FDA Pauses Newron’s Phase III Schizophrenia Trial Following Patient Death

The U.S. Food and Drug Administration has halted enrollment in Newron Pharmaceuticals’ Phase III ENIGMA-TRS 2 trial evaluating evenamide for treatment-resistant schizophrenia (TRS), after a participant’s sudden death at a non-US study site.

Although investigators determined the death was not related to the treatment, the trial remains on hold pending FDA review. The independent safety monitoring board has recommended continuing the broader ENIGMA-TRS programme as planned. Meanwhile, the ENIGMA-TRS 1 study, which has enrolled over 400 patients across 21 countries, is ongoing.

Evenamide (NW-3509) is a first-in-class add-on therapy that targets glutamate pathways, differing from traditional dopamine-based antipsychotics. According to Newron, no increased mortality risk has been observed in the development programme so far.

Treatment-resistant schizophrenia remains a significant unmet need, with only clozapine currently approved specifically for this condition, underscoring the importance of continued innovation in this space.

03-05-2026