Nezglyal Receives Positive CHMP(Committee for Medicinal Products for Human Use of the European Medicines Agency) Opinion for Boys With cALD (Cerebral adrenoleukodystrophy)

Cerebral adrenoleukodystrophy is a rare and severe neurodegenerative disease in which brain lesions may progress rapidly, causing serious neurological decline.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of Nezglyal, or leriglitazone, for the treatment of cerebral adrenoleukodystrophy. The medicine is intended for boys aged 2 to 12 years with gadolinium-negative brain lesions. A final decision from the European Commission is expected by the end of September 2026.

The recommendation is based on results from the phase 2/3 NEXUS1 study and real-world evidence collected through compassionate-use programmes.There are currently no approved pharmacological treatments for cALD in the European Union. If authorised, Neuraxpharm will commercialise Nezglyal across Europe.