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Gadopiclenol Pharmacokinetics, Safety and Efficacy in Pediatric Patients < 2 Years of Age

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Trial Profile

Gadopiclenol Pharmacokinetics, Safety and Efficacy in Pediatric Patients < 2 Years of Age

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 03 Mar 2026

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At a glance

  • Drugs Gadopiclenol (Primary)
  • Indications CNS disorders; Liver cancer
  • Focus Pharmacokinetics
  • Sponsors Guerbet

Most Recent Events

  • 20 Feb 2026 According to a Guerbet media release, 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.
  • 28 Jan 2026 According to the Bracco Imaging media release, 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.
  • 25 Dec 2025 According to the Bracco Imaging media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended an extension of the approved indications of Vueway to pediatric patients below 2 years of age. based on the results from study GDX-44-015.

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