{"id":"ctap101-injection","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Infusion-related reactions"}]},"_chembl":{"chemblId":"CHEMBL2108760","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"CTAP101 replaces deficient or dysfunctional C1-esterase inhibitor protein, which normally suppresses excessive activation of the complement cascade and bradykinin-generating contact system. By restoring C1-INH levels and activity, the drug prevents the uncontrolled release of vasoactive mediators that cause the characteristic swelling episodes in hereditary angioedema (HAE).","oneSentence":"CTAP101 is a recombinant human C1-esterase inhibitor (C1-INH) that regulates complement and contact system activation to prevent hereditary angioedema attacks.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:08:03.153Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hereditary angioedema (HAE) Types I and II — prophylaxis and acute attack treatment"}]},"trialDetails":[{"nctId":"NCT00888069","phase":"PHASE1","title":"Pharmacokinetics and Safety Pilot Study of Single-Dose Oral and Intravenous CTAP101 in Stage 3 and 4 Chronic Kidney Disease Subjects","status":"COMPLETED","sponsor":"OPKO IP Holdings II, Inc.","startDate":"2009-05","conditions":"Chronic Kidney Disease, Secondary Hyperparathyroidism, Chronic Renal Insufficiency","enrollment":28}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":595852,"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":"CTAP101 Injection","genericName":"CTAP101 Injection","companyName":"OPKO IP Holdings II, Inc.","companyId":"opko-ip-holdings-ii-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"CTAP101 is a recombinant human C1-esterase inhibitor (C1-INH) that regulates complement and contact system activation to prevent hereditary angioedema attacks. Used for Hereditary angioedema (HAE) Types I and II — prophylaxis and acute attack treatment.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}