Injectafer (ferric carboxymaltose) / Zeria Pharma, Daiichi Sankyo, CSL Behring - LARVOL DELTA

HI-COR-65: Effect of Intravenous Iron on Quality of Life in Older Patients With Acute Coronary Syndrome (clinicaltrials.gov) - P4 | N=538 | Recruiting | Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia

HEOR • New P4 trial • Acute Coronary Syndrome • Cardiovascular • Hematological Disorders

Hypophosphataemia with IV iron therapy in a paediatric renal population (UKKW 2026) - "Introduction Hypophosphataemia is a well-recognised adverse effect in adult patients following the administration of intravenous ferric carboxymaltose (Ferinject)...There was high variability in post-dose monitoring. Local guidelines were updated to include a standard monitoring frequency recommendation and disseminated."

Clinical • Chronic Kidney Disease • Hematological Disorders • Musculoskeletal Diseases • Nephrology • Orthopedics • Pediatrics • Renal Disease

HI-COR-65: Effect of intravenous iron on quality of life in older adults with acute coronary syndrome: a phase IV clinical study (clinicaltrialsregister.eu) - P4 | N=538 | Recruiting | Sponsor: Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA | Not yet recruiting ➔ Recruiting

Enrollment open • HEOR • Acute Coronary Syndrome • Cardiovascular

HI-COR-65: Effect of intravenous iron on quality of life in older adults with acute coronary syndrome: a phase IV clinical study (clinicaltrialsregister.eu) - P4 | N=538 | Not yet recruiting | Sponsor: Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA

HEOR • New P4 trial • Acute Coronary Syndrome • Cardiovascular

Stability Assessment of Intravenous Iron-Carbohydrate Complexes in Commercial All-in-One Parenteral Nutrition: Potential for Therapeutic Iron Dose Admixing. (PubMed, Pharmaceutics) - " Ferric carboxymaltose demonstrated stable intravenous iron admixtures within the PN formulations tested. Before the clinical application of these findings, further studies should specifically evaluate the lipid peroxidation and stability of the lipid emulsions, the most sensitive and important PN compatibility and safety characteristics of AIO PN."

Journal • Hematological Disorders

ED-Heme FCM: The Role of Ferric Carboxymaltose in the Treatment of Pediatric Iron Deficiency Anemia in the Emergency Department (clinicaltrials.gov) - P4 | N=150 | Not yet recruiting | Sponsor: Children's Hospital of Orange County

New P4 trial • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Pediatrics • Renal Disease

Fetal Safety of Intravenous Ferric Carboxymaltose in Pregnancy: A Cardiotocography Study from a Tertiary Care Hospital in Italy. (PubMed, Hematol Rep) - "Ferric carboxymaltose (FCM; Ferinject®) is an IV iron preparation that allows rapid administration of high single doses of iron with a favorable safety profile...Concerning fetal safety, 100% of the cardiotocography records were deemed "normal" using the Dawes-Redman criteria. In conclusion, FCM proved effective in treating anemia in this clinically complex population of pregnant women in the third trimester and appeared safe in this cohort, though larger prospective studies are warranted."

Journal • Dermatology • Hematological Disorders

IDA-II: Postoperative i.v. Iron Substitution in Patients With Diagnosed Iron Deficiency (clinicaltrials.gov) - P3 | N=187 | Completed | Sponsor: Prof. Dr. Frank Behrens | Recruiting ➔ Completed | N=407 ➔ 187

Enrollment change • Trial completion • Anemia • Hematological Disorders

Prolonged and Refractory Hypophosphataemia Following Intravenous Ferric Carboxymaltose Administration Delaying Hospital Discharge: A Case Report. (PubMed, Cureus) - "Hypophosphataemia is an under-recognised complication of intravenous ferric carboxymaltose (Ferinject)...This required repeated intravenous phosphate replacement and delayed hospital discharge by eight days, despite the patient being otherwise medically fit. The case underscores that ferric carboxymaltose can cause clinically important hypophosphataemia, even in younger patients, and that routine monitoring should be considered."

Journal • Hematological Disorders • Renal Disease

A Randomized, Open-Label, Single-Dose, Parallel-Group Bioequivalence Study of Ferric Carboxymaltose Injection Under Fasting Conditions in Chinese Adult Subjects With Iron Deficiency Anemia. (PubMed, Pharmacol Res Perspect) - "Ltd.) and reference (R) preparation (Ferinject, Vifor France) after intravenous injection in Chinese adult subjects with iron deficiency anemia (IDA) under fasting conditions...There were no significant differences in the safety profile between the two groups. This study confirmed the bioequivalence of the T and R preparations under fasting conditions, along with good safety."

Clinical • Journal • Anemia • Hematological Disorders

IRONEASE: Efficacy of Ferric Carboxymaltose Versus Iron Sucrose in Non-dialysis Dependent Chronic Kidney Disease Patients (clinicaltrials.gov) - P=N/A | N=128 | Recruiting | Sponsor: Sindh Institute of Urology and Transplantation | Not yet recruiting ➔ Recruiting

Enrollment open • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

The use of parenteral application of ferric carboxymaltose in the prevention of iron deficiency anaemia in suckling piglets. (PubMed, Vet Med (Praha)) - "In group A (n = 8), piglets were administered iron in the form of iron carboxymaltose complex (Ferinject®) at a dose of 200 mg i.m. (neck muscle) at the age of 3 days. The results of haematological and biochemical examinations achieved in our study show that the application of iron carboxymaltase was successful in preventing iron deficiency anaemia in piglets. The results indicate comparable efficacy of iron carboxymaltase and iron dextran."

Journal • Anemia • Hematological Disorders

INFERRCT: Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion (clinicaltrials.gov) - P4 | N=1000 | Recruiting | Sponsor: Wroclaw Medical University | N=2000 ➔ 1000 | Trial completion date: Jun 2026 ➔ Dec 2026 | Trial primary completion date: Jun 2026 ➔ Dec 2026

Enrollment change • HEOR • Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure • Myocardial Infarction

Auditing a switch from ferinject to ferric derisomaltose for intravenous iron in patients with GI bleed or symptomatic IDA (BSG 2025) - "There were no adverse events reported in our cohort.Conclusions Ferric derisomaltose switch results indicate higher first doses of IV iron with lower need for 2nd dose prescriptions, significantly reducing the burden on day case units to arrange out-patient follow up infusions. However, further work is still needed to improve protocol adherence locally for those that require a single infusion but also for those that need a 2nd dose arranging at follow up."

Clinical • Anemia • Gastroenterology • Hematological Disorders

Hypophosphatemia Following Intravenous Iron in Chronic Kidney Disease (ERA 2025) - "Among available formulations, ferric carboxymaltose (FC) has been shown to induce a more profound and sustained decrease in serum phosphate compared to other formulations such as ferric derisomaltose and iron sucrose...The available intravenous iron formulations were Ferinject 50 mg/mL (FC) and Venofer 20 mg/mL (IS)...This effect is more pronounced until stage 3 and with higher cumulative iron doses, independently of baseline vitamin D and calcium levels. Given its potential clinical implications, routine phosphate monitoring should be considered, especially in patients receiving prolonged or high-dose IVIT."

Anemia • Chronic Kidney Disease • Hematological Disorders • Musculoskeletal Pain • Nephrology • Pain • Renal Disease • FGF23

Efficacy of Ferric Carboxymaltose Versus Iron Sucrose in Non-dialysis Dependent Chronic Kidney Disease Patients (clinicaltrials.gov) - P=N/A | N=128 | Not yet recruiting | Sponsor: Sindh Institute of Urology and Transplantation

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

Evaluate the Utility of Serum Hepcidin Levels to Predict Response to Oral or IV Iron (clinicaltrials.gov) - P4 | N=1025 | Completed | Sponsor: American Regent, Inc. | Unknown status ➔ Completed

HEOR • Trial completion • Anemia • Hematological Disorders

Signal detection of ferric carboxymaltose-induced serious adverse events: disproportionality analysis of FAERS and VigiBase data and systematic review of case reports. (PubMed, Eur J Clin Pharmacol) - "This study reveals that FCM carries SAEs. Providers must weigh the benefits and risks on a case-by-case basis, considering patient-specific factors. Continuous monitoring and further research are crucial for the safe use of FCM in iron deficiency anemia."

Adverse events • Journal • Serious adverse event • Cardiovascular • Dermatology • Hematological Disorders • Hypotension • Immunology • Pain • Renal Disease • Urticaria

Cost-effectiveness Analysis of Ferric Carboxymaltose (Renegy®) for the Treatment of Iron Deficiency Anemia During Pregnancy: The Mexican Social Security Institute (IMSS) Perspective (ISPOR 2025) - "From the IMSS perspective, FCM is a clinically superior and a cost-effective treatment for IDA in pregnant women compared to ISC. Also, FCM offers faster and more significant Hb improvement, better tolerability, and substantial cost savings, solidifying its role as the preferred therapeutic option for managing IDA during pregnancy."

Cost effectiveness • HEOR • Anemia • Hematological Disorders

Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants (clinicaltrials.gov) - P1 | N=84 | Completed | Sponsor: Sichuan Huiyu Pharmaceutical Co., Ltd | Not yet recruiting ➔ Completed

Trial completion

ENHANCING PREOPERATIVE IRON SUPPLEMENTATION IN LIPOABDOMINOPLASTY: A COMPARATIVE STUDY OF FERRIC CARBOXYMALTOSE AND LIPOSOMAL IRON. (PubMed, Plast Reconstr Surg) - "Intravenous ferric carboxymaltose is a superior strategy for preoperative iron optimization in lipoabdominoplasty, ensuring better perioperative stability, faster recovery, and reduced anemia-related complications compared to oral liposomal iron. Integrating this approach into perioperative protocols could enhance surgical outcomes."

Journal • Aesthetic Medicine • Gastrointestinal Disorder • Hematological Disorders

Intravenous Iron Metabolism in Restless Legs Syndrome (clinicaltrials.gov) - P2 | N=12 | Completed | Sponsor: American Regent, Inc. | N=36 ➔ 12

Enrollment change • Movement Disorders • Restless Legs Syndrome • Sleep Disorder

The Effect of Preoperative Ferric Carboxymaltose Administration on Mortality in Geriatric Hip Fractures (clinicaltrials.gov) - P4 | N=209 | Completed | Sponsor: Istanbul University | Recruiting ➔ Completed | Phase classification: PN/A ➔ P4 | Trial primary completion date: Dec 2024 ➔ Jun 2024

Phase classification • Trial completion • Trial primary completion date • Anemia • Hematological Disorders • Musculoskeletal Diseases • Orthopedics

Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants (clinicaltrials.gov) - P1 | N=84 | Not yet recruiting | Sponsor: Sichuan Huiyu Pharmaceutical Co., Ltd

New P1 trial

A cost-effective innovation in anaemia management for paediatric haemodialysis-dependant chronic kidney disease patients (IPNA 2025) - "Following Ferinject® infusion, we observed significant increases in laboratory parameters including haemoglobin level, transferrin saturation and reticulocyte haemoglobin content and levels were maintained at 3-months post-infusion (Figure 1a). Ferinject® demonstrated comparable efficacy to Venofer® in maintaining laboratory parameters (Figure 1b). Strikingly, Ferinject® treatment was associated with significantly decreased number of infusions per month (~ 10-fold) and a significant cost-saving (~ 5-fold) (Figure 1c)."

Clinical • Cost effectiveness • HEOR • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Pediatrics • Renal Disease