Monofer (iron isomaltoside 1000) / Pharmacosmos - LARVOL DELTA

The Effects of Ferric Derisomaltose on Postoperative Anemia in Spinal Deformity Surgery (clinicaltrials.gov) - P4 | N=120 | Recruiting | Sponsor: Peking Union Medical College Hospital | Trial completion date: Jun 2025 ➔ Dec 2025 | Trial primary completion date: Jun 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • Anemia • Hematological Disorders • Movement Disorders

Effectiveness and safety of intravenous iron in ulcerative colitis: A real-world study of impact of disease activity and iron preparations. (PubMed, Indian J Gastroenterol) - "Although there was a tendency towards better response to intravenous iron in those with remission, the findings were not statistically different. Larger studies are needed to provide conclusive evidence. Iron isomaltoside may be preferable over FCM due to risk of hypophosphatemia with the latter."

Journal • Real-world evidence • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Renal Disease • Ulcerative Colitis • Venous Ulcer

IVIDA2: Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy (clinicaltrials.gov) - P3 | N=300 | Recruiting | Sponsor: Women and Infants Hospital of Rhode Island | N=746 ➔ 300

Enrollment change • Anemia • Hematological Disorders

The protective effect of iron isomaltoside on myocardial ischemia-reperfusion injury via the suppression of KLF4/NF-κB signaling. (PubMed, PLoS One) - "Interestingly, the function of IIM on apoptosis, MMP, inflammation and autophagy were abolished by KLF4 overexpression in H/R-induced H9C2 cells. In conclusion, IIM could repress cardiomyocyte apoptosis, inflammation and autophagy through the inhibition of the KLF4/NF-κB pathway and thus reduced myocardial injury in vivo and in vitro."

Journal • Cardiovascular • Inflammation • Myocardial Infarction • Myocardial Ischemia • Reperfusion Injury • KLF4

Ferric Derisomaltose (Iron Isomaltoside) Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy (clinicaltrials.gov) - P3 | N=280 | Recruiting | Sponsor: Saskatchewan Health Authority - Regina Area | Trial completion date: Feb 2025 ➔ Feb 2027 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Anemia • Hematological Disorders

Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery) (clinicaltrials.gov) - P3 | N=82 | Recruiting | Sponsor: AHS Cancer Control Alberta | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Sep 2025 ➔ Dec 2026

Enrollment open • Trial completion date • Trial primary completion date • Anemia • Gynecologic Cancers • Hematological Disorders • Oncology

Neuroimaging Ancillary Study (clinicaltrials.gov) - P=N/A | N=184 | Completed | Sponsor: Thomas Jefferson University | Active, not recruiting ➔ Completed

Trial completion • Anemia • CNS Disorders • Developmental Disorders • Hematological Disorders • Psychiatry

Comparing High and Low Dose Iron Treatments for People on Peritoneal Dialysis: The PALaDIN Study (clinicaltrials.gov) - P3 | N=30 | Not yet recruiting | Sponsor: Hull University Teaching Hospitals NHS Trust

New P3 trial • Anemia • Hematological Disorders

Multi-center Trial of Ferric Derisomaltose in Children 0 to <18 Years of Age with Iron Deficiency Anemia (clinicaltrials.gov) - P3 | N=200 | Recruiting | Sponsor: Pharmacosmos A/S | Trial completion date: Jun 2025 ➔ Apr 2026 | Trial primary completion date: Apr 2025 ➔ Apr 2026

Trial completion date • Trial primary completion date • Anemia • Chronic Kidney Disease • Hematological Disorders

Iron Isomaltoside for the Treatment of Anemia in Peritoneal Dialysis Patients (clinicaltrials.gov) - P4 | N=124 | Not yet recruiting | Sponsor: Xie Jingyuan, MD

New P4 trial • Anemia • Hematological Disorders

Anemia in inflammatory bowel disease-A comprehensive review. (PubMed, Indian J Gastroenterol) - "Other causes include vitamin B12 and folate deficiency, hemolytic anemia and medications such as azathioprine and sulfasalazine...However, a significant proportion of IBD patients with anemia go undetected or untreated and there is a need for improved recognition and better management practices. This review discusses various aspects of anemia in IBD and the current approach to diagnosis and management."

Journal • Review • Anemia • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammation • Inflammatory Bowel Disease

POAM: Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: University Health Network, Toronto | Not yet recruiting ➔ Recruiting | Trial completion date: Jun 2026 ➔ Jun 2027 | Initiation date: Sep 2024 ➔ Feb 2025 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Anemia • Cardiovascular • Hematological Disorders

COMPARATIVE STUDY ON SAFETY AND EFFICACY OF IRON ISOMALTOSIDE VERSUS IRON SUCROSE IN PATIENTS OF ANEMIA IN CHRONIC KIDNEY DISEASE STAGE 3-5 ND (ISN-WCN 2025) - "IIM group showed a significant rise in TSAT over IS group at week 4 and week8 , but showed non inferiority at week 2.In terms of rise in ferritin IIM group showed superiorty over IS group at week 4 and week 8. Conclusions A single dose of IIM showed a better 8-week haematological response (in terms of Hb ,TSAT and serum ferritin ) as compared to multiple doses of IS and also showed low rates of hypersensitivity reactions."

Clinical • Anemia • Chronic Kidney Disease • Hematological Disorders • Immunology • Nephrology • Renal Disease

IV Iron Trial for Anemia Related to Uterine Bleeding in Female Patients Presenting to the Emergency Department (clinicaltrials.gov) - P3 | N=40 | Recruiting | Sponsor: Baylor College of Medicine | Trial completion date: Oct 2024 ➔ Apr 2025 | Trial primary completion date: Oct 2024 ➔ Mar 2025

Trial completion date • Trial primary completion date • Anemia • Hematological Disorders

Effect of preoperative combination of low-dose dexamethasone with iron isomaltoside on prognosis of elderly intertrochanteric hip fractures ---- Single-center, randomized, single-blind, blank controlled clinical trial (ChiCTR) - P=N/A | N=160 | Not yet recruiting | Sponsor: Guabgzhou First People‘s Hospital; Guabgzhou First People‘s Hospital

New trial • Musculoskeletal Diseases • Orthopedics

Multi-center Trial of Ferric Derisomaltose in Children 0 to <18 Years of Age with Iron Deficiency Anemia (clinicaltrials.gov) - P3 | N=200 | Recruiting | Sponsor: Pharmacosmos A/S | Trial completion date: Jun 2024 ➔ Jun 2025 | Trial primary completion date: Apr 2024 ➔ Apr 2025

Trial completion date • Trial primary completion date • Anemia • Chronic Kidney Disease • Hematological Disorders

A phase III, prospective, open-label, multi-center trial of ferric derisomaltose in children 0 to <18 years of age with iron deficiency anemia due to non-dialysis dependent chronic kidney disease or with iron deficiency anemia who are intolerant or unresponsive to oral iron. (clinicaltrialsregister.eu) - P3 | N=200 | Sponsor: Pharmacosmos A/S

New P3 trial • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Monoferric for Prenatal Iron Deficiency (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Oregon Health and Science University | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Disorders • Obstetrics

ITACS: Intravenous Iron for Treatment of Anaemia Before Cardiac Surgery (clinicaltrials.gov) - P4 | N=1000 | Completed | Sponsor: Bayside Health | Recruiting ➔ Completed | Trial completion date: Jun 2024 ➔ Sep 2024 | Trial primary completion date: Dec 2023 ➔ Apr 2024

Surgery • Trial completion • Trial completion date • Trial primary completion date • Anemia • Cardiovascular • Hematological Disorders

IVORY: IV Iron-induced Hypophosphatemia After RYGB (clinicaltrials.gov) - P4 | N=94 | Recruiting | Sponsor: Lucie Favre | Not yet recruiting ➔ Recruiting

Bariatric surgery • Enrollment open • Renal Disease

Fetal bradycardia and acidosis during maternal parenteral iron: Case reports and literature review. (PubMed, Int J Gynaecol Obstet) - "We report two cases of fetal bradycardia after iron isomaltoside (IIM), in women with otherwise good maternal and fetal health...While rarely reported so far, fetal bradycardia is a possible consequence, commonly preceded by respiratory symptoms. Fetal monitoring should therefore be considered during infusion."

Journal • Review • Cardiovascular • Crohn's disease • Gastroenterology • Hematological Disorders • Immunology • Inflammatory Bowel Disease • Metabolic Disorders • Pulmonary Disease

Dissimilar ferric derisomaltose formulations - In vitro comparisons between an originator and its intended similars. (PubMed, Eur J Pharm Biopharm) - "Simple in vitro tests demonstrated that, aside from total iron content, the first intended similars of FDI bear little resemblance to their originator drug. It is clear that the efficacy and safety profile of Monofer® cannot be extrapolated to the two intended similars. The results call for increased regulatory scrutiny of intended IV iron similars."

Journal • Preclinical • Hematological Disorders

POAM: Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: University Health Network, Toronto | Trial completion date: Jun 2025 ➔ Jun 2026 | Initiation date: Apr 2024 ➔ Sep 2024 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Surgery • Trial completion date • Trial initiation date • Trial primary completion date • Anemia • Cardiovascular • Hematological Disorders

PEDIATRIC INTRAVENOUS IRON THERAPY: EVALUATING SAFETY AND EFFICACY OF IRON ISOMALTOSIDE (EHA 2024) - "Safety and efficacy in the diversity of the pediatric population support IIS use in this age group for thetreatment of ID and IDA. In moderate-to-severe anemia, IV iron can reduce the need for red blood celltransfusion. Further research with larger cohorts is needed to confirm these results and evaluate long-termsafety and efficacy."

Clinical • Anemia • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Pediatrics

THE INFLUENCE OF INFLAMMATORY CYTOKINES AND HEPSIDIN ON THE DEVELOPMENT OF ANEMIA AND THE EFFECTIVENESS OF ANEMIA CORRECTION WITHOUT RED BLOOD TRANSFUSIONS IN GASTRIC CANCER AFTER NEOADJUVANT THERAPY (EHA 2024) - "Anemiacorrection was performed with epoetin alfa (Eralfon) 150 IU/kg subcutaneously 3 times a week (4 weeks) andintravenous iron III valent oligoisomaltosate (Monofer) 1000 mg once. Anemia in gastric cancer patients who received neoadjuvant therapy is not due to hepcidin hyperproduction,but to the negative effect of chemotherapy on erythropoiesis and iron deficiency, which made it possible toachieve a positive effect of erythropoietin and intravenous iron therapy in 91. 3% of patients."

Clinical • Anemia • CNS Disorders • Depression • Gastric Cancer • Gastrointestinal Cancer • Hematological Disorders • Oncology • Psychiatry • Solid Tumor • IL10 • IL1B • IL6 • TNFA