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Sodium ferric gluconate
Sodium ferric gluconate is an iron replacement therapy that delivers ferric iron in a stable gluconate complex to replenish depleted iron stores.
Sodium ferric gluconate is an iron replacement therapy that delivers ferric iron in a stable gluconate complex to replenish depleted iron stores. Used for Iron deficiency anemia in patients with chronic kidney disease on hemodialysis, Iron deficiency anemia in non-dialysis chronic kidney disease patients.
At a glance
| Generic name | Sodium ferric gluconate |
|---|---|
| Also known as | Ferrlecit |
| Sponsor | University of North Carolina, Chapel Hill |
| Drug class | Iron replacement agent |
| Target | Iron (Fe3+) delivery system |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
Mechanism of action
The drug consists of ferric iron bound to gluconate, which allows for intravenous administration and cellular uptake of iron. Once administered, the iron is released and incorporated into hemoglobin and other iron-dependent proteins, restoring oxygen-carrying capacity and correcting iron deficiency anemia. This formulation is designed to minimize adverse effects associated with free iron while maintaining bioavailability.
Approved indications
- Iron deficiency anemia in patients with chronic kidney disease on hemodialysis
- Iron deficiency anemia in non-dialysis chronic kidney disease patients
Common side effects
- Hypotension
- Flushing
- Chest pain
- Back pain
- Nausea
- Vomiting
- Abdominal pain
Key clinical trials
- Effect of Intravenously Iron Infusion on the Prevention and Treatment of Anemia in Ovarian Cancer (PHASE3)
- IV Iron in Acute Decompensated Heart Failure (PHASE4)
- IV Sodium Ferric Gluconate Complex in Patients Undergoing TAVI (PHASE4)
- IV Iron Safety: Evaluation of Iron Species in Healthy Subjects (PHASE4)
- Study of Roxadustat (FG-4592) to Correct Anemia in Newly Initiated Dialysis Participants Not on Erythropoiesis-Stimulating Agent Treatment (PHASE2)
- Study of the Efficacy and Safety of Ferrlecit in the Maintenance Dosing in Hemodialysis Patients. (PHASE4)
- Clinical Burden of Anemia in Inflammatory Bowel Disease: Therapeutic Trial (PHASE3)
- Cost Comparison Study of Darbepoetin Versus Epoetin Therapy to Treat Anemia in Hemodialysis Patients (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:
- Sodium ferric gluconate CI brief — competitive landscape report
- Sodium ferric gluconate updates RSS · CI watch RSS
- University of North Carolina, Chapel Hill portfolio CI