FERAHEME (ferumoxytol)
FERAHEME is indicated for the treatment of Iron Deficiency Anemia; Chronic Kidney Disease.
How FERAHEME Works
Feraheme consists of a superparamagnetic iron oxide nanoparticles coated with a carbohydrate shell. This structure isolates bioactive iron from plasma components until the complex is internalized by macrophages in the reticuloendothelial system (liver, spleen, and bone marrow). Once released from the complex within the macrophages, the iron is either stored intracellularly as ferritin or coupled to plasma transferrin. Transferrin then transports the iron to erythroid precursor cells for incorporation into hemoglobin.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2009-06-30
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
FERAHEME Approval History
What FERAHEME Treats
2 indicationsFERAHEME is approved for 2 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Iron Deficiency Anemia
- Chronic Kidney Disease
FERAHEME Boxed Warning
RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest. • Only administer Feraheme as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. [ see Warnings...
WARNING: RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest. • Only administer Feraheme as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. [ see Warnings and Precautions (5.1) ]. • Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following Feraheme infusion including monitoring of blood pressure and pulse during and after Feraheme administration [ see Warnings and Precautions (5.1) ]. • Hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated [ see Warnings and Precautions (5.1) ]. WARNING: RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS See full prescribing information for complete boxed warning . Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest. • Only administer Feraheme as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. ( 5.1 ) • Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following Feraheme infusion including monitoring of blood pressure and pulse during and after Feraheme administration. ( 5.1 ) • Hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated. ( 5.1 )
FERAHEME Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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.
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Clinical Trial Registry
40 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06483061 | Pro00132487 | Ph 2 | recruiting | Enhanced MRI Imaging in Healthy Participants and Participants With Epilepsy |
| NCT02511028 | 150156 15-N-0156 | Ph 1 | completed | In Vivo Characterization of Inflammation With Ferumoxytol, an Ultrasmall Superparamagnetic Iron Oxide Nanoparticle, on 7 Tesla Magnetic Resonance Imaging |
| 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) |
| NCT00707876 results posted | FER-PAD-001 | Ph 2 | completed | Magnetic Resonance Angiography for Peripheral Arterial Disease (PAD) |
| NCT05515874 | STU00212754 | Ph 4 | completed | Predicting Stroke Risk in ICAD With Novel MRI |
| NCT07461948 | 25-1450 NCI-2025-07966, KL2TR001882 | Ph 3 | recruiting | Advanced Imaging Techniques for Evaluating the Tumor Immune Microenvironment in Glioblastoma Patients |
| NCT03270059 | STUDY00017028 NCI-2017-01460, STUDY00017028 | Ph 2 | recruiting | Gadolinium and Ferumoxytol MRI in Diagnosing Patients With Abnormalities in the Central Nervous System |
| NCT04278651 EASI-A | 19G.929 | Ph 4 | recruiting | Early Antenatal Support for Iron Deficiency Anemia |
| NCT04268849 | BariatricsProtocol100719 | Ph 3 | recruiting | Trial of IV vs Oral Iron Treatment of Iron Deficiency Anemia in the Post-Operative Bariatric Surgical Patient |
| NCT03347617 results posted | STUDY00016046 NCI-2017-02008, STUDY00016046 | Ph 2 | terminated | Ferumoxytol MRI in Assessing Response to Pembrolizumab in Patients With Glioblastoma |
| NCT06440408 PVS-WSS | IRB 23-021612 | Ph 1 | recruiting | Calculating Wall Shear Stress in Infant Pulmonary Veins |
| NCT02631733 | NCI-2015-02125 NCI-2015-02125, 17-C-0012 | Ph 1 | completed | Liposomal Irinotecan and Veliparib in Treating Patients With Solid Tumors |
| NCT01542879 | IRB-20221 IRB-20221, PEDSVAR0017 | Ph 1, Ph 2 | recruiting | Development of Radiation Free Whole Body Magnetic Resonance (MR) Imaging Technique for Staging Children With Cancer |
| NCT01336803 Osteosarcoma results posted | IRB-20253(osteosarcoma) SU-04062011-7666, PEDSBONE0006 | Ph 2 | completed | Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI |
| 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 |
| NCT02694978 results posted | AMAG-FER-IDA-304 | Ph 3 | completed | A Phase III Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA) |
| NCT02752191 results posted | 16-00016 | Ph 4 | completed | Feraheme As An MRI Contrast Agent For Pediatric Congenital Heart Disease |
| NCT03657433 | 1807765944 | Ph 3 | completed | Intravenous Infusions of Ferumoxytol Compared to Oral Ferrous Sulfate for the Treatment of Anemia in Pregnancy |
| NCT03325166 results posted | STUDY00016709 NCI-2017-01730, STUDY00016709 | Ph 2 | terminated | Pembrolizumab and Magnetic Resonance Imaging With Ferumoxytol in Treating Patients With Non-small Cell Lung Cancer and Brain Metastases |
| NCT03173066 | 0430172034 | Ph 1 | completed | Ferumoxytol as a Contrast Agent for Pulmonary Magnetic Resonance Angiography |
| NCT01155388 results posted | AMAG-FER-CKD-252 | Ph 3 | terminated | A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Participants With Nondialysis-Dependent Chronic Kidney Disease |
| NCT01264679 results posted | AMAG-FER-CKD-253 | Ph 3 | terminated | A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia in Pediatric Participants With Chronic Kidney Disease |
| NCT01114139 results posted | AMAG-FER-IDA-301 | Ph 3 | completed | A Trial Comparing Ferumoxytol With Placebo for the Treatment of Iron Deficiency Anemia |
| 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 |
| NCT01114217 results posted | AMAG-FER-IDA-303 | Ph 3 | completed | A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia |
| NCT01155375 results posted | AMAG-FER-CKD-251 | Ph 3 | terminated | A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Participants With Chronic Kidney Disease |
| NCT03234309 | STUDY00016165 NCI-2017-00713, STUDY00016165 | Ph 2 | withdrawn | Ferumoxytol in Magnetic Resonance Imaging of Pediatric Patients With Brain Tumors |
| NCT02189889 APART results posted | APART.V1.2013 | Ph 1, Ph 2 | terminated | Active Preoperative Anemia Management in Patients Undergoing Cardiac Surgery |
| NCT01770353 results posted | MM-398-01-01-02 | Ph 1 | completed | MM-398 (Nanoliposomal Irinotecan, Nal-IRI) to Determine Tumor Drug Levels and to Evaluate the Feasibility of Ferumoxytol Magnetic Resonance Imaging to Measure Tumor Associated Macrophages and to Predict Patient Response to Treatment |
| NCT02141490 results posted | 140107 14-C-0107 | Ph 2 | completed | Study of Ferumoxytol Enhanced MRI for Detecting Lymph Node Metastases in Prostate, Bladder, and Kidney Cancers |
| NCT01296139 | 110098 11-C-0098 | Ph 1 | completed | Ferumoxytol Enhanced MRI for the Detection of Lymph Node Involvement in Prostate Cancer |
| NCT01665846 | H015 | Ph 1 | completed | Ferumoxytol-enhanced Brain MRI in HIV-associated Neurocognitive Disorders |
| NCT02678767 | 2013-077 H032, 1R21NS087951-01A1 | Ph 2 | completed | Ferumoxytol-enhanced Imaging and Mapping in neuroAIDS |
| NCT02319278 DECIFER | 2013-002336-24 | Ph 2, Ph 3 | completed | DEtection of Cellular Inflammation With FERumoxytol in the HEART |
| NCT00769093 | IRB00003678 26XS293, 3678 | Ph 1 | terminated | Assessing Dynamic Magnetic Resonance (MR) Imaging in Patients With Recurrent High Grade Glioma Receiving Chemotherapy |
| NCT02689401 | 15-419 | Ph 1 | withdrawn | MRI Iron Oxide Imaging for Lymph Node Staging in Esophageal Cancer |
| NCT01942460 | FER-CA-IIT-001 | Ph 4 | completed | Ferumoxytol for Iron-Deficiency Anemia in Chronic Kidney Disease and Peritoneal Dialysis Patients |
| NCT01148745 results posted | DCI-0001 | Ph 4 | completed | Iron Indices and Intravenous Ferumoxytol: Time to Steady State |
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.
FERAHEME FDA Label Details
Indications & Usage
FDA Label (PDF)FERAHEME is indicated for the treatment of Iron Deficiency Anemia; Chronic Kidney Disease.
WARNING: RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest. • Only administer F...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment