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First approval for Bayer’s low-dose MRI contrast agent Ambelvist™ (gadoquatrane) in Japan
- Approval granted for all indications and all age groups including children and newborns
- First high relaxivity low-dose MRI contrast agent in Japan – 60 percent less gadolinium compared to products on the Japanese market
- Further submissions to health authorities worldwide ongoing to secure marketing authorization in additional markets
Berlin, March 23, 2026 – Bayer today announced the world’s first approval of the MRI contrast agent gadoquatrane by the Ministry of Health, Labour, and Welfare in Japan. The next-generation high relaxivity low-dose macrocyclic gadolinium-based contrast agent (GBCA) is approved under the brand name Ambelvist™ for detecting and visualizing known or suspected pathologies in all body regions and the central nervous system (CNS) in adults and pediatric patients including newborns. The product delivers the lowest gadolinium (Gd) dose of all macrocyclic MRI contrast agents, with a 60% reduction per procedure compared to current options on the Japanese market, while maintaining image quality.
In light of health authority guidance and medical societies consistently recommending the lowest dose to achieve diagnostic goals, there is a clear demand for low-dose MRI contrast agents worldwide, including Japan. “All medicines should be administered at the lowest effective dose, and MRI contrast agents are no exception,” said Prof. Kohsuke Kudo, Department of Diagnostic Imaging, Hokkaido University, Japan. “Reducing patients’ lifetime exposure to gadolinium is therefore an important consideration. This is particularly relevant for patients with chronic conditions such as cancer and cardiovascular disease who require repeated MRI examinations, as well as for those with renal impairment and for pediatric patients. By substantially reducing the gadolinium dose while maintaining diagnostic image quality, gadoquatrane may represent a highly valuable option in advancing patient-centered care.”
With an aging population and an increase in chronic diseases such as cancer and heart disease, Japan has the highest number of MRI scanners per capita worldwide. Gadoquatrane is the first low-dose MRI contrast agent available on the Japanese market.
The approval is based on the clinical development program for gadoquatrane including the pivotal Phase III QUANTI studies and a Phase I/III pediatric study.
“This first approval for Ambelvist™ is supported by compelling clinical data, underlining its diagnostic value for broad clinical use. The approved comprehensive label in Japan comprises all patient populations and age groups, reducing the need for alternative agents for different patient populations,” said Dr. Konstanze Diefenbach, Head of Radiology R&D at Bayer’s Pharmaceuticals Division. “With this next generation high-relaxivity, low-dose MRI contrast agent demonstrating high stability, Bayer responds to the evolving demand for low-dose options to achieve diagnostic goals. This also showcases our commitment to advancing radiology with innovations that support patients and their treating physicians in getting clear answers about their health.”
Bayer has submitted applications for marketing authorization of gadoquatrane in additional markets around the world, including the U.S., the EU, and China, with more to follow. If approved, gadoquatrane would become the lowest dose macrocyclic gadolinium-based contrast agent available on the respective markets.
About QUANTI
The pivotal QUANTI clinical development program for gadoquatrane consisted of two large multinational, randomized, prospective double-blind, crossover Phase III studies – QUANTI CNS (Central Nervous System) and QUANTI OBR (Other Body Regions) – as well as the QUANTI Pediatric study in children. All studies evaluated gadoquatrane with a dose of 0.04 mmol gadolinium (Gd) per kilogram body weight. Images were assessed in a blinded, independent central read, with similar visualization scores for gadoquatrane compared to the macrocyclic trial comparators dosed at 0.1 mmol Gd/kg body weight while reducing the gadolinium dose by 60 percent. Several sub-analyses – including cardiac, abdominal and CNS imaging as well as magnetic resonance angiography (MRA) – confirmed the non-inferior performance of gadoquatrane in several clinical settings compared to the trial comparators. The pediatric study demonstrated similar pharmacokinetic and safety profiles for gadoquatrane in the pediatric population and adults, indicating that its diagnostic performance in adults can also be applied to children.
Across all studies, the observed safety profile was generally consistent with previous data on gadoquatrane and other macrocyclic GBCAs. No new safety signals were observed.
About gadoquatrane
Gadoquatrane is Bayer’s extracellular macrocyclic contrast agent for contrast enhancement in MRI. This low-dose gadolinium-based contrast agent features a distinct tetrameric structure with high stability and high relaxivity.
The compound has been approved in Japan under the brand name Ambelvist™ in March 2026. It has not been approved in any other jurisdiction. Bayer has submitted applications for marketing authorization of gadoquatrane in additional markets around the world.
About MRI
MRI is a non-invasive, radiation-free imaging method that provides detailed images of the body, helping to identify and distinguish potential abnormalities in organs and tissues. This supports physicians in answering critical medical questions related to the detection and monitoring of diseases. MRI contrast agents commonly contain gadolinium. For 2024, it is estimated that over 60 million doses of gadolinium-based contrast agents were administered worldwide. Cumulatively, since 1988, more than 900 million GBCA doses have been delivered globally.
About Radiology at Bayer
Building on a century of expertise, Bayer is committed to innovative products and high-quality services in diagnostic imaging to enhance patient care. Its leading radiology portfolio features contrast agents and devices for precise administration across modalities including computed tomography (CT), X-ray and magnetic resonance imaging (MRI), and positron emission tomography (PET). Bayer’s comprehensive offerings also include informatics solutions. In 2025, Bayer’s radiology products generated €2.2 billion in sales. Bayer continues to advance research and innovation in medical imaging, including in molecular imaging and other promising fields.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com.
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