New indication in pediatric patients, including term neonates for Guerbet’s half-dose GBCA, Elucirem™ (Gadopiclenol) Injection
Excerpt from the Press Release:
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.
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]:
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