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iron sucrose injection USP
Iron sucrose delivers iron directly into the bloodstream as a stable complex to replenish iron stores and support hemoglobin synthesis in patients with iron deficiency.
Iron sucrose delivers iron directly into the bloodstream as a stable complex to replenish iron stores and support hemoglobin synthesis in patients with iron deficiency. 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, Iron deficiency anemia in patients receiving erythropoiesis-stimulating agents.
At a glance
| Generic name | iron sucrose injection USP |
|---|---|
| Sponsor | American Regent, Inc. |
| Drug class | Iron replacement agent |
| Target | Iron (Fe3+) delivery; transferrin receptor-mediated uptake |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
Iron sucrose is a polynuclear iron(III) hydroxide sucrose complex that provides bioavailable iron for erythropoiesis. The sucrose coating protects iron from premature release and oxidation, allowing efficient uptake by iron-binding proteins and incorporation into hemoglobin and myoglobin. This formulation is particularly useful in patients who cannot tolerate or absorb oral iron, such as those with chronic kidney disease on hemodialysis.
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
- Iron deficiency anemia in patients receiving erythropoiesis-stimulating agents
Common side effects
- Hypotension
- Headache
- Nausea
- Vomiting
- Abdominal pain
- Diarrhea
- Injection site reactions
Key clinical trials
- Evaluation and Treatment of Iron Deficiency in Ovarian Cancer Patients (PHASE1, PHASE2)
- Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis (PHASE3)
- Bioequivalence Study Assessing Iron Sucrose or Venofer® in Healthy Adult Subjects (PHASE1)
- Intravenous (IV) Iron vs. No Iron as the Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy (PHASE3)
- Bioequivalency Study Comparing Hospira's Generic Iron Sucrose Injection to Venofer (PHASE1)
- Comparison Between Effects of Two Iron Preparations on Protein in the Urine (PHASE1)
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 sucrose injection USP CI brief — competitive landscape report
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- American Regent, Inc. portfolio CI