# Gadoquatrane

Source: https://onco.cc/drugs/gadoquatrane/  
OnCo record `gadoquatrane` (Imaging agent). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Imaging agent
- Status: approved
- Last checked: 2026-11-04
- Also known as: gadoquatrane; Ambelvist
- Tags: contrast-agents-gaps-2026-11; diagnostic
- 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: US 2026: MRI of lesions with abnormal vascularity in the central nervous system and the body

## Sources

- Drugs@FDA Ambelvist (NDA 219627): https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219627
- DailyMed label: Ambelvist: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fac80f5d-8d37-4237-bb52-0faef0dd46aa
- WHO ATC index V08CA: paramagnetic contrast media: https://atcddd.fhi.no/atc_ddd_index/?code=V08CA&showdescription=no

## Connected records

- cancers: [Brain metastases (secondary brain tumours)](https://onco.cc/cancers/secondary-brain-tumours/), [Glioma & glioblastoma](https://onco.cc/cancers/glioblastoma/)
- technologies: [Gadolinium-based and other MRI contrast agents](https://onco.cc/technologies/gadolinium-based-contrast-agents/), [MRI](https://onco.cc/technologies/mri/)
- companies: [Bayer](https://onco.cc/companies/bayer/)

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