{"entity":{"id":"ferabright-ferumoxytol","kind":"drug","name":"Ferumoxytol for brain MRI (FeraBright)","aka":["FeraBright","ferumoxytol MRI contrast"],"tldr":"An iron-based MRI dye, not gadolinium, approved in the United States in 2025 for brain scans in adults with known or suspected brain tumours.","summary":"Azurity's FeraBright (NDA 219868, first approved 16 October 2025) \"is indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier\". Its label carries a boxed warning: \"Fatal and serious hypersensitivity reactions, including anaphylaxis, have occurred in patients receiving ferumoxytol products that contain the same active ingredient as FERABRIGHT\". Ferumoxytol is also sold as an iron replacement medicine; this record is about the imaging product.","status":"approved","asOf":"2026-11-04","links":[{"label":"Drugs@FDA FeraBright (NDA 219868)","url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219868"},{"label":"DailyMed label: FeraBright","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac666008-a14f-43b4-9d06-ec70f45a4234"}],"tags":["contrast-agents-gaps-2026-11","diagnostic"],"related":[],"cancers":["glioblastoma","secondary-brain-tumours"],"sections":[],"technologies":["mri","gadolinium-based-contrast-agents"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo contrast agent gap fill (Drugs@FDA, FDA labels, DailyMed, EMA register, WHO ATC index)","editedOn":"2026-11-04"},"brand":"FeraBright","modality":"Iron-based contrast agent for MRI of the brain (intravenous)","mechanism":"Iron oxide nanoparticles coated with carbohydrate stay in the blood for a long time and alter the MRI signal where they leak into tissue through a disrupted blood-brain barrier.","approvals":[{"region":"US","year":2025,"indication":"MRI of the brain in adults with known or suspected malignant neoplasms in the brain","note":"NDA 219868; Azurity"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/ferabright-ferumoxytol/","neighbours":{"cancer":[{"id":"secondary-brain-tumours","kind":"cancer","name":"Brain metastases (secondary brain tumours)","route":"/cancers/secondary-brain-tumours/"},{"id":"glioblastoma","kind":"cancer","name":"Glioma & glioblastoma","route":"/cancers/glioblastoma/"}],"technology":[{"id":"gadolinium-based-contrast-agents","kind":"technology","name":"Gadolinium-based and other MRI contrast agents","route":"/technologies/gadolinium-based-contrast-agents/"},{"id":"mri","kind":"technology","name":"MRI","route":"/technologies/mri/"}]}}