GRIN Therapeutics wins PRIME designation from EMA

The European Medicines Agency (EMA) has granted Priority Medicine (PRIME) designation to radiprodil, an investigational, potent negative allosteric modulator selectively targeting the N-methyl-D-aspartate receptor subtype 2B (NR2B or GluN2B), for the treatment of GRIN-related neurodevelopmental disorder (NDD), from neurodevelopmental disorders company GRIN Therapeutics.

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. The company remains on track to initiate a global pivotal Phase III clinical trial for radiprodil for the treatment of GRIN-related NDD in mid-2025.

“The decision by the EMA to award PRIME designation highlights the global unmet need for treatment options for individuals suffering from GRIN-related NDD and our efforts to develop the first selectively targeted treatment for this condition,” said Dr Michael Panzara, chief medical officer at Neurvati Neurosciences and GRIN Therapeutics. “We look forward to continuing to work with global regulatory authorities and the patient community to achieve this goal,” he added.