{"id":"cinryze-500-u","safety":{"commonSideEffects":[{"rate":null,"effect":"Thrombosis / thromboembolic events"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Hypersensitivity reactions"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Hereditary angioedema (HAE) results from deficiency or dysfunction of C1 esterase inhibitor, a regulatory protein in the contact system cascade. Without adequate C1-INH, uncontrolled activation of Factor XII and kallikrein leads to excessive bradykinin production, causing severe angioedema. CINRYZE provides exogenous C1-INH to restore normal regulation of this cascade and prevent acute swelling episodes.","oneSentence":"CINRYZE is a C1 esterase inhibitor (C1-INH) that replaces deficient or dysfunctional C1 inhibitor protein to prevent excessive bradykinin generation and control hereditary angioedema attacks.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:05:56.085Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hereditary angioedema (HAE) Types I and II — acute attack treatment and prophylaxis"}]},"trialDetails":[{"nctId":"NCT04696146","phase":"PHASE1, PHASE2","title":"Berinert (C1INH) vs Placebo for DGF/IRI","status":"COMPLETED","sponsor":"Cedars-Sinai Medical Center","startDate":"2021-03-03","conditions":"End Stage Renal Disease, Chronic Kidney Diseases","enrollment":45},{"nctId":"NCT01095510","phase":"PHASE2","title":"CINRYZE for the Treatment of Hereditary Angioedema Attacks in Children Under the Age of 12","status":"COMPLETED","sponsor":"Shire","startDate":"2010-06-02","conditions":"Hereditary Angioedema (HAE)","enrollment":9},{"nctId":"NCT02865720","phase":"PHASE3","title":"Study of C1 Inhibitor (Human) for the Prevention of Angioedema Attacks and Treatment of Breakthrough Attacks in Japanese Subjects With Hereditary Angioedema (HAE)","status":"COMPLETED","sponsor":"Shire","startDate":"2016-09-08","conditions":"Hereditary Angioedema (HAE)","enrollment":8},{"nctId":"NCT00292981","phase":"PHASE3","title":"C1 Esterase Inhibitor in Hereditary Angioedema (HAE)(Extension Study)","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2005-08","conditions":"Hereditary Angioedema","enrollment":57}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"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":"CINRYZE 500 U","genericName":"CINRYZE 500 U","companyName":"Shire","companyId":"shire","modality":"Small molecule","firstApprovalDate":"","aiSummary":"CINRYZE is a C1 esterase inhibitor (C1-INH) that replaces deficient or dysfunctional C1 inhibitor protein to prevent excessive bradykinin generation and control hereditary angioedema attacks. Used for Hereditary angioedema (HAE) Types I and II — acute attack treatment and prophylaxis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}