Newron Pharmaceuticals held a Type A meeting with the U.S. FDA to address the clinical hold affecting enrollment in its Phase III ENIGMA-TRS 2 study of evenamide in patients with treatment-resistant schizophrenia.
The hold, first disclosed on April 29, 2026, paused new patient enrollment at U.S. trial sites. Following the face-to-face meeting, Newron said discussions with the agency were “constructive,” with both sides reviewing the issues that triggered the regulatory action and potential pathways toward resolution.
According to the company, Newron and the FDA discussed changes required for the study to potentially restart enrollment in the United States. The company now plans to submit proposed protocol and operational modifications addressing the regulator’s concerns.
The ENIGMA-TRS 2 study is part of Newron’s broader Phase III development program for evenamide, a glutamate-modulating therapy being evaluated as an add-on treatment for patients who do not adequately respond to existing antipsychotic therapies.
The U.S.-focused trial is designed as a 12-week, randomized, double-blind, placebo-controlled study enrolling at least 400 patients. It was initiated in December 2025 following prior FDA and Institutional Review Board approvals, but enrollment was later suspended pending regulatory review.
Newron emphasized that the meeting helped clarify next steps and said it is working with the agency to expedite resolution of the outstanding issues.
ENIGMA-TRS 2 is running in the U.S. and selected additional countries and is intended to evaluate the efficacy, safety, and tolerability of evenamide at a 15 mg twice-daily dose compared with placebo.
The program sits within Newron’s larger ENIGMA-TRS Phase III initiative, which also includes a global study enrolling more than 600 patients across Europe, Asia, Latin America, and Canada.
