Bayer has submitted marketing authorization applications for gadoquatrane, its investigational low-dose MRI contrast agent, marking a potential paradigm shift in medical imaging safety and efficacy. The company filed applications with both the U.S. FDA and Japan's Ministry of Health, Labour, and Welfare (MHLW), with additional global submissions planned for 2025.
Addressing the Gadolinium Safety Challenge
Gadoquatrane delivers a 60% reduction in gadolinium dosing at 0.04 mmol/kg compared to standard macrocyclic contrast agents dosed at 0.1 mmol/kg, while maintaining diagnostic quality. This breakthrough addresses growing concerns about gadolinium retention in tissues, which can lead to nephrogenic systemic fibrosis in patients with kidney disease and potential long-term neurological impacts.
"As a leader in radiology, we are committed to bringing forward innovations for the benefit of patients, including potential options to reduce the gadolinium dose," said Dr. Konstanze Diefenbach, head of radiology research & development at Bayer. "If approved, gadoquatrane would offer radiologists a low-dose option to assist in diagnosing their patients."
Phase III Clinical Evidence
The regulatory submissions are supported by positive data from the pivotal QUANTI clinical development program, which investigated gadoquatrane across 808 patients in 15 countries. The program consisted of two large multinational, randomized, prospective double-blind, crossover Phase III studies: QUANTI CNS (Central Nervous System) and QUANTI OBR (Other Body Regions), plus the QUANTI Pediatric study.
Results from the QUANTI CNS trial, presented at the 2025 European Congress of Radiology, demonstrated that gadoquatrane met primary and secondary efficacy endpoints. The agent achieved non-inferiority to comparator agents in key visualization parameters including contrast enhancement and lesion delineation, while demonstrating superiority over unenhanced MRI. Secondary endpoints for sensitivity and specificity in lesion detection also met non-inferiority thresholds.
Safety data showed that adverse events observed with gadoquatrane were similar to those seen with comparator macrocyclic gadolinium-based contrast agents, with a low incidence of intervention-related treatment emergent adverse events.
Market Impact and Strategic Positioning
Gadoquatrane targets the $3.5 billion global MRI contrast agent market, where approximately 65 million contrast-enhanced procedures are performed annually worldwide. The agent's tetrameric macrocyclic structure provides high stability and high relaxivity, distinguishing it from existing products in a market dominated by legacy agents.
Japan represents a particularly strategic market, with the highest number of MRI scanners per capita worldwide and approximately 20 million procedures performed annually. The country's aging population and increasing prevalence of chronic diseases such as cancer and heart disease create significant demand for safer imaging options. Currently, no low-dose MRI contrast agents are available in Japan.
Clinical Applications and Patient Benefits
The reduced gadolinium dose could prove particularly valuable for patients requiring multiple MRI examinations throughout their lifetime, such as those with multiple sclerosis or brain tumors, as well as pediatric populations where minimizing exposure is paramount. The agent is indicated for contrast enhancement in MRI to detect and visualize known or suspected pathologies in all body regions and the central nervous system in both adults and pediatric patients, including neonates.
Regulatory Timeline and Commercial Outlook
The FDA's standard review timeline of 10-12 months suggests a potential 2026 U.S. launch, though priority review could accelerate approval. If successful, gadoquatrane would become the first low-dose macrocyclic GBCA available, potentially capturing significant market share in high-volume markets.
Bayer's radiology portfolio generated €2.1 billion in sales in 2024, and the company continues to advance research and innovation in medical imaging, including artificial intelligence integration. The success of gadoquatrane could significantly impact Bayer's pharmaceutical division, which has faced challenges with declining sales of legacy drugs.
