Monofer (iron isomaltoside 1000) / Pharmacosmos - LARVOL DELTA

Uniportal NI-VATS right upper lobe cuff resection with intraoperative management of PA bleeding.Video presentation of a challenging operation. (DGT 2026) - "Material and Video presentation of a uniportal upper lobe bronchus cuff resection on the right in spontaneous breathing with minimally invasive treatment of a bleeding from a rupture of the A2 to the centralClamping. In a 64-year-old patient with a central PECA of the right OL, cT3,N1,M0, a uniportal NI-VATS on the right was performed after 4 courses of neoadjuvant ICTx and good response, with good lung function.The tear in the A2 under slight tension was sewn over after central clamping.Blood loss 800ml.This is followed by OL bronchus cuff resection with end-to-end anastomosis and radical LAD.The drop in Hb from an initial 10.1g/dl to 7.7g/dl was substituted with 1000mg of Monofer and led to an increase to 8.9g/dl after 6 days.The bronchoscopy check on POD 6 was unremarkable.Discharge home on POD 6. Intraoperative bleeding in NI-VATS can be treated by central clamping and oversewing, as with the conventional approach.The movement of the mediastinum represents a..."

Video

A Study of Ferric Derisomaltose Injection in Chinese Participants With Iron Deficiency Anemia Under Fasting Conditions (clinicaltrials.gov) - P1 | N=88 | Recruiting | Sponsor: Sichuan Huiyu Pharmaceutical Co., Ltd

New P1 trial • Anemia • Hematological Disorders

IRONMETHFpEF: Impact of Intravenous Iron Repletion On Mechanisms of Exercise InTolerance in HFpEF (IRONMET-HFpEF) (clinicaltrials.gov) - P2/3 | N=65 | Completed | Sponsor: Massachusetts General Hospital | Active, not recruiting ➔ Completed | Phase classification: P4 ➔ P2/3

Phase classification • Trial completion • Cardiovascular • Heart Failure • Hematological Disorders

Preoperative Monoferric for Abdominal Surgery (clinicaltrials.gov) - P4 | N=37 | Completed | Sponsor: Brigham and Women's Hospital | Not yet recruiting ➔ Completed

Trial completion • Anemia • Hematological Disorders

IRONMETHFpEF: Impact of Intravenous Iron Repletion On Mechanisms of Exercise InTolerance in HFpEF (IRONMET-HFpEF) (clinicaltrials.gov) - P4 | N=65 | Active, not recruiting | Sponsor: Massachusetts General Hospital | Completed ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Heart Failure • 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: Apr 2026 ➔ Apr 2027 | Trial primary completion date: Apr 2026 ➔ Apr 2027

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

IRONMETHFpEF: Impact of Intravenous Iron Repletion On Mechanisms of Exercise InTolerance in HFpEF (IRONMET-HFpEF) (clinicaltrials.gov) - P4 | N=65 | Completed | Sponsor: Massachusetts General Hospital | Recruiting ➔ Completed

Trial completion • Cardiovascular • Heart Failure • Hematological Disorders

Perioperative multidose tranexamic acid combined with erythropoietin and iron isomaltoside supplementation reduces transfusion requirements of elderly patients with intertrochanteric fractures. (PubMed, Injury) - "TXA early and continuous antifibrinolytic therapy combined with EPO/IM rapid iron supplementation and erythropoiesis appears to safely and effectively reduce the perioperative blood transfusion rate and the occurrence of anemia in elderly patients with intertrochanteric fractures without increasing complication risk."

Journal • Cardiovascular • Geriatric Disorders • Hematological Disorders • Musculoskeletal Diseases • Orthopedics

Phase III, randomized, single blind, comparative safety, and efficacy trial of intravenous iron isomaltoside (i3R) and ferric carboxy maltose in subjects with iron deficiency anaemia. (PubMed, Med J Armed Forces India) - "The study demonstrates the comparable efficacy of i3R and FCM in improving Hb and serum ferritin levels in IDA patients. Both treatments demonstrated safety and tolerability in a well-designed RCT."

Journal • P3 data • Anemia • Hematological Disorders

Drug Utilization and Safety Profile of Intravenous Iron Isomaltoside 1000 in Cancer Patients With Iron Deficiency Anemia: A Retrospective Study. (PubMed, Cureus) - " IV iron isomaltoside 1000 was associated with significant improvement in hematologic parameters and demonstrated a favorable safety profile in cancer patients with IDA. It can be considered a safe and practical option for rapid iron repletion in cancer management."

Journal • Retrospective data • Anemia • Hematological Disorders • Musculoskeletal Diseases • Musculoskeletal Pain • Oncology • Pain

AGE-ANEMIA: Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients (clinicaltrials.gov) - P4 | N=310 | Recruiting | Sponsor: dr. P. Noordzij | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Sep 2025 ➔ Nov 2026

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

IIISAS: Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis (clinicaltrials.gov) - P2 | N=149 | Completed | Sponsor: Oslo University Hospital | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Congestive Heart Failure • Hematological Disorders

AGE-ANEMIA: Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients (clinicaltrials.gov) - P4 | N=310 | Recruiting | Sponsor: dr. P. Noordzij | Not yet recruiting ➔ Recruiting

Enrollment open • Anemia • Cardiovascular • Hematological Disorders

5 Years activity in a Renal Day Case unit. (UKKW 2026) - "Many infusions are offered on RDC including monofer, rituximab and cyclophosphamide as well as research medications. Further work should be carried out to the cost effectiveness of the service and to look for opportunities to increase patient numbers further to relieve pressures on other assessment areas."

Clinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Individualized Multiplex Pathophysiological Treatment of Severe Acute Infections (IMPACT) (clinicaltrialsregister.eu) - P4 | N=300 | Sponsor: Copenhagen University Hospital

New P4 trial • Infectious Disease

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

Enrollment open • Anemia • Hematological Disorders

Preoperative Iron Isomaltoside administration enhances postoperative anemia recovery in robotic pancreatic surgery. (PubMed, J Robot Surg) - No abstract available

Journal • Anemia • Hematological Disorders

Iatrogenic iron overload caused by iron isomaltoside treatment: A case report. (PubMed, Medicine (Baltimore)) - "This case highlights the risk of iron overload associated with unmonitored IV iron supplementation. Monitoring iron levels is crucial to prevent complications, particularly in high-risk patients. Iatrogenic iron overload can arise from excessive IV iron isomaltoside administration, emphasizing the importance of vigilant monitoring of iron metabolism to prevent adverse outcomes."

Journal • Fatigue • Hematological Disorders • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

PRAYAS: individual patient data meta-analysis database for Pooled Research and Analysis for Yielding Anemia-free Solutions in India. (PubMed, Front Public Health) - "Of the total sample, 10.8% had complete blood count data, 9% ferritin, and 4.5% vitamin B12.Among interventions, pregnant women received intravenous iron sucrose, ferric carboxymaltose, iron isomaltoside, combined IV iron with vitamin B12/folic acid/niacinamide, integrated packages, and low-dose calcium supplementation...Findings will directly inform the Anemia Mukt Bharat program, supporting targeted, evidence-driven interventions to reduce anemia and associated health burdens across children, women, and pregnant populations in India. OSF-https://doi.org/10.17605/OSF.IO/6YRXF."

Journal • Retrospective data • Anemia • Hematological Disorders

Study on Supplement of Intravenous Ferric Derisomaltose to Prevent Anemia and Improve the Quality of Life in Obese Patients With Iron Deficiency. (clinicaltrials.gov) - P=N/A | N=200 | Recruiting | Sponsor: China-Japan Friendship Hospital

HEOR • New trial • Anemia • Genetic Disorders • Hematological Disorders • Obesity

Efficacy and safety of intravenous iron supplementation for perioperative iron deficiency anemia: a systematic review and network meta-analysis of randomized controlled trials. (PubMed, J Clin Anesth) - "FCM improves perioperative Hb concentrations and reduces transfusion requirements. All intravenous iron preparations demonstrated acceptable safety profiles. Further research is needed to validate these findings and refine perioperative iron supplementation strategies."

Journal • Retrospective data • Review • Anemia • Fatigue • Hematological Disorders • Immunology • Pulmonary Disease • Renal Disease

IRONMETHFpEF: Impact of Intravenous Iron Repletion On Mechanisms of Exercise InTolerance in HFpEF (IRONMET-HFpEF) (clinicaltrials.gov) - P4 | N=66 | Recruiting | Sponsor: Massachusetts General Hospital | Trial completion date: May 2025 ➔ May 2026 | Trial primary completion date: Feb 2025 ➔ Feb 2026

Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Disorders

Pediatric Intravenous Iron Therapy: Evaluating the Safety and Efficacy of Iron Isomaltoside and Low-Molecular-Weight Dextran. (PubMed, Pediatr Blood Cancer) - "Our findings suggest that IIM and LMWD are effective and safe IV iron therapies for pediatric ID/IDA. Given the lack of data on the safety and efficacy of IIM in the pediatric population, our findings provide valuable preliminary evidence."

Journal • Hematological Disorders • Pediatrics

Determination of free iron content in pharmaceutical products containing different iron complexes by using polarography method: "Method development and validation study". (PubMed, J Pharm Sci) - "Iron carbohydrate complexes such as iron gluconate, iron sucrose, ferric carboxy-maltose, iron isomaltoside, ferumoxytol, and iron dextrans, which have been used in the treatment of iron deficiency anemia for many years, release excess iron into the circulation and produce free iron, which leads to oxidative stress and tissue damage. The critical steps such as the selection process of parameters and analytical conditions and the accuracy of the obtained results for the polarography-based analytical method optimization of different pharmaceutical forms are examined by utilizing differential pulse polarography (DPP), which has advantages such as high sensitivity, reproducibility, and detection limits in the determination of different valence ions compared to classical methods. Thus, we aim to shed light on validation processes for the direct determination of free iron in various pharmaceutical formulations, expand the existing literature on the subject, and contribute to..."

Journal • Hematological Disorders

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