{"id":"iron-isomaltoside","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Hypophosphatemia"}]},"_chembl":{"chemblId":"CHEMBL4298046","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Iron isomaltoside is a carbohydrate-based iron complex that provides bioavailable iron for patients with iron deficiency. The isomaltoside carbohydrate shell protects the iron core during transit through the gastrointestinal tract and facilitates cellular uptake via transferrin-mediated pathways, enabling rapid repletion of iron stores and restoration of oxygen-carrying capacity.","oneSentence":"Iron isomaltoside is an iron replacement therapy that delivers ferric iron complexed with isomaltoside, allowing efficient absorption and utilization for hemoglobin synthesis in iron-deficient patients.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:50:14.843Z","_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 non-responsive to oral iron"}]},"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":"NCT02632760","phase":"PHASE4","title":"Intravenous Iron for Treatment of Anaemia Before Cardiac Surgery","status":"COMPLETED","sponsor":"Bayside Health","startDate":"2016-07-15","conditions":"Anaemia","enrollment":955},{"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, Iron Deficiency Anemia of Pregnancy, Neurodevelopmental Disorder of Foetus","enrollment":184},{"nctId":"NCT06830941","phase":"PHASE4","title":"Iron Isomaltoside for the Treatment of Anemia in Peritoneal Dialysis Patients","status":"NOT_YET_RECRUITING","sponsor":"Xie Jingyuan, MD","startDate":"2025-02-15","conditions":"Renal Anemia, Peritoneal Dialysis (PD)","enrollment":124},{"nctId":"NCT06350955","phase":"PHASE4","title":"IV Iron-induced Hypophosphatemia After RYGB","status":"RECRUITING","sponsor":"Lucie Favre","startDate":"2024-05-02","conditions":"Hypophosphatemia, Roux-en-Y Gastric Bypass","enrollment":94},{"nctId":"NCT05358509","phase":"PHASE4","title":"Reducing Anemia in Pregnancy in India: the RAPIDIRON Trial","status":"COMPLETED","sponsor":"Thomas Jefferson University","startDate":"2021-03-15","conditions":"Iron Deficiency Anemia, Infant, Low Birth Weight, Anemia of Pregnancy","enrollment":4368},{"nctId":"NCT06248749","phase":"PHASE3","title":"Effect of Intravenously Iron Infusion on the Prevention and Treatment of Anemia in Ovarian Cancer","status":"NOT_YET_RECRUITING","sponsor":"University of Saskatchewan","startDate":"2024-02-29","conditions":"Anaemia in Ovarian Carcinoma","enrollment":200},{"nctId":"NCT05504863","phase":"","title":"RAPIDIRON Trial Follow-up Study: RAPIDIRON-KIDS Study","status":"UNKNOWN","sponsor":"Thomas Jefferson University","startDate":"2022-10-11","conditions":"Iron Deficiency Anemia, Neurodevelopmental Abnormality, Autism Spectrum 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":"NCT04318405","phase":"","title":"Real Life Study on Iron Isomaltoside 1000 in the Treatment of ID in CKD, Heart Failure, ObGyn, IBD, Cancer and Elective Surgery (Real-CHOICE).","status":"COMPLETED","sponsor":"Pierre Fabre Pharma AG","startDate":"2020-07-10","conditions":"Iron-Deficiency Anemia, Iron-Deficiency","enrollment":327},{"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":"NCT05913414","phase":"PHASE2","title":"Iron Isomaltide for Iron-deficiency Anemia Patients With Locally Advanced Nasopharyngeal Carcinoma","status":"RECRUITING","sponsor":"Sun Yat-sen University","startDate":"2023-05-05","conditions":"Nasopharyngeal Carcinoma, Iron-deficiency, Anemia","enrollment":120},{"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":"NCT02972294","phase":"PHASE3","title":"HiFIT Study : Hip Fracture: Iron and Tranexamic Acid","status":"TERMINATED","sponsor":"University Hospital, Angers","startDate":"2017-03-31","conditions":"Hip Fractures Pathologic, Anemia","enrollment":419},{"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":"NCT03957057","phase":"PHASE3","title":"Intravenous Iron Carboxymaltose, Isomaltoside and Oral Iron Sulphate for Postpartum Anemia","status":"COMPLETED","sponsor":"University Medical Centre Ljubljana","startDate":"2020-09-10","conditions":"Postpartum Anemia Nos, Iron-deficiency","enrollment":300},{"nctId":"NCT05299411","phase":"PHASE2","title":"Intravenous Iron Infusion on Chemotherapy-induced Anemia","status":"UNKNOWN","sponsor":"Korea University Guro Hospital","startDate":"2023-04-20","conditions":"Colon Cancer, Chemotherapeutic-Induced Anemia","enrollment":80},{"nctId":"NCT05220800","phase":"PHASE2","title":"Effects of Intravenous Administered Iron in Non-anemic Iron Deficient Patients With Colorectal Cancer","status":"NOT_YET_RECRUITING","sponsor":"Zealand University Hospital","startDate":"2022-03-01","conditions":"Iron-deficiency, Colorectal Cancer","enrollment":134},{"nctId":"NCT05221957","phase":"NA","title":"Effects of Preoperative Correction of Anemia With Intravenously Iron in Colorectal Cancer Patients.","status":"UNKNOWN","sponsor":"Zealand University Hospital","startDate":"2022-03-01","conditions":"Colorectal Cancer, Anemia, Iron-deficiency","enrollment":200},{"nctId":"NCT04206228","phase":"PHASE2","title":"Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis","status":"UNKNOWN","sponsor":"Oslo University Hospital","startDate":"2020-01-02","conditions":"Severe Aortic Stenosis, Iron-deficiency","enrollment":149},{"nctId":"NCT03610230","phase":"NA","title":"Iron Isomaltoside Compared With Iron Sucrosein Peritoneal Dialysis Patients","status":"TERMINATED","sponsor":"The University of Hong Kong","startDate":"2019-02-01","conditions":"Iron Deficiency Anemia Treatment","enrollment":16},{"nctId":"NCT03662789","phase":"PHASE2, PHASE3","title":"Intravenous Iron Supplement for Iron Deficiency in Cardiac Transplant Recipients","status":"COMPLETED","sponsor":"Oslo University Hospital","startDate":"2018-04-25","conditions":"Heart Transplant Recipients","enrollment":102},{"nctId":"NCT03466983","phase":"PHASE4","title":"A Trial Comparing the Incidence of Hypophosphatemia in Relation to Treatment With Iron Isomaltoside and Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia Due to Inflammatory Bowel Disease","status":"COMPLETED","sponsor":"Pharmacosmos A/S","startDate":"2018-05-23","conditions":"IBD","enrollment":97},{"nctId":"NCT02905539","phase":"PHASE4","title":"A Study Comparing the Iron Substitution With the Medicinal Products Ferinject or Monofer","status":"COMPLETED","sponsor":"Universität des Saarlandes","startDate":"2016-07","conditions":"Anemia, Iron-Deficiency","enrollment":26},{"nctId":"NCT03188445","phase":"PHASE4","title":"Intravenous Iron Isomaltoside Versus Oral Iron Supplementation for Treatment of Iron Deficiency in Pregnancy.","status":"COMPLETED","sponsor":"Pharmacosmos A/S","startDate":"2017-07-11","conditions":"Iron Deficiency Anemia of Pregnancy","enrollment":201},{"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":"NCT02862665","phase":"NA","title":"Effect of Perioperative Iron Isomaltoside 1000 Administration on Transfusion Requirements in Patients Undergoing Complex Valvular Heart Surgery: a Randomized Clinical Trial","status":"COMPLETED","sponsor":"Yonsei University","startDate":"2016-08","conditions":"Complex Valvular Heart Surgery","enrollment":214},{"nctId":"NCT04505514","phase":"PHASE4","title":"Single Dose Intravenous Iron Isomaltoside in Combination With Oral Iron vs Oral Iron Monotherapy in Patients With Anemia After Postpartum Haemorrhage","status":"UNKNOWN","sponsor":"University of Malaya","startDate":"2020-08-01","conditions":"Post Partum Hemorrhage, Anemia","enrollment":60},{"nctId":"NCT03565354","phase":"PHASE3","title":"Efficacy of Preoperative Intravenous Iron in Anaemic Colorectal Cancer Surgical Patients","status":"COMPLETED","sponsor":"Prince of Wales Hospital, Shatin, Hong Kong","startDate":"2018-07-01","conditions":"Anemia, Iron-Deficiency, Colorectal Cancer","enrollment":40},{"nctId":"NCT04346004","phase":"PHASE4","title":"Effect of Preoperative Iron Isomaltoside 1000 Administration on Hemoglobin Concentration in Patients Undergoing Transcatheter Aortic Valve Implantation","status":"UNKNOWN","sponsor":"Yonsei University","startDate":"2020-04-27","conditions":"Aortic Stenosis (Treated With TAVI)","enrollment":214},{"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 Deficiency Anaemia","enrollment":103},{"nctId":"NCT03237065","phase":"PHASE3","title":"Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose or Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia","status":"COMPLETED","sponsor":"Pharmacosmos A/S","startDate":"2017-10-30","conditions":"Iron Deficiency Anaemia, Iron Deficiency Anemia","enrollment":122},{"nctId":"NCT03238911","phase":"PHASE3","title":"Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose vs Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia","status":"COMPLETED","sponsor":"Pharmacosmos A/S","startDate":"2017-10-24","conditions":"Iron Deficiency Anaemia, Iron Deficiency Anemia","enrollment":123},{"nctId":"NCT04061655","phase":"EARLY_PHASE1","title":"Effect of Intravenous Iron Supplementation in Reducing Allogenic Blood Transfusion","status":"COMPLETED","sponsor":"Ain Shams University","startDate":"2019-09-20","conditions":"Complications","enrollment":80},{"nctId":"NCT03888768","phase":"NA","title":"ProPBM : A Modified Patient Blood Management Protocol","status":"UNKNOWN","sponsor":"Ministry of Health, Malaysia","startDate":"2019-08-01","conditions":"Iron-deficiency","enrollment":180},{"nctId":"NCT02546154","phase":"","title":"Time to Relapse of Iron Deficiency Anaemia After Standard Treatment With The Intravenous Iron (Monofer®)","status":"COMPLETED","sponsor":"Pharmacosmos UK Ltd","startDate":"2016-01-22","conditions":"Iron Deficiency Anaemia","enrollment":359},{"nctId":"NCT03470649","phase":"NA","title":"Effect of IV Iron Isomaltoside on Postoperative Anemia in Total Knee Arthroplasty Patients","status":"COMPLETED","sponsor":"Seoul National University Hospital","startDate":"2018-03-29","conditions":"Anemia, Knee Arthropathy","enrollment":100},{"nctId":"NCT03094182","phase":"NA","title":"Efficacy of Intravenous Iron Therapy in Maintaining Hemoglobin Concentration on Patients Undergoing Bimaxillary Orthognathic Surgery","status":"UNKNOWN","sponsor":"Yonsei University","startDate":"2017-03-02","conditions":"Facial Asymmetry, Retrognathism, Prognathism","enrollment":58},{"nctId":"NCT03229954","phase":"PHASE4","title":"Intravenous Iron Isomaltoside 1000 (Monofer®) Compared With Oral Iron in the Treatment of Postgastrectomy Anemia: An Open-label Randomized Controlled Trial","status":"UNKNOWN","sponsor":"Yonsei University","startDate":"2017-08-28","conditions":"Post Gastrectomy Anemia","enrollment":358},{"nctId":"NCT02130063","phase":"PHASE3","title":"IDA-01 A Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose","status":"COMPLETED","sponsor":"Pharmacosmos A/S","startDate":"2014-05","conditions":"Iron Deficiency Anaemia","enrollment":511},{"nctId":"NCT01895231","phase":"PHASE3","title":"A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions to Iron-deficient Blood Donors","status":"COMPLETED","sponsor":"Pharmacosmos A/S","startDate":"2013-06","conditions":"Iron-deficiency","enrollment":107},{"nctId":"NCT03013439","phase":"PHASE1","title":"Dose-escalation Trial of the Safety, Pharmacokinetics, and Pharmacodynamics of Iron Isomaltoside (Monofer®)","status":"COMPLETED","sponsor":"Pharmacosmos A/S","startDate":"2017-01-06","conditions":"Anemia, Deficiency Diseases, Anemia, Iron Deficiency","enrollment":24},{"nctId":"NCT02301026","phase":"","title":"A Non-interventional Study of Diafer in Subjects With CKD on Haemodialysis for Treatment of Iron Deficiency","status":"COMPLETED","sponsor":"Pharmacosmos A/S","startDate":"2014-09-01","conditions":"Anaemia in Chronic Kidney Disease","enrollment":209},{"nctId":"NCT02999217","phase":"PHASE4","title":"Intravenous Iron for Correction of Anaemia After Colorectal Surgery","status":"UNKNOWN","sponsor":"Kaunas University of Medicine","startDate":"2016-10","conditions":"Anemia, Iron-Deficiency, Intravenous Drug Usage, Colorectal Neoplasms","enrollment":100},{"nctId":"NCT01927328","phase":"PHASE4","title":"Iron Replacement in Oesophagogastric Neoplasia","status":"UNKNOWN","sponsor":"Nottingham University Hospitals NHS Trust","startDate":"2013-08","conditions":"Anemia, Esophageal Cancer, Gastric Cancer","enrollment":40},{"nctId":"NCT02172001","phase":"PHASE3","title":"A Randomized, Double-blind, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Against Placebo","status":"WITHDRAWN","sponsor":"Pharmacosmos A/S","startDate":"","conditions":"Iron Deficiency Anemia","enrollment":""},{"nctId":"NCT01628770","phase":"NA","title":"Use of Iron Isomaltoside 1000 (Monofer) in Postpartum Anemia","status":"COMPLETED","sponsor":"Dow University of Health Sciences","startDate":"2012-05","conditions":"Postpartum Anemia","enrollment":271},{"nctId":"NCT01900197","phase":"","title":"Time to Relapse of Iron Deficiency Anemia After Standard Treatment With a New Intravenous Iron (Monofer®)","status":"COMPLETED","sponsor":"Pharmacosmos A/S","startDate":"2013-08","conditions":"Iron Deficiency Anemia","enrollment":391},{"nctId":"NCT01102413","phase":"PHASE3","title":"Iron Isomaltoside 1000 (Monofer®) in Non-Dialysis Dependent Chronic Kidney Disease and With Renal-Related Anaemia","status":"COMPLETED","sponsor":"Pharmacosmos A/S","startDate":"2010-04","conditions":"Iron Deficiency Anemia, Chronic Kidney Disease","enrollment":351},{"nctId":"NCT01145638","phase":"PHASE3","title":"A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)","status":"COMPLETED","sponsor":"Pharmacosmos A/S","startDate":"2010-10","conditions":"Non-myeloid Malignancies, Chemotherapy Induced Anaemia","enrollment":350},{"nctId":"NCT01222884","phase":"PHASE3","title":"A Randomized, Comparative, Open-label Study of IV Monofer® Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison With IV Iron Sucrose in Subjects With CKD-5D","status":"COMPLETED","sponsor":"Pharmacosmos A/S","startDate":"2011-06","conditions":"Chronic Kidney Disease Stage 5 (Dialysis Dependent)","enrollment":351},{"nctId":"NCT01895205","phase":"PHASE3","title":"Treatment of Women After Severe Postpartum Haemorrhage","status":"COMPLETED","sponsor":"Pharmacosmos A/S","startDate":"2013-06","conditions":"Severe Postpartum Haemorrhage","enrollment":13},{"nctId":"NCT02484768","phase":"PHASE2","title":"IV Iron Treatment of Restless Legs Syndrome","status":"WITHDRAWN","sponsor":"Pharmacosmos A/S","startDate":"2015-01","conditions":"Restless Legs Syndrome","enrollment":""},{"nctId":"NCT01599702","phase":"PHASE3","title":"Iron Isomaltoside 1000 (Monofer®) Administered by a High Dosing Regimen in Subjects With Inflammatory Bowel Disease","status":"COMPLETED","sponsor":"Pharmacosmos A/S","startDate":"2012-05","conditions":"Inflammatory Bowel Disease","enrollment":21},{"nctId":"NCT01895218","phase":"PHASE3","title":"Treatment of Women After Postpartum Haemorrhage","status":"COMPLETED","sponsor":"Pharmacosmos A/S","startDate":"2013-06","conditions":"Postpartum Haemorrhage","enrollment":200},{"nctId":"NCT02385383","phase":"","title":"An Intravenous Iron Based Protocol for Preoperative Anaemia in Hip and Knee Surgery - An Observational Study","status":"UNKNOWN","sponsor":"Rigshospitalet, Denmark","startDate":"2014-10","conditions":"Anemia, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee","enrollment":300},{"nctId":"NCT01563367","phase":"PHASE3","title":"A Prospective, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions to Non-Anaemic Patients Undergoing Elective or Sub-Acute Coronary Artery Bypass Graft, Valve Replacement or a Combination Thereof","status":"COMPLETED","sponsor":"Pharmacosmos A/S","startDate":"2012-01","conditions":"Non-anaemic Patients Undergoing Cardiac Surgery","enrollment":74},{"nctId":"NCT01410435","phase":"PHASE3","title":"Safety and Efficacy Extension Study of Iron Isomaltoside 1000 (Monofer®) in Subjects With Inflammatory Bowel Disease","status":"COMPLETED","sponsor":"Pharmacosmos A/S","startDate":"2011-06","conditions":"Inflammatory Bowel Disease, Anaemia","enrollment":39},{"nctId":"NCT01213680","phase":"PHASE1","title":"Open-label PK Study of Iron Isomaltoside 1000 (Monofer) Administered by 500 mg IV Injection or 1000 mg IV Infusion to Patients With Inflammatory Bowel Disease","status":"COMPLETED","sponsor":"Pharmacosmos A/S","startDate":"2012-02","conditions":"Inflammatory Bowel Disease","enrollment":16},{"nctId":"NCT01213992","phase":"PHASE1","title":"Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered by 500 mg IV Bolus Injection or 1000 mg Intravenous to Patients With CKD","status":"COMPLETED","sponsor":"Pharmacosmos A/S","startDate":"2012-03","conditions":"Non-dialysis Dependent Chronic Kidney Disease","enrollment":16},{"nctId":"NCT01213979","phase":"PHASE1","title":"Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered by 500 mg IV Bolus Injection or 1000 mg Intravenous Infusion to Patients With Non-hematological Malignancies Associated With Chemotherapy Induced Anaemia (CIA)","status":"COMPLETED","sponsor":"Pharmacosmos A/S","startDate":"2012-02","conditions":"Non-hematological Malignancies","enrollment":16},{"nctId":"NCT01280240","phase":"PHASE1","title":"Pharmacokinetic Study of Iron Isomaltoside 1000 Administered by 250 mg IV Bolus Injection or 500 mg Intravenous Infusion to Patients With Non-hematological Malignancies Associated With Chemotherapy Induced Anaemia","status":"COMPLETED","sponsor":"Pharmacosmos A/S","startDate":"2012-03","conditions":"Patients With Chemotherapy Induced Anemia (CIA)","enrollment":11},{"nctId":"NCT01469078","phase":"PHASE1","title":"Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered as Single Bolus Injections in Subjects With Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D)","status":"COMPLETED","sponsor":"Pharmacosmos A/S","startDate":"2011-10","conditions":"Chronic Kidney Disease","enrollment":18}],"_emaApprovals":[],"_faersSignals":[{"count":36,"reaction":"DYSPNOEA"},{"count":25,"reaction":"MATERNAL EXPOSURE DURING PREGNANCY"},{"count":23,"reaction":"BRADYCARDIA"},{"count":20,"reaction":"HYPOTENSION"},{"count":20,"reaction":"NAUSEA"},{"count":14,"reaction":"CHEST DISCOMFORT"},{"count":14,"reaction":"DIZZINESS"},{"count":13,"reaction":"CHEST PAIN"},{"count":13,"reaction":"OFF LABEL USE"},{"count":13,"reaction":"PYREXIA"}],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Ferric derisomaltose","Monofer","Intravenous iron isomaltoside"],"phase":"marketed","status":"active","brandName":"Iron isomaltoside","genericName":"Iron isomaltoside","companyName":"Thomas Jefferson University","companyId":"thomas-jefferson-university","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Iron isomaltoside is an iron replacement therapy that delivers ferric iron complexed with isomaltoside, allowing efficient absorption and utilization for hemoglobin synthesis in iron-deficient patients. Used for Iron deficiency anemia in patients with chronic kidney disease, Iron deficiency anemia in patients intolerant to or non-responsive to oral iron.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}