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# FDA Maintains Clinical Hold on Newron Phase 3 Evenamide Study
- URL: https://www.fdaweb.com/fda-maintains-clinical-hold-on-newron-phase-3-evenamide-study/
- Published: 2026-09-28T22:17:19.000Z
- Updated: 2026-09-29T01:03:10.000Z
- Author: David McFarland
- Tags: Drugs

FDA is maintaining a clinical hold preventing enrollment of new U.S. patients in Newron Pharmaceuticals’ Phase 3 ENIGMA-TRS 2 study of evenamide for treatment-resistant schizophrenia. Newron says it expects written communication from the agency providing additional information on the decision and identifying any further protocol changes that could be required to lift the hold.

FDA initially imposed the hold 4/29 after Newron notified the agency of the sudden, unexpected death of a study participant at a clinical site outside the U.S. According to Newron, the investigator assessed the death as unrelated to study treatment. An independent international safety monitoring board reviewed the event and recommended that the ENIGMA-TRS studies continue as designed.

The study is continuing outside the U.S., Newron says, expanding clinical sites and enrollment in Europe, Asia and Latin America to support the trial. About 80 patients have entered screening to date, with at least 400 patients expected to be enrolled after completing a 42-day screening period.

While patients at U.S. sites had entered screening before the hold, Newron says no U.S. patients have been dosed with evenamide in ENIGMA-TRS 2.

“Newron is highly confident in the significant body of clinical and preclinical safety data for evenamide, and we will continue to work constructively with the FDA to address the clinical hold,” chief medical officer **Ravi Anand** says.

ENIGMA-TRS 2 is a 12-week, randomized, double-blind, placebo-controlled Phase 3 study evaluating evenamide 15 mg twice daily against placebo in at least 400 patients with treatment-resistant schizophrenia. The trial began in the U.S. in December 2025 following FDA and Institutional Review Board clearance.

Evenamide is designed to modulate excessive glutamate release, offering a mechanism distinct from conventional antipsychotics, the company says.