NDAINTRAVENOUSSOLUTION
Approved
Jun 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
FERAHEME (ferumoxytol) by Novartis is shell, which helps to isolate the bioactive iron from plasma components until the iron-carbohydrate complex enters the reticuloendothelial system macrophages of the liver, spleen and bone marrow. First approved in 2009.
Drug data last refreshed 11h ago · AI intelligence enriched 18h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FERAHEME (ferumoxytol) is a parenteral iron replacement therapy administered intravenously as a solution. It treats iron deficiency anemia by delivering iron via a carbohydrate shell that protects bioactive iron until macrophages in the liver, spleen, and bone marrow uptake and process it for hemoglobin synthesis. The iron is released intracellularly and either stored as ferritin or transferred to plasma transferrin for transport to erythroid precursor cells.
LOE Approaching
Product approaching loss of exclusivity with modest competitive pressure (30/100); brand teams face consolidation as patent protection erodes and generic iron products enter the market.
Mechanism of Action
shell, which helps to isolate the bioactive iron from plasma components until the iron-carbohydrate complex enters the reticuloendothelial system macrophages of the liver, spleen and bone marrow. The iron is released from the iron-carbohydrate complex within vesicles in the macrophages. Iron then…
Pharmacologic Class:
Parenteral Iron Replacement
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance for the Detection of Calcified Coronary Arteries
Started Jan 2024
100 enrolled
Coronary Artery Calcification
A Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance Imaging for the Detection of Intracardiac Thrombus
Started Nov 2023
320 enrolled
Heart Aneurysm
A Safety Study of Pharmacologic Ascorbate and Ferumoxytol in Addition to Standard of Care Chemoradiation in Glioblastoma
Started Feb 2023
16 enrolled
GlioblastomaGlioblastoma Multiforme
Assessment of Renal Vasculature and Function with Ferumoxytol-enhanced Magnetic Resonance Imaging
Started Sep 2021
44 enrolled
Chronic Kidney Diseases
Comparison of Oral Ferrous Sulfate to Intravenous Ferumoxytol in Antepartum Iron Deficiency Anemia
Started Jan 2021
83 enrolled
Pregnancy RelatedAnemia, Iron Deficiency
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.