CLINICAL TRIALS PROFILE FOR FERUMOXYTOL

All Clinical Trials for FERUMOXYTOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00087347 ↗	Magnetic Resonance Imaging of Lymph Nodes Using Ferumoxytol in Patients With Primary Prostate or Breast Cancer	Completed	National Cancer Institute (NCI)		2004-09-01	RATIONALE: Diagnostic procedures such as magnetic resonance imaging (MRI) using ferumoxytol may improve the ability to detect cancer that has spread to the lymph nodes and may help plan effective cancer treatment. PURPOSE: This clinical trial is studying how well MRI using ferumoxytol works in detecting metastases to the lymph nodes in patients with primary prostate cancer or primary breast cancer.
NCT00087347 ↗	Magnetic Resonance Imaging of Lymph Nodes Using Ferumoxytol in Patients With Primary Prostate or Breast Cancer	Completed	Massachusetts General Hospital		2004-09-01	RATIONALE: Diagnostic procedures such as magnetic resonance imaging (MRI) using ferumoxytol may improve the ability to detect cancer that has spread to the lymph nodes and may help plan effective cancer treatment. PURPOSE: This clinical trial is studying how well MRI using ferumoxytol works in detecting metastases to the lymph nodes in patients with primary prostate cancer or primary breast cancer.
NCT00103038 ↗	Ferumoxytol in Improving MR Imaging in Patients With High-Grade Brain Tumors or Cerebral Metastases	Unknown status	National Cancer Institute (NCI)	N/A	2004-02-01	This clinical trial studies magnetic resonance imaging (MRI) using a contrast imaging agent ferumoxytol (ferumoxytol non-stoichiometric magnetite) in improving viewing tumors in patients with high-grade brain tumors or cancer that has spread to the brain. Diagnostic procedures, such as MRI, may help find and diagnose brain tumors and find out how far the disease has spread. The contrast imaging agent ferumoxytol non-stoichiometric magnetite consists of small iron particles taken by the blood stream to the brain and to the area of the tumor. It may help visualize the blood flow going through the tumor better than the standard substance gadolinium-based contrast agent.
NCT00103038 ↗	Ferumoxytol in Improving MR Imaging in Patients With High-Grade Brain Tumors or Cerebral Metastases	Unknown status	OHSU Knight Cancer Institute	N/A	2004-02-01	This clinical trial studies magnetic resonance imaging (MRI) using a contrast imaging agent ferumoxytol (ferumoxytol non-stoichiometric magnetite) in improving viewing tumors in patients with high-grade brain tumors or cancer that has spread to the brain. Diagnostic procedures, such as MRI, may help find and diagnose brain tumors and find out how far the disease has spread. The contrast imaging agent ferumoxytol non-stoichiometric magnetite consists of small iron particles taken by the blood stream to the brain and to the area of the tumor. It may help visualize the blood flow going through the tumor better than the standard substance gadolinium-based contrast agent.

Clinical Trial Conditions for FERUMOXYTOL

Condition Name

Condition Name for FERUMOXYTOL
Intervention	Trials
Iron Deficiency Anemia	14
Anemia	7
Metastatic Malignant Neoplasm in the Brain	4
Anemia, Iron Deficiency	4

Condition MeSH

Condition MeSH for FERUMOXYTOL
Intervention	Trials
Anemia	25
Anemia, Iron-Deficiency	24
Deficiency Diseases	14
Brain Neoplasms	11

Clinical Trial Locations for FERUMOXYTOL

Trials by Country

Trials by Country for FERUMOXYTOL
Location	Trials
United States	282
India	16
Canada	16
Poland	7
Hungary	5

Trials by US State

Trials by US State for FERUMOXYTOL
Location	Trials
Massachusetts	23
California	21
Oregon	16
Maryland	15
Pennsylvania	14

Clinical Trial Progress for FERUMOXYTOL

Clinical Trial Phase

Clinical Trial Phase for FERUMOXYTOL
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	19
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for FERUMOXYTOL
Clinical Trial Phase	Trials
Completed	33
Recruiting	18
Withdrawn	9

Clinical Trial Sponsors for FERUMOXYTOL

Sponsor Name

Sponsor Name for FERUMOXYTOL
Sponsor	Trials
AMAG Pharmaceuticals, Inc.	27
National Cancer Institute (NCI)	20
OHSU Knight Cancer Institute	13

Sponsor Type

Sponsor Type for FERUMOXYTOL
Sponsor	Trials
Other	88
Industry	38
NIH	30

FERUMOXYTOL Market Analysis and Financial Projection

Ferumoxytol: Clinical Trials, Market Analysis, and Projections

Introduction to Ferumoxytol

Ferumoxytol, a superparamagnetic iron oxide nanoparticle, has been gaining significant attention in both clinical and market spheres. Initially approved for intravenous iron replacement therapy, it has expanded its applications into diagnostic imaging, particularly in magnetic resonance imaging (MRI).

Clinical Trials Update

Ongoing Clinical Trials

One notable ongoing clinical trial involves the use of ferumoxytol in magnetic resonance imaging (MRI) of pediatric patients with brain tumors. This Phase II drug clinical trial, funded by the National Cancer Institute (NCI) and the National Institute of Child Health and Human Development (NICHD), is currently recruiting participants. The trial aims to evaluate the safety and efficacy of ferumoxytol as an MRI contrast agent in this specific patient population[1].

Previous Clinical Trials

Previous clinical trials have been instrumental in expanding the indications for ferumoxytol. For instance, the FDA approved a supplemental new drug application for ferumoxytol injection in 2021, allowing its use in all eligible adults with iron-deficiency anemia (IDA) who cannot tolerate or have not responded to oral iron. This approval was based on several Phase III trials that compared ferumoxytol with other intravenous iron therapies, such as iron sucrose and ferric carboxymaltose. These trials demonstrated that ferumoxytol was comparable in efficacy and had a favorable safety profile, with lower incidence of severe hypophosphatemia compared to ferric carboxymaltose[4].

Market Analysis

Current Market Size and Growth

The global intravenous iron drugs market, which includes ferumoxytol, is experiencing significant growth. As of 2021, the market was valued at approximately $2.6 billion and is projected to reach $6.3 billion by 2032, growing at a CAGR of 8.5%[5].

Market Segmentation

The intravenous iron drugs market is segmented by product, application, and region. Ferumoxytol, as a product, is part of the broader category of intravenous iron drugs. The market is dominated by ferric carboxymaltose, which held nearly 50% of the revenue share in 2021 due to its high-dose replacement capability, improved performance, and lower cost. However, ferumoxytol remains a significant player, especially with its expanding use in MRI diagnostics[5].

Competitive Landscape

The market for intravenous iron drugs is competitive, with several industry players introducing innovative products. For example, Sandoz U.S. received approval for ferumoxytol in July 2021, further expanding its market presence[2].

Projections and Future Outlook

Market Projections

The global intravenous iron drugs market is expected to continue its upward trajectory, driven by increasing demand for effective and safe iron replacement therapies. By 2028, the market is projected to reach $4.02 billion, with ferumoxytol contributing significantly to this growth[2].

Diagnostic Imaging

Ferumoxytol's role in MRI diagnostics is expected to grow, particularly given its advantages over traditional gadolinium-based contrast agents. These include reduced contrast agent dosage, extended imaging windows, no nephrotoxicity, and higher MRI time efficiency. The off-label use of ferumoxytol for ferumoxytol-enhanced MRI (FE-MRI) has already reshaped CE-MRI practices, and ongoing research is likely to further solidify its position in diagnostic imaging[3].

Safety and Efficacy

As more clinical data becomes available, concerns about the safety of ferumoxytol, especially in pregnant and pediatric populations, have lessened. The FDA's recommendation for slow titration in 2015 has also contributed to safer administration practices. The unique advantages of ferumoxytol, including its molecular imaging capabilities and reduced risk of severe hypophosphatemia, are expected to drive its adoption in various clinical settings[3][4].

Key Takeaways

• Clinical Trials: Ongoing Phase II trials are exploring ferumoxytol's use in MRI for pediatric patients with brain tumors.
• Market Growth: The intravenous iron drugs market, including ferumoxytol, is projected to reach $6.3 billion by 2032.
• Diagnostic Imaging: Ferumoxytol is revolutionizing MRI diagnostics with its safer and more efficient contrast options.
• Safety and Efficacy: Ferumoxytol has a favorable safety profile and is effective in treating iron-deficiency anemia and enhancing MRI imaging.
• Market Competition: The market is competitive, but ferumoxytol's unique benefits position it as a significant player.

FAQs

Q: What is ferumoxytol primarily used for?

Ferumoxytol is primarily used for intravenous iron replacement therapy, particularly in patients with iron-deficiency anemia (IDA) who cannot tolerate or have not responded to oral iron.

Q: What are the advantages of ferumoxytol in MRI diagnostics?

Ferumoxytol offers several advantages in MRI diagnostics, including reduced contrast agent dosage, extended imaging windows, no nephrotoxicity, and higher MRI time efficiency compared to traditional gadolinium-based contrast agents.

Q: What is the current market size of the intravenous iron drugs market?

As of 2021, the global intravenous iron drugs market was valued at approximately $2.6 billion.

Q: What is the projected growth of the intravenous iron drugs market?

The market is expected to reach $6.3 billion by 2032, growing at a CAGR of 8.5%.

Q: What are the common side effects associated with ferumoxytol?

Common side effects include diarrhea, headache, nausea, dizziness, hypotension, constipation, and peripheral edema.

Sources

1. Orphanet: Ferumoxytol in Magnetic Resonance Imaging of Pediatric Patients With Brain Tumors.
2. Polaris Market Research: Intravenous Iron Drugs Market Size Worth $4.02 Billion by 2028.
3. Oxford Academic: Unveiling the next generation of MRI contrast agents: current status and future directions.
4. ASH Clinical News: FDA Expands Approval of Ferumoxytol Injection for Iron Deficiency Anemia.
5. PharmiWeb: Sales of Intravenous Iron Drugs Market is Estimated to hit US$ 6.3 Bn at a CAGR of 8.5% by year 2032-end.