{"id":"levamlodipine-besylate","safety":{"commonSideEffects":[{"rate":null,"effect":"Peripheral edema"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Flushing"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Palpitations"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"As a dihydropyridine calcium channel blocker, levamlodipine selectively inhibits calcium influx through L-type voltage-gated calcium channels in the cell membrane of vascular smooth muscle cells. This prevents calcium-dependent contraction, leading to vasodilation of coronary and peripheral arteries, reduced peripheral vascular resistance, and decreased blood pressure. The L-enantiomer is the pharmacologically active form and may offer improved efficacy and tolerability compared to the racemic mixture.","oneSentence":"Levamlodipine besylate is the active L-enantiomer of amlodipine that blocks L-type calcium channels in vascular smooth muscle and cardiac tissue, causing vasodilation and reducing blood pressure.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:33:57.669Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypertension"},{"name":"Angina pectoris"}]},"trialDetails":[{"nctId":"NCT05958524","phase":"","title":"Analysis of Factors Influencing the Efficacy of Levamlodipine Benzoate and Its Population Pharmacodynamic Modeling","status":"UNKNOWN","sponsor":"The Second Affiliated Hospital of Chongqing Medical University","startDate":"2022-12-15","conditions":"Hypertensive Patients, Monotherapy","enrollment":150},{"nctId":"NCT05126381","phase":"","title":"Population Pharmacokinetic - Pharmacodynamic Models of Chronic Disease Therapeutics for Smokers","status":"UNKNOWN","sponsor":"The Second Affiliated Hospital of Chongqing Medical University","startDate":"2022-01-13","conditions":"Chronic Disease, Smoking","enrollment":200},{"nctId":"NCT03657550","phase":"PHASE1","title":"Bioavailability of 5 mg of Levamlodipine Maleate Tablets Versus 10 mg of Amlodipine Besylate Tablet in Healthy Subjects","status":"COMPLETED","sponsor":"Conjupro Biotherapeutics, Inc.","startDate":"2018-05-31","conditions":"Hypertension","enrollment":36},{"nctId":"NCT04885660","phase":"PHASE1","title":"Bioequivalence Evaluation of Two Fixed-dose Combination of Lisinopril 10mg/Levamlodipine Besylate 5mg in Healthy Chinese Subjects","status":"COMPLETED","sponsor":"The Affiliated Hospital of Qingdao University","startDate":"2018-10-12","conditions":"Therapeutic Equivalency","enrollment":92},{"nctId":"NCT04411875","phase":"PHASE1","title":"Bioequivalence of Levamlodipine Besylate Tablets in Healthy Chinese Subjects","status":"COMPLETED","sponsor":"The Affiliated Hospital of Qingdao University","startDate":"2018-11-13","conditions":"Healthy Subjects","enrollment":48},{"nctId":"NCT03648333","phase":"PHASE1","title":"Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects (N=27)","status":"COMPLETED","sponsor":"Hanlim Pharm. Co., Ltd.","startDate":"2013-12","conditions":"Healthy Male Subjects","enrollment":27},{"nctId":"NCT01819779","phase":"PHASE1","title":"Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects (N=60)","status":"COMPLETED","sponsor":"Hanlim Pharm. Co., Ltd.","startDate":"2013-03","conditions":"Healthy Male Subjects","enrollment":53},{"nctId":"NCT03038451","phase":"PHASE4","title":"Efficacy and Safety of S-amlodipine 2,5 mg and 5 mg in Hypertension Patients","status":"COMPLETED","sponsor":"Neutec Ar-Ge San ve Tic A.Ş","startDate":"2013-03-20","conditions":"Hypertension","enrollment":43},{"nctId":"NCT01844570","phase":"","title":"Levamlodipine Maleate or Amlodipine Besylate for Treatment of Hypertension: A Comparative Effectiveness Research","status":"UNKNOWN","sponsor":"Peking University First Hospital","startDate":"2013-02","conditions":"Primary Hypertension","enrollment":10000},{"nctId":"NCT01652339","phase":"PHASE1","title":"Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects","status":"COMPLETED","sponsor":"Hanlim Pharm. Co., Ltd.","startDate":"2012-07","conditions":"Healthy Male Subjects","enrollment":40},{"nctId":"NCT01131546","phase":"PHASE4","title":"Efficacy and Safety of Levamlodipine Besylate Compared to Amlodipine Maleate in Patients With Essential Hypertension","status":"COMPLETED","sponsor":"Jiangsu Simcere Pharmaceutical Co., Ltd.","startDate":"2009-12","conditions":"Essential Hypertension","enrollment":1080},{"nctId":"NCT00289406","phase":"PHASE3","title":"Efficacy and Safety Study of S-Amlodipine Gentisate Compared to Amlodipine Besylate to Treat Mild-to-Moderate Hypertension","status":"COMPLETED","sponsor":"SK Chemicals Co., Ltd.","startDate":"2006-01","conditions":"Hypertension","enrollment":110}],"_emaApprovals":[],"_faersSignals":[{"count":17,"reaction":"PNEUMONIA"},{"count":12,"reaction":"PLATELET COUNT DECREASED"},{"count":11,"reaction":"ANAEMIA"},{"count":11,"reaction":"OFF LABEL USE"},{"count":10,"reaction":"MYELOSUPPRESSION"},{"count":9,"reaction":"OVERDOSE"},{"count":8,"reaction":"DECREASED APPETITE"},{"count":8,"reaction":"DIZZINESS"},{"count":8,"reaction":"HEPATIC FUNCTION ABNORMAL"},{"count":8,"reaction":"HYPOKALAEMIA"}],"_approvalHistory":[],"publicationCount":15,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Levamlodipine besylate","genericName":"Levamlodipine besylate","companyName":"Jiangsu Simcere Pharmaceutical Co., Ltd.","companyId":"jiangsu-simcere-pharmaceutical-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Levamlodipine besylate is the active L-enantiomer of amlodipine that blocks L-type calcium channels in vascular smooth muscle and cardiac tissue, causing vasodilation and reducing blood pressure. Used for Hypertension, Angina pectoris.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}