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A Multinational, Multicenter Study With an Open-Label Phase 1b and a Randomized, Double-Blind, Placebo-Controlled Phase 3 Followed by an Open-Label Extension to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of Radiprodil in Participants With GRIN-Related Neurodevelopmental Disorder

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Trial Profile

A Multinational, Multicenter Study With an Open-Label Phase 1b and a Randomized, Double-Blind, Placebo-Controlled Phase 3 Followed by an Open-Label Extension to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of Radiprodil in Participants With GRIN-Related Neurodevelopmental Disorder

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Nov 2025

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At a glance

  • Drugs Radiprodil (Primary)
  • Indications Behavioural disorders; Neurodevelopmental disorders; Seizures
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms Beeline
  • Sponsors GRIN Therapeutics

Most Recent Events

  • 04 Nov 2025 Status changed from planning to recruiting.
  • 27 May 2025 According to a GRIN Therapeutics media release, company remains on track to initiate a global, pivotal Phase 3 clinical trial for radiprodil in GRIN-NDD in the third quarter of 2025.
  • 17 Mar 2025 According to a GRIN Therapeutics media release, company is on track to initiate a pivotal Phase 3 trial for radiprodil in mid-2025.

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