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IV iron - Sodium Ferric Gluconate Complex
IV iron - Sodium Ferric Gluconate Complex is a Iron replacement therapy Small molecule drug developed by Rambam Health Care Campus. It is currently FDA-approved for Iron deficiency anemia in patients with chronic kidney disease on hemodialysis, Iron deficiency anemia in patients with chronic kidney disease not on dialysis. Also known as: IV Ferrlecit.
Sodium ferric gluconate complex delivers iron directly into the bloodstream to replenish depleted iron stores and restore hemoglobin production.
Sodium ferric gluconate complex delivers iron directly into the bloodstream to replenish depleted iron stores and restore hemoglobin production. Used for Iron deficiency anemia in patients with chronic kidney disease on hemodialysis, Iron deficiency anemia in patients with chronic kidney disease not on dialysis.
At a glance
| Generic name | IV iron - Sodium Ferric Gluconate Complex |
|---|---|
| Also known as | IV Ferrlecit |
| Sponsor | Rambam Health Care Campus |
| Drug class | Iron replacement therapy |
| Target | Iron (Fe3+) delivery to erythropoietic tissues |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
Mechanism of action
The complex dissociates in vivo to release ferric iron, which binds to transferrin for transport to bone marrow erythroid precursors where it is incorporated into hemoglobin and myoglobin. This bypasses the need for oral iron absorption and is particularly useful in patients with impaired gastrointestinal absorption or those requiring rapid iron repletion, such as hemodialysis patients with chronic kidney disease-related anemia.
Approved indications
- Iron deficiency anemia in patients with chronic kidney disease on hemodialysis
- Iron deficiency anemia in patients with chronic kidney disease not on dialysis
Common side effects
- Hypotension
- Flushing
- Nausea
- Abdominal pain
- Headache
- Chest pain
- Anaphylactic reactions
Key clinical trials
- IV Iron in Acute Decompensated Heart Failure (PHASE4)
- IV Sodium Ferric Gluconate Complex in Patients Undergoing TAVI (PHASE4)
- Study of Roxadustat (FG-4592) to Correct Anemia in Newly Initiated Dialysis Participants Not on Erythropoiesis-Stimulating Agent Treatment (PHASE2)
- Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients (PHASE4)
- Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents (PHASE4)
- Comparison Between Effects of Two Iron Preparations on Protein in the Urine (PHASE1)
- Darbepoetin Alfa With or Without Iron in Treating Anemia Caused By Chemotherapy in Patients With Cancer (PHASE3)
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:
- IV iron - Sodium Ferric Gluconate Complex CI brief — competitive landscape report
- IV iron - Sodium Ferric Gluconate Complex updates RSS · CI watch RSS
- Rambam Health Care Campus portfolio CI
Frequently asked questions about IV iron - Sodium Ferric Gluconate Complex
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Related
- Drug class: All Iron replacement therapy drugs
- Target: All drugs targeting Iron (Fe3+) delivery to erythropoietic tissues
- Manufacturer: Rambam Health Care Campus — full pipeline
- Therapeutic area: All drugs in Hematology
- Indication: Drugs for Iron deficiency anemia in patients with chronic kidney disease on hemodialysis
- Indication: Drugs for Iron deficiency anemia in patients with chronic kidney disease not on dialysis
- Also known as: IV Ferrlecit
- Compare: IV iron - Sodium Ferric Gluconate Complex vs similar drugs
- Pricing: IV iron - Sodium Ferric Gluconate Complex cost, discount & access