Gadopiclenol

PRINCETON, N.J., Feb. 20, 2026 /PRNewswire/ -- Guerbet, a global specialist in contrast media and solutions for medical imaging, is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved a labeling update for Elucirem™ (gadopiclenol) injection. The new indication includes approval for pediatric patients aged 0-2 years (including term neonates) for its macrocyclic high-relaxivity gadolinium-based contrast agent. Continue Reading elucirem Guerbet's innovation, Elucirem™ is the first gadolinium-based contrast agent approved at half dose of gadolinium, and with the highest relaxivity, in comparison to other available gadolinium-based contrast agents (GBCA) [1]. Elucirem™ was approved by the FDA in September 2022 and by the EMA in December 2023. It is produced in France and also in the U.S. and is marketed by Guerbet in the following forms: vials and prefilled syringes. In the U.S., Elucirem is indicated in adults and now in pediatric patients including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in [2]: The central nervous system (brain, spine, and associated tissues) The body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) For these indications, an MRI examination with Elucirem™ requires half the conventional dose compared to that required with existing nonspecific contrast agents, thus addressing a concern of practitioners about gadolinium exposure.[3], [4], [5]"The new indication of Elucirem™ for pediatric patients, including term neonates, reflects our commitment to combining medical innovation and patient experience. Imaging departments will be able to perform contrast-enhanced MR imaging using half the conventional gadolinium dose, which is critical for patients, especially those requiring serial MRI examinations during their lifetime, as it reduces cumulative gadolinium exposure", explains Jim Patterson, General Manager North America"Our pediatric patients are still developing and often vulnerable and we want to consider that with everything we do. One key asset of Elucirem™ is that, thanks to its higher relaxivity, we can get good image quality using only half the conventional gadolinium dose. That makes a real difference in terms of amount of gadolinium injected, especially for these young patients, without losing diagnostic accuracy.", says Dr. Azam Eghbal, Medical Director, Pediatric Radiology, Children's Hospital of Orange County ELUCIREMTM (gadopiclenol) injection Important Safety Information Indications and Usage ELUCIREMTM (gadopiclenol) injection is 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), and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system). Contraindications Contraindicated in patients with history of hypersensitivity reactions to ELUCIREM. Warnings and Precautions Risk Associated with Intrathecal Use: Intrathecal administration of GBCAs can cause serious adverse reactions including death, coma, encephalopathy, and seizures. The safety and effectiveness of ELUCIREM have not been established with intrathecal use. ELUCIREM is not approved for intrathecal use. Nephrogenic Systemic Fibrosis: GBCAs increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of ELUCIREM among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities. Hypersensitivity Reactions: With GBCAs, serious hypersensitivity reactions have occurred. Before ELUCIREM administration, assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders. Gadolinium Retention: Gadolinium is retained in the body for months or years in several organs. 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. Minimize repetitive GBCA imaging studies, particularly closely spaced studies when possible. Acute Kidney Injury: In patients with chronically reduced renal function, acute kidney injury requiring dialysis has occurred with the use of GBCAs. Extravasation and Injection Site Reactions: Injection site pain have been reported in the clinical studies with ELUCIREM. Extravasation during ELUCIREM administration may result in tissue irritation. Ensure catheter and venous patency before the injection of ELUCIREM. Interference with Visualization of Lesions Visible with Non-Contrast MRI: As with any GBCA, ELUCIREM may impair the visualization of lesions seen on non-contrast MRI. Adverse Reactions: In clinical trials, the most frequent adverse reactions that occurred in > 0.2% of patients who received ELUCIREM included: injection site pain, headache, nausea, injection site warmth, injection site coldness, dizziness, localized swelling and erythema. Postmarketing Experience with use of ELUCIREM or other GBCAs: Acute pancreatitis, acute respiratory distress syndrome, pulmonary edema. Use in Specific Populations Pregnancy: GBCAs cross the human placenta and result in fetal exposure. Lactation: There are no data on the presence of ELUCIREM in human milk, the effects on the breastfed infant, or the effects on milk production. Pediatric Use: The safety and effectiveness of ELUCIREM for use with MRI to detect and visualize lesions with abnormal vascularity have been established in pediatric patients including term neonates. The safety of ELUCIREM has not been established in preterm neonates. Geriatric Use: Elucirem is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Renal Impairment: Avoid use of GBCAs among patients with renal impairment unless the diagnostic information is essential and not available with non-contrast MRI or other modalities You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please see the full Prescribing Information , including the Medication Guide, for additional important safety information. About Guerbet At Guerbet, we build lasting relationships to enable better living. This is our Purpose. We are a global leader in medical imaging, offering a comprehensive range of pharmaceutical products, medical devices, and digital and AI solutions for diagnostic and interventional imaging.Pioneers in contrast agents for 99 years, with 2,905 employees worldwide, we continuously innovate and dedicate 9% of our revenue to Research & Development across four centers in France and the United States. Guerbet (GBT) is listed on Euronext Paris, Compartment B, and achieved €841 million in revenue in 2024. For more information, please visit . About Gadopiclenol Gadopiclenol, initially invented by Guerbet, with the subsequent contribution of intellectual property held by Bracco, is a gadolinium-based macrocyclic contrast agent (GBCA) with high relaxivity. The efficacy and safety of Gadopiclenol have been evaluated in MRI to detect and visualize lesions with abnormal vascularity in: central nervous system, head and neck, thorax, abdomen, pelvis and musculoskeletal system. Please click here for full Prescribing Information. About the Guerbet / Bracco Imaging 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. The strategic collaboration is expected to accelerate access to Gadopiclenol and deliver innovation, as well as better care to patients and caregivers alike. 1 GBCA: Gadolinium-Based Contrast Agent 2 Elucirem™ (Gadopiclenol) Prescribing information. 3 Robic C et al. Invest Radiol. 2019;54(8):475-484. 4 PRAC, European Medicines Agency, 2017 5 FDA Drug Safety Communication, 2017 Contacts: Jamie KULOW Email : [email protected] Phone : +1-314-828-9788 GU022600323 SOURCE Guerbet 21% more press release views with Request a Demo

Expanded EU approval reflects positive benefit-risk ratio of Vueway ® in children from birth MILAN , Jan. 27, 2026 /PRNewswire/ -- Bracco Imaging S.p.A., a global leader in diagnostic imaging, announces that on January 23, 2026, the European Commission (EC) amended the Marketing Authorisation for Vueway ® (gadopiclenol) in the European Union (EU), extending its approved indications to pediatric patients below 2 years of age. The extension granted by the EC followed the relevant positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), and the recommendation sent by EMA to the EC. (1) Vueway ® (gadopiclenol) is a novel macrocyclic gadolinium-based contrast agent (GBCA) approved in 36 countries and used to provide contrast enhancement in Magnetic Resonance Imaging (MRI) examinations, thus helping doctors find certain pathologies in patients in whom this would not be possible otherwise. (2) In the European Union (EU), Vueway ® was approved in December 2023 for its use in adults and children aged 2 years and older for contrast-enhanced MRI to improve the detection and visualization of pathologies with disruption of the blood-brain-barrier (BBB) and/or abnormal vascularity of the brain, spine, and associated tissues of the central nervous system, as well as contrast-enhanced MRI of the liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system. (3) On 11 December 2025, the CHMP adopted in EU a positive opinion for the extension of the approved indications of Vueway ® to infants and young children, including neonates, reinforcing the established safety and diagnostic performance of this new GBCA. (1) Vueway ® (gadopiclenol) is a highly stable, macrocyclic GBCA with the highest values of longitudinal relaxivity (r1) among all the currently approved GBCAs. (4) Large, multicenter clinical studies have shown that Vueway ® delivers comparable diagnostic efficacy at half the gadolinium dose of gadobutrol (5) , a GBCA widely used in clinical practice across the world. Lower-dose imaging offers the important clinical benefit of reducing exposure of patients to gadolinium. (6) "The ability to reduce exposure to gadolinium without affecting the diagnostic performance of MRI examinations is important for all patients receiving GBCAs, " said Alberto Spinazzi, Chief Medical & Regulatory Officer, Bracco Group. "This is particularly important when GBCAs are used in special patient populations, such as neonates, infants and toddlers, whose brains and body tissues are still maturing, and potential long-term effects of retained gadolinium are still unknown. Therefore, this approval on the extension of the use of Vueway ® from birth addresses a critical need." The positive CHMP opinion, the EMA recommendation, and the final EC approval were based on the results from study GDX-44-015 (study information and results are available here ). About gadolinium-based contrast agents Gadolinium-based contrast agents (GBCAs) are widely and routinely used to enhance the diagnostic performance of magnetic resonance imaging (MRI) examinations. Gadolinium is a rare earth metal that has unique magnetic properties that make it useful for the use in MRI imaging. 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 radiology 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 and radiology professionals in over 100 countries. Discover Bracco Imaging at . The Guerbet and Bracco Imaging 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. Furthermore, after an agreed transition period when Guerbet manufactures Gadopiclenol for both Guerbet and Bracco, both companies will manufacture the Gadopiclenol active ingredient and finished product. The strategic collaboration is expected to accelerate access to Gadopiclenol and deliver innovation, as well as better care to patients and caregivers alike. Media Contact: Bracco Press Contact: Carolina Bargoni Bracco Imaging, Communications Director Carolina.bargoni@bracco.com References CHMP post-authorisation summary of positive opinion for Vueway (EMAVR0000249008). Available at: . Accessed on December 17, 2025. Vueway® (gadopiclenol). Overview. Available at: . Accessed on December 17, 2025. Vueway® (gadopiclenol). Summary of Product Characteristics. Available at : . Accessed on December 17, 2025. 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. 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. 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. SOURCE Bracco Group