{"id":"extended-release-niacin-ern","safety":{"commonSideEffects":[{"rate":"40-80","effect":"Flushing"},{"rate":"20-40","effect":"Pruritus"},{"rate":"10-30","effect":"Gastrointestinal upset (nausea, dyspepsia)"},{"rate":"5-15","effect":"Hyperglycemia"},{"rate":"5-10","effect":"Hyperuricemia / gout exacerbation"},{"rate":"1-5","effect":"Hepatotoxicity"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Niacin (vitamin B3) acts as a ligand for GPR109A and other receptors involved in lipid homeostasis, reducing hepatic VLDL production and increasing HDL-mediated reverse cholesterol transport. The extended-release formulation allows for once-daily dosing with improved tolerability compared to immediate-release formulations.","oneSentence":"Extended-release niacin increases HDL cholesterol and reduces triglycerides and LDL cholesterol by modulating lipid metabolism.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:12:06.129Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Dyslipidemia / hyperlipidemia (elevated triglycerides and/or low HDL cholesterol)"},{"name":"Cardiovascular risk reduction in patients with established coronary artery disease"}]},"trialDetails":[{"nctId":"NCT01274559","phase":"PHASE3","title":"Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients With High Cholesterol or Abnormal Lipid Levels (MK-0524A-133)","status":"TERMINATED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2011-03-01","conditions":"Primary Hypercholesterolemia, Mixed Dyslipidemia","enrollment":1173},{"nctId":"NCT01308203","phase":"PHASE4","title":"Lipid Efficacy of the Extended Release Niacin/Laropiprant Combination in Patients With Cardiovascular Disease","status":"TERMINATED","sponsor":"Daniel A. Siniawski","startDate":"2011-10","conditions":"Coronary Artery Disease, Dyslipidemias","enrollment":32},{"nctId":"NCT01335997","phase":"PHASE3","title":"Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143)","status":"TERMINATED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2011-05-01","conditions":"Primary Hypercholesterolemia, Mixed Dyslipidemia","enrollment":1139},{"nctId":"NCT01294683","phase":"PHASE3","title":"A Study to Evaluate Efficacy and Safety of Extended-Release Niacin + Laropiprant + Simvastatin in Participants With Primary Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-118)","status":"TERMINATED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2011-02-04","conditions":"Primary Hypercholesterolemia, Dyslipidemia","enrollment":977},{"nctId":"NCT01052311","phase":"PHASE4","title":"The Impact of Tredaptive on Flow-Mediated Dilation in Cardiac Patients","status":"TERMINATED","sponsor":"Sheba Medical Center","startDate":"2010-07","conditions":"Coronary Artery Disease, Dyslipidemia","enrollment":8},{"nctId":"NCT01414166","phase":"PHASE3","title":"Niacin/Laropiprant Tablet for South and Southeast Asians With Low High-Density Lipoprotein Cholesterol (LDL-C) at Risk for Cardiovascular Disease (MK-0524A-108)","status":"TERMINATED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2011-09","conditions":"Dyslipidemia","enrollment":244},{"nctId":"NCT00961636","phase":"PHASE3","title":"A Long-term Study of ERN/LRPT (Extended Release Niacin/Laropiprant [MK0524A]) in Patients With Dyslipidemia (0524A-102)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2009-10","conditions":"Dyslipidemia","enrollment":1152},{"nctId":"NCT01942291","phase":"PHASE4","title":"Short-term Effect of Extended-release Niacin on Endothelial Function.","status":"COMPLETED","sponsor":"University of Campinas, Brazil","startDate":"2012-03","conditions":"Hypoalphalipoproteinemia","enrollment":18}],"_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":"phase_3","status":"active","brandName":"Extended-release niacin (ERN)","genericName":"Extended-release niacin (ERN)","companyName":"Merck Sharp & Dohme LLC","companyId":"merck","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Extended-release niacin is a small molecule used to treat conditions such as primary hypercholesterolemia, mixed dyslipidemia, and coronary artery disease. It is administered in various formulations, including extended-release niacin/laropiprant and extended-release niacin/laropiprant/simvastatin, to help manage these conditions.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}