{"id":"cinryze-500","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Infusion site reactions"},{"rate":null,"effect":"Thrombotic events (rare)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"CINRYZE replaces or augments deficient or dysfunctional C1 esterase inhibitor protein, which normally regulates the intrinsic coagulation cascade and contact system. By restoring C1-INH activity, the drug prevents excessive bradykinin generation, thereby reducing the frequency and severity of acute angioedema episodes in hereditary angioedema (HAE) patients.","oneSentence":"CINRYZE is a C1 esterase inhibitor (C1-INH) that suppresses activation of the contact system to prevent bradykinin-mediated angioedema attacks.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:05:55.078Z","_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":"NCT05010876","phase":"PHASE2","title":"Evaluation of the Effects of Bradykinin Antagonists on Pulmonary Manifestations of COVID-19 Infections (AntagoBrad-Cov Study).","status":"COMPLETED","sponsor":"GCS Ramsay Santé pour l'Enseignement et la Recherche","startDate":"2021-02-04","conditions":"Covid19","enrollment":44},{"nctId":"NCT02052141","phase":"PHASE3","title":"Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema","status":"COMPLETED","sponsor":"Shire","startDate":"2014-03-20","conditions":"Hereditary Angioedema (HAE)","enrollment":12},{"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":"NCT01467947","phase":"PHASE4","title":"Postmarketing Immunogenicity Study in HAE Subjects Treated With Berinert","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2011-11","conditions":"Hereditary Angioedema Types I and II","enrollment":46},{"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":[{"count":1,"reaction":"DIZZINESS"},{"count":1,"reaction":"DYSPNOEA"},{"count":1,"reaction":"PALLOR"},{"count":1,"reaction":"PANIC ATTACK"},{"count":1,"reaction":"PHARYNGEAL OEDEMA"},{"count":1,"reaction":"THROAT TIGHTNESS"}],"_approvalHistory":[],"publicationCount":36,"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","genericName":"CINRYZE 500","companyName":"Shire","companyId":"shire","modality":"Biologic","firstApprovalDate":"","aiSummary":"CINRYZE is a C1 esterase inhibitor (C1-INH) that suppresses activation of the contact system to prevent bradykinin-mediated 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}}