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iron isomaltoside(Monofer®)
Iron isomaltoside is an iron carbohydrate complex that delivers iron to iron-deficient patients by binding iron in a stable complex that is taken up by iron-transporting cells.
Iron isomaltoside is an iron carbohydrate complex that delivers iron to iron-deficient patients by binding iron in a stable complex that is taken up by iron-transporting cells. Used for Iron deficiency anemia in patients with chronic kidney disease, Iron deficiency anemia in patients intolerant to or unresponsive to oral iron.
At a glance
| Generic name | iron isomaltoside(Monofer®) |
|---|---|
| Sponsor | Prince of Wales Hospital, Shatin, Hong Kong |
| Drug class | Iron replacement agent |
| Target | Iron transporter (DMT1/SLC11A2) |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
Iron isomaltoside consists of iron(III) oxyhydroxide stabilized by isomaltoside, a carbohydrate ligand. The complex protects iron from premature release in the bloodstream while allowing controlled iron delivery to erythroid precursor cells and iron storage sites. This mechanism enables rapid iron repletion with a favorable safety profile compared to older iron dextran formulations.
Approved indications
- Iron deficiency anemia in patients with chronic kidney disease
- Iron deficiency anemia in patients intolerant to or unresponsive to oral iron
Common side effects
- Headache
- Nausea
- Dizziness
- Hypophosphatemia
- Injection site reactions
Key clinical trials
- IV Iron-induced Hypophosphatemia After RYGB (PHASE4)
- A Clinical Trial Assessing the Efficacy of Intravenous Iron for the Treatment of Anemia Following Cardiac Surgery (PHASE4)
- Intravenous Iron Carboxymaltose, Isomaltoside and Oral Iron Sulphate for Postpartum Anemia (PHASE3)
- Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis (PHASE2)
- Iron Isomaltoside Compared With Iron Sucrosein Peritoneal Dialysis Patients (NA)
- Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA) (PHASE3)
- Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease (PHASE3)
- Effect of Perioperative Iron Isomaltoside 1000 Administration on Transfusion Requirements in Patients Undergoing Complex Valvular Heart Surgery: a Randomized Clinical Trial (NA)
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(Monofer®) CI brief — competitive landscape report
- iron isomaltoside(Monofer®) updates RSS · CI watch RSS
- Prince of Wales Hospital, Shatin, Hong Kong portfolio CI