MILAN, Italy, and MORRISTOWN, N.J., July 2, 2026
Newron Pharmaceuticals announced a constructive Type A meeting with the U.S. Food and Drug Administration (FDA) regarding the clinical hold affecting enrollment of new patients at U.S. sites in the Phase 3 ENIGMA-TRS 2 trial evaluating evenamide for treatment-resistant schizophrenia (TRS). The company and the FDA discussed the information previously submitted by Newron, along with the regulatory changes required to support the potential restart of patient enrollment in the United States. Newron confirmed it will submit protocol modifications requested by the FDA, aiming to resolve the remaining issues and resume trial recruitment as quickly as possible.
FDA Meeting Advances Path Toward Restarting U.S. Enrollment
The Type A meeting follows the FDA’s enrollment hold announced in April 2026 for U.S. sites participating in the ENIGMA-TRS 2 study. According to Newron, discussions with the agency were constructive and focused on identifying practical solutions to address the FDA’s concerns. The company plans to propose the requested protocol and study changes to facilitate regulatory review and potentially lift the enrollment hold. Evenamide, a first-in-class glutamate modulator, is designed to reduce excessive glutamate release and is being developed as an add-on therapy for patients with treatment-resistant schizophrenia, a population with significant unmet medical need and limited treatment options.
Global Phase 3 ENIGMA Program Continues Outside the U.S.
While U.S. enrollment remains paused, ENIGMA-TRS 1, the company’s global Phase 3 study, continues to recruit patients across 15 countries in Europe, Asia, Latin America, and Canada. The randomized, double-blind, placebo-controlled trial is expected to enroll at least 600 patients and is evaluating 15 mg BID and 30 mg BID doses of evenamide alongside standard second-generation antipsychotic therapy. The study’s primary endpoint is the change in Positive and Negative Syndrome Scale (PANSS) scores after 12 weeks, with top-line efficacy data anticipated in the fourth quarter of 2026. ENIGMA-TRS 2, designed to enroll at least 400 patients, continues preparations internationally while awaiting FDA clearance for U.S. enrollment to resume.
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Evenamide Remains Newron’s Lead Late-Stage Neuroscience Program
Evenamide represents Newron Pharmaceuticals’ lead investigational therapy and has the potential to become the first add-on treatment specifically developed for treatment-resistant schizophrenia. Clinical studies conducted to date have demonstrated progressive improvements in efficacy over time, together with a favorable safety profile compared with existing antipsychotic therapies. Newron has already established regional development and commercialization partnerships with EA Pharma for Japan and selected Asian markets and Myung In Pharm for South Korea. The company remains focused on advancing the global ENIGMA Phase 3 program while working closely with the FDA to restore full enrollment in the United States and continue development of evenamide for patients with schizophrenia.
Source: Newron Pharmaceuticals press release
