{"entity":{"id":"gadopiclenol","kind":"drug","name":"Gadopiclenol","aka":["gadopiclenol","Elucirem","Vueway"],"tldr":"A newer MRI dye given into a vein, approved in 2022 in the United States and 2023 in Europe, for brain and body scans including the liver, breast, lung and prostate in Europe.","summary":"Guerbet's Elucirem (NDA 216986, first approved 21 September 2022) and Bracco's Vueway carry the same American indication: 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)\" in adults and children including term neonates. Both were authorised in the European Union on 7 December 2023 (EMEA/H/C/005626 and 006172) for pathologies of the central nervous system and of \"the liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system\". ATC V08CA12. 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 Elucirem (NDA 216986)","url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216986"},{"label":"DailyMed label: Vueway","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=192725e9-e83e-1a36-33f2-abee55792ab3"},{"label":"EMA: Elucirem","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/elucirem"},{"label":"EMA: Vueway","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/vueway"},{"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","hcc","breast-cancer","prostate"],"sections":[],"technologies":["gadolinium-based-contrast-agents","mri"],"targets":[],"drugs":[],"companies":["guerbet","bracco"],"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":"Elucirem","modality":"Gadolinium-based contrast agent for MRI of the brain and body (intravenous)","mechanism":"A gadolinium chelate that brightens tissue on MRI where it leaks from abnormal blood vessels.","approvals":[{"region":"US","year":2022,"indication":"MRI of lesions with abnormal vascularity in the central nervous system and the body","note":"NDA 216986; Guerbet (Elucirem) and Bracco (Vueway)"},{"region":"EU","year":2023,"indication":"Contrast-enhanced MRI of the central nervous system and the liver, kidney, pancreas, breast, lung, prostate and musculoskeletal system","note":"Authorised 7 Dec 2023; Guerbet and Bracco Imaging"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/gadopiclenol/","neighbours":{"cancer":[{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"},{"id":"glioblastoma","kind":"cancer","name":"Glioma & glioblastoma","route":"/cancers/glioblastoma/"},{"id":"hcc","kind":"cancer","name":"Hepatocellular carcinoma","route":"/cancers/hcc/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"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":"bracco","kind":"company","name":"Bracco (Bracco Imaging and Bracco Diagnostics)","route":"/companies/bracco/"},{"id":"guerbet","kind":"company","name":"Guerbet","route":"/companies/guerbet/"}]}}