{"id":"ferric-derisomaltose-injection","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Hypersensitivity reactions"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Ferric derisomaltose is a ferric iron carbohydrate complex designed for intravenous administration. The derisomaltose ligand stabilizes the ferric iron and facilitates cellular uptake via transferrin-independent pathways, allowing rapid iron delivery to iron-deficient tissues and bone marrow for hemoglobin synthesis.","oneSentence":"Ferric derisomaltose is an iron replacement therapy that delivers ferric iron complexed with derisomaltose to replenish depleted iron stores.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:12:28.112Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Iron deficiency anemia in patients with chronic kidney disease"},{"name":"Iron deficiency anemia in patients intolerant to or unresponsive to oral iron therapy"}]},"trialDetails":[{"nctId":"NCT06287619","phase":"PHASE2","title":"Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery","status":"RECRUITING","sponsor":"University Health Network, Toronto","startDate":"2025-04-03","conditions":"Chronic Iron Deficiency Anaemia, Cardiac Surgery","enrollment":60},{"nctId":"NCT07314424","phase":"PHASE4","title":"The Effect of Preoperative Intravenous Ferric Derisomaltose and EPO and Tranexamic Acid in Patients With Preoperative Anemia or Iron Deficiency in Bone Tumor","status":"NOT_YET_RECRUITING","sponsor":"Tang Xiaodong","startDate":"2026-01-01","conditions":"Anemia","enrollment":160},{"nctId":"NCT07236788","phase":"NA","title":"Study on Supplement of Intravenous Ferric Derisomaltose to Prevent Anemia and Improve the Quality of Life in Obese Patients With Iron Deficiency.","status":"RECRUITING","sponsor":"China-Japan Friendship Hospital","startDate":"2025-03-01","conditions":"Obesity, Anemia, Iron Deficiencies","enrollment":200},{"nctId":"NCT05991128","phase":"PHASE4","title":"The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life","status":"UNKNOWN","sponsor":"China-Japan Friendship Hospital","startDate":"2023-08-01","conditions":"Heart Failure With Preserved Ejection Fraction, Iron Deficiencies, Acute Heart Failure","enrollment":170},{"nctId":"NCT05971732","phase":"PHASE4","title":"The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)","status":"UNKNOWN","sponsor":"China-Japan Friendship Hospital","startDate":"2023-08-01","conditions":"Heart Failure With Reduced Ejection Fraction, Iron Deficiency, Acute Heart Failure","enrollment":146},{"nctId":"NCT05911438","phase":"NA","title":"Accelerated Recovery for Total Knee Replacement Surgery With Preoperative Intravenous Iron Combined With Human Erythropoietin for Rapid Hematopoietic Mobilization to Prevent Postoperative Anemia","status":"UNKNOWN","sponsor":"West China Hospital","startDate":"2023-07","conditions":"Total Knee Arthroplasty","enrollment":419},{"nctId":"NCT05768997","phase":"PHASE3","title":"High Dose IV Iron Plus ESA in Chemotherapy-induced Anemia","status":"UNKNOWN","sponsor":"Hallym University Medical Center","startDate":"2023-03-01","conditions":"Anemia","enrollment":312},{"nctId":"NCT05467319","phase":"PHASE3","title":"Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS","status":"UNKNOWN","sponsor":"Alberta Health Services, Calgary","startDate":"2022-09-30","conditions":"Gynecologic Cancer, Anemia, Iron Deficiency, Surgery","enrollment":82},{"nctId":"NCT02940886","phase":"PHASE3","title":"Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA)","status":"COMPLETED","sponsor":"Pharmacosmos A/S","startDate":"2016-11-08","conditions":"Iron Deficiency Anaemia, Iron Deficiency Anemia","enrollment":1512},{"nctId":"NCT02940860","phase":"PHASE3","title":"Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease","status":"COMPLETED","sponsor":"Pharmacosmos A/S","startDate":"2016-11-29","conditions":"Iron Deficiency Anaemia, Iron Deficiency Anemia, Chronic Kidney Disease","enrollment":1538}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":5,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["iron isomaltoside","Monoferric","Monofer"],"phase":"phase_3","status":"active","brandName":"Ferric Derisomaltose Injection","genericName":"Ferric Derisomaltose Injection","companyName":"Hallym University Medical Center","companyId":"hallym-university-medical-center","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ferric derisomaltose is an iron replacement therapy that delivers ferric iron complexed with derisomaltose to replenish depleted iron stores. Used for Iron deficiency anemia in patients with chronic kidney disease, Iron deficiency anemia in patients intolerant to or unresponsive to oral iron therapy.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}