{"id":"lapaquistat-acetate-and-simvastatin","safety":{"commonSideEffects":[{"rate":null,"effect":"Elevated liver transaminases"},{"rate":null,"effect":"Myalgia"},{"rate":null,"effect":"Gastrointestinal disturbances"},{"rate":null,"effect":"Headache"}]},"_chembl":{"chemblId":"CHEMBL1201391","moleculeType":"Small molecule","molecularWeight":"436.59"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This combination targets two key steps in cholesterol metabolism. Lapaquistat acetate blocks ACAT, an enzyme that esterifies cholesterol in the intestine, reducing dietary cholesterol absorption. Simvastatin simultaneously inhibits HMG-CoA reductase in the liver, suppressing endogenous cholesterol synthesis. Together, these complementary mechanisms produce additive reductions in LDL cholesterol and total cholesterol levels.","oneSentence":"Lapaquistat acetate inhibits ACAT (acyl-CoA:cholesterol acyltransferase) to reduce cholesterol absorption, while simvastatin inhibits HMG-CoA reductase to decrease cholesterol synthesis, providing dual lipid-lowering effects.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:18:17.762Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypercholesterolemia / dyslipidemia (LDL cholesterol reduction)"}]},"trialDetails":[{"nctId":"NCT00532311","phase":"PHASE3","title":"Efficacy of Lapaquistat Acetate Co-Administered With Statins in Subjects With Hypercholesterolemia","status":"TERMINATED","sponsor":"Takeda","startDate":"2007-07","conditions":"Hypercholesterolemia","enrollment":411},{"nctId":"NCT00251680","phase":"PHASE3","title":"Efficacy of Lapaquistat Acetate in Subjects Currently Treated With Lipid-Lowering Therapy.","status":"COMPLETED","sponsor":"Takeda","startDate":"2005-10","conditions":"Type 2 Diabetes","enrollment":400},{"nctId":"NCT00286481","phase":"PHASE3","title":"Efficacy of Lapaquistat Acetate Alone or Combined With Simvastatin in Subjects With Hypercholesterolemia","status":"COMPLETED","sponsor":"Takeda","startDate":"2006-03","conditions":"Hypercholesterolemia","enrollment":1362},{"nctId":"NCT00256178","phase":"PHASE3","title":"Efficacy of Lapaquistat Acetate and Simvastatin in Subjects With Primary Dyslipidemia.","status":"COMPLETED","sponsor":"Takeda","startDate":"2005-10","conditions":"Hypercholesterolemia","enrollment":411},{"nctId":"NCT00249899","phase":"PHASE3","title":"Efficacy of Lapaquistat Acetate Alone or Combined With High-Dose Statin Therapy in Subjects With Hypercholesterolemia","status":"TERMINATED","sponsor":"Takeda","startDate":"2005-11","conditions":"Hypercholesterolemia","enrollment":649}],"_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":["TAK-475","Zocor","Lapaquistat"],"phase":"phase_3","status":"active","brandName":"Lapaquistat acetate and simvastatin","genericName":"Lapaquistat acetate and simvastatin","companyName":"Takeda","companyId":"takeda","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Lapaquistat acetate inhibits ACAT (acyl-CoA:cholesterol acyltransferase) to reduce cholesterol absorption, while simvastatin inhibits HMG-CoA reductase to decrease cholesterol synthesis, providing dual lipid-lowering effects. Used for Hypercholesterolemia / dyslipidemia (LDL cholesterol reduction).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}