":"University of Southern Denmark","startDate":"2005-03-01","conditions":"Myocardial Infarction","enrollment":200},{"nctId":"NCT01712113","phase":"NA","title":"Crossover Bioequivalence Study of Irbesartan 300 mg Tablets Under Fasted Conditions","status":"COMPLETED","sponsor":"Roxane Laboratories","startDate":"2007-08","conditions":"Hypertension","enrollment":33},{"nctId":"NCT01712100","phase":"NA","title":"Crossover Bioequivalence Study of Irbesartan 300 mg Tablets Under Fed Conditions","status":"COMPLETED","sponsor":"Roxane Laboratories","startDate":"2007-08","conditions":"Hypertension","enrollment":34},{"nctId":"NCT03016832","phase":"EARLY_PHASE1","title":"Clinical Trial of HuangKui Capsule to Treat Diabetic Kidney Disease","status":"UNKNOWN","sponsor":"Jiangsu Famous Medical Technology Co., Ltd.","startDate":"2017-01","conditions":"Diabetic Kidney Disease","enrollment":414},{"nctId":"NCT01968759","phase":"PHASE2","title":"Sevelamer in Proteinuric CKD","status":"COMPLETED","sponsor":"Mario Negri Institute for Pharmacological Research","startDate":"2013-10","conditions":"Chronic Kidney Disease","enrollment":53},{"nctId":"NCT02502110","phase":"PHASE4","title":"Study of Statin for Reduction of Postoperative Paroxysmal Atrial Fibrillation","status":"UNKNOWN","sponsor":"The Third Xiangya Hospital of Central South University","startDate":"2015-08","conditions":"Paroxysmal Atrial Fibrillation","enrollment":346},{"nctId":"NCT00249873","phase":"PHASE3","title":"Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE A)","status":"COMPLETED","sponsor":"Sanofi","startDate":"2003-06","conditions":"Atrial Fibrillation, Vascular Risk","enrollment":7554},{"nctId":"NCT00095238","phase":"PHASE3","title":"Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2002-06","conditions":"Congestive Heart Failure","enrollment":4128},{"nctId":"NCT02380625","phase":"PHASE1, PHASE2","title":"Multiple Treatments for Ebola Virus Disease (EVD)","status":"UNKNOWN","sponsor":"Clinical Research Management, Inc.","startDate":"2015-04","conditions":"Ebola Virus Disease","enrollment":150},{"nctId":"NCT01992796","phase":"PHASE3","title":"Angiotensin II Antagonist in Severe Sepsis","status":"UNKNOWN","sponsor":"University of Salerno","startDate":"2014-01","conditions":"Severe Sepsis","enrollment":300},{"nctId":"NCT01625494","phase":"PHASE3","title":"Study of Efficacy and Safety of Irbesartan/Amlodipine 4 Fixed Combination Therapy in Hypertensive Patients Uncontrolled on Irbesartan or Amlodipine Monotherapy","status":"COMPLETED","sponsor":"Sanofi","startDate":"2012-05","conditions":"Hypertension","enrollment":158},{"nctId":"NCT00660309","phase":"PHASE4","title":"A Clinical Study to Evaluate Renal Hemodynamic Responses to Aliskiren in Patients With Type 2 Diabetes Mellitus","status":"COMPLETED","sponsor":"Novartis","startDate":"2008-04","conditions":"Type 2 Diabetes Mellitus","enrollment":45},{"nctId":"NCT00095394","phase":"PHASE3","title":"Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy as First Line Treatment for Severe Hypertension","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2004-09","conditions":"Hypertension","enrollment":645},{"nctId":"NCT00095290","phase":"PHASE4","title":"Irbesartan Versus Placebo in Combination With Ramipril for Treatment of Albuminuria","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2004-09","conditions":"Albuminuria","enrollment":400},{"nctId":"NCT00095550","phase":"PHASE3","title":"Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy for Patients With Moderate Hypertension","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2004-10","conditions":"Hypertension","enrollment":496},{"nctId":"NCT00110422","phase":"PHASE4","title":"Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2005-11","conditions":"Metabolic Syndrome, Hypertension","enrollment":400},{"nctId":"NCT00362258","phase":"PHASE4","title":"I PREVENT - Irbesartan In Hypertensive Diabetic Patients","status":"COMPLETED","sponsor":"Sanofi","startDate":"2006-02","conditions":"Hypertension","enrollment":797},{"nctId":"NCT00335673","phase":"PHASE4","title":"I SAVE - Irbesartan in Mild to Moderate Hypertensive Patients","status":"COMPLETED","sponsor":"Sanofi","startDate":"2006-02","conditions":"Hypertension","enrollment":1630},{"nctId":"NCT00742066","phase":"NA","title":"Role of AT1-receptor Blockers in Insulin-induced Vasodilation.","status":"UNKNOWN","sponsor":"Maastricht University Medical Center","startDate":"2008-03","conditions":"Hypertension, Insulin Resistance, Microcirculation","enrollment":32},{"nctId":"NCT00956644","phase":"PHASE3","title":"Irbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Amlodipine 5 mg Monotherapy","status":"COMPLETED","sponsor":"Sanofi","startDate":"2009-07","conditions":"Hypertension","enrollment":406},{"nctId":"NCT00957554","phase":"PHASE3","title":"Irbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Irbesartan 150 mg Monotherapy","status":"COMPLETED","sponsor":"Sanofi","startDate":"2009-07","conditions":"Hypertension","enrollment":435},{"nctId":"NCT00249795","phase":"PHASE3","title":"Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE I)","status":"COMPLETED","sponsor":"Sanofi","startDate":"2003-06","conditions":"Atrial Fibrillation, Cardiovascular Disease","enrollment":9016},{"nctId":"NCT00500604","phase":"PHASE4","title":"Efficacy of Irbesartan/Hydrochlorothiazide Versus Valsartan/Hydrochlorothiazide in Mild to Moderate Hypertension","status":"COMPLETED","sponsor":"Sanofi","startDate":"2007-07","conditions":"Hypertension","enrollment":1617},{"nctId":"NCT00352560","phase":"PHASE3","title":"Electrophysiological Effects of Irbesartan in Patients With Paroxysmal Atrial Fibrillation (AF)","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2006-07","conditions":"Atrial Fibrillation","enrollment":44},{"nctId":"NCT00562809","phase":"PHASE4","title":"The Efficacy and Safety of Irbesartan 150/12.5 mg and 300/25 mg in Patients With Mild Hypertension","status":"COMPLETED","sponsor":"Sanofi","startDate":"2003-07","conditions":"Hypertension","enrollment":1005}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Irbesartan Oral Tablet","genericName":"Irbesartan Oral Tablet","companyName":"University of Southern Denmark","companyId":"university-of-southern-denmark","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Irbesartan blocks angiotensin II type 1 (AT1) receptors, preventing vasoconstriction and aldosterone release to lower blood pressure. Used for Hypertension, Diabetic nephropathy in patients with type 2 diabetes and hypertension.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}