Newron Launches US Phase III Study on Evenamide for Schizophrenia

Newron Pharmaceuticals S.p.A. has announced the US start of its ENIGMA-TRS 2 Phase III clinical trial, evaluating evenamide as an add-on therapy for treatment-resistant schizophrenia (TRS). This 12-week, global, randomized, double-blind, placebo-controlled study aims to enroll at least 400 participants, with results anticipated by Q4 2026.

Evenamide, a glutamate modulator, is being tested due to its potential benefits for TRS patients who do not respond to existing antipsychotic treatments. The study has received approvals from the US FDA and aims to establish evenamide as a possible first-in-class add-on therapy for TRS, offering new hope to this challenging patient group.

Led by Prof. Stephen Marder, the trial is underway at the Semel Translational Research Center for Neuropsychiatry at UCLA. Regulatory submissions are ongoing for other participating countries.