The European Commission extended the Marketing Authorisation for Vueway® (gadopiclenol) in the European Union for use in pediatric patients under 2 years of age

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 www.bracco.com.

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

1. CHMP post-authorisation summary of positive opinion for Vueway (EMAVR0000249008). Available at: https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-vueway-emavr0000249008_en.pdf. Accessed on December 17, 2025.
2. Vueway® (gadopiclenol). Overview. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/vueway#overview. Accessed on December 17, 2025.
3. Vueway® (gadopiclenol). Summary of Product Characteristics. Available at : https://www.ema.europa.eu/en/documents/product-information/vueway-epar-product-information_en.pdf. Accessed on December 17, 2025.
4. 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.
5. 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.
6. 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.

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