Bayer Seeks FDA Nod for Gadoquatrane as MRI Contrast Agent for CNS Use

• Bayer files NDA with FDA for gadoquatrane as an MRI contrast agent
• Phase III QUANTI trials support safety and efficacy across all age groups
• High relaxivity and stability offer effective imaging at reduced dose

Bayer has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for gadoquatrane, the firm's investigational gadolinium-based contrast agent for use in contrast-enhanced CNS and other body region MRI. The product will be approved for adult and pediatric patients, including term neonates, in doses of 0.04 mmol per kilogram of body weight of 60 percent below the dose levels will be standard macrocyclic GBCA dose levels.

The slide is grounded on Phase III QUANTI study findings, which assessed gadoquatrane safety and efficacy in various age groups in a universal environment. Preliminary results of the QUANTI CNS trial were showcased at the European Congress of Radiology (ECR) this year, and further updates shall be presented at future scientific events.

Bayer emphasized growing demand for MRI diagnosis, fueled by rates of chronic illness like cancer and cardiovascular disease that are soaring. Minimizing the dose of gadolinium is particularly significant for patients who need contrast-enhanced MRIs multiple times, according to worldwide health guidelines to reduce contrast usage and ensure image quality.

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Along with its U.S. filing, Bayer also filed in Japan, with additional filings throughout the world to follow.

The QUANTI clinical program enrolled more than 800 patients in 15 nations, with three studies of QUANTI CNS, QUANTI OBR (Other Body Regions), and QUANTI Paediatric. Results indicated that gadoquatrane achieved all major endpoints with a uniform safety profile and pharmacokinetics that were similar in adults and children.

Gadoquatrane has a tetrameric macrocyclic structure with high relaxivity and stability to provide clean imaging using a significantly reduced dose of gadolinium. Bayer continues to push the boundaries of radiology innovation in driving solutions across MRI, CT, and AI platforms to enable high-quality diagnostic care worldwide.