{"id":"low-volume-c1-esterase-inhibitor","safety":{"commonSideEffects":[{"rate":null,"effect":"Thrombosis / thromboembolic events"},{"rate":null,"effect":"Hypersensitivity reactions"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Headache"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"C1-esterase inhibitor is a serine protease inhibitor that regulates the contact system (kallikrein-kinin pathway) and classical complement pathway. Deficiency or dysfunction of C1-INH leads to uncontrolled bradykinin generation and complement activation, causing angioedema and other inflammatory manifestations. This low-volume formulation provides C1-INH replacement therapy to restore normal regulation of these pathways.","oneSentence":"Low-volume C1-esterase inhibitor (C1-INH) replaces or augments deficient or dysfunctional C1-esterase inhibitor protein to suppress excessive contact system and complement activation.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:49:45.434Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hereditary angioedema (HAE) with C1-INH deficiency or dysfunction"},{"name":"Acute angioedema attacks in HAE patients"}]},"trialDetails":[{"nctId":"NCT01912456","phase":"PHASE3","title":"A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2014-01","conditions":"Hereditary Angioedema Types I and II","enrollment":90},{"nctId":"NCT02316353","phase":"PHASE3","title":"A Study to Evaluate the Long-term Clinical Safety and Efficacy of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2014-12-31","conditions":"Hereditary Angioedema Types I and II","enrollment":126}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":4,"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":"Low-volume C1-esterase inhibitor","genericName":"Low-volume C1-esterase inhibitor","companyName":"CSL Behring","companyId":"csl-behring","modality":"Biologic","firstApprovalDate":"","aiSummary":"Low-volume C1-esterase inhibitor (C1-INH) replaces or augments deficient or dysfunctional C1-esterase inhibitor protein to suppress excessive contact system and complement activation. Used for Hereditary angioedema (HAE) with C1-INH deficiency or dysfunction, Acute angioedema attacks in HAE patients.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}