Gadopiclenol

Key Facts: Bayer’s AMBELVIST ® (gadoquatrane) becomes the lowest-dose macrocyclic gadolinium (Gd)-based contrast agent (mGBCA) approved in the U.S., with a recommended dose of 0.01 mmol/kg actual body weight delivering 0.04 mmol Gd/kg body weight 1 Approval is supported by data from the Phase III QUANTI clinical studies, which demonstrated efficacy at a fraction of the dose compared to mGBCAs dosed at 0.1 mmol Gd/kg body weight 1 WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer today announced that the U.S. Food and Drug Administration (FDA) approved AMBELVIST ® (gadoquatrane), a new, intravenous macrocyclic gadolinium (Gd)-based contrast agent (mGBCA) indicated for contrast-enhanced magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system (CNS) and non-CNS body regions in adult and pediatric patients, including term neonates. 1 AMBELVIST is a next-generation mGBCA with a novel tetrameric structure and high relaxivity (a measure of signal enhancement). 1 With this approval, AMBELVIST becomes the lowest-dose mGBCA in the U.S. AMBELVIST has a recommended dose of 0.01 mmol/kg actual body weight (which delivers 0.04 mmol Gd/kg body weight), representing 60% less Gd compared to mGBCAs with a Gd content of 0.1 mmol Gd/kg body weight and 20% less Gd compared to gadopiclenol with a Gd content of 0.05 mmol Gd/kg body weight. 1,2 WHY THIS APPROVAL MATTERS: Contrast-enhanced MRI is a medical imaging examination often used by clinicians to gain insight into what’s happening in the human body. This type of study can play an important role in detecting abnormalities, monitoring disease progression and informing treatment decisions. 3 For some adults and children with chronic diseases or conditions that require close, long-term monitoring—such as multiple sclerosis, other neurological or spinal conditions as well as different types of cancer—regular, serial images may be required. “I often rely on contrast-enhanced MRI exams to inform clinical decision making,” said Dr. Christopher Hancock, Director of Neuroradiology at HALO Diagnostics Desert Cities and an investigator for the QUANTI clinical studies. “With this approval, we now have an additional option that can help deliver contrast-enhanced images at the lowest macrocyclic GBCA dose, reducing gadolinium exposure while preserving the clinical information we often need.” KEY CLINICAL TRIAL FINDINGS: The FDA approval is based on the global pivotal Phase III QUANTI clinical studies, which evaluated the efficacy and safety of A MBELVIST in adult and pediatric patients, including term neonates, undergoing contrast-enhanced MRI. 1 Key findings demonstrated: Increased lesion visualization with the combined pre-contrast and post-contrast MRI sets with the decreased Gd dose in AMBELVIST compared with only pre-contrast MRI images. 1 Visualization scores and number of lesions identified per blinded independent reader for AMBELVIST dosed at 0.01 mmol/kg body weight (which delivers 0.04 mmol Gd/kg body weight) were similar to other tested mGBCAs with a Gd content of 0.1 mmol Gd/kg body weight in descriptive analyses. 1 The safety and effectiveness of AMBELVIST for use with MRI to detect and visualize lesions with abnormal vascularity in the CNS (brain, spine and associated tissues) and the body (head and neck, thorax, abdomen, pelvis and musculoskeletal system) have been established in pediatric patients, including term neonates. Use of AMBELVIST in this age group is supported by evidence from adequate and well-controlled studies of AMBELVIST in adults, with additional pharmacokinetic and safety data from 93 pediatric patients aged 28 days to less than 18 years who received one 0.01 mmol/kg dose of AMBELVIST and underwent MRI of any body region. 1 AMBELVIST is associated with a Boxed Warning regarding risks associated with intrathecal administration and nephrogenic systemic fibrosis and is contraindicated in patients with a history of severe hypersensitivity reactions to AMBELVIST. Additionally, there are Warnings and Precautions related to hypersensitivity reactions, gadolinium retention, acute kidney injury and interference with lesion visualization. Please see AMBELVIST Important Safety Information below for additional information. BAYER PERSPECTIVE ON AMBELVIST APPROVAL: Bayer has played a pioneering role in MRI contrast agent development, having launched the first GBCA in 1988, and is now adding AMBELVIST to its radiology portfolio as the lowest-dose mGBCA approved in the U.S. “At Bayer, our focus has always been on enhancing patient care, and we are proud to introduce AMBELVIST as our next-generation option for contrast-enhanced MRI,” said Jill Carbone, Vice President and Head of Radiology, North America Product & Pipeline, Bayer. “As a lower-gadolinium-dose GBCA, AMBELVIST supports healthcare providers in adhering to growing clinical guidance to utilize the lowest gadolinium dose necessary to adequately image patients.” 4 INDICATIONS AND IMPORTANT SAFETY INFORMATION INDICATIONS AMBELVIST ® (gadoquatrane) is a gadolinium-based contrast agent indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine, and associated tissues) the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) IMPORTANT SAFETY INFORMATION WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS Risk Associated with Intrathecal Use Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. AMBELVIST is not approved for intrathecal use. Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of AMBELVIST in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs. The risk for NSF appears highest among patients with: Chronic, severe kidney disease (GFR 60 years, hypertension, or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. For patients at highest risk for NSF, do not exceed the recommended AMBELVIST dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration. Contraindication and Important Information about Hypersensitivity Reactions: AMBELVIST ® is contraindicated in patients with a history of severe hypersensitivity reactions to AMBELVIST ® . Serious hypersensitivity reactions have occurred with GBCAs. Before AMBELVIST ® administration, assess all patients for any history of a reaction to contrast media, bronchial asthma, and/or allergic disorders. These patients may have an increased risk for a hypersensitivity reaction to AMBELVIST ® . Gadolinium Retention: Gadolinium is retained for months or years in several organs. Linear GBCAs cause more retention than macrocyclic GBCAs. At equivalent doses, retention varies among the linear agents. Retention is lowest and similar among the macrocyclic GBCAs. Consequences of gadolinium retention in the brain have not been established, but they have been established in the skin and other organs in patients with impaired renal function. While clinical consequences of gadolinium retention have not been established in patients with normal renal function, certain patients might be at higher risk. These include patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions. Consider the retention characteristics of the agent and minimize repetitive GBCA studies, when possible. Acute Kidney Injury: In patients with chronic renal impairment, acute kidney injury sometimes requiring dialysis has been observed with the use of some GBCAs. Do not exceed the recommended dose; the risk of acute kidney injury may increase with higher than recommended doses. Interference with Lesion Visualization As with other GBCAs, AMBELVIST ® may obscure certain lesions that are visible on non-contrast MRI. When available, non-contrast MRI images should be reviewed during the interpretation of AMBELVIST ® MRI scans. Adverse Reactions: The most frequently observed adverse reactions (incidence ≥ 0.2%) were dizziness, headache, injection site reactions, nausea, vomiting, feeling hot, paresthesia, and pruritus. Please click here for the Full Prescribing Information for AMBELVIST ® . About Radiology at Bayer Bayer’s Radiology business is a world leader among medical imaging solutions providers. The business transforms insight into technology and services with the goal of providing radiology solutions to help its customers enhance patient care. Its leading radiology portfolio features contrast agents and devices to help enable precise dose administration across modalities, equipment services, informatics and connected solution offerings. 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 . Find more information at Follow us on Facebook: Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. __________________________ 1 Bayer Pharmaceuticals. AMBELVIST (gadoquatrane) [package insert]. U.S. Food and Drug Administration. Available at: . 2 Bracco. Vueway (gadopiclenol) package insert. U.S. Food and Drug Administration. Available at: . 3 National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institutes of Health. Magnetic Resonance Imaging (MRI). Available at: . Accessed: 15 April 2026. 4 ACR manual on contrast media (2026) ACR . Available at: . Accessed: 15 April 2026. Contacts Contact for media inquiries: Elaine Colón Phone: +1-732-236-1587 Email: elaine.colon@bayer.com Contact for investor inquiries: Bayer Investor Relations Team Phone: +49 214 30-72704 Email: ir@bayer.com

Approval marks a major milestone in reducing gadolinium exposure while maintaining diagnostic performance, aligning with clinical guidance to use the lowest effective dose MONTREAL, April 17, 2026 /PRNewswire/ -- Bracco Imaging, a global leader in diagnostic imaging, today announced that Health Canada approved VUEWAY® injection (gadopiclenol), a macrocyclic gadolinium-based contrast agent (GBCA), for use in contrast-enhanced magnetic resonance imaging (CE-MRI). VUEWAY® injection is a highly kinetically stable, macrocyclic GBCA with the highest values of longitudinal relaxivity (r1) among macrocyclic GBCAs approved in major global markets.1 In clinical studies, VUEWAY® injection has demonstrated effective contrast enhancement at a dose of 0.05 mmol/kg—half of the 0.1 mmol/kg dose used with other GBCAs—resulting in reduced gadolinium exposure for patients.2,3,4 This approach aligns with clinical guidance from radiology societies, which emphasizes the use of the lowest effective GBCA dose when contrast-enhanced imaging is required.4 "Reducing gadolinium exposure is not only a clinical priority but increasingly an environmental one," said Dr. Kate Hanneman, Radiologist & Deputy Lead for Sustainability at the Joint Department of Medical Imaging, University of Toronto. "High-relaxivity gadolinium-based contrast agents that deliver diagnostic confidence at half the standard dose represent an important advance for Canadian patients, supporting both patient safety and environmental stewardship." VUEWAY® injection is indicated for use in adults and children 2 years and older for CE-MRI to detect and visualize lesions with disruption of the blood-brain-barrier (BBB) and/or abnormal vascularity in: the Central Nervous System (CNS), including brain, spine and surrounding tissues the Body, including head and neck, thorax (including breast), abdomen (including liver and kidneys), pelvis (including prostate), and musculo-skeletal system. The approval of VUEWAY® injection in Canada follows successful regulatory milestones in other major markets, including the United States (2022) and the European Union (2023). VUEWAY® injection is now approved in 37 countries, with more than 4 million patient doses administered worldwide, further strengthening Bracco Imaging's position in MRI.5 "The Health Canada approval of VUEWAY® injection is a pivotal milestone in Contrast Enhancement MRI procedures as it is meeting radiologists' goals to reduce exposure to Gadolinium agents to the patient population, such as children and adults who require frequent MRI procedures for screening, surveillance and evaluation of disease progression or regression," said Mr. Patrice Plourde, Sr. Director Sales & Marketing at Bracco Imaging Canada. "Alongside radiologists and technologists, we are guided by the ALARA (as low as reasonably achievable) principle to strive to meet the highest standards of safety and efficacy while minimizing the environmental footprint. Today, the entire Bracco organization looks forward to elevating the standard of care in the Canadian diagnostic imaging landscape." About Gadopiclenol Gadopiclenol, initially invented by Guerbet with subsequent contribution of Bracco IP, is a new macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity. The efficacy and safety of Gadopiclenol have been evaluated in MRI of the Central Nervous System, head and neck, thorax, abdomen, pelvis, and musculoskeletal system (refer to the approved USPI and Core SPC for full information). The product has been also approved for use on paediatric population from birth by FDA in US and EMA in Europe. Details on Phase III clinical trials are available on : Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) Full Text View - ClinicalTrials.gov Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI) Full Text View - ClinicalTrials.gov The Bracco Imaging and Guerbet collaboration Bracco Imaging and Guerbet in December 2021 entered a worldwide collaboration on Gadopiclenol manufacturing and research and development activities. Gadopiclenol will be commercialized independently under separate brands. Both Guerbet and Bracco Imaging each own valuable intellectual property on Gadopiclenol. Both companies will manufacture the product. The strategic collaboration is expected to accelerate access to Gadopiclenol and deliver innovation, as well as better care to patients and caregivers alike. About Bracco Imaging Bracco Imaging is a global leader in diagnostic imaging, dedicated to improving people's lives by shaping the future of prevention and precision medicine. With a strong passion for innovation, the company develops and provides a broad portfolio of pharmaceutical products for diagnostic imaging: contrast agents for X-ray, Computed Tomography (CT), and Magnetic Resonance Imaging (MRI), as well microbubbles for Contrast Enhanced Ultrasound (CEUS), and Molecular Imaging through radioactive tracers and novel PET imaging agents, alongside specialized medical devices and related services. The company is committed to advancing diagnostic imaging by sharing knowledge to cultivate future thought leaders, linking today's practice with tomorrow's progress. Since 1927, Bracco Imaging has grown to more than 3,800 employees and now supports patients, healthcare professionals, and healthcare systems in over 100 countries. Discover Bracco Imaging at . VUEWAY is a registered trademark of Bracco Imaging S.p.A. All other trademarks and registered trademarks are the property of their respective owners. ©2026 Bracco Diagnostics Inc. All Rights Reserved. Media Contact: Monica Rentschler Bracco Diagnostics Inc., Assoc. Director, Marketing Communications, Americas T +1 609.514.2382 [email protected] CA-VW-2600001 4/26 1. VUEWAY®. Product Monograph. Bracco Imaging S.p.A. April 2026. 2. Robic C, Port M, Rousseaux O, Louguet S, Fretellier N, Catoen S, Factor C, Le Greneur S, Medina C, Bourrinet P, Raynal I, Idée JM, Corot C. Physicochemical and Pharmacokinetic Profiles of Gadopiclenol: A New Macrocyclic Gadolinium Chelate With High T1 Relaxivity. Invest Radiol 2019; 54(8):475-484. 3. Hao J, Pitrou C, Bourrinet P. A Comprehensive Overview of the Efficacy and Safety of Gadopiclenol: A New Contrast Agent for MRI of the CNS and Body. Invest Radiol 2024; 59(2):124-130. 4. Kanal E, Maki JH, Schramm P, Marti-Bonmati L. Evolving Characteristics of Gadolinium-Based Contrast Agents for MR Imaging: A Systematic Review of the Importance of Relaxivity. J Magn Reson Imaging 2025; 61(1):52-69. 5. Data on file 4 million VW Calculator (19-MAR-2026) (v1.0) SOURCE Bracco Group 21% more press release views with Request a Demo