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Monoferric (FERRIC DERISOMALTOSE)
Monoferric works by binding to serotransferrin, a protein that transports iron in the body, allowing it to be absorbed and utilized by red blood cells.
Monoferric (FERRIC DERISOMALTOSE) is a small molecule developed by Pharmacosmos, targeting serotransferrin to treat iron deficiency anemia. It was FDA approved in 2020 and is currently owned by Pharmacosmos. Monoferric is used to treat iron deficiency anemia, a condition where the body does not have enough iron to produce healthy red blood cells. The commercial status of Monoferric is patented, with no generic manufacturers available. Key safety considerations include the potential for gastrointestinal side effects.
At a glance
| Generic name | FERRIC DERISOMALTOSE |
|---|---|
| Sponsor | Pharmacosmos |
| Target | Serotransferrin |
| Modality | Oligosaccharide |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
| First approval | 2020 |
Mechanism of action
Ferric derisomaltose is complex of iron (III) hydroxide and derisomaltose, an iron carbohydrate oligosaccharide that releases iron. Iron binds to transferrin for transport to erythroid precursor cells to be incorporated into hemoglobin.
Approved indications
- Iron deficiency anemia
Common side effects
- Hypophosphatemia
- Nausea
- Rash
- Hypersensitivity reactions
- Abdominal pain
- Vomiting
- Constipation
- Diarrhea
- Fatigue
- Pyrexia
- Chest pain
- Chills
Key clinical trials
- Comparing High and Low Dose Iron Treatments for People on Peritoneal Dialysis: The PALaDIN Study (PHASE3)
- Impact of Intravenous Iron Repletion On Mechanisms of Exercise InTolerance in HFpEF (IRONMET-HFpEF) (PHASE4)
- Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery (PHASE2)
- The Effect of Preoperative Intravenous Ferric Derisomaltose and EPO and Tranexamic Acid in Patients With Preoperative Anemia or Iron Deficiency in Bone Tumor (PHASE4)
- The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery (PHASE4)
- Methemoglobinemia Following Intravenous Iron Treatment
- Postoperative Intravenous Ferric Derisomaltose for Prevention of Long-term Anemia After 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)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Monoferric CI brief — competitive landscape report
- Monoferric updates RSS · CI watch RSS
- Pharmacosmos portfolio CI