FDA approves gadopiclenol extension in neonates

The FDA has approved an extension of intravenous gadopiclenol (Vueway; Bracco) in infants and neonates, according to Bracco.¹

Gadopiclenol has proven efficacy for contrast enhancement at half the dose of other gadolinium-based contrast agents (GBCAs), which normally require a 0.1-mmol/kg dose. This allows reduced gadolinium exposure without compromising image quality, which is vital during MRI, especially in infants and neonates.¹

"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 at the University of Wisconsin.¹

Clinical efficacy and comparative studies

Among currently approved GBCAs, gadopiclenol has shown the greatest longitudinal relaxivity values, along with significant stability. Its efficacy at half the dose of other GBCAs has been proven in large, multicenter clinical studies. These trials compared it with gadobutrol, a GBCA often used in clinical practice.¹

Among these trials was the GDX-44-015 trial (NCT05590884), which led to the initial FDA approval.² The phase 2 trial included 3 groups of patients, with the first including those aged 3 to 23 months, the second those aged 28 days to less than 3 months, and the third those aged from birth to 27 days.

All patients received a single dose of gadopiclenol based on their body weight. Alongside efficacy outcomes, adverse events (AEs) were reported in these populations. No cases of all-cause mortality were reported, and serious adverse events were not reported in the younger groups.²

A rate of 24.24% was reported for serious adverse events in patients aged 3 to 23 months. This included blood and lymphatic system disorders, general disorders, infections and infestations, metabolism and nutrition disorders, nervous system disorders, product issues, renal and urinary disorders, and surgical and medical procedures, each reported in 1 patient.²

Nonserious AEs were reported in 39.39% of patients aged 3 to 23 months. Of these, vomiting was the most common in 15.15%. Notably, only 2 patients aged 28 to 89 days could be included in the population pharmacokinetic analysis, and none younger than 28 days could be included.²

Growing clinical adoption

In the US, over 3.5 million doses of gadopiclenol have been provided across approximately 900 customer sites.¹ According to experts, this highlights growing clinical adoption, alongside patient preference for lower-dose contrast agents.

The initial FDA approval for patients aged at least 2 years was given in September 2022, followed by European Union (EU) approval in December 2023. This EU approval was expanded in January 2026 to include infants and neonates.¹

The medication is available in multiple dosage forms. These include the following¹:

• Single-dose vials
• Single-dose prefilled syringes
• Pharmacy bulk packages
• Imaging bulk packages

When used in MRIs, gadopiclenol can improve the detection of lesions with abnormal vascularity in the central nervous system and the body. This includes, brain, spine, and associated tissues, as well as the head and neck, thorax, abdomen, pelvis, and musculoskeletal system.¹

"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,” said Chapman.¹

References

1. FDA approves Vueway (gadopiclenol) solution for injection, intravenous use, for use in neonates and infants. News release. Bracco Group. February 23, 2026. Accessed February 23, 2026. https://www.prnewswire.com/news-releases/fda-approves-vueway-gadopiclenol-solution-for-injection-intravenous-use-for-use-in-neonates-and-infants-302694204.html
2. Gadopiclenol pharmacokinetics, safety and efficacy in children < 2 years of age. ClinicalTrials.gov. Updated October 28, 2025. Accessed February 23, 2026. https://clinicaltrials.gov/study/NCT05590884?term=gadopiclenol%20pediatric&rank=1&tab=results#limitations-and-caveats