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The FDA on June 12, 2026 approved Ambelvist (gadoquatrane), Bayer's intravenous contrast agent, for MRI of the central nervous system and the rest of the body in adults and children, including term neonates.
Gadoquatrane is a tetrameric macrocyclic complex, binding four gadolinium centers to a single molecule, which lets it work at 0.01 mmol per kilogram and deliver 0.04 mmol of gadolinium per kilogram. Standard macrocyclic agents deliver 0.1 and gadopiclenol 0.05. Bayer says that makes it the lowest gadolinium dose approved in the United States.
Two crossover trials gave each patient Ambelvist and a comparator agent between two and 14 days apart. Study 1 covered 305 patients with central nervous system disease and Study 2 covered 410 with disease elsewhere. Three blinded readers scored enhancement, border delineation and internal morphology, and every reader scored the contrast-enhanced images above the unenhanced ones.
A boxed warning covers nephrogenic systemic fibrosis in patients who clear the drug poorly, and intrathecal use, for which the agent is not approved.
The label reports the comparison against existing agents descriptively, calling the scores similar rather than establishing non-inferiority. What the trials measured is contrast against no contrast in the labeled population.
Sources: FDA prescribing information; Drugs@FDA, NDA 219627; Bayer press release; QUANTI CNS study (NCT05915702); Applied Radiology
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