Gadopiclenol

Approval expands low-dose MRI contrast options for the youngest patients and reflects a positive benefit–risk profile of VUEWAY® injection from birth through adulthood Feb. 23, 2026 -- Bracco, a global leader in diagnostic imaging, today announced that the U.S. Food and Drug Administration (FDA) has approved the extension of the current VUEWAY® (gadopiclenol) solution for injection, intravenous use, for use in neonates and infants. VUEWAY® injection is a macrocyclic gadolinium-based contrast agent (GBCA) that provides effective contrast enhancement at half the gadolinium dose (0.05 mmol/kg) compared with other macrocyclic GBCAs approved in the United States (0.1 mmol/kg), helping reduce cumulative gadolinium exposure without compromising image quality.1,2,3 Reducing gadolinium exposure while maintaining diagnostic performance is important for all patients undergoing contrast-enhanced MRI, and is particularly critical in neonates and infants, whose brains and body tissues are still developing.4 Clinical guidance from radiology societies emphasizes the use of the lowest effective GBCA dose when contrast-enhanced imaging is required.4 "In the delivery of medical care, and particularly for our care of neonates and young children, we must consider potential long-term implications of our decisions today," said Teresa Chapman, MD, MA, FACR, Director of Fetal and Pediatric MR Imaging, Department of Radiology, University of Wisconsin School of Medicine & Public Health. "For diagnostic magnetic resonance imaging exams that require intravenous gadolinium contrast, we have a responsibility to achieve high-quality imaging while reducing cumulative exposure to gadolinium. An FDA-approved contrast agent that provides our required diagnostic quality with half the gadolinium dose represents meaningful progress for pediatric MRI. Additionally, limiting gadolinium amounts in production and in medical waste supports responsible contrast stewardship, which is an increasing focus for radiology sustainability efforts." VUEWAY® injection is a highly stable macrocyclic GBCA with the highest longitudinal relaxivity (r1) values among currently approved GBCAs. Large, multicenter clinical studies have demonstrated that VUEWAY® injection provides comparable diagnostic efficacy at half the gadolinium dose of gadobutrol, a GBCA widely used in clinical practice.5,6,7 "Imaging neonates and infants demands both precision and restraint," said Jeffrey H. Miller, MD, Pediatric Neuroradiologist and Chief of Radiology at Phoenix Children's Hospital. "The availability of a contrast agent that delivers strong visualization at a lower gadolinium dose gives clinicians another tool to balance diagnostic confidence with thoughtful exposure management. For practices caring for children who may require multiple MRIs over time, this represents a practical and clinically meaningful advancement." More than 3.5 million doses of VUEWAY® injection have been administered across approximately 900 customer sites in the U.S., reflecting growing clinical adoption and patient preference for lower-dose contrast agents.8,9 "When imaging is needed early in life, families want reassurance that every decision has been made with long-term safety in mind," said Gary Ray, Associate Director, MR Contrast, Bracco Americas. "This FDA approval provides clinicians with an approved option for contrast-enhanced MRI in neonates and infants that delivers diagnostic confidence at a lower gadolinium dose. By extending VUEWAY® injection to patients from birth, we are helping support essential imaging while being intentional about exposure in populations where long-term considerations matter most." The FDA approval was based on data from study GDX-44-015, which evaluated the safety and efficacy of VUEWAY® injection in pediatric patients. Gadopiclenol was first approved by the FDA in September 2022 and obtained EU approval in December 2023 for use in adult patients and in pediatric patients aged 2 years and older.10,11 In January 2026, gadopiclenol received EU approval expanding its approved indications to include neonates and infants.11 1 VUEWAY® (gadopiclenol) solution for injection, intravenous use. Full Prescribing Information and Patient Medication Guide. Princeton, NJ: Bracco Diagnostics Inc.; December 2025. 2 Loevner LA, Kolumban B, Hutóczki G, et al. Efficacy and safety of gadopiclenol for contrast-enhanced MRI of the central nervous system: the PICTURE randomized clinical trial. Invest Radiol. 2023 May;58(5):307-313. 3 Kuhl C, Csőszi T, Piskorski W, Miszalski T, Lee JM, Otto PM. Efficacy and safety of half-dose gadopiclenol versus full-dose gadobutrol for contrast-enhanced body MRI. Radiology. 2023 Jul; 308(1): e222612 4 American College of Radiology. ACR Manual on Contrast Media. 2025. Available at: https://www.acr.org/Clinical-Resources/Clinical-Tools-and-Reference/Contrast-Manua. Accessed January 29, 2026. 5 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. 6 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. 7 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. 8 Data on file. Three Million Doses. Bracco Diagnostics Inc.; September 2025. 9 Data on file. No. of Accounts. Bracco Diagnostics Inc.; September 2025. 10 U.S. Food and Drug Administration: 2022 Novel Drug Approvals (gadopiclenol). Available at: https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2022. Accessed on January 27, 2026. 11 European Medicines Agency European Commission decision on VUEWAY. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/vueway#authorisation-details. Accessed on January 28, 2026. 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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