{"id":"fenofibrate-and-tibolone","safety":{"commonSideEffects":[{"rate":null,"effect":"Myalgia or muscle pain"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Vaginal bleeding or spotting"},{"rate":null,"effect":"Gastrointestinal upset"},{"rate":null,"effect":"Elevated liver enzymes"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Fenofibrate is a fibric acid derivative that activates peroxisome proliferator-activated receptor alpha (PPAR-α), increasing lipoprotein lipase activity and reducing triglyceride-rich lipoprotein production. Tibolone is a synthetic steroid that acts as a selective estrogen receptor modulator (SERM) and provides combined estrogenic, progestagenic, and weak androgenic effects for menopausal symptom relief. The combination addresses both cardiovascular lipid abnormalities and menopausal symptoms in postmenopausal women.","oneSentence":"This combination product uses fenofibrate to lower triglycerides and raise HDL cholesterol via PPAR-alpha activation, while tibolone provides hormone replacement therapy through selective tissue-specific estrogenic, progestagenic, and androgenic activity.","_ai_confidence":"low"},"_scrapedAt":"2026-03-27T23:46:19.742Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypertriglyceridemia in postmenopausal women"},{"name":"Menopausal symptoms with dyslipidemia"}]},"trialDetails":[{"nctId":"NCT00809068","phase":"PHASE4","title":"High-density Lipoprotein (HDL) Cholesterol in Women Taking Tibolone","status":"COMPLETED","sponsor":"Keogh Institute for Medical Research","startDate":"2005-08","conditions":"HDL Cholesterol","enrollment":20}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Lipidil","Livial"],"phase":"marketed","status":"active","brandName":"fenofibrate and tibolone","genericName":"fenofibrate and tibolone","companyName":"Keogh Institute for Medical Research","companyId":"keogh-institute-for-medical-research","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This combination product uses fenofibrate to lower triglycerides and raise HDL cholesterol via PPAR-alpha activation, while tibolone provides hormone replacement therapy through selective tissue-specific estrogenic, progestagenic, and androgenic activity. Used for Hypertriglyceridemia in postmenopausal women, Menopausal symptoms with dyslipidemia.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}