{"entity":{"id":"gadoquatrane","kind":"drug","name":"Gadoquatrane","aka":["gadoquatrane","Ambelvist"],"tldr":"A gadolinium MRI dye approved in the United States in 2026 for brain and body scans.","summary":"Bayer's Ambelvist (NDA 219627, original approval dated 12 June 2026 in Drugs@FDA) is indicated in adults and children, including term neonates, for MRI \"to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine, and associated tissues) the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system)\". ATC V08CA13. Like every gadolinium-based contrast agent in the United States, its label carries a boxed warning on the risks of intrathecal use and nephrogenic systemic fibrosis, a thickening of skin and organs seen in people with severe kidney disease.","status":"approved","asOf":"2026-11-04","links":[{"label":"Drugs@FDA Ambelvist (NDA 219627)","url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219627"},{"label":"DailyMed label: Ambelvist","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fac80f5d-8d37-4237-bb52-0faef0dd46aa"},{"label":"WHO ATC index V08CA: paramagnetic contrast media","url":"https://atcddd.fhi.no/atc_ddd_index/?code=V08CA&showdescription=no"}],"tags":["contrast-agents-gaps-2026-11","diagnostic"],"related":[],"cancers":["glioblastoma","secondary-brain-tumours"],"sections":[],"technologies":["gadolinium-based-contrast-agents","mri"],"targets":[],"drugs":[],"companies":["bayer"],"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":"Ambelvist","modality":"Gadolinium-based contrast agent for MRI of the brain and body (intravenous)","mechanism":"A gadolinium-based chelate that brightens tissue on MRI where it leaks from abnormal blood vessels.","approvals":[{"region":"US","year":2026,"indication":"MRI of lesions with abnormal vascularity in the central nervous system and the body","note":"NDA 219627; Bayer"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/gadoquatrane/","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/"}],"company":[{"id":"bayer","kind":"company","name":"Bayer","route":"/companies/bayer/"}]}}