{"id":"lovastatin","rwe":[{"pmid":"41889884","year":"2026","title":"In vivo discovery of blood-brain barrier opening small molecules with FishNAP.","finding":"","journal":"bioRxiv : the preprint server for biology","studyType":"Clinical Study"},{"pmid":"41884463","year":"2026","title":"Temperature regulates flavor and bioactivity in dark tea fermentation: Insights from an A spergillus tubingensis single-strain model.","finding":"","journal":"Food chemistry: X","studyType":"Clinical Study"},{"pmid":"41813498","year":"2026","title":"Identification of drug repurposing candidates for amyotrophic lateral sclerosis using electronic health records: a retrospective cohort study.","finding":"","journal":"The Lancet. Digital health","studyType":"Clinical Study"},{"pmid":"41798138","year":"2026","title":"A 12-year expanding pink plaque on the chest.","finding":"","journal":"JAAD case reports","studyType":"Clinical Study"},{"pmid":"41770296","year":"2026","title":"Enhanced gibberellic acid production in Fusarium fujikuroi through ARTP-EMS mutagenesis and fermentation optimization.","finding":"","journal":"Biotechnology letters","studyType":"Clinical Study"}],"tags":[{"label":"HMG-CoA Reductase Inhibitor","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"3-hydroxy-3-methylglutaryl-coenzyme A reductase","category":"target"},{"label":"HMGCR","category":"gene"},{"label":"HCAR2","category":"gene"},{"label":"HCAR3","category":"gene"},{"label":"C10AA02","category":"atc"},{"label":"Oral","category":"route"},{"label":"Tablet","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Arteriosclerotic vascular disease","category":"indication"},{"label":"Familial hypercholesterolemia - heterozygous","category":"indication"},{"label":"Hypercholesterolemia","category":"indication"},{"label":"Hyperlipidemia","category":"indication"},{"label":"Hypertriglyceridemia","category":"indication"},{"label":"Hypoalphalipoproteinemia","category":"indication"},{"label":"Merck","category":"company"},{"label":"Approved 1980s","category":"decade"},{"label":"Anticholesteremic Agents","category":"pharmacology"},{"label":"Antimetabolites","category":"pharmacology"},{"label":"Enzyme Inhibitors","category":"pharmacology"},{"label":"Hydroxymethylglutaryl-CoA Reductase Inhibitors","category":"pharmacology"},{"label":"Hypolipidemic Agents","category":"pharmacology"},{"label":"Lipid Regulating Agents","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":107.948,"date":"","count":162,"signal":"Rhabdomyolysis","source":"DrugCentral FAERS","actionTaken":"Reported 162 times (LLR=108)"},{"llr":93.207,"date":"","count":192,"signal":"Cardiac failure congestive","source":"DrugCentral FAERS","actionTaken":"Reported 192 times (LLR=93)"},{"llr":85.324,"date":"","count":226,"signal":"Myalgia","source":"DrugCentral FAERS","actionTaken":"Reported 226 times (LLR=85)"},{"llr":68.359,"date":"","count":214,"signal":"Off label use","source":"DrugCentral FAERS","actionTaken":"Reported 214 times (LLR=68)"},{"llr":62.179,"date":"","count":177,"signal":"Cerebrovascular accident","source":"DrugCentral FAERS","actionTaken":"Reported 177 times (LLR=62)"},{"llr":60.726,"date":"","count":192,"signal":"Myocardial infarction","source":"DrugCentral FAERS","actionTaken":"Reported 192 times (LLR=61)"},{"llr":60.306,"date":"","count":4,"signal":"Synovitis","source":"DrugCentral FAERS","actionTaken":"Reported 4 times (LLR=60)"},{"llr":58.785,"date":"","count":22,"signal":"Infusion related reaction","source":"DrugCentral FAERS","actionTaken":"Reported 22 times (LLR=59)"},{"llr":55.461,"date":"","count":13,"signal":"Contraindicated product administered","source":"DrugCentral FAERS","actionTaken":"Reported 13 times (LLR=55)"},{"llr":52.493,"date":"","count":141,"signal":"Blood glucose increased","source":"DrugCentral FAERS","actionTaken":"Reported 141 times (LLR=52)"},{"llr":51.493,"date":"","count":10,"signal":"Systemic lupus erythematosus","source":"DrugCentral FAERS","actionTaken":"Reported 10 times (LLR=51)"},{"llr":51.378,"date":"","count":191,"signal":"Atrial fibrillation","source":"DrugCentral FAERS","actionTaken":"Reported 191 times (LLR=51)"},{"llr":49.353,"date":"","count":277,"signal":"Drug hypersensitivity","source":"DrugCentral FAERS","actionTaken":"Reported 277 times (LLR=49)"},{"llr":49.072,"date":"","count":50,"signal":"Myopathy","source":"DrugCentral FAERS","actionTaken":"Reported 50 times (LLR=49)"},{"llr":48.674,"date":"","count":380,"signal":"Asthenia","source":"DrugCentral FAERS","actionTaken":"Reported 380 times (LLR=49)"}],"drugInteractions":[{"url":"/drug/danazol","drug":"danazol","action":"Monitor closely","effect":"May interact with Danazol","source":"DrugCentral","drugSlug":"danazol"},{"url":"/drug/dronedarone","drug":"dronedarone","action":"Monitor closely","effect":"May interact with Dronedarone","source":"DrugCentral","drugSlug":"dronedarone"},{"url":"/drug/nefazodone","drug":"nefazodone","action":"Avoid combination","effect":"May interact with Nefazodone","source":"DrugCentral","drugSlug":"nefazodone"},{"url":"/drug/nelfinavir","drug":"nelfinavir","action":"Avoid combination","effect":"May interact with Nelfinavir Mesylate","source":"DrugCentral","drugSlug":"nelfinavir"},{"url":"/drug/nicotinic-acid","drug":"nicotinic acid","action":"Monitor closely","effect":"May interact with Niacin","source":"DrugCentral","drugSlug":"nicotinic-acid"},{"url":"/drug/posaconazole","drug":"posaconazole","action":"Avoid combination","effect":"May interact with Posaconazole","source":"DrugCentral","drugSlug":"posaconazole"},{"url":"/drug/ritonavir","drug":"ritonavir","action":"Avoid combination","effect":"May interact with Ritonavir","source":"DrugCentral","drugSlug":"ritonavir"},{"url":"/drug/saquinavir","drug":"saquinavir","action":"Avoid combination","effect":"May interact with Saquinavir","source":"DrugCentral","drugSlug":"saquinavir"},{"url":"/drug/telithromycin","drug":"telithromycin","action":"Avoid combination","effect":"May interact with Telithromycin","source":"DrugCentral","drugSlug":"telithromycin"},{"url":"/drug/ticagrelor","drug":"ticagrelor","action":"Monitor closely","effect":"May interact with Ticagrelor","source":"DrugCentral","drugSlug":"ticagrelor"},{"url":"/drug/troleandomycin","drug":"troleandomycin","action":"Avoid combination","effect":"May interact with Troleandomycin","source":"DrugCentral","drugSlug":"troleandomycin"},{"url":"/drug/verapamil","drug":"verapamil","action":"Avoid combination","effect":"May interact with Verapamil","source":"DrugCentral","drugSlug":"verapamil"},{"url":"/drug/voriconazole","drug":"voriconazole","action":"Avoid combination","effect":"May interact with Voriconazole","source":"DrugCentral","drugSlug":"voriconazole"},{"url":"/drug/warfarin","drug":"warfarin","action":"Monitor closely","effect":"May interact with Warfarin","source":"DrugCentral","drugSlug":"warfarin"}],"commonSideEffects":[{"effect":"Myopathy","drugRate":"reported","severity":"serious"},{"effect":"Rhabdomyolysis","drugRate":"reported","severity":"serious"},{"effect":"Pancreatitis","drugRate":"reported","severity":"serious"},{"effect":"Hepatitis","drugRate":"reported","severity":"serious"},{"effect":"Fulminant hepatic necrosis","drugRate":"reported","severity":"serious"},{"effect":"Hepatoma","drugRate":"reported","severity":"serious"},{"effect":"Cirrhosis","drugRate":"reported","severity":"serious"},{"effect":"Non-fatal hepatic failure","drugRate":"reported","severity":"serious"},{"effect":"Muscle cramps","drugRate":"reported","severity":"mild"},{"effect":"Myalgia","drugRate":"reported","severity":"mild"},{"effect":"Arthralgias","drugRate":"reported","severity":"mild"},{"effect":"Dyspnea","drugRate":"reported","severity":"mild"},{"effect":"Anorexia","drugRate":"reported","severity":"mild"},{"effect":"Vomiting","drugRate":"reported","severity":"mild"},{"effect":"Nausea","drugRate":"reported","severity":"mild"},{"effect":"Diarrhea","drugRate":"reported","severity":"mild"},{"effect":"Fatigue","drugRate":"reported","severity":"mild"},{"effect":"Chest pain","drugRate":"reported","severity":"mild"},{"effect":"Leg pain","drugRate":"reported","severity":"mild"},{"effect":"Shoulder pain","drugRate":"reported","severity":"mild"},{"effect":"Insomnia","drugRate":"reported","severity":"mild"},{"effect":"Paresthesia","drugRate":"reported","severity":"mild"},{"effect":"Tremor","drugRate":"reported","severity":"mild"},{"effect":"Dizziness","drugRate":"reported","severity":"mild"},{"effect":"Vertigo","drugRate":"reported","severity":"mild"},{"effect":"Anxiety","drugRate":"reported","severity":"mild"},{"effect":"Depression","drugRate":"reported","severity":"mild"}],"contraindications":["Acute coronary syndrome","Acute nephropathy","Alcoholism","Arterial hemorrhage","Blood coagulation disorder","Breastfeeding (mother)","Diabetes mellitus","Disease of liver","Disorder of coronary artery","Disorder of muscle","Gout","Hemorrhagic cerebral infarction","Hyperglycemia","Hypophosphatemia","Liver function tests abnormal","Low blood pressure","Myocardial infarction","Peptic ulcer","Pregnancy, function","Rhabdomyolysis","Surgical procedure","Thrombocytopenic disorder","Traumatic injury","Uncontrolled Epilepsy"],"specialPopulations":{"Pregnancy":"Altoprev is contraindicated for use in pregnant women since safety in pregnant women has not been established and there is no apparent benefit to therapy with Altoprev during pregnancy. Altoprev should be discontinued as soon as pregnancy is recognized.","Geriatric use":"pharmacokinetic study with lovastatin showed the mean plasma level of HMG-CoA reductase inhibitory activity to be approximately 45% higher in elderly patients between 70-78 years of age compared with patients between 18-30 years of age;","Paediatric use":"Safety and effectiveness in patients 10-17 years of age with heFH have been evaluated in controlled clinical trials of 48 weeks duration in adolescent boys and controlled clinical trials of 24 weeks duration in girls who were at least year post-menarche.","Renal impairment":"Severe renal impairment patients: dosage increases above 20 mg/day should be carefully considered."}},"trials":[],"aliases":[],"company":"Merck & Co.","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.0401/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$15","description":"LOVASTATIN 10 MG TABLET","retrievedDate":"2026-04-07"}],"allNames":"mevacor","offLabel":[],"synonyms":["lovastatin","lostatin","mevacor"],"timeline":[{"date":"1987-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from MERCK to Merck"},{"date":"1987-08-31","type":"positive","source":"DrugCentral","milestone":"FDA approval (Merck)"},{"date":"2002-06-26","type":"positive","source":"FDA Orange Book","milestone":"Altoprev approved — 10MG"},{"date":"2006-04-14","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 7 manufacturers approved"}],"aiSummary":"Mevacor (Lovastatin) is a small molecule HMG-CoA Reductase Inhibitor developed by Merck, targeting the enzyme 3-hydroxy-3-methylglutaryl-coenzyme A reductase. It was FDA approved in 1987 for various indications related to high cholesterol and cardiovascular disease. As an off-patent medication, Mevacor is available from multiple generic manufacturers. Key safety considerations include potential liver damage and muscle pain. Mevacor is used to treat conditions such as hypercholesterolemia, hyperlipidemia, and familial hypercholesterolemia.","approvals":[{"date":"1987-08-31","orphan":false,"company":"MERCK","regulator":"FDA"}],"brandName":"Mevacor","ecosystem":[{"indication":"Arteriosclerotic vascular disease","otherDrugs":[{"name":"atorvastatin","slug":"atorvastatin","company":"Pfizer"},{"name":"fluvastatin","slug":"fluvastatin","company":"Novartis"},{"name":"pravastatin","slug":"pravastatin","company":"Bristol Myers Squibb"},{"name":"rosuvastatin","slug":"rosuvastatin","company":"Ipr"}],"globalPrevalence":523000000},{"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":"choline fenofibrate","slug":"choline-fenofibrate","company":"Abbvie"}],"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":"choline fenofibrate","slug":"choline-fenofibrate","company":"Abbvie"},{"name":"clofibrate","slug":"clofibrate","company":""},{"name":"colestipol","slug":"colestipol","company":"Pharmacia And Upjohn"}],"globalPrevalence":390000000},{"indication":"Hypertriglyceridemia","otherDrugs":[{"name":"atorvastatin","slug":"atorvastatin","company":"Pfizer"},{"name":"choline fenofibrate","slug":"choline-fenofibrate","company":"Abbvie"},{"name":"fenofibrate","slug":"fenofibrate","company":"Abbvie"},{"name":"gemfibrozil","slug":"gemfibrozil","company":"Pfizer Pharms"}],"globalPrevalence":1680000000},{"indication":"Hypoalphalipoproteinemia","otherDrugs":[{"name":"choline fenofibrate","slug":"choline-fenofibrate","company":"Abbvie"},{"name":"fenofibrate","slug":"fenofibrate","company":"Abbvie"},{"name":"inositol","slug":"inositol","company":""},{"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":"choline fenofibrate","slug":"choline-fenofibrate","company":"Abbvie"},{"name":"ezetimibe","slug":"ezetimibe","company":"Msd Intl Gmbh"}],"globalPrevalence":390000000},{"indication":"Myocardial Infarction Prevention","otherDrugs":[{"name":"amlodipine","slug":"amlodipine","company":"Pfizer"},{"name":"atorvastatin","slug":"atorvastatin","company":"Pfizer"},{"name":"perindopril","slug":"perindopril","company":"Symplmed Pharms Llc"},{"name":"pravastatin","slug":"pravastatin","company":"Bristol Myers Squibb"}],"globalPrevalence":523000000}],"mechanism":{"target":"3-hydroxy-3-methylglutaryl-coenzyme A reductase","novelty":"Follow-on","targets":[{"gene":"HMGCR","source":"DrugCentral","target":"3-hydroxy-3-methylglutaryl-coenzyme A reductase","protein":"3-hydroxy-3-methylglutaryl-coenzyme A reductase"},{"gene":"HCAR2","source":"DrugCentral","target":"Hydroxycarboxylic acid receptor 2","protein":"Hydroxycarboxylic acid receptor 2"},{"gene":"HCAR3","source":"DrugCentral","target":"Hydroxycarboxylic acid receptor 3","protein":"Hydroxycarboxylic acid receptor 3"},{"gene":"NR1I2","source":"DrugCentral","target":"Nuclear receptor subfamily 1 group I member 2","protein":"Nuclear receptor subfamily 1 group I member 2"},{"gene":"SLC6A3","source":"DrugCentral","target":"Sodium-dependent dopamine transporter","protein":"Sodium-dependent dopamine transporter"},{"gene":"SLC6A2","source":"DrugCentral","target":"Sodium-dependent noradrenaline transporter","protein":"Sodium-dependent noradrenaline transporter"},{"gene":"TACR2","source":"DrugCentral","target":"Substance-K receptor","protein":"Substance-K receptor"},{"gene":"HDAC1","source":"DrugCentral","target":"Histone deacetylase 1","protein":"Histone deacetylase 1"},{"gene":"ITGAL","source":"DrugCentral","target":"Leukocyte adhesion glycoprotein LFA-1 alpha","protein":"Integrin alpha-L"},{"gene":"ADORA1","source":"DrugCentral","target":"Adenosine receptor A1","protein":"Adenosine receptor A1"}],"moaClass":"Hydroxymethylglutaryl-CoA Reductase Inhibitors","modality":"Small Molecule","drugClass":"HMG-CoA Reductase Inhibitor","explanation":"Lovastatin is lactone that is readily hydrolyzed in vivo to the corresponding -hydroxyacid, strong inhibitor of HMG-CoA reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate. The conversion of HMG-CoA to mevalonate is an early step in the biosynthetic pathway for cholesterol.","oneSentence":"Mevacor works by inhibiting the enzyme HMG-CoA reductase, which plays a key role in cholesterol production in the liver.","technicalDetail":"Mevacor specifically inhibits the enzyme HMG-CoA reductase, which catalyzes the conversion of HMG-CoA to mevalonate, a crucial step in the biosynthesis of cholesterol. By blocking this enzyme, Mevacor reduces the hepatic production of cholesterol, leading to decreased levels of low-density lipoprotein (LDL) cholesterol and increased levels of high-density lipoprotein (HDL) cholesterol."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Lovastatin","title":"Lovastatin","extract":"Lovastatin, sold under the brand name Mevacor among others, is a statin medication, to treat high blood cholesterol and reduce the risk of cardiovascular disease. Its use is recommended together with lifestyle changes. It is taken by mouth.","wiki_history":"==History==\nthumb|left|[[Pleurotus ostreatus, the oyster mushroom, naturally contains up to 2.8% lovastatin on a dry weight basis.]]\nCompactin and lovastatin, natural products with a powerful inhibitory effect on HMG-CoA reductase, were discovered in the 1970s, and taken into clinical development as potential drugs for lowering LDL cholesterol.\n\nIn 1982, some small-scale clinical investigations of lovastatin, a polyketide-derived natural product isolated from Aspergillus terreus, in very high-risk patients were undertaken, in which dramatic reductions in LDL cholesterol were observed, with very few adverse effects. After the additional animal safety studies with lovastatin revealed no toxicity of the type thought to be associated with compactin, clinical studies continued.\n\nLarge-scale trials confirmed the effectiveness of lovastatin. Observed tolerability continued to be excellent, and lovastatin was approved by the US FDA in 1987. It was the first statin approved by the FDA.\n\nLovastatin is also naturally produced by certain higher fungi, such as Pleurotus ostreatus (oyster mushroom) and closely related Pleurotus spp.  Research into the effect of oyster mushroom and its extracts on the cholesterol levels of laboratory animals has been extensive, although the effect has been demonstrated in a very limited number of human subjects.\n\nIn 1998, the FDA placed a ban on the sale of dietary supplements derived from red yeast rice, which naturally contains lovastatin, arguing that products containing prescription agents require drug approval.  Judge Dale A. Kimball of the United States District Court for the District of Utah, granted a motion by Cholestin's manufacturer, Pharmanex, that the agency's ban was illegal under the 1994 Dietary Supplement Health and Education Act because the product was marketed as a dietary supplement, not a drug.\n\n180px|thumb|right|A ball-and-stick model of lovastatin\nThe objective is to decrease excess levels of cholesterol to an amount consist","wiki_society_and_culture":"==Society and culture==\n===Natural sources===\nLovastatin is a naturally occurring compound found in low concentrations in food such as oyster mushrooms, red yeast rice, and Pu-erh.\n\n===Brand names===\nMevacor, Advicor (as a combination with niacin), Altocor, Altoprev\n\n===Other applications===\nIn plant physiology, lovastatin has occasionally been used as inhibitor of cytokinin biosynthesis."},"commercial":{"launchDate":"1987","_launchSource":"DrugCentral (FDA 1987-08-31, MERCK)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1612","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=LOVASTATIN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=LOVASTATIN","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Lovastatin","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T15:05:00.579430","biosimilars":[],"competitors":[{"drugName":"simvastatin","drugSlug":"simvastatin","fdaApproval":"1991-12-23","patentExpiry":"Feb 23, 2030","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"pravastatin","drugSlug":"pravastatin","fdaApproval":"1991-10-31","genericCount":16,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"fluvastatin","drugSlug":"fluvastatin","fdaApproval":"1993-12-31","genericCount":5,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"atorvastatin","drugSlug":"atorvastatin","fdaApproval":"1996-12-17","patentExpiry":"Jun 7, 2037","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"cerivastatin","drugSlug":"cerivastatin","fdaApproval":"1997-06-26","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"rosuvastatin","drugSlug":"rosuvastatin","fdaApproval":"2003-08-12","patentExpiry":"Feb 12, 2036","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"pitavastatin","drugSlug":"pitavastatin","fdaApproval":"2009-08-03","genericCount":8,"patentStatus":"Off-patent — generic available","relationship":"same-class"}],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"lovastatin","indications":{"approved":[{"name":"Arteriosclerotic vascular disease","source":"DrugCentral","snomedId":72092001,"regulator":"FDA","eligibility":"Individuals with dyslipidemia at risk for atherosclerotic vascular disease","usPrevalence":null,"globalPrevalence":523000000,"prevalenceMethod":"curated","prevalenceSource":"Lancet, 2023"},{"name":"Familial hypercholesterolemia - heterozygous","source":"DrugCentral","snomedId":238079002,"regulator":"FDA","eligibility":"Adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with heFH","usPrevalence":86000000,"globalPrevalence":390000000,"prevalenceMethod":"curated","prevalenceSource":"WHO Global Health Estimates, 2023"},{"name":"Hypercholesterolemia","source":"DrugCentral","snomedId":13644009,"regulator":"FDA","eligibility":"Individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia","usPrevalence":86000000,"globalPrevalence":390000000,"prevalenceMethod":"curated","prevalenceSource":"WHO Global Health Estimates, 2023"},{"name":"Hyperlipidemia","source":"DrugCentral","snomedId":55822004,"regulator":"FDA","eligibility":"Not specified","usPrevalence":null,"globalPrevalence":390000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2023"},{"name":"Hypertriglyceridemia","source":"DrugCentral","snomedId":302870006,"regulator":"FDA","eligibility":"Not indicated for patients with TG levels >400 mg/dL (>4.5 mmol/L)","usPrevalence":null,"globalPrevalence":1680000000,"prevalenceMethod":"curated","prevalenceSource":"J Health Popul Nutr, 2025 (PMID:40859400)"},{"name":"Hypoalphalipoproteinemia","source":"DrugCentral","snomedId":190785000,"regulator":"FDA","eligibility":"Not specified"},{"name":"Mixed hyperlipidemia","source":"DrugCentral","snomedId":267434003,"regulator":"FDA","eligibility":"Not specified","usPrevalence":null,"globalPrevalence":390000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2023"},{"name":"Myocardial Infarction Prevention","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"Individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C, and below average HDL-C","usPrevalence":null,"globalPrevalence":523000000,"prevalenceMethod":"curated","prevalenceSource":"WHO CVD Factsheet, 2023"},{"name":"Myocardial Reinfarction Prevention","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"Not specified"},{"name":"Primary Prevention of Coronary Heart Disease","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"Individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C, and below average HDL-C"},{"name":"Slow Progression of Coronary Artery Disease","source":"DrugCentral","snomedId":"","regulator":"FDA"}],"offLabel":[{"name":"Cerebrovascular accident","source":"DrugCentral","drugName":"LOVASTATIN"},{"name":"Prevention of Transient Ischemic Attacks","source":"DrugCentral","drugName":"LOVASTATIN","evidenceCount":21,"evidenceLevel":"moderate"}],"pipeline":[]},"currentOwner":"Merck","drugCategory":"established","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"simvastatin","brandName":"simvastatin","genericName":"simvastatin","approvalYear":"1991","relationship":"same-class"},{"drugId":"pravastatin","brandName":"pravastatin","genericName":"pravastatin","approvalYear":"1991","relationship":"same-class"},{"drugId":"fluvastatin","brandName":"fluvastatin","genericName":"fluvastatin","approvalYear":"1993","relationship":"same-class"},{"drugId":"atorvastatin","brandName":"atorvastatin","genericName":"atorvastatin","approvalYear":"1996","relationship":"same-class"},{"drugId":"cerivastatin","brandName":"cerivastatin","genericName":"cerivastatin","approvalYear":"1997","relationship":"same-class"},{"drugId":"rosuvastatin","brandName":"rosuvastatin","genericName":"rosuvastatin","approvalYear":"2003","relationship":"same-class"},{"drugId":"pitavastatin","brandName":"pitavastatin","genericName":"pitavastatin","approvalYear":"2009","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT02968810","phase":"PHASE2","title":"Simvastatin in Preventing Liver Cancer in Patients With Liver Cirrhosis","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2017-06-21","conditions":["Cirrhosis","Hepatocellular Carcinoma"],"enrollment":52,"completionDate":"2026-12-23"},{"nctId":"NCT07392541","phase":"PHASE1,PHASE2","title":"Adebrelimab Combined With Gemcitabine, Cisplatin, and Simvastatin for Advanced Biliary Tract Cancer","status":"RECRUITING","sponsor":"Tongji Hospital","startDate":"2026-01-30","conditions":["Advanced Biliary Tract Carcinoma"],"enrollment":29,"completionDate":"2028-01-30"},{"nctId":"NCT06437574","phase":"PHASE2","title":"Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer","status":"RECRUITING","sponsor":"Cedars-Sinai Medical Center","startDate":"2024-07-16","conditions":["Prostate Cancer"],"enrollment":140,"completionDate":"2028-05-31"},{"nctId":"NCT07459972","phase":"PHASE4","title":"Clinical Evaluation of Simcyp-Guided Simvastatin Dosing in Patients With 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