GRIN Therapeutics Inc, a developer of therapies to treat serious neurodevelopmental disorders, announced on Tuesday that it has received Priority Medicine (PRIME) designation for radiprodil from the European Medicines Agency (EMA).

Radiprodil is an investigational, potent negative allosteric modulator selectively targeting the N-methyl-D-aspartate receptor subtype 2B (NR2B or GluN2B), intended for the treatment of GRIN-related neurodevelopmental disorder (NDD).

This decision follows the recent announcements that radiprodil was awarded Breakthrough Therapy designation for the treatment of seizures associated with GRIN-related NDD with gain-of-function (GoF) mutations and Orphan Drug designation for the treatment of GRIN-related NDD by the US Food and Drug Administration (FDA) in February and March 2025, respectively.

GRIN Therapeutics said that it remains on track to initiate a global pivotal Phase 3 clinical trial for radiprodil for the treatment of GRIN-related NDD in mid-2025.