Bayer says Gadoquatrane met primary, secondary endpoints in trial

Bayer (BAYRY) announced results from the QUANTI Pediatric study, adding to the pharmacokinetic, safety and efficacy data of the investigational low-dose MRI gadolinium-based contrast agent adoquatrane. QUANTI Pediatric evaluated gadoquatrane in children with known or suspected disease undergoing contrast-enhanced magnetic resonance imaging at a gadolinium dose of 0.04 mmol Gd/kg body weight, representing a dose reduction of 60 percent compared to the macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight. Similar pharmacokinetic behavior was observed in the pediatric population, indicating that diagnostic performance of gadoquatrane in adults can also be applied to children. Details of QUANTI Pediatric were presented as late-breaking clinical trial data at this year’s annual congress of the Radiological Society of North America taking place in Chicago, USA, from November 30 to December 4, 2025. QUANTI Pediatric is part of Bayer’s pivotal QUANTI clinical development program, which also encompassed two multinational Phase III studies in adults. Based on positive QUANTI data, including the pediatric study, Bayer has submitted applications for marketing authorization of gadoquatrane in markets around the world, including Japan, the U.S., the EU and China, with further markets to follow in the next months. If approved, gadoquatrane would become the lowest dose macrocyclic gadolinium-based contrast agent available in the respective markets.