{"id":"rosuvastatin-calcium-20-mg-qd","safety":{"commonSideEffects":[{"rate":"2-5","effect":"Myalgia (muscle pain)"},{"rate":"1-3","effect":"Elevated liver enzymes (ALT/AST)"},{"rate":"5-10","effect":"Headache"},{"rate":"<0.1","effect":"Rhabdomyolysis (rare)"},{"rate":"2-4","effect":"Nausea"}]},"_chembl":{"chemblId":"CHEMBL1744447","moleculeType":"Small molecule","molecularWeight":"1001.15"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Rosuvastatin is a statin that competitively inhibits HMG-CoA reductase, which catalyzes the conversion of HMG-CoA to mevalonate in the cholesterol biosynthetic pathway. This inhibition decreases hepatic cholesterol production, leading to upregulation of LDL receptors on hepatocytes and increased clearance of LDL cholesterol from the bloodstream. The net result is a significant reduction in serum LDL cholesterol and triglycerides, with modest increases in HDL cholesterol.","oneSentence":"Rosuvastatin inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby reducing LDL cholesterol levels.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:32:52.754Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypercholesterolemia and dyslipidemia"},{"name":"Primary prevention of cardiovascular disease"},{"name":"Secondary prevention of cardiovascular events in patients with established coronary artery disease"}]},"trialDetails":[{"nctId":"NCT07432516","phase":"NA","title":"Optimal Antiplatelet and Lipid Therapy in ACS With DES: OPACT Trial","status":"NOT_YET_RECRUITING","sponsor":"Yonsei University","startDate":"2026-02","conditions":"Coronary Artery Disease","enrollment":4400},{"nctId":"NCT05579626","phase":"PHASE4","title":"Comparison of Low-Intensity Statin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus (PROVE-DM)","status":"ENROLLING_BY_INVITATION","sponsor":"Seung-Whan Lee, M.D., Ph.D.","startDate":"2023-03-14","conditions":"Pre Diabetes, ASCVD","enrollment":4000},{"nctId":"NCT06742853","phase":"PHASE1","title":"A Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of AZD0780 With Ezetimibe Combinations in Healthy Adults With Elevated LDL-C.","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2024-12-20","conditions":"Dyslipidemia","enrollment":81},{"nctId":"NCT03169985","phase":"PHASE4","title":"Randomized Controlled Trial of Moderate-Intensity Rosuvastatin With Ezetimibe Combination Therapy Versus High-Intensity Rosuvastatin on Progression of Coronary Atherosclerotic Plaque","status":"ACTIVE_NOT_RECRUITING","sponsor":"Samsung Medical Center","startDate":"2017-07-12","conditions":"Coronary Artery Disease","enrollment":280},{"nctId":"NCT06779253","phase":"PHASE1","title":"A Study to Investigate The Effect of Pimicotinib on The Pharmacokinetics of Metformin, Fexofenadine and Rosuvastatin In Healthy Subjects","status":"COMPLETED","sponsor":"Abbisko Therapeutics Co, Ltd","startDate":"2025-03-14","conditions":"Healthy Subjects","enrollment":39},{"nctId":"NCT05657613","phase":"PHASE1","title":"Drug-Drug Interaction Study of Pacritinib and CYP450,Transporter Substrates, and CYP450 3A4 in Healthy Male Subjects","status":"COMPLETED","sponsor":"CTI BioPharma","startDate":"2023-01-03","conditions":"Drug Interactions","enrollment":60},{"nctId":"NCT03864042","phase":"PHASE1","title":"Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors","status":"COMPLETED","sponsor":"Pfizer","startDate":"2018-01-02","conditions":"Advanced Solid Tumors, Metastatic Melanoma","enrollment":56},{"nctId":"NCT05176314","phase":"PHASE1","title":"A Drug Drug Interaction (DDI) Study of Pirtobrutinib (LY3527727) and Rosuvastatin in Healthy Participants","status":"COMPLETED","sponsor":"Loxo Oncology, Inc.","startDate":"2022-01-11","conditions":"Healthy","enrollment":32},{"nctId":"NCT05658692","phase":"PHASE4","title":"Platform Adaptive Embedded Trial for Acute Respiratory Distress Syndrome","status":"UNKNOWN","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","startDate":"2022-10-01","conditions":"Acute Respiratory Distress Syndrome","enrollment":1000},{"nctId":"NCT01730053","phase":"PHASE3","title":"Study of Alirocumab (REGN727/SAR236553) added-on to Rosuvastatin Versus Other Lipid Modifying Treatments (LMT) (ODYSSEY OPTIONS II)","status":"COMPLETED","sponsor":"Regeneron Pharmaceuticals","startDate":"2012-11-30","conditions":"Hypercholesterolemia","enrollment":305},{"nctId":"NCT03801733","phase":"PHASE1","title":"Drug-Drug Interaction Study of Vadadustat With Rosuvastatin, Sulfasalazine, Pravastatin, Atorvastatin and Simvastatin","status":"COMPLETED","sponsor":"Akebia Therapeutics","startDate":"2018-06-17","conditions":"Drug Interaction Potentiation","enrollment":134},{"nctId":"NCT02977065","phase":"PHASE2","title":"To Assess the Safety, Efficacy and Tolerability of CKD-519, Administered With HMG-CoA Reductase Inhibitors","status":"COMPLETED","sponsor":"Chong Kun Dang Pharmaceutical","startDate":"2017-03-23","conditions":"Dyslipidemias","enrollment":62},{"nctId":"NCT03026933","phase":"PHASE3","title":"Evaluate the Efficacy and Safety of KI1107 in Patients Whose TG Level is Not Adequately Controlled With Rosuvastatin Calcium Monotherapy While LDL-C is Properly Controlled","status":"COMPLETED","sponsor":"Kuhnil Pharmaceutical Co., Ltd.","startDate":"2014-05","conditions":"Dyslipidemias","enrollment":215},{"nctId":"NCT01925300","phase":"PHASE1","title":"Pharmacokinetic Interactions of Bisoprolol and Rosuvastatin","status":"WITHDRAWN","sponsor":"HK inno.N Corporation","startDate":"2013-07","conditions":"Healthy","enrollment":""},{"nctId":"NCT02859129","phase":"PHASE1","title":"Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova™ and a Single Dose of Rosuvastatin (Crestor®)","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2013-09","conditions":"Hypertriglyceridemia","enrollment":114},{"nctId":"NCT01730040","phase":"PHASE3","title":"Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I)","status":"COMPLETED","sponsor":"Regeneron Pharmaceuticals","startDate":"2012-10","conditions":"Hypercholesterolemia","enrollment":355},{"nctId":"NCT01870466","phase":"PHASE1","title":"Pharmacodynamic Drug Interaction Between Cilostazol and Statins","status":"COMPLETED","sponsor":"Samsung Medical Center","startDate":"2012-06","conditions":"Healthy","enrollment":63},{"nctId":"NCT00986999","phase":"PHASE2, PHASE3","title":"Effect of Rosuvastatin on Endothelial Function","status":"TERMINATED","sponsor":"University of Hawaii","startDate":"2009-09","conditions":"HIV Infections, Cardiovascular Disease","enrollment":7},{"nctId":"NCT01490398","phase":"PHASE4","title":"Rosuvastatin Effect on Serial Echocardiographic Measurement of Coronary Flow Velocity Reserve","status":"COMPLETED","sponsor":"Asan Medical Center","startDate":"2011-12","conditions":"Hypertension, Cardiovascular Risk Factors","enrollment":56},{"nctId":"NCT00249912","phase":"PHASE3","title":"Efficacy of Lapaquistat Acetate Alone or Combined With Rosuvastatin in Subjects With Hypercholesterolemia","status":"COMPLETED","sponsor":"Takeda","startDate":"2005-10","conditions":"Hypercholesterolemia","enrollment":415},{"nctId":"NCT00683618","phase":"PHASE3","title":"Compare the Efficacy of Rosuvastatin to Atorvastatin in High Risk Patients With Hypercholesterolemia","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2008-05","conditions":"Hypercholesterolemia","enrollment":934}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":3,"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":"Rosuvastatin Calcium 20 MG, QD","genericName":"Rosuvastatin Calcium 20 MG, QD","companyName":"Kuhnil Pharmaceutical Co., Ltd.","companyId":"kuhnil-pharmaceutical-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Rosuvastatin inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby reducing LDL cholesterol levels. Used for Hypercholesterolemia and dyslipidemia, Primary prevention of cardiovascular disease, Secondary prevention of cardiovascular events in patients with established coronary artery disease.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}