{"id":"irbesartan-monotherapy","safety":{"commonSideEffects":[{"rate":"9","effect":"Dizziness"},{"rate":"3","effect":"Fatigue"},{"rate":"7","effect":"Musculoskeletal pain"},{"rate":null,"effect":"Hyperkalemia"},{"rate":null,"effect":"Cough"},{"rate":"12","effect":"Headache"}]},"_chembl":{"chemblId":"CHEMBL1513","moleculeType":"Small molecule","molecularWeight":"428.54"},"_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 other tissues. By blocking angiotensin II signaling, it causes vasodilation, reduces peripheral vascular resistance, and decreases aldosterone secretion, leading to lower blood pressure and reduced sodium retention. This mechanism also provides renal protection in patients with hypertension and diabetes.","oneSentence":"Irbesartan blocks angiotensin II type 1 (AT1) receptors, preventing vasoconstriction and reducing blood pressure.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:17:10.047Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypertension"},{"name":"Diabetic nephropathy in patients with type 2 diabetes and hypertension"}]},"trialDetails":[{"nctId":"NCT03476616","phase":"PHASE4","title":"Antihypertensive Pharmacological Therapy With Mineralocorticoid Receptor Antagonists in Obese Hypertensive Patients","status":"COMPLETED","sponsor":"Hippocration General Hospital","startDate":"2018-09-01","conditions":"Hypertension, Obesity","enrollment":198},{"nctId":"NCT06515678","phase":"","title":"Impact of Antihypertensive Therapy on Recurrence Risk of Ovarian Cancer for Bevacizumab-associated Hypertension","status":"ACTIVE_NOT_RECRUITING","sponsor":"Groupe Hospitalier Pitie-Salpetriere","startDate":"2024-05-20","conditions":"Ovarian Cancer, Antiangiogenic-Associated Hypertension, Adjuvant Bevacizumab","enrollment":9464},{"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":"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":"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":"NCT00950066","phase":"PHASE2","title":"Irbesartan and Amlodipine Combination in Controlling Blood Pressure","status":"COMPLETED","sponsor":"Sanofi","startDate":"2009-07","conditions":"Hypertension","enrollment":270},{"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":"NCT00708344","phase":"PHASE4","title":"ACTUAL: Efficacy and Safety of Irbesartan/Hydrochlorothiazide Combination","status":"COMPLETED","sponsor":"Sanofi","startDate":"2008-06","conditions":"Hypertension","enrollment":832},{"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":24,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Avapro"],"phase":"phase_3","status":"active","brandName":"Irbesartan monotherapy","genericName":"Irbesartan monotherapy","companyName":"Bristol-Myers Squibb","companyId":"bristol-myers-squibb","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Irbesartan blocks angiotensin II type 1 (AT1) receptors, preventing vasoconstriction and reducing blood pressure. Used for Hypertension, Diabetic nephropathy in patients with type 2 diabetes and hypertension.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}