European Commission grants marketing authorisation for NEZGLYAL® (leriglitazone), the first pharmacological treatment approved for cerebral Adrenoleukodystrophy (cALD), a rare neurodegenerative disease

News | 09. 25. 2026

Minoryx

BARCELONA, Spain and DÜSSELDORF, Germany, Sept. 25, 2026 -- Neuraxpharm Group and Minoryx Therapeutics today announce that the European Commission (EC) has granted marketing authorisation under exceptional circumstances for NEZGLYAL® (leriglitazone), an orally bioavailable, brain penetrating, selective PPAR gamma agonist, as a treatment for male cALD patients, aged 2-12 years with Gadolinium (Gd)-negative brain lesions. The therapy is the first approved pharmacological treatment for cALD in the European Union (EU). The approval is based on results from the Phase 2/3 NEXUS 1 study and additional real-world evidence from compassionate use programmes. The first European launch is expected in Germany by the end of the year, with additional launches in Europe anticipated pending completion of national reimbursement negotiations.