{"id":"ckd-11101-darbepoetin-alfa","safety":{"commonSideEffects":[{"rate":"20-30","effect":"Hypertension"},{"rate":"10-20","effect":"Headache"},{"rate":"5-10","effect":"Thrombotic events (DVT, PE, stroke)"},{"rate":"5-15","effect":"Injection site pain"},{"rate":"10-15","effect":"Fatigue"},{"rate":"5-10","effect":"Fever"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Darbepoetin alfa is a recombinant human erythropoietin analog with a longer half-life than epoetin alfa due to additional carbohydrate chains. It binds to erythropoietin receptors on erythroid progenitor cells in the bone marrow, activating JAK2 signaling and promoting proliferation, differentiation, and maturation of red blood cells. This increases hemoglobin levels and reduces the need for blood transfusions in patients with anemia.","oneSentence":"Darbepoetin alfa is an erythropoiesis-stimulating agent that binds to the erythropoietin receptor to stimulate red blood cell production.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:06:09.078Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Anemia associated with chronic kidney disease"},{"name":"Chemotherapy-induced anemia in cancer patients"}]},"trialDetails":[{"nctId":"NCT03431623","phase":"PHASE3","title":"CKD-11101 Phase 3 SC Study","status":"COMPLETED","sponsor":"Chong Kun Dang Pharmaceutical","startDate":"2015-05","conditions":"Anemia of Chronic Kidney Disease","enrollment":248},{"nctId":"NCT03428594","phase":"PHASE3","title":"CKD-11101 Phase 3 IV Study in Patients Who Had Renal Anemia Receiving Hemodialysis","status":"COMPLETED","sponsor":"Chong Kun Dang Pharmaceutical","startDate":"2015-06","conditions":"Anemia of Chronic Kidney Disease","enrollment":403},{"nctId":"NCT01685671","phase":"PHASE1","title":"Pharmacokinetics Study of CKD-11101 and NESP After SC Administration in Health Male Volunteers","status":"COMPLETED","sponsor":"Chong Kun Dang Pharmaceutical","startDate":"2012-10-26","conditions":"Anemia","enrollment":34},{"nctId":"NCT01684605","phase":"PHASE1","title":"Pharmacokinetics Study of CKD-11101 and NESP After IV Administration in Health Male Volunteers","status":"COMPLETED","sponsor":"Chong Kun Dang Pharmaceutical","startDate":"2012-10-12","conditions":"Anemia","enrollment":31}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":3,"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":"CKD-11101(Darbepoetin alfa)","genericName":"CKD-11101(Darbepoetin alfa)","companyName":"Chong Kun Dang Pharmaceutical","companyId":"chong-kun-dang-pharmaceutical","modality":"Biologic","firstApprovalDate":"","aiSummary":"Darbepoetin alfa is an erythropoiesis-stimulating agent that binds to the erythropoietin receptor to stimulate red blood cell production. Used for Anemia associated with chronic kidney disease, Chemotherapy-induced anemia in cancer patients.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}