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Feraheme

(Ferumoxytol)

ApprovedSmall molecule

AAzurity Pharmaceuticals

Ferumoxytol is used to treat iron deficiency anemia in patients with chronic kidney disease. It works by providing iron to the body, which is needed to make healthy red blood cells.[2] Feraheme is currently approved and in use across 19 indications[4].[1]

Feraheme is one of 530 small molecule programs targeting Anemia (phenotype). It is currently in Approved.

19

Indications

73

Total Trials

13

Active Trials

529

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Anemia (phenotype)Active, not recruiting

Type 1 Diabetes MellitusActive, not recruiting

Temporal Lobe EpilepsyApproved

AIDS DementiaApproved

Glioblastoma MultiformeApproved

Breast CancerActive, not recruiting

Colorectal CancerActive, not recruiting

Pancreatic CancerActive, not recruiting

Type 1 DiabetesActive, not recruiting

Thyroid CancerActive, not recruiting

Anemia (phenotype)Approved

Active, not recruiting

Type 1 Diabetes MellitusPreclinical

Active, not recruiting

Temporal Lobe EpilepsyApproved

Approved

AIDS DementiaApproved

Approved

Glioblastoma MultiformeApproved

Approved

Breast CancerPreclinical

Active, not recruiting

Colorectal CancerPreclinical

Active, not recruiting

Pancreatic CancerPreclinical

Active, not recruiting

Type 1 DiabetesPreclinical

Active, not recruiting

Thyroid CancerPreclinical

Active, not recruiting

Showing 10 of 19 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Feraheme

AAzurity Pharmaceuticals

Zolymbus

Blenoxane

Bristol-Myers Squibb

Methylthioninium Chloride

PProvepharm SAS

MS Contin

HHikma Pharmaceuticals LLC

Duragesic-100

MS Contin

HHikma Pharmaceuticals LLC

Spravato

Acupan

YYonsei University

Chantix

PPrism Pharmaceuticals

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1/2Recruiting

Children

NCT01542879

Post-ApprovalRecruiting

Iron Deficiency Anemia

NCT04278651

Phase 1Active, not recruiting

Glioblastoma

NCT04900792

Q2 2027

Phase 2Recruiting

Infants

NCT05340465

Q2 2028

Phase 1Recruiting

Stenosis

NCT06440408

Q4 2028

Phase 3Recruiting

Glioblastoma

NCT07461948

Clinical

Trials by Indication[1]

Iron deficiency anemia9 trials

Total Dose Infusion of Ferumoxytol(1020mg) in 15 Minutes for Iron Deficiency Anemia

Completed·AAuerbach Hematology Oncology Associates P C·N/A·NCT01374919·60 enrolled

A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia

Completed·AAMAG Pharmaceuticals, Inc.·Phase 3·NCT01114217·634 enrolled

A Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia

Completed·AAMAG Pharmaceuticals, Inc.·Phase 3·NCT01114204·605 enrolled

Show 6 more trials

A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects

Recruiting·AAMAG Pharmaceuticals, Inc.·Phase 3·NCT03893045·75 enrolled

A Phase III Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)

Completed·AAMAG Pharmaceuticals, Inc.·Phase 3·NCT02694978·2,014 enrolled

Early Antenatal Support for Iron Deficiency Anemia

Recruiting·TThomas Jefferson University·Phase 4·NCT04278651·80 enrolled

A Trial Comparing Ferumoxytol With Placebo for the Treatment of Iron Deficiency Anemia

Completed·AAMAG Pharmaceuticals, Inc.·Phase 3·NCT01114139·812 enrolled

Intravenous (IV) Versus Oral Iron Treatment of Iron Deficiency Anemia in the Post-operative Bariatric Surgical Patient

Withdrawn·JJohns Hopkins University·N/A·NCT03777514

Trial of IV vs Oral Iron Treatment of Iron Deficiency Anemia in the Post-Operative Bariatric Surgical Patient

Recruiting·AAuerbach Hematology Oncology Associates P C·Phase 3·NCT04268849·104 enrolled

Chronic Kidney Disease6 trials

A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia in Pediatric Participants With Chronic Kidney Disease

Terminated·AAMAG Pharmaceuticals, Inc.·Phase 3·NCT01264679·8 enrolled

A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Participants With Nondialysis-Dependent Chronic Kidney Disease

Terminated·AAMAG Pharmaceuticals, Inc.·Phase 3·NCT01155388·14 enrolled

A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Participants With Chronic Kidney Disease

Terminated·AAMAG Pharmaceuticals, Inc.·Phase 3·NCT01155375·14 enrolled

Show 3 more trials

Ferumoxytol for Iron-Deficiency Anemia in Chronic Kidney Disease and Peritoneal Dialysis Patients

Completed·GGeorges Ouellet·Phase 4·NCT01942460·15 enrolled

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)

Recruiting·AAMAG Pharmaceuticals, Inc.·Phase 3·NCT03619850·129 enrolled

A Trial Comparing Ferumoxytol to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease

Completed·AAMAG Pharmaceuticals, Inc.·Phase 2·NCT01052779·162 enrolled

Glioblastoma4 trials

Advanced Imaging Techniques for Evaluating the Tumor Immune Microenvironment in Glioblastoma Patients

Recruiting·JJonsson Comprehensive Cancer Center·Phase 3·NCT07461948·15 enrolled

Steady State Blood Volume Maps Using Ferumoxytol Non-stoichiometric Magnetite MRI in Imaging Patients With Glioblastoma

Completed·OOHSU Knight Cancer Institute·N/A·NCT02359097·29 enrolled

Ferumoxytol MRI in Assessing Response to Pembrolizumab in Patients With Glioblastoma

Terminated·OOHSU Knight Cancer Institute·Phase 2·NCT03347617·52 enrolled

Show 1 more trial

A First-in-Human Clinical Trial of Pharmacologic Ascorbate and Ferumoxytol Combined With Concomitant Temozolomide and External Beam Radiation Therapy for Newly Diagnosed Glioblastoma

Active, not recruiting·BBryan Allen·Phase 1·NCT04900792·16 enrolled

Magnetic Resonance Imaging4 trials

Ferumoxytol-enhanced Magnetic Resonance Imaging

Terminated·TTransmed Solutions·Phase 3·NCT06348524·36 enrolled

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

Completed· Ipsen logo

Ipsen·Phase 1·NCT01770353·45 enrolled

Ferumoxytol in Magnetic Resonance Imaging of Pediatric Patients With Brain Tumors

Withdrawn·OOHSU Knight Cancer Institute·Phase 2·NCT03234309

Show 1 more trial

Ferumoxytol-enhanced Magnetic Resonance Imaging

Unknown status·—·Phase 3·NCT02954510·185 enrolled

Inflammation3 trials

Advanced MRI for Uteroplacental Flow, Perfusion, Oxygenation & Inflammation

Completed·UUniversity of Wisconsin, Madison··NCT02791568·121 enrolled

DEtection of Cellular Inflammation With FERumoxytol in the HEART

Completed·UUniversity of Edinburgh·Phase 2/3·NCT02319278·58 enrolled

Using Ferumoxytol-Enhanced MRI to Measure Inflammation in Patients With Brain Tumors or Other Conditions of the CNS

Completed·MMichael Iv·Phase 1·NCT02452216·10 enrolled

44 more indications

Esophageal Cancer3 trials

Ferumoxytol-Enhanced MRI in Imaging Lymph Nodes in Patients With Stage IIB-IIIC Esophageal Cancer

Withdrawn·OOHSU Knight Cancer Institute·Phase 1·NCT02857218

MRI Iron Oxide Imaging for Lymph Node Staging in Esophageal Cancer

Withdrawn·—·Phase 1·NCT02689401

Innovative MRI Techniques to Improve Treatment Stratification of Patients With Esophageal Cancer

Completed·—·N/A·NCT02253602·41 enrolled

Brain Tumors2 trials

Ferumoxytol- and Gadolinium-Labeled MRI in Measuring Tumors Before or After Treatment in Patients With Primary or Metastatic Brain Tumors

Terminated·OOHSU Knight Cancer Institute·Phase 2·NCT00659126·40 enrolled

Ferumoxytol in Improving MR Imaging in Patients With High-Grade Brain Tumors or Cerebral Metastases

Completed·OOHSU Knight Cancer Institute·N/A·NCT00103038·155 enrolled

Prostate Cancer1 trial

Ferumoxytol Enhanced MRI for the Detection of Lymph Node Involvement in Prostate Cancer

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01296139·21 enrolled

Sarcomas1 trial

Ferumoxytol-Enhanced MRI in Adult/Pedi Sarcomas

Withdrawn·—·N/A·NCT01663090

Children1 trial

Development of Radiation Free Whole Body Magnetic Resonance (MR) Imaging Technique for Staging Children With Cancer

Recruiting·HHeike E Daldrup-Link·Phase 1/2·NCT01542879·75 enrolled

Cognitive Disorder1 trial

Ferumoxytol-enhanced Brain MRI in HIV-associated Neurocognitive Disorders

Completed·UUniversity of Hawaii·Phase 1·NCT01665846·4 enrolled

Kidney Cancer1 trial

Study of Ferumoxytol Enhanced MRI for Detecting Lymph Node Metastases in Prostate, Bladder, and Kidney Cancers

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT02141490·43 enrolled

Type 1 Diabetes1 trial

Imaging of Type 1 Diabetes Progression

Unknown status·JJason Gaglia··NCT01521520·65 enrolled

Epilepsy1 trial

Enhanced MRI Imaging in Healthy Participants and Participants With Epilepsy

Recruiting·UUniversity of Alberta·Phase 2·NCT06483061·50 enrolled

Imaging1 trial

Ferumoxytol-enhanced Imaging and Mapping in neuroAIDS

Completed·BBeau Nakamoto·Phase 2·NCT02678767·30 enrolled

Pancreatic Cancer1 trial

DCE MRI in Patients With Pancreatic Cancer

Terminated·OOHSU Knight Cancer Institute·N/A·NCT02070705·77 enrolled

Breast Cancer1 trial

Magnetic Resonance Imaging of Lymph Nodes Using Ferumoxytol in Patients With Primary Prostate or Breast Cancer

Completed·MMassachusetts General Hospital··NCT00087347·14 enrolled

Malignant Brain Tumors1 trial

In Vivo Characterization of Macrophages in Pediatric Patients With Malignant Brain Tumors Using Ferumoxytol-enhanced MRI

Withdrawn·MMichael Iv·Phase 1·NCT03179449

Pregnancy1 trial

Intravenous Infusions of Ferumoxytol Compared to Oral Ferrous Sulfate for the Treatment of Anemia in Pregnancy

Completed·UUniversity of Arizona·Phase 3·NCT03657433·124 enrolled

Patients With Locally Advanced Rectal Cancer1 trial

Ferumoxytol-Enhanced MRI in Imaging Lymph Nodes in Patients With Locally Advanced Rectal Cancer

Terminated·OOHSU Knight Cancer Institute·Phase 1·NCT03280277·2 enrolled

Central Nervous System1 trial

MR, Histologic And EM Imaging Of Intravenous Ferumoxytol In Central Nervous System (CNS) Inflammation

Terminated·OOregon Health and Science University·Phase 2·NCT00659776·255 enrolled

Non-Small Cell Lung Cancer1 trial

Pembrolizumab and Magnetic Resonance Imaging With Ferumoxytol in Treating Patients With Non-small Cell Lung Cancer and Brain Metastases

Terminated·OOHSU Knight Cancer Institute·Phase 2·NCT03325166·2 enrolled

Hepatic Cancer1 trial

Radiotherapy With Iron Oxide Nanoparticles (SPION) on MR-Linac for Primary & Metastatic Hepatic Cancers

Unknown status·—··NCT04682847·40 enrolled

Infants1 trial

Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants

Recruiting·UUniversity of Washington·Phase 2·NCT05340465·120 enrolled

Atherosclerosis1 trial

Treatment Targets for Inflamed Intracranial Atherosclerosis on Vessel Wall MRI

Completed·YYale University·Phase 1·NCT03084523·30 enrolled

Patients With Solid Tumors1 trial

Liposomal Irinotecan and Veliparib in Treating Patients With Solid Tumors

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT02631733·18 enrolled

ESS1 trial

Study to Assess Feasibility and Safety of Iron Repletion With Feraheme in Iron Deficient Patients With Durable Ventricular Assist Device Support

Terminated·NNYU Langone Health·Phase 4·NCT04080908·1 enrolled

Pilot Study1 trial

Pilot Study: Randomized, Placebo-controlled Comparator Trial of IV vs Oral Iron Treatment of RLS With IDA. (IVOR-IDA)

Completed·AAuerbach Hematology Oncology Associates P C·Phase 2·NCT02499354·100 enrolled

Fetal Growth Restriction1 trial

Placental Lesions in Fetal Growth Restrictions

Completed·UUniversity of Wisconsin, Madison·Phase 1·NCT04839185·3 enrolled

Contrast Agent1 trial

Ferumoxytol as a Contrast Agent for Pulmonary Magnetic Resonance Angiography

Completed·—·Phase 1·NCT03173066·1 enrolled

Hemodialysis1 trial

Compare Efficacy/Safety of Repeat Doses of Ferumoxytol With Iron Sucrose in CKD Subjects With IDA and on Hemodialysis

Completed·AAMAG Pharmaceuticals, Inc.·Phase 4·NCT01227616·296 enrolled

Anemia1 trial

IV Iron vs Oral Iron for Treatment of Anemia in Women With Abnormal Uterine Bleeding

Unknown status·TThomas Jefferson University·Phase 4·NCT04205266·76 enrolled

Intravenous1 trial

Iron Indices and Intravenous Ferumoxytol: Time to Steady State

Completed·DDialysis Clinic, Inc.·Phase 4·NCT01148745·15 enrolled

Glioma1 trial

Assessing Dynamic Magnetic Resonance (MR) Imaging in Patients With Recurrent High Grade Glioma Receiving Chemotherapy

Terminated·OOHSU Knight Cancer Institute·Phase 1·NCT00769093·6 enrolled

Thyroid Cancer1 trial

Pre-Operative Nodal Staging of Thyroid Cancer Using USPIO MRI: Preliminary Study

Completed·MMassachusetts General Hospital·N/A·NCT01927887·12 enrolled

Congenital Heart Disease1 trial

Feraheme As An MRI Contrast Agent For Pediatric Congenital Heart Disease

Completed·PPaul Finn·Phase 4·NCT02752191·17 enrolled

Colorectal Cancer1 trial

Diagnostic Accuracy of Ferumoxytol-Enhanced MRI for Detecting Lymph Node Metastases in Colorectal Cancer

Withdrawn·—·N/A·NCT01983371

Peripheral Arterial Disease1 trial

Magnetic Resonance Angiography for Peripheral Arterial Disease (PAD)

Unknown status·AAMAG Pharmaceuticals, Inc.·Phase 2·NCT00707876·108 enrolled

Nanoparticle1 trial

Ferumoxytol - Iron Oxide Nanoparticle Magnetic Resonance Dynamic Contrast Enhanced MRI

Terminated·MM.D. Anderson Cancer Center·Phase 1·NCT01895829·7 enrolled

Women1 trial

A Study of the Electrocardiogram Effects and Pharmacokinetics of Ferumoxytol in Healthy Men and Women

Completed·AAMAG Pharmaceuticals, Inc.·Phase 1·NCT00360425·174 enrolled

Multiple Sclerosis1 trial

In Vivo Characterization of Inflammation With Ferumoxytol, an Ultrasmall Superparamagnetic Iron Oxide Nanoparticle, on 7 Tesla Magnetic Resonance Imaging

Completed·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 1·NCT02511028·14 enrolled

Glioblastoma Multiforme1 trial

Feasibility of [¹⁸F]-Fluoromisonidazole (FMISO) in Assessment of Malignant Brain Tumors

Recruiting·OOHSU Knight Cancer Institute·Phase 2·NCT03649880·77 enrolled

Central Nervous System Neoplasm1 trial

The Feasibility of Steady State CBV Mapping Using Ferumoxytol Immediately After Gadolinium Enhanced MRI of the CNS

Recruiting·OOHSU Knight Cancer Institute·Phase 2·NCT03270059·150 enrolled

Secondary Progressive Multiple Sclerosis1 trial

Novel Imaging Markers of Innate Immune Activation in Secondary Progressive Multiple Sclerosis

Completed·UUniversity of Utah·Phase 1·NCT05357833·11 enrolled

Intracranial Atherosclerosis1 trial

Predicting Stroke Risk in Intracranial Atherosclerotic Disease With Novel High Resolution, Functional and Molecular MRI Techniques

Withdrawn·NNorthwestern University·Approved·NCT05515874

Stenosis1 trial

Calculating Wall Shear Stress in Pulmonary Veins of Infants Using Cardiac Magnetic Resonance Imaging: A Pilot Study

Recruiting·CChildren's Hospital of Philadelphia·Phase 1·NCT06440408·20 enrolled

Interstitial Cystitis1 trial

Phenotyping Interstitial Cystitis/Bladder Pain Syndrome by ICE-MRI Bladder Permeability Assay

Completed·CChristopher J Chermansky, MD··NCT05811377·7 enrolled

Pregnancy Related1 trial

Comparison of Oral Ferrous Sulfate to Intravenous Ferumoxytol in Antepartum Iron Deficiency Anemia

Completed·SStanford University·Phase 3·NCT04253626·83 enrolled

Unspecified1 trial

Ferumoxytol-enhanced Magnetic Resonance Venography in Patients With Venous Diseases

Recruiting·MMin Zhou·Phase 2·NCT07452250·50 enrolled

Regulatory

FDA Approval Timeline[5]

Jun 30, 2009

FERAHEME

NDA NDA022180

Oct 16, 2025

FERABRIGHT

NDA NDA219868

Sources

References

[1]
ClinicalTrials.gov — 73 trial records for Ferumoxytol. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Feraheme drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Ferumoxytol compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Ferumoxytol. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA219868). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Azurity Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AAzurity Pharmaceuticals

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