A Pilot Study on the Use of Gadopiclenol for Enhanced Cardiac MRI in Children with Congenital Heart Conditions: A self-controlled, non-randomised, open-label study to compare the image quality and diagnostic performance of gadopiclenol versus gadoterate meglumine

Start Date15 Feb 2026

Sponsor / Collaborator-

NCT07348640

/ Not yet recruitingPhase 3

A Prospective, Multi-National, Randomized, Double-Blind, Crossover Study to Evaluate the Efficacy and Safety of Gadopiclenol-enhanced MRA Compared to Gadoterate Meglumine-enhanced MRA in the Assessment of Steno-occlusive Disease in Adult Patients With Suspected Vascular Disease

Compare the diagnostic performance of gadopiclenol against gadoterate meglumine in patients with vascular diseases of supra-aortic, peripheral, or abdominal / renal arteries using MRI

Start Date02 Feb 2026

Sponsor / Collaborator

Guerbet SA

[+1]

100 Clinical Results associated with Gadopiclenol

100 Translational Medicine associated with Gadopiclenol

100 Patents (Medical) associated with Gadopiclenol

Literatures (Medical) associated with Gadopiclenol

06 Feb 2026·AMERICAN JOURNAL OF NEURORADIOLOGY

Prospective MR Evaluation of Endolymphatic Hydrops Using Half-dose Gadopiclenol.

Article

Author: Landegger, Lukas D ; Fu, Fanrui ; Blevins, Nikolas ; Christodoulou, Rafail ; Malik, Sachin ; Fischbein, Nancy ; Pham, Nancy

BACKGROUND AND PURPOSE:

Gadopiclenol is a next-generation macrocyclic gadolinium-based contrast agent (GBCA) distinguished by its high T1 relaxivity and kinetic stability. It was developed to address the clinical need for reduced gadolinium dosing while maintaining high diagnostic accuracy, thereby minimizing potential long-term risks associated with gadolinium retention. Although various neuroradiology applications have been explored, the potential benefits of gadopiclenol's increased T1 relaxivity have not been investigated for the purpose of evaluating endolymphatic hydrops (EH) using delayed contrast-enhanced inner ear imaging.

MATERIALS AND METHODS:

We prospectively enrolled 26 consecutive patients at our institution's Otology clinic based on the 2015 American Academy of Otolaryngology-Head and Neck Surgery criteria for Ménière disease (MD), including acute or fluctuating symptoms of vertigo, hearing loss, tinnitus, or aural fullness. Each patient underwent 4-hour delayed contrast-enhanced inner ear imaging at 3T with half-dose (0.05 mmol/kg) GBCA administration using gadopiclenol. The contrast-to-noise ratio (CNR) and signal-to-noise ratio (SNR) were determined. Assessment of blood-labyrinthine barrier (BLB) permeability, utricle-saccule discrimination, and endolymphatic hydrops was performed by two head and neck neuroradiologists. Image quality, SNR, and CNR was compared to previously published data that utilized the same technical parameters with a contrast dose of 0.1 mmol/kg.

RESULTS:

Fifty-one ears were analyzed. One ear was excluded based on a prior history of left labyrinthectomy after failed medical management of MD. There were 31 symptomatic and 20 asymptomatic ears determined by clinical and hearing evaluation. Delayed contrast-enhanced inner ear imaging with gadopiclenol at 0.05 mmol/kg provided comparable CNR and SNR to gadobenate dimeglumine at 0.1 mmol/kg, with no statistically significant difference (P > 0.05). There was excellent interobserver agreement for the grading EH (κ>0.80).

CONCLUSIONS:

Our study demonstrates that 3D-FLAIR inner ear imaging using gadopiclenol at 0.05 mmol/kg is a reliable method for detecting clinically concordant EH and that image quality, based on qualitative and quantitative metrics, is comparable to a previously published study using gadobenate dimeglumine at a single-dose of 0.1 mmol/kg.

01 Dec 2025·Japanese Journal of Radiology

Pharmacokinetics and safety of gadopiclenol in Japanese healthy volunteers

Article

Author: Pitrou, Camille ; Taoka, Toshiaki ; Felices, Mathieu ; Eto, Takashi

Abstract:

Purpose:

The aim of this study was to evaluate the pharmacokinetics and safety of gadopiclenol in Japanese healthy volunteers. A population-based pharmacokinetic approach was used to compare pharmacokinetic parameters with a non-Japanese adult population.

Materials and methods:

In this double-blind, placebo-controlled phase I study, Japanese healthy volunteers were randomized to receive gadopiclenol (at 0.025, 0.05, or 0.1 mmol/kg) or a placebo. Blood and urine samples were collected up to 24- and 48-h post-administration, respectively. The pharmacokinetic profile of gadopiclenol was evaluated using standard non-compartmental analysis. Adverse events (AEs) were collected during the whole study period.

Results:

Overall, 27 participants were randomized (median [range] age: 22 [20–43] years; 52% male): 18 received gadopiclenol (6 in each dose group), and 9 received the placebo. The mean systemic exposure of gadopiclenol increased proportionally with the injected dose (area under the curve [AUC]: 215–1034 μg/mL.h) and was comparable between the three dose groups when normalized to dose (AUC/dose: 182–189 μg/mL/g.h) and to non-Japanese (168–183 μg/mL.h). The mean terminal half-life (1.43–1.86 h), and the distribution volume (11.3–15.2 L) were also similar to those of non-Japanese healthy volunteers (1.50–1.73 h and 13.0–15.5 L, respectively). The mean fraction of gadopiclenol excreted in urine was between 87 and 95%, depending on the administered dose. Most of gadopiclenol (median of 95.7%) was excreted within 24 h after administration. The mean total clearance was comparable between the different administered doses (5.3–5.6 L/h) and similar to the mean renal clearance. No gadopiclenol-related AEs were reported.

Conclusions:

The pharmacokinetic profile of gadopiclenol is similar in Japanese and non-Japanese healthy volunteers. The population pharmacokinetic analysis showed no significant ethnic disparities between these two populations and suggested that no dose adjustment was required for Japanese patients. Gadopiclenol had a very good tolerability in Japanese healthy volunteers with no adverse reactions reported.

01 Oct 2025·ANALYTICA CHIMICA ACTA

Interaction study between gadolinium-based contrast agents and lysozyme using frontal analysis continuous capillary electrophoresis

Article

Author: Chamieh, Joseph ; Rousseaux, Olivier ; Somnin, Chutintorn ; Leclercq, Laurent ; Cottet, Hervé ; Medina, Christelle

BACKGROUND:

Gadolinium-based contrast agents (GBCA) are widely used in magnetic resonance imaging (MRI) to enhance image contrast. However, their interactions with biological macromolecules remain an important area of investigation due to potential safety concerns. Developing robust analytical methods to study these interactions is essential for improving safety assessments and guiding the design of next-generation contrast agents.

RESULTS:

In this study, we employed Frontal Analysis Continuous Capillary Electrophoresis (FACCE) to investigate the binding interactions between lysozyme, a model protein, and several GBCA, including Gd-DTPA (Gadopentetate, Magnevist®), Gd-BOPTA (Gadobenate, Multihance®), Gd-DOTA (Gadoterate, Dotarem®), Gd-PCTA D2 (Gadopiclenol, Elucirem™) and Gd-HP-DO3A (Gadoteridol, Prohance®). Our results demonstrate that GBCA exhibit varying degrees of cooperative binding to lysozyme, with stoichiometry (n) of 4 for Gd-DTPA, Gd-BOPTA, and Gd-DOTA. The strength of interactions followed the trend: Gd-BOPTA (Multihance®) > Gd-DTPA (Magnevist®) > Gd-DOTA (Dotarem®), while Gd-PCTA D2 (Elucirem™) showed no significant binding. However, FACCE was unable to resolve interactions for Gd-HP-DO3A (Prohance®) due to interference with lysozyme.

SIGNIFICANCE:

FACCE is a well-adapted method to investigate GBCA-protein interaction. It requires low sample volumes and allows determining the stoichiometry, binding constant, and cooperativity of the interaction. This work emphasizes the cooperative nature of the GBCA-lysozyme interactions and indicates that the Hill model is suitable for analysing the interactions within the tested concentration range of GBCAs.

News (Medical) associated with Gadopiclenol

23 Feb 2026

·www.prnewswire.com

FDA Approves VUEWAY® (gadopiclenol) Solution for Injection, Intravenous Use, for Use in Neonates and Infants

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 PRINCETON, N.J., Feb. 23, 2026 /PRNewswire/ -- 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 Please see Important Safety Information below. VUEWAY® (gadopiclenol) injection for intravenous use Dosage Forms VUEWAY® is available in single-dose vials, single-dose prefilled syringes, pharmacy bulk packages, and imaging bulk packages. The VUEWAY Imaging Bulk Package (IBP) is for intravenous use and not for direct infusion. IBP is used for dispensing multiple single doses of gadopiclenol injection for multiple patients, using an automated contrast injection system, or contrast management system approved or cleared for use with this contrast agent in this Imaging Bulk Package. See drug and device labeling for information on devices indicated for use with this Imaging Bulk Package and techniques to help assure safe use. Indications VUEWAY injection is indicated in adults and children, including term neonates (children younger than 2 years of age), 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. VUEWAY is not approved for intrathecal use. NEPHROGENIC SYSTEMIC FIBROSIS Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs 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 < 30 mL/min/1.73 m²), or Acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g., age > 60 years, hypertension, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. For patients at highest risk for NSF, do not exceed the recommended VUEWAY dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration. Contraindications VUEWAY injection is contraindicated in patients with history of hypersensitivity reactions to VUEWAY. Warnings and Precautions There are risks associated with intrathecal use of GBCAs that can cause serious adverse reactions including death, coma, encephalopathy, and seizures. The safety and effectiveness of VUEWAY have not been established with intrathecal use and VUEWAY is not approved for intrathecal use. Risk of nephrogenic systemic fibrosis is increased in patients using GBCA agents that have impaired elimination of the drugs, with the highest risk in patients with chronic, severe kidney disease as well as patients with acute kidney injury. Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities. Hypersensitivity reactions, including serious hypersensitivity reactions, could occur during use or shortly following VUEWAY administration. Assess all patients for any history of a reaction to contrast media, bronchial asthma, and/or allergic disorders, administer VUEWAY only in situations where trained personnel and therapies are promptly available for the treatment of hypersensitivity reactions, and observe patients for signs and symptoms of hypersensitivity reactions after administration. Gadolinium retention can be for months or years in several organs after administration. The highest concentrations (nanomoles per gram of tissue) have been identified in the bone, followed by other organs (brain, skin, kidney, liver, and spleen). Minimize repetitive GBCA imaging studies, particularly closely spaced studies, when possible. Acute kidney injury requiring dialysis has occurred with the use of GBCAs in patients with chronically reduced renal function. The risk of acute kidney injury may increase with increasing dose of the contrast agent. Extravasation and injection site reactions can occur with administration of VUEWAY. Ensure catheter and venous patency before the injection of VUEWAY. VUEWAY may impair the visualization of lesions seen on non-contrast MRI. Therefore, caution should be exercised when VUEWAY MRI scans are interpreted without a companion non-contrast MRI scan. The most common adverse reactions (incidence ≥ 0.5%) are injection site pain (0.7%), and headache (0.7%). POST-MARKETING EVENTS The following adverse reactions have been identified during postmarketing use of GBCAs. Gastrointestinal Disorders: Acute pancreatitis with onset within 48 hours after GBCA administration. General Disorders and Administration Site Conditions: Fatigue, asthenia, pain syndromes, and heterogeneous clusters of symptoms in the neurological, cutaneous, and musculoskeletal systems with variable onset and duration after GBCA administration. Respiratory, Thoracic and Mediastinal Disorders: Acute respiratory distress syndrome, pulmonary edema. Skin Disorders: Gadolinium-associated plaques. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please click here for full Prescribing Information for VUEWAY (gadopiclenol) injection for intravenous use, including BOXED WARNING on Nephrogenic Systemic Fibrosis. Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08540, by BIPSO GmbH, 78224 Singen (Germany): (vials only). VUEWAY is a registered trademark of Bracco Imaging S.p.A. All other trademarks and registered trademarks are the property of their respective owners. Bracco Diagnostics Inc. 510 Carnegie Center Suite 300 Princeton, NJ 08540 USA Phone: 609-514-2200 Toll-Free: 1-800-631-5245 (U.S. only) Fax: 609-514-2424 ©2026 Bracco Diagnostics Inc. All Rights Reserved. 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: . 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: . Accessed on January 27, 2026. 11 European Medicines Agency European Commission decision on VUEWAY. Available at: . Accessed on January 28, 2026. US-VW-2600001 2/26 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 SOURCE Bracco Group 21% more press release views with Request a Demo

Drug ApprovalDiagnostic Reagents

20 Feb 2026

·www.prnewswire.com

New indication in pediatric patients, including term neonates for Guerbet's half-dose GBCA, Elucirem™ (Gadopiclenol) Injection

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

Drug Approval

28 Jan 2026

·www.biospace.com

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 . 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

Drug Approval

100 Deals associated with Gadopiclenol

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Contrast agents	South Korea	Guertbet Korea Ltd	12 Jan 2026
Diagnostic agents	European Union	Bracco Imaging SpA	07 Dec 2023
Diagnostic agents	European Union	Guerbet SA	07 Dec 2023
Diagnostic agents	Iceland	Bracco Imaging SpA	07 Dec 2023
Diagnostic agents	Iceland	Guerbet SA	07 Dec 2023
Diagnostic agents	Liechtenstein	Guerbet SA	07 Dec 2023
Diagnostic agents	Liechtenstein	Bracco Imaging SpA	07 Dec 2023
Diagnostic agents	Norway	Bracco Imaging SpA	07 Dec 2023
Diagnostic agents	Norway	Guerbet SA	07 Dec 2023
Central Nervous System Diseases	United States	Guerbet LLC	21 Sep 2022
Vascular Diseases	United States	Guerbet LLC	21 Sep 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Vascular Malformations	NDA/BLA	Canada	Bracco Imaging SpA	01 Apr 2025
Heart Defects, Congenital	Phase 3	United States	Bracco Imaging SpA	01 May 2024
Glioma	Phase 3	Hungary	Guerbet LLC	07 Sep 2023
Glioma	Phase 3	Italy	Guerbet LLC	07 Sep 2023
Glioma	Phase 3	Poland	Guerbet LLC	07 Sep 2023
Brain Stem Glioma	Phase 3	Hungary	Guerbet SA	20 Mar 2023
Brain Injuries	Phase 3	Italy	Guerbet SA	12 Jun 2019
Neoplasm Metastasis	Phase 3	Italy	Guerbet SA	12 Jun 2019
Blood brain barrier defect	Phase 3	United States	Guerbet LLC	03 Jun 2019
Blood brain barrier defect	Phase 3	Belgium	Guerbet LLC	03 Jun 2019

Clinical Result

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Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06057168 (GDX-44-016, CTgov)	Phase 3	Glioma \| Brain Stem Glioma	138	Elucirem (Elucirem)	gmakqmcsng = ekwojqchkg tebvzwbfjr (uugituvvfv, qwrswixiri - cuymxumhtp) View more	-	29 Jan 2026
				Dotarem (Dotarem)	gmakqmcsng = wvzdyazbeu tebvzwbfjr (uugituvvfv, wvowxllkeu - jsxmsnuizh) View more
NCT05590884 (CTgov)	Phase 2	Central Nervous System Diseases	36	Gadopiclenol (Age Group 1: Patients Aged 3 to 23 Months)	ymnovurizl(msrbjgprsb) = xljazjsfhe mknjutnktx (sushlawdna, 27.6) View more	-	28 Oct 2025
				Gadopiclenol (Age Group 2: Patients Aged 28 Days to Less Than 3 Months)	ymnovurizl(msrbjgprsb) = izgnfrojnc mknjutnktx (sushlawdna, 9.9) View more
NCT03986138 (PROMISE, CTgov)	Phase 3	-	324	Gadopiclenol (Patients With Gadopiclenol Paired Images)	maxfuennwz(paqzqdbelp) = xfvkcxijvs zxrkewuqqi (mnrewjxqvv, 0.03) View more	-	27 Oct 2025
				Gadopiclenol (Patients With Gadopiclenol Pre Images)	maxfuennwz(paqzqdbelp) = gvdzaeplzv zxrkewuqqi (mnrewjxqvv, 0.03) View more
NCT03996447 (PICTURE, CTgov)	Phase 3	Blood brain barrier defect	260	Gadopiclenol (Patients With Gadopiclenol Paired Images)	ebtsdkxscx(lfvywfgxqy) = toynppfdrv ikeluzvnms (nuiqmifevk, 0.02) View more	-	22 Sep 2025
				Gadopiclenol (Patients With Gadopiclenol Pre Images)	ebtsdkxscx(lfvywfgxqy) = qmvfgysbcv ikeluzvnms (nuiqmifevk, 0.02) View more
phase IIb study (ASCO2024)	Phase 2	Brain metastases	13	Gadopiclenol 0.1 mmol/kg	xldoeinkcq(mtrqdoqipj) = ngrennhyvz ouriqhehhd (htdftcfcbi ) View more	Positive	24 May 2024
NCT03749252 (CTgov)	Phase 2	Central Nervous System Cysts	80	P03277 (CNS Cohort 2-6 Years)	jokdybhuxu(lyamgdkmyq) = fdkvosbvxq awobdqhxby (czcitsidqk, iznvwswwus - pwcgfysfoy) View more	-	01 Jun 2022
				P03277 (CNS Cohort 7-11 Years)	jokdybhuxu(lyamgdkmyq) = broqyqvmlf awobdqhxby (czcitsidqk, aqrqtyuezl - eootcjwlti) View more
NCT02973516 (CTgov)	Phase 2	Hepatocellular Carcinoma \| Chronic liver disease	41	Gadopiclenol (Cohort 1)	uyfrggmzxm = jwydofewjg mnbmeovpqf (awqywpeohc, phdhjroxus - loiwwpfokb) View more	-	06 Oct 2021
				Gadopiclenol (Cohort 2)	uyfrggmzxm = omojhojafp mnbmeovpqf (awqywpeohc, jnpisjoqsl - kobpunusat) View more
NCT03657784 (Pubmed \| Invest Radiol)	Phase 1	Renal Insufficiency	40	Gadopiclenol (Healthy subjects)	cdarudreax(slnupwzerx) = mhakbgitev oalmwqtclo (rbvdwgpqfu )	-	01 Aug 2021
				Gadopiclenol (Subjects with mild renal impairment)	cdarudreax(slnupwzerx) = cnxzmrhpfc oalmwqtclo (rbvdwgpqfu )
NCT03996447 \| NCT03986138 (PICTURE \| PROMISE, Corporate Publications) Manual	Phase 3	Contrast agents	560	Gadopiclenol+gadobutrol	gmnflhmkzk(djarpanzxc) = the non-inferiority of Gadopiclenol (0.05 mmol/kg) compared to Gadobutrol (0.1 mmol/kg) for the visualization and detection of lesions of the central nervous system and in the other anatomical areas studied. owiknjeloy (jcwdmdgzjt ) View more	Positive	24 Mar 2021
				Gadobutrol+Gadopiclenol
NCT03657264 (CTgov)	Phase 1	-	48	P03277 (P03277 0.1 mmol/kg)	ddyanonmvw(dretiprgef) = njgjetooyo bttbzahqsc (oxreitlwlb, 0.88) View more	-	22 Aug 2019
				P03277 (P03277 0.3 mmol/kg)	ddyanonmvw(dretiprgef) = iiyjptddhz bttbzahqsc (oxreitlwlb, 0.89) View more

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