Bayer HealthCare Pharmaceuticals has released Phase III clinical trial results confirming the efficacy of Gadobutrol, a macrocyclic 1.0 molar gadolinium-based contrast agent (GBCA) in patients referred for contrast-enhanced MRI of the central nervous system.
Gadobutrol, which is not yet approved by the US Food and Drug Administration, has met the primary efficacy objectives of the study.
By comparing unenhanced CNS MRI versus the combined unenhanced and Gadobutrol-enhanced CNS MRI, the trial showed statistically significant superiority (P<0.0001) of Gadobutrol images compared to unenhanced images.
The trial results were based on MRI images from 321 patients who underwent two sets of MRI scans.
GBCAs are used to detect and visualise certain lesions that are detected through unenhanced MRI scans.