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Iron isomaltoside/ferric derisomaltose
Iron isomaltoside/ferric derisomaltose is a Iron replacement therapy Small molecule drug developed by Pharmacosmos A/S. It is currently in Phase 3 development for Iron deficiency anemia in adult patients, Iron deficiency anemia in pediatric patients. Also known as: Monofer®, Monoferric®, Monover®, Monofar®, Monoferro®.
Iron isomaltoside delivers ferric iron complexed with isomaltoside, a carbohydrate polymer, to replenish iron stores and treat iron deficiency anemia.
Iron isomaltoside delivers ferric iron complexed with isomaltoside, a carbohydrate polymer, to replenish iron stores and treat iron deficiency anemia. Used for Iron deficiency anemia in adult patients, Iron deficiency anemia in pediatric patients.
At a glance
| Generic name | Iron isomaltoside/ferric derisomaltose |
|---|---|
| Also known as | Monofer®, Monoferric®, Monover®, Monofar®, Monoferro® |
| Sponsor | Pharmacosmos A/S |
| Drug class | Iron replacement therapy |
| Target | Iron metabolism pathway; ferric iron (Fe3+) |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
The isomaltoside carbohydrate shell protects the ferric iron core during transit through the gastrointestinal tract and facilitates absorption and cellular uptake. Once absorbed, the iron is released and incorporated into hemoglobin and other iron-dependent proteins to restore oxygen-carrying capacity and correct anemia. This formulation allows for rapid iron repletion with improved tolerability compared to traditional iron salts.
Approved indications
- Iron deficiency anemia in adult patients
- Iron deficiency anemia in pediatric patients
Common side effects
- Nausea
- Abdominal pain
- Diarrhea
- Headache
- Injection site reactions (if parenteral formulation)
Key clinical trials
- Comparing High and Low Dose Iron Treatments for People on Peritoneal Dialysis: The PALaDIN Study (PHASE3)
- 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
- Reducing Anemia in Pregnancy in India: the RAPIDIRON Trial (PHASE4)
- Effect of Intravenously Iron Infusion on the Prevention and Treatment of Anemia in Ovarian Cancer (PHASE3)
- RAPIDIRON Trial Follow-up Study: RAPIDIRON-KIDS Study
- The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life (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/ferric derisomaltose CI brief — competitive landscape report
- Iron isomaltoside/ferric derisomaltose updates RSS · CI watch RSS
- Pharmacosmos A/S portfolio CI
Frequently asked questions about Iron isomaltoside/ferric derisomaltose
What is Iron isomaltoside/ferric derisomaltose?
How does Iron isomaltoside/ferric derisomaltose work?
What is Iron isomaltoside/ferric derisomaltose used for?
Who makes Iron isomaltoside/ferric derisomaltose?
Is Iron isomaltoside/ferric derisomaltose also known as anything else?
What drug class is Iron isomaltoside/ferric derisomaltose in?
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Related
- Drug class: All Iron replacement therapy drugs
- Target: All drugs targeting Iron metabolism pathway; ferric iron (Fe3+)
- Manufacturer: Pharmacosmos A/S — full pipeline
- Therapeutic area: All drugs in Hematology
- Indication: Drugs for Iron deficiency anemia in adult patients
- Indication: Drugs for Iron deficiency anemia in pediatric patients
- Also known as: Monofer®, Monoferric®, Monover®, Monofar®, Monoferro®
- Compare: Iron isomaltoside/ferric derisomaltose vs similar drugs
- Pricing: Iron isomaltoside/ferric derisomaltose cost, discount & access