{"id":"khk7580","safety":{"commonSideEffects":[{"rate":null,"effect":"Bleeding"},{"rate":null,"effect":"Gastrointestinal adverse events"}]},"_chembl":null,"_fixedAt":"2026-03-30T11:42:46.640185","_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"KHK7580 selectively inhibits Factor XIa, an enzyme involved in the contact phase of blood coagulation. By blocking Factor XIa, the drug reduces the amplification of thrombin generation while potentially preserving hemostasis through the tissue factor pathway, which may provide a favorable safety profile with reduced bleeding risk compared to conventional anticoagulants.","oneSentence":"KHK7580 is a Factor XIa inhibitor that reduces thrombin generation by blocking a key enzyme in the intrinsic coagulation pathway.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:18:02.039Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Thromboembolism prevention"},{"name":"Atrial fibrillation stroke prevention"}]},"_fixedFields":["modality→Small Molecule"],"trialDetails":[{"nctId":"NCT03822507","phase":"PHASE3","title":"Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia","status":"COMPLETED","sponsor":"Kyowa Kirin Co., Ltd.","startDate":"2019-04-09","conditions":"Secondary Hyperparathyroidism","enrollment":404},{"nctId":"NCT04206657","phase":"PHASE1","title":"Pharmacokinetic Study of KHK7580 in Healthy Adult Volunteers","status":"COMPLETED","sponsor":"Kyowa Kirin Co., Ltd.","startDate":"2019-12-20","conditions":"Healthy Volunteer","enrollment":42},{"nctId":"NCT03280264","phase":"PHASE3","title":"Phase 3 Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism","status":"COMPLETED","sponsor":"Kyowa Kirin Co., Ltd.","startDate":"2017-08-30","conditions":"Parathyroid Carcinoma, Primary Hyperparathyroidism","enrollment":18},{"nctId":"NCT02216656","phase":"PHASE2","title":"Phase 2 Study of KHK7580","status":"COMPLETED","sponsor":"Kyowa Kirin Co., Ltd.","startDate":"2014-07","conditions":"Secondary Hyperparathyroidism","enrollment":201},{"nctId":"NCT02549404","phase":"PHASE3","title":"Phase 3 Study of KHK7580","status":"COMPLETED","sponsor":"Kyowa Kirin Co., Ltd.","startDate":"2015-09-28","conditions":"Secondary Hyperparathyroidism","enrollment":137},{"nctId":"NCT02549417","phase":"PHASE3","title":"Phase 3 Study of KHK7580","status":"COMPLETED","sponsor":"Kyowa Kirin Co., Ltd.","startDate":"2015-09-29","conditions":"Secondary Hyperparathyroidism","enrollment":39},{"nctId":"NCT02549391","phase":"PHASE2, PHASE3","title":"Phase 3 Study of KHK7580","status":"COMPLETED","sponsor":"Kyowa Kirin Co., Ltd.","startDate":"2015-09","conditions":"Secondary Hyperparathyroidism","enrollment":634},{"nctId":"NCT01935856","phase":"PHASE1, PHASE2","title":"Phase 1/2 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis","status":"COMPLETED","sponsor":"Kyowa Kirin Co., Ltd.","startDate":"2013-08","conditions":"Hyperparathyroidism","enrollment":20},{"nctId":"NCT02143271","phase":"PHASE1","title":"Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis","status":"COMPLETED","sponsor":"Kyowa Kirin Co., Ltd.","startDate":"2014-05","conditions":"Secondary Hyperparathyroidism","enrollment":13}],"_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":["evocalcet"],"phase":"phase_3","status":"active","brandName":"KHK7580","genericName":"KHK7580","companyName":"Kyowa Kirin Co., Ltd.","companyId":"kyowa-kirin-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"KHK7580 is a Factor XIa inhibitor that reduces thrombin generation by blocking a key enzyme in the intrinsic coagulation pathway. Used for Thromboembolism prevention, Atrial fibrillation stroke prevention.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":4,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}