{"id":"choline-fenofibrate","rwe":[{"pmid":"34518033","year":"2021","title":"Efficacy and Safety of Fenofibrate-Statin Combination Therapy in Patients With Inadequately Controlled Triglyceride Levels Despite Previous Statin Monotherapy: A Multicenter, Randomized, Double-blind, Phase IV Study.","finding":"","journal":"Clinical therapeutics","studyType":"Clinical Study"},{"pmid":"30000697","year":"2006","title":"Fenofibrate.","finding":"","journal":"","studyType":"Clinical Study"},{"pmid":"33434562","year":"2021","title":"Targeting Peroxisome Proliferator-Activated Receptor-α (PPAR- α) to reduce paclitaxel-induced peripheral neuropathy.","finding":"","journal":"Brain, behavior, and immunity","studyType":"Clinical Study"},{"pmid":"30802201","year":"2019","title":"Pharmacokinetics and bioequivalence of two fenofibrate choline formulations in healthy subjects under fed and fasted condition
.","finding":"","journal":"International journal of clinical pharmacology and therapeutics","studyType":"Clinical Study"},{"pmid":"30294571","year":"2018","title":"Comparison of Efficacy and Safety of Fixed Dose Combination of Rosuvastatin and Choline Fenofibrate to Fixed Dose Combination of Rosuvastatin and Fenofibrate in Patients of Mixed Dyslipidemia: A Randomized, Open-label, Multicentre Clinical Trial in Indian Population.","finding":"","journal":"Indian journal of endocrinology and metabolism","studyType":"Clinical Study"}],"tags":[{"label":"Peroxisome Proliferator Receptor alpha Agonist","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Fatty acid-binding protein, intestinal","category":"target"},{"label":"FABP2","category":"gene"},{"label":"SLC22A12","category":"gene"},{"label":"PPARA","category":"gene"},{"label":"C10AB11","category":"atc"},{"label":"Oral","category":"route"},{"label":"Capsule","category":"form"},{"label":"Tablet","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Familial hypercholesterolemia - heterozygous","category":"indication"},{"label":"Hypercholesterolemia","category":"indication"},{"label":"Hyperlipidemia","category":"indication"},{"label":"Hypertriglyceridemia","category":"indication"},{"label":"Hypoalphalipoproteinemia","category":"indication"},{"label":"Mixed hyperlipidemia","category":"indication"},{"label":"Abbvie","category":"company"},{"label":"Approved 2000s","category":"decade"},{"label":"Anticholesteremic Agents","category":"pharmacology"},{"label":"Antimetabolites","category":"pharmacology"},{"label":"Hypolipidemic Agents","category":"pharmacology"},{"label":"Lipid Regulating Agents","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":228.626,"date":"","count":54,"signal":"High density lipoprotein decreased","source":"DrugCentral FAERS","actionTaken":"Reported 54 times (LLR=229)"},{"llr":225.115,"date":"","count":74,"signal":"Blood triglycerides increased","source":"DrugCentral FAERS","actionTaken":"Reported 74 times (LLR=225)"},{"llr":204.35,"date":"","count":122,"signal":"Blood creatinine increased","source":"DrugCentral FAERS","actionTaken":"Reported 122 times (LLR=204)"},{"llr":198.606,"date":"","count":131,"signal":"Myalgia","source":"DrugCentral FAERS","actionTaken":"Reported 131 times (LLR=199)"},{"llr":109.152,"date":"","count":63,"signal":"Pancreatitis","source":"DrugCentral FAERS","actionTaken":"Reported 63 times (LLR=109)"},{"llr":106.666,"date":"","count":34,"signal":"Low density lipoprotein increased","source":"DrugCentral FAERS","actionTaken":"Reported 34 times (LLR=107)"},{"llr":78.845,"date":"","count":48,"signal":"Blood creatine phosphokinase increased","source":"DrugCentral FAERS","actionTaken":"Reported 48 times (LLR=79)"},{"llr":65.601,"date":"","count":50,"signal":"Rhabdomyolysis","source":"DrugCentral FAERS","actionTaken":"Reported 50 times (LLR=66)"},{"llr":60.491,"date":"","count":127,"signal":"Rash","source":"DrugCentral FAERS","actionTaken":"Reported 127 times (LLR=60)"},{"llr":53.713,"date":"","count":65,"signal":"Hepatic enzyme increased","source":"DrugCentral FAERS","actionTaken":"Reported 65 times (LLR=54)"},{"llr":51.719,"date":"","count":33,"signal":"Pancreatitis acute","source":"DrugCentral FAERS","actionTaken":"Reported 33 times (LLR=52)"},{"llr":42.123,"date":"","count":17,"signal":"Blood creatine increased","source":"DrugCentral FAERS","actionTaken":"Reported 17 times (LLR=42)"},{"llr":40.811,"date":"","count":10,"signal":"Creatinine renal clearance increased","source":"DrugCentral FAERS","actionTaken":"Reported 10 times (LLR=41)"},{"llr":40.784,"date":"","count":33,"signal":"Liver function test abnormal","source":"DrugCentral FAERS","actionTaken":"Reported 33 times (LLR=41)"},{"llr":37.777,"date":"","count":21,"signal":"Glomerular filtration rate decreased","source":"DrugCentral FAERS","actionTaken":"Reported 21 times (LLR=38)"}],"commonSideEffects":[{"effect":"Headache","drugRate":"","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"5.5%","severity":"common","organSystem":""},{"effect":"Diarrhea","drugRate":"6.9%","severity":"common","organSystem":""},{"effect":"Dyspepsia","drugRate":"4.7%","severity":"common","organSystem":""},{"effect":"Constipation","drugRate":"3.3%","severity":"common","organSystem":""},{"effect":"Back pain","drugRate":"","severity":"common","organSystem":""},{"effect":"Nasopharyngitis","drugRate":"","severity":"common","organSystem":""},{"effect":"Myalgia","drugRate":"","severity":"common","organSystem":""},{"effect":"Upper respiratory tract infection","drugRate":"","severity":"common","organSystem":""},{"effect":"Bronchitis","drugRate":"","severity":"common","organSystem":""},{"effect":"Influenza","drugRate":"","severity":"common","organSystem":""},{"effect":"Urinary tract infection","drugRate":"","severity":"common","organSystem":""},{"effect":"AST increased","drugRate":"","severity":"common","organSystem":""},{"effect":"Blood CPK increased","drugRate":"","severity":"common","organSystem":""},{"effect":"Hepatic enzyme increased","drugRate":"","severity":"common","organSystem":""},{"effect":"Musculoskeletal pain","drugRate":"","severity":"common","organSystem":""},{"effect":"Insomnia","drugRate":"","severity":"common","organSystem":""},{"effect":"Cough","drugRate":"","severity":"common","organSystem":""},{"effect":"Pharyngolaryngeal pain","drugRate":"","severity":"common","organSystem":""},{"effect":"Hypertension","drugRate":"","severity":"common","organSystem":""}],"contraindications":["Acute nephropathy","Acute pancreatitis","Agranulocytosis","Anemia","Breastfeeding (mother)","Calculus in biliary tract","Chronic renal failure syndrome","Diabetes mellitus","Disease of liver","Disorder of gallbladder","Disorder of muscle","Hepatic failure","Hypothyroidism","Impaired renal function disorder","Leukopenia","Liver function tests abnormal","Myositis","Primary biliary cirrhosis","Rhabdomyolysis","Thrombocytopenic disorder","Thromboembolic disorder"],"specialPopulations":{"Pregnancy":"Limited available data with fenofibrate use in pregnant women are insufficient to determine drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, no evidence of embryo-fetal toxicity was observed with oral administration of fenofibrate in rats and rabbits during organogenesis at doses less than or equivalent to the maximum recommended clinical dose of 135 mg daily, based on body surface area (mg/m2). Adverse reproductive outcomes occurred at higher doses in the presence of maternal toxicity (see Data). Fenofibric acid delayed-release capsules should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20","Geriatric use":"Trilipix is substantially excreted by the kidney as fenofibric acid and fenofibric acid glucuronide, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Since elderly patients have higher incidence of renal impairment, the dose selection for the elderly should be made on the basis of renal function [see CLINICAL PHARMACOLOGY (12.3)]. Consider monitoring renal function in elderly patients taking Trilipix.","Paediatric use":"The safety and effectiveness of fenofibric acid in pediatric patients have not been established.","Renal impairment":"Avoid use in severe renal impairment patients. Dose adjustment is required in mild to moderate renal impairment patients"},"seriousAdverseEvents":[{"effect":"Rhabdomyolysis","drugRate":"","severity":"serious"},{"effect":"Pancreatitis","drugRate":"","severity":"serious"},{"effect":"Renal failure","drugRate":"","severity":"serious"},{"effect":"Acute renal failure","drugRate":"","severity":"serious"},{"effect":"Hepatitis","drugRate":"","severity":"serious"},{"effect":"Cirrhosis","drugRate":"","severity":"serious"},{"effect":"Increased creatine phosphokinase","drugRate":"","severity":"serious"},{"effect":"Increased alanine aminotransaminase","drugRate":"","severity":"serious"},{"effect":"Increased aspartate aminotransaminase","drugRate":"","severity":"serious"},{"effect":"Muscle spasms","drugRate":"","severity":"serious"}]},"trials":[],"aliases":[],"company":"AbbVie","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=CHOLINE FENOFIBRATE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:39:22.771569+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:39:27.964515+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CHOLINE FENOFIBRATE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:39:28.297561+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Peroxisome proliferator-activated receptor alpha agonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:39:29.359637+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1201745/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:39:29.011906+00:00"}},"allNames":"trilipix","offLabel":[],"synonyms":["choline fenofibrate","fenofibric acid","procetofenic acid"],"timeline":[{"date":"2008-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from ABBVIE to Abbvie"},{"date":"2008-12-15","type":"positive","source":"DrugCentral","milestone":"FDA approval (Abbvie)"},{"date":"2020-12-23","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 11 manufacturers approved"}],"aiSummary":"Trilipix (Choline Fenofibrate) is a peroxisome proliferator receptor alpha agonist, originally developed by Abbvie and currently owned by the same company. It targets the fatty acid-binding protein in the intestine to lower cholesterol and triglyceride levels in the blood. Trilipix is approved to treat various lipid disorders, including familial hypercholesterolemia, hypercholesterolemia, and hypertriglyceridemia. The drug is now off-patent, with multiple generic manufacturers available. Key safety considerations include monitoring liver function and potential interactions with other medications.","approvals":[{"date":"2008-12-15","orphan":false,"company":"ABBVIE","regulator":"FDA"}],"brandName":"Trilipix","ecosystem":[{"indication":"Familial hypercholesterolemia - heterozygous","otherDrugs":[{"name":"alirocumab","slug":"alirocumab","company":"Sanofi Aventis"},{"name":"atorvastatin","slug":"atorvastatin","company":"Pfizer"},{"name":"bempedoic acid","slug":"bempedoic-acid","company":"Esperion Theraps Inc"},{"name":"evolocumab","slug":"evolocumab","company":"Repatha"}],"globalPrevalence":390000000},{"indication":"Hypercholesterolemia","otherDrugs":[{"name":"alirocumab","slug":"alirocumab","company":"Sanofi Aventis"},{"name":"atorvastatin","slug":"atorvastatin","company":"Pfizer"},{"name":"cerivastatin","slug":"cerivastatin","company":"Bayer Pharms"},{"name":"cholestyramine","slug":"cholestyramine","company":"Bristol Myers"}],"globalPrevalence":390000000},{"indication":"Hyperlipidemia","otherDrugs":[{"name":"cholestyramine","slug":"cholestyramine","company":"Bristol Myers"},{"name":"clofibrate","slug":"clofibrate","company":""},{"name":"colestipol","slug":"colestipol","company":"Pharmacia And Upjohn"},{"name":"dextrothyroxine","slug":"dextrothyroxine","company":"Abbvie"}],"globalPrevalence":390000000},{"indication":"Hypertriglyceridemia","otherDrugs":[{"name":"atorvastatin","slug":"atorvastatin","company":"Pfizer"},{"name":"fenofibrate","slug":"fenofibrate","company":"Abbvie"},{"name":"gemfibrozil","slug":"gemfibrozil","company":"Pfizer Pharms"},{"name":"icosapent ethyl","slug":"icosapent-ethyl","company":"Amarin Pharms"}],"globalPrevalence":1680000000},{"indication":"Hypoalphalipoproteinemia","otherDrugs":[{"name":"fenofibrate","slug":"fenofibrate","company":"Abbvie"},{"name":"inositol","slug":"inositol","company":""},{"name":"lovastatin","slug":"lovastatin","company":"Merck"},{"name":"simvastatin","slug":"simvastatin","company":"Merck"}],"globalPrevalence":null},{"indication":"Mixed hyperlipidemia","otherDrugs":[{"name":"atorvastatin","slug":"atorvastatin","company":"Pfizer"},{"name":"cerivastatin","slug":"cerivastatin","company":"Bayer Pharms"},{"name":"ezetimibe","slug":"ezetimibe","company":"Msd Intl Gmbh"},{"name":"fenofibrate","slug":"fenofibrate","company":"Abbvie"}],"globalPrevalence":390000000}],"mechanism":{"target":"Fatty acid-binding protein, intestinal","novelty":"Follow-on","targets":[{"gene":"FABP2","source":"DrugCentral","target":"Fatty acid-binding protein, intestinal","protein":"Fatty acid-binding protein, intestinal"},{"gene":"SLC22A12","source":"DrugCentral","target":"Solute carrier family 22 member 12","protein":"Solute carrier family 22 member 12"},{"gene":"PPARA","source":"DrugCentral","target":"Peroxisome proliferator-activated receptor alpha","protein":"Peroxisome proliferator-activated receptor alpha"}],"modality":"Small Molecule","drugClass":"Peroxisome Proliferator Receptor alpha Agonist","explanation":"","oneSentence":"","technicalDetail":"Trilipix, a peroxisome proliferator receptor alpha agonist, activates the peroxisome proliferator-activated receptor alpha (PPARα), which regulates the expression of genes involved in lipid metabolism, leading to increased lipolysis and clearance of triglycerides from the bloodstream."},"commercial":{"launchDate":"2008","_launchSource":"DrugCentral (FDA 2008-12-15, ABBVIE)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4505","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=CHOLINE%20FENOFIBRATE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CHOLINE FENOFIBRATE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T09:59:16.037576","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:39:30.937639+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"clofibrate","drugSlug":"clofibrate","fdaApproval":"1967-02-08","genericCount":5,"patentStatus":"Off-patent — generic 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serum lipids with non-drug methods"},"usPrevalence":86000000,"globalPrevalence":390000000,"prevalenceMethod":"curated","prevalenceSource":"WHO Global Health Estimates, 2023"},{"name":"Hyperlipidemia","source":"DrugCentral","snomedId":55822004,"regulator":"FDA","eligibility":{"Age":"No specific age mentioned","Stage":"Hyperlipidemia","Biomarkers":"Elevated LDL-C, Total-C, TG and Apo B","Prior Treatment":"Every reasonable attempt should be made to control serum lipids with non-drug methods"},"usPrevalence":null,"globalPrevalence":390000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2023"},{"name":"Hypertriglyceridemia","source":"DrugCentral","snomedId":302870006,"regulator":"FDA","eligibility":{"Age":"No specific age mentioned","Stage":"Hypertriglyceridemia","Biomarkers":"Markedly elevated levels of serum triglycerides (e.g. 2,000 mg/dL)","Prior Treatment":"Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacological intervention"},"globalPrevalence":1680000000,"prevalenceMethod":"ai-extracted","prevalenceSource":"J Health Popul Nutr, 2025 (PMID:40859400)"},{"name":"Hypoalphalipoproteinemia","source":"DrugCentral","snomedId":190785000,"regulator":"FDA","eligibility":{"Age":"No specific age mentioned","Stage":"Hypoalphalipoproteinemia","Biomarkers":"No specific biomarkers mentioned","Prior Treatment":"No specific prior treatment mentioned"}},{"name":"Mixed hyperlipidemia","source":"DrugCentral","snomedId":267434003,"regulator":"FDA","usPrevalence":null,"globalPrevalence":390000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2023"}],"offLabel":[],"pipeline":[]},"currentOwner":"Abbvie","drugCategory":"mature","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book 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