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Ferric Carboxymaltose (FCM)
Ferric carboxymaltose delivers iron directly into the bloodstream as a stable iron-carbohydrate complex that is taken up by iron-binding proteins to replenish depleted iron stores.
Ferric carboxymaltose delivers iron directly into the bloodstream as a stable iron-carbohydrate complex that is taken up by iron-binding proteins to replenish depleted iron stores. Used for Iron deficiency anemia in patients with chronic kidney disease (CKD), including those on hemodialysis and non-dialysis dependent patients, Iron deficiency anemia in patients with heart failure, Iron deficiency anemia in non-dialysis dependent CKD patients.
At a glance
| Generic name | Ferric Carboxymaltose (FCM) |
|---|---|
| Also known as | Injectafer, infusion, VIT-45, Ferinject, injectafer |
| Sponsor | American Regent, Inc. |
| Drug class | Intravenous iron replacement agent |
| Target | Iron (Fe³⁺) delivery; transferrin and ferritin binding |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
Mechanism of action
FCM is an intravenous iron replacement therapy consisting of ferric iron stabilized in a carbohydrate shell. Once administered, the iron is released and binds to transferrin and ferritin, allowing rapid replenishment of iron stores and hemoglobin synthesis. This mechanism bypasses gastrointestinal absorption limitations and is effective in patients with iron deficiency anemia who cannot tolerate or absorb oral iron.
Approved indications
- Iron deficiency anemia in patients with chronic kidney disease (CKD), including those on hemodialysis and non-dialysis dependent patients
- Iron deficiency anemia in patients with heart failure
- Iron deficiency anemia in non-dialysis dependent CKD patients
Common side effects
- Hypophosphatemia
- Diarrhea
- Nausea
- Headache
- Injection site reactions
- Hypersensitivity reactions
Key clinical trials
- Effect of Intravenous Iron on Quality of Life in Older Patients With Acute Coronary Syndrome (PHASE4)
- The Role of Ferric Carboxymaltose in the Treatment of Pediatric Iron Deficiency Anemia in the Emergency Department (PHASE4)
- The Impact of IV Iron on Exercise Capacity and Quality of Life in Pulmonary Hypertension (PHASE4)
- Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation (PHASE4)
- An Open Study on the Efficacy of Iron Therapy Using iv Iron Relative to Oral Iron for Increasing LV Systolic Function (NA)
- Ferric Carboxymaltose Methemoglobinemia Study
- Efficacy of Ferric Carboxymaltose Versus Iron Sucrose in Non-dialysis Dependent Chronic Kidney Disease Patients (NA)
- Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ferric Carboxymaltose (FCM) CI brief — competitive landscape report
- Ferric Carboxymaltose (FCM) updates RSS · CI watch RSS
- American Regent, Inc. portfolio CI