{"id":"simvast-cr","safety":{"commonSideEffects":[{"rate":"1-3","effect":"Myalgia (muscle pain)"},{"rate":"1-3","effect":"Elevated liver enzymes (ALT/AST)"},{"rate":"2-5","effect":"Headache"},{"rate":"<0.1","effect":"Rhabdomyolysis (rare)"},{"rate":"1-2","effect":"Gastrointestinal upset"}]},"_chembl":{"chemblId":"CHEMBL1628102","moleculeType":"Small molecule","molecularWeight":"468.51"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Simvastatin competitively inhibits HMG-CoA reductase, the rate-limiting enzyme in the mevalonate pathway of cholesterol biosynthesis. This reduces hepatic cholesterol production, leading to upregulation of LDL receptors on liver cells and increased clearance of LDL cholesterol from the bloodstream. The CR (controlled-release) formulation provides sustained drug delivery to optimize cholesterol-lowering efficacy.","oneSentence":"Simvastatin is an HMG-CoA reductase inhibitor that lowers cholesterol by blocking the enzyme responsible for cholesterol synthesis in the liver.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:08:08.045Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypercholesterolemia and dyslipidemia"},{"name":"Primary and secondary prevention of cardiovascular disease"}]},"trialDetails":[{"nctId":"NCT00973115","phase":"PHASE3","title":"Efficacy and Safety of Morning Versus Evening Intake of Simvast Controlled Release (CR) Tablet in Patients With Hyperlipidemia","status":"COMPLETED","sponsor":"Hanmi Pharmaceutical Company Limited","startDate":"2007-11","conditions":"Hyperlipidemia","enrollment":132},{"nctId":"NCT01564875","phase":"PHASE4","title":"Efficacy and Safety of Simvast Controlled Release (CR) and Zocor in Chronic Kidney Disease(CKD) Stage 3, 4 and 5 Patients With Hyperlipidemia","status":"UNKNOWN","sponsor":"Hanmi Pharmaceutical Company Limited","startDate":"2010-12","conditions":"Chronic Kidney Disease, Hyperlipidemia","enrollment":122}],"_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":"Simvast CR","genericName":"Simvast CR","companyName":"Hanmi Pharmaceutical Company Limited","companyId":"hanmi-pharmaceutical-company-limited","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Simvastatin is an HMG-CoA reductase inhibitor that lowers cholesterol by blocking the enzyme responsible for cholesterol synthesis in the liver. Used for Hypercholesterolemia and dyslipidemia, Primary and secondary prevention of cardiovascular disease.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}