{"id":"olmesartan-medoxomil-amlodipine-or-azelnidipine","brandName":"olmesartan medoxomil / amlodipine or azelnidipine","genericName":"olmesartan medoxomil / amlodipine or azelnidipine","companyId":"colm-study-research-organization","companyName":"COLM Study Research Organization","phase":"marketed","status":"active","modality":"Small molecule","aliases":[],"developmentCodes":[],"firstApprovalDate":null,"firstApprovalCountry":null,"aiSummary":"Olmesartan medoxomil/amlodipine or azelnidipine is a fixed-dose combination antihypertensive marketed by the COLM Study Research Organization, combining an angiotensin II receptor blocker (ARB) with a calcium channel blocker (CCB) to provide dual-pathway blood pressure reduction. The combination leverages olmesartan's selective AT1 receptor antagonism with amlodipine's or azelnidipine's L-type calcium channel inhibition, offering complementary mechanisms for enhanced BP control in hypertensive patients. Approved for hypertension management, the drug has been evaluated in two Phase 4 trials (COLM and OSCAR studies) enrolling over 6,000 patients, demonstrating efficacy in high-risk elderly populations with cardiovascular disease and diabetes comorbidities. Clinical differentiation centers on the synergistic antihypertensive effect of ARB+CCB combinations versus monotherapy, with particular utility in patients requiring intensive BP control or those intolerant to single agents. Commercial significance remains limited to research and institutional settings given the COLM Study Research Organization's academic sponsorship; no major pharmaceutical company commercialization or significant revenue data are publicly available. The combination represents a rational polypharmacy approach supported by contemporary hypertension guidelines, though market penetration depends on regulatory approval status and manufacturing partnerships outside the research domain.","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 sodium retention. Amlodipine and azelnidipine are dihydropyridine calcium channel blockers that relax vascular smooth muscle. Together, they provide complementary antihypertensive effects through different mechanisms.","oneSentence":"This combination lowers blood pressure by blocking angiotensin II receptors (olmesartan medoxomil) and calcium channels (amlodipine or azelnidipine) to relax blood vessels.","_ai_confidence":"medium"},"administration":{},"safety":{"commonSideEffects":[{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Peripheral edema"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Hyperkalemia"}]},"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}}