{"id":"iron-isomaltoside-1000-ferric-derisomaltose","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Hypophosphatemia"}]},"_chembl":{"chemblId":"CHEMBL4298046","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The drug consists of ferric iron complexed with isomaltoside, a carbohydrate polymer that protects the iron and facilitates its absorption and transport. Once administered, the iron is released and binds to transferrin in the bloodstream for transport to bone marrow and other tissues, where it is incorporated into hemoglobin and other iron-dependent proteins to treat iron deficiency anemia.","oneSentence":"Iron isomaltoside 1000 is an iron-carbohydrate complex that delivers ferric iron to bind transferrin and replenish iron stores in patients with iron deficiency.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:17:11.114Z","_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":"NCT06884280","phase":"PHASE3","title":"Comparing High and Low Dose Iron Treatments for People on Peritoneal Dialysis: The PALaDIN Study","status":"RECRUITING","sponsor":"Hull University Teaching Hospitals NHS Trust","startDate":"2025-11-13","conditions":"Peritoneal Dialysis, Anaemia, Iron Deficiency, Anaemia","enrollment":30},{"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":"NCT05251493","phase":"PHASE3","title":"Ferric Derisomaltose (Iron Isomaltoside) Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy","status":"RECRUITING","sponsor":"Saskatchewan Health Authority - Regina Area","startDate":"2022-06-06","conditions":"Iron Deficiency Anaemia in Childbirth","enrollment":280},{"nctId":"NCT05545527","phase":"","title":"Neuroimaging Ancillary Study","status":"COMPLETED","sponsor":"Thomas Jefferson University","startDate":"2023-02-21","conditions":"Iron Deficiency Anemia, 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Disorder","enrollment":538},{"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":"NCT04608539","phase":"PHASE4","title":"A Clinical Trial Assessing the Efficacy of Intravenous Iron for the Treatment of Anemia Following Cardiac Surgery","status":"COMPLETED","sponsor":"Michael Kremke","startDate":"2021-05-21","conditions":"Anemia Postoperative","enrollment":110},{"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":"NCT02642562","phase":"PHASE4","title":"Intravenous Iron Treatment in Patients With Heart Failure and Iron Deficiency: IRONMAN","status":"COMPLETED","sponsor":"University of Glasgow","startDate":"2016-08","conditions":"Chronic Heart Failure, Iron Deficiency, Left Ventricular Systolic Dysfunction","enrollment":1160},{"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},{"nctId":"NCT02962648","phase":"PHASE3","title":"An Extension Trial to Assess the Safety of Re-dosing of Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®)","status":"COMPLETED","sponsor":"Pharmacosmos A/S","startDate":"2017-01-09","conditions":"Iron Deficiency Anemia, Iron 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Anemia","enrollment":123}],"_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":["Monoferric DIN 22477777"],"phase":"phase_3","status":"active","brandName":"Iron Isomaltoside 1000, ferric derisomaltose","genericName":"Iron Isomaltoside 1000, ferric derisomaltose","companyName":"Saskatchewan Health Authority - Regina Area","companyId":"saskatchewan-health-authority-regina-area","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Iron isomaltoside 1000 is an iron-carbohydrate complex that delivers ferric iron to bind transferrin and replenish iron stores in patients with iron deficiency. 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":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}