17 June 2025 - Bayer today announced the submission of a new drug application to the US FDA for its investigational contrast agent gadoquatrane for contrast-enhanced magnetic resonance imaging of the CNS and other body regions in adults and paediatric patients including term neonates.
The submitted dose is 0.04 mmol gadolinium/kg body weight. If approved, gadoquatrane would become the lowest dose macrocyclic GBCA available in the US, corresponding to a 60 percent reduction compared to standard of care macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight.