India Pharma Outlook Team | Monday, 08 December 2025
Bayer’s investigational MRI contrast agent gadoquatrane is drawing industry attention today after new pediatric data strengthened its safety and performance profile.
The company revealed fresh results from its QUANTI Pediatric study at the RSNA annual congress, adding weight to its push for a next-generation, low-dose gadolinium option for children.
The open-label study evaluated children from birth through 17 years who required contrast-enhanced MRI. Even at a 0.04 mmol Gd/kg dose—a 60% reduction compared to standard macrocyclic GBCAs—gadoquatrane met every primary and secondary endpoint tied to safety and pharmacokinetics.
Researchers also found that children showed pharmacokinetic behavior similar to adults, suggesting consistent diagnostic reliability across age groups.
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“Contrast-enhanced MRI is increasingly used to assist in diagnosis and monitoring of certain conditions, from newborns to adulthood,” said Talissa Altes, Professor and Chair of Radiology at the University of Missouri, USA. She emphasized MRI’s value in diagnosing tumors and neurological diseases, noting that children who undergo multiple scans may benefit from a lower lifetime exposure option.
The QUANTI program spans 808 patients across 15 countries, including 93 children, and continues to show strong lesion detection at a significantly reduced gadolinium dose. Importantly, no new safety concerns have emerged. Bayer has already submitted global marketing applications in the U.S., EU, Japan, and China, positioning gadoquatrane to become the lowest-dose macrocyclic GBCA available if approved.
“Contrast-enhanced MRI serves as a crucial tool for disease detection and the ongoing condition management, including in children, and Bayer is committed to driving innovation in this important area,” said Dr. Konstanze Diefenbach, Head of Radiology Research & Development at Bayer’s Pharmaceuticals Division.
With pediatric MRI usage rising 5% each year, today’s results signal meaningful progress toward safer, low-dose imaging for young patients.
