{"id":"csl312","safety":{"commonSideEffects":[{"rate":null,"effect":"Infusion-related reactions"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"CSL312 is designed to mimic the structure and function of apolipoprotein A-I, the major protein component of HDL particles. By enhancing HDL-mediated reverse cholesterol transport, the drug aims to reduce atherosclerotic cardiovascular disease risk. It works by facilitating the removal of cholesterol from peripheral tissues and atherosclerotic plaques, promoting their transport to the liver for excretion.","oneSentence":"CSL312 is an apolipoprotein A-I (apoA-I) mimetic that increases HDL cholesterol and promotes reverse cholesterol transport.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:08:05.452Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Acute coronary syndrome with elevated lipoprotein(a)"},{"name":"Cardiovascular risk reduction in patients with low HDL cholesterol"}]},"trialDetails":[{"nctId":"NCT06806657","phase":"PHASE4","title":"Safety Study in Subjects ≥ 12 Years of Age With Hereditary Angioedema Switching to Garadacimab","status":"RECRUITING","sponsor":"CSL Behring","startDate":"2025-03-19","conditions":"Hereditary Angioedema","enrollment":30},{"nctId":"NCT05819775","phase":"PHASE3","title":"CSL312_3003 Safety and Pharmacokinetic Study in Subjects 2 to 11 Years of Age With Hereditary Angioedema","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2023-05-30","conditions":"Hereditary Angioedema (HAE)","enrollment":22},{"nctId":"NCT04739059","phase":"PHASE3","title":"Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2021-04-29","conditions":"Hereditary Angioedema","enrollment":171},{"nctId":"NCT07159464","phase":"","title":"Post Study Access of CSL312 (Garadacimab) for Pediatric Participants With Hereditary Angioedema Who Have Completed the CSL312_3003 Study","status":"AVAILABLE","sponsor":"CSL Behring","startDate":"","conditions":"Hereditary Angioedema (HAE)","enrollment":""},{"nctId":"NCT05130970","phase":"PHASE2","title":"Garadacimab Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2022-02-03","conditions":"Idiopathic Pulmonary Fibrosis","enrollment":81},{"nctId":"NCT04656418","phase":"PHASE3","title":"CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2021-01-27","conditions":"Hereditary Angioedema","enrollment":64},{"nctId":"NCT03712228","phase":"PHASE2","title":"A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE)","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2018-10-29","conditions":"Hereditary Angioedema","enrollment":44},{"nctId":"NCT05306275","phase":"PHASE1","title":"A Study to Compare the Pharmacokinetics of CSL312 Administered by Prefilled Syringe Assembled to Autoinjector to the Pharmacokinetics Administered by Prefilled Syringe Assembled to Needle Safety Device in Healthy Subjects","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2022-04-04","conditions":"Healthy Participants","enrollment":132},{"nctId":"NCT04580654","phase":"PHASE1","title":"A Study to Assess the Pharmacokinetics and Safety of CSL312 in Healthy Japanese and Caucasian Adults","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2020-10-29","conditions":"Healthy Volunteers","enrollment":38},{"nctId":"NCT04409509","phase":"PHASE2","title":"Treatment With CSL312 in Adults With Coronavirus Disease 2019 (COVID-19)","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2020-07-01","conditions":"Coronavirus Disease 2019 (COVID-19)","enrollment":124},{"nctId":"NCT04281524","phase":"PHASE1, PHASE2","title":"A Clinical Study to Test the Efficacy and Safety of CSL312 on Catheter-associated Blood Clot Formation in Subjects With Cancer Who Receive Chemotherapy Through a PICC Line","status":"WITHDRAWN","sponsor":"CSL Behring","startDate":"2020-03","conditions":"PICC-associated Thrombosis","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":8,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Garadacimab","Factor XIIa inhibitor monoclonal antibody","garadacimab","Factor XIIa antagonist monoclonal antibody","Gardacimab"],"phase":"phase_3","status":"active","brandName":"CSL312","genericName":"CSL312","companyName":"CSL Behring","companyId":"csl-behring","modality":"Biologic","firstApprovalDate":"","aiSummary":"CSL312 is an apolipoprotein A-I (apoA-I) mimetic that increases HDL cholesterol and promotes reverse cholesterol transport. Used for Acute coronary syndrome with elevated lipoprotein(a), Cardiovascular risk reduction in patients with low HDL cholesterol.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":3,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}