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Iron isomaltoside
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.
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.
At a glance
| Generic name | Iron isomaltoside |
|---|---|
| Also known as | Ferric derisomaltose, Monofer, Intravenous iron isomaltoside |
| Sponsor | Thomas Jefferson University |
| Drug class | Iron replacement agent |
| Target | Iron (Fe3+) / transferrin receptor |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
Mechanism of action
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.
Approved indications
- Iron deficiency anemia in patients with chronic kidney disease
- Iron deficiency anemia in patients intolerant to or non-responsive to oral iron
Common side effects
- Injection site reactions
- Nausea
- Headache
- Dizziness
- Hypophosphatemia
Key clinical trials
- Comparing High and Low Dose Iron Treatments for People on Peritoneal Dialysis: The PALaDIN Study (PHASE3)
- Intravenous Iron for Treatment of Anaemia Before Cardiac Surgery (PHASE4)
- Study on Supplement of Intravenous Ferric Derisomaltose to Prevent Anemia and Improve the Quality of Life in Obese Patients With Iron Deficiency. (NA)
- Ferric Derisomaltose (Iron Isomaltoside) Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy (PHASE3)
- Neuroimaging Ancillary Study
- Iron Isomaltoside for the Treatment of Anemia in Peritoneal Dialysis Patients (PHASE4)
- IV Iron-induced Hypophosphatemia After RYGB (PHASE4)
- Reducing Anemia in Pregnancy in India: the RAPIDIRON Trial (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:
- Iron isomaltoside CI brief — competitive landscape report
- Iron isomaltoside updates RSS · CI watch RSS
- Thomas Jefferson University portfolio CI