{"id":"olmesartan-medoxomil-azelnidipine","brandName":"Olmesartan medoxomil ＋Azelnidipine","genericName":"Olmesartan medoxomil ＋Azelnidipine","companyId":"jichi-medical-university","companyName":"Jichi Medical University","phase":"marketed","status":"active","modality":"Small molecule","aliases":["arm A"],"developmentCodes":[],"firstApprovalDate":null,"firstApprovalCountry":null,"aiSummary":"Olmesartan medoxomil/azelnidipine is a fixed-dose combination antihypertensive marketed in Japan by Jichi Medical University, combining an angiotensin II receptor blocker (ARB) with a calcium channel blocker (CCB). The combination leverages complementary mechanisms: olmesartan blocks AT1 receptors to reduce vasoconstriction and aldosterone secretion, while azelnidipine inhibits L-type calcium channels to promote vasodilation, providing synergistic blood pressure reduction. Approved for hypertension management, the drug has been evaluated in three Phase 4 outcome trials (COLM, OSCAR, and Japan-Combined Treatment studies) enrolling over 6,300 patients, demonstrating cardiovascular benefits in high-risk elderly populations and superiority or non-inferiority versus alternative combination strategies. The fixed-dose combination addresses polypharmacy burden in hypertension management and competes with other ARB/CCB combinations like candesartan/amlodipine. Commercial data specific to this combination is limited; the product is primarily marketed in Japan with no FDA approval. The formulation represents a rational combination approach supported by comparative efficacy data published in peer-reviewed literature.","enrichmentLevel":3,"visitCount":0,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Olmesartan medoxomil is an angiotensin II receptor blocker (ARB) that prevents vasoconstriction and reduces aldosterone secretion. Azelnidipine is a dihydropyridine calcium channel blocker that causes vasodilation by blocking calcium influx into vascular smooth muscle cells. Together, they provide complementary antihypertensive effects through different mechanisms.","oneSentence":"This combination lowers blood pressure by blocking angiotensin II receptors (olmesartan medoxomil) and inhibiting L-type calcium channels (azelnidipine).","_ai_confidence":"medium"},"administration":{},"safety":{"commonSideEffects":[{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Hyperkalemia"},{"rate":null,"effect":"Peripheral edema"}]},"trials":[],"indications":{"approved":[{"name":"Hypertension"}]},"commercial":null,"patents":[],"timeline":[],"rwe":[],"competitors":[],"ownershipHistory":[],"trialDetails":[],"genericFilers":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"labelChanges":[],"nice":null,"revenue":null,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":false,"score":3}}