Japan’s Ministry of Health, Labour, and Welfare has approved Bayer’s gadolinium-based MR contrast agent gadoquatrane, marking the first global authorization for the product. It will be marketed in the country under the name Ambelvist and is cleared for use across all indications and age groups, including newborns.

The agent is designed to deliver diagnostic imaging with a substantially lower gadolinium dose than currently available options. According to Bayer, gadoquatrane uses about 60% less gadolinium per scan than other macrocyclic contrast agents on the Japanese market, while maintaining comparable image quality.

The approval is supported by data from the QUANTI clinical program, which included two Phase III trials, focused on central nervous system and other body regions, as well as a pediatric study. Across these studies, gadoquatrane met noninferiority endpoints when compared with standard-dose macrocyclic agents, based on blinded image assessments. The trials evaluated a dose of 0.04 mmol/kg, versus 0.1 mmol/kg for comparator agents.
Safety findings were consistent with existing gadolinium-based contrast agents, with no new safety signals identified. The pediatric study also showed similar pharmacokinetics and safety profiles between children and adults.

Kohsuke Kudo, professor in the department of diagnostic imaging at Hokkaido University, said lower-dose contrast agents are aligned with clinical guidance. “All medicines should be administered at the lowest effective dose, and MR contrast agents are no exception,” he said. “Reducing patients’ lifetime exposure to gadolinium is therefore an important consideration.”

Japan represents a significant initial market, with the highest number of MR scanners per capita globally and a growing demand driven by aging demographics and chronic disease prevalence.

Bayer has submitted gadoquatrane for regulatory review in other regions, including the U.S., EU, and China. The agent is not yet approved outside Japan.

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