{"id":"comparator-fenofibrate-monotherapy","safety":{"commonSideEffects":[{"rate":"3-5%","effect":"Elevated liver enzymes (ALT/AST)"},{"rate":"3-5%","effect":"Myalgia or muscle pain"},{"rate":"1-2%","effect":"Gallstones (cholelithiasis)"},{"rate":"2-4%","effect":"Gastrointestinal upset"},{"rate":"1-3%","effect":"Headache"}]},"_chembl":{"chemblId":"CHEMBL1201745","moleculeType":"Small molecule","molecularWeight":"421.92"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Fenofibrate works by binding to and activating PPARα, a nuclear receptor that regulates genes involved in lipid metabolism. This activation increases the catabolism of triglyceride-rich lipoproteins and reduces hepatic triglyceride production, while simultaneously increasing HDL cholesterol levels. It is commonly used as monotherapy or in combination with statins to manage dyslipidemia and reduce cardiovascular risk.","oneSentence":"Fenofibrate is a fibric acid derivative that activates peroxisome proliferator-activated receptor alpha (PPARα) to reduce triglycerides and increase HDL cholesterol.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:43:28.777Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypertriglyceridemia"},{"name":"Mixed dyslipidemia"},{"name":"Primary hypercholesterolemia (as adjunct to diet)"}]},"trialDetails":[{"nctId":"NCT00092560","phase":"PHASE3","title":"Two Investigational Drugs in Patients With Mixed Hyperlipidemia (0653-036)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2002-12","conditions":"Hypercholesterolemia, Hypertriglyceridemia","enrollment":587},{"nctId":"NCT00092573","phase":"PHASE3","title":"Study of Ezetimibe and Fenofibrate in Patients With Mixed Hyperlipidemia (0653-036)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2003-04","conditions":"Hypercholesterolemia, Hypertriglyceridemia","enrollment":576},{"nctId":"NCT02262143","phase":"PHASE3","title":"Phase III Study of Rosuvastatin and Fenofibrate Versus Rosuvastatin in Mixed Dyslipidemia","status":"COMPLETED","sponsor":"IlDong Pharmaceutical Co Ltd","startDate":"2014-11","conditions":"Mixed Dyslipidemias","enrollment":362},{"nctId":"NCT00349375","phase":"PHASE3","title":"Comparison of the Combination of Fenofibrate and 20 mg Simvastatin Versus 40 mg Simvastatin Monotherapy","status":"COMPLETED","sponsor":"Solvay Pharmaceuticals","startDate":"2005-11","conditions":"Hyperlipidemia","enrollment":1040}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":7,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Comparator: fenofibrate monotherapy","genericName":"Comparator: fenofibrate monotherapy","companyName":"Organon and Co","companyId":"organon-and-co","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Fenofibrate is a fibric acid derivative that activates peroxisome proliferator-activated receptor alpha (PPARα) to reduce triglycerides and increase HDL cholesterol. Used for Hypertriglyceridemia, Mixed dyslipidemia, Primary hypercholesterolemia (as adjunct to diet).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}