IRON SUCROSE
Iron sucrose is an injectable iron replacement used for patients with chronic kidney disease who have developed iron deficiency anemia. It helps these patients by restoring the iron levels necessary for the production of healthy red blood cells. This medication is specifically prescribed to address the iron shortages often associated with long-term kidney conditions.
How IRON SUCROSE Works
Once administered intravenously, this drug breaks down into iron and sucrose. The iron then binds with transferrin to reach erythroid precursor cells, where it is incorporated into hemoglobin as these cells mature into red blood cells.
Details
- Status
- Prescription
- First Approved
- 2025-08-08
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE
IRON SUCROSE Approval History
What IRON SUCROSE Treats
2 indicationsIRON SUCROSE is approved for 2 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Iron Deficiency Anemia
- Chronic Kidney Disease
IRON SUCROSE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to IRON SUCROSE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
22 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03893045 | AMAG-FER-IDA-352 | Ph 3 | recruiting | A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects |
| NCT03619850 | AMAG-FER-CKD-354 | Ph 3 | recruiting | A Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects With Chronic Kidney Disease (CKD) |
| NCT05251493 | HC6-024-c260086 SHA REB-21-64 | Ph 3 | recruiting | Ferric Derisomaltose (Iron Isomaltoside) Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy |
| NCT06487299 | TET- RCT-Fe | Ph 2 | not yet recruiting | Iron Administration Via Colonic TET Combined With WMT for ID |
| NCT01052779 FIRST results posted | FER-CKD-201 2009-015630-30 | Ph 2 | completed | A Trial Comparing Ferumoxytol to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease |
| NCT01227616 results posted | AMAG-FER-CKD-401 | Ph 4 | completed | Compare Efficacy/Safety of Repeat Doses of Ferumoxytol With Iron Sucrose in CKD Subjects With IDA and on Hemodialysis |
| NCT01114204 results posted | AMAG-FER-IDA-302 | Ph 3 | completed | A Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia |
| NCT03528564 HOPE-Hb | HOPE-Hb | Ph 2 | terminated | Hemoglobin Optimization to Prevent Transfusion and Adverse Events in Perioperative Patients With Iron Restricted Anemia |
| NCT03591406 results posted | VIT-IRON-2011-004 | Ph 3 | completed | To Assess the Impact of Ferric Carboxymaltose Compared With Iron Sucrose in Chinese Subjects on Correcting Iron Deficiency Anaemia |
| NCT02707757 PRIME results posted | 14HH1987 | Ph 4 | completed | Treatment Response in Dialysis Anaemia |
| NCT02940860 results posted | P-Monofer-CKD-04 | Ph 3 | completed | Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease |
| NCT02940886 results posted | P-Monofer-IDA-03 | Ph 3 | completed | Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA) |
| NCT02047552 | 14-0167 | Ph 2 | withdrawn | RCT of Goal-directed Iron Supplementation of Anemic, Critically Ill Trauma Patients, With and Without Oxandrolone |
| NCT02009943 | COMIRB 13-3151 | Ph 1 | withdrawn | Randomized Study Comparing Ferric Carboxymaltose to Iron Sucrose to Treat Fe Deficiency in the Surgically Critically Ill |
| NCT00384657 | AWG_06_01 | Ph 3 | withdrawn | Intravenous Iron in Patients With Severe Chronic Heart Failure and Chronic Kidney Disease |
| NCT02977611 | 1611-56 | Ph 2 | withdrawn | The Safety of a High-Dose, Rapid Infusion of Iron Sucrose |
| NCT00719459 | IRON-07-04 | Ph 1 | completed | Bioequivalency Study Comparing Hospira's Generic Iron Sucrose Injection to Venofer |
| NCT01309659 results posted | Pro00028687 U01AG034661, PACTTE_01 | Ph 2 | terminated | Trial To Evaluate the Efficacy of Intravenous Iron in Older Adults With Unexplained Anemia |
| NCT01222884 results posted | P-Monofer-CKD-03 | Ph 3 | completed | A Randomized, Comparative, Open-label Study of IV Monofer® Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison With IV Iron Sucrose in Subjects With CKD-5D |
| NCT01067547 | UA 2009 TL | Ph 4 | completed | A Trial of Iron Replacement in Patients With Iron Deficiency. |
| NCT00810030 FER-IBD-COR | FER-IBD-07-COR | Ph 3 | completed | FERINJECT for Correction of Anaemia in IBD Patients, FER-IBD-COR |
| NCT00593619 | HSREB13767 | Ph 4 | suspended | Trial Comparing the Safety of Two Different Intravenous Iron Formulations |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
IRON SUCROSE FDA Label Details
Indications & Usage
IRON SUCROSE is indicated for the treatment of Iron Deficiency Anemia; Chronic Kidney Disease.
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VENOFER
Full clinical data, patents, trials, and competitive landscape for iron sucrose.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.