Newron reports FDA safety concerns as US evenamide trial hold continues
Published in Brain/Neurology, Drugs development & discovery.
October 8, 2026 — Newron Pharmaceuticals reported receiving written FDA feedback on the continuing clinical hold at US sites of its ENIGMA-TRS 2 phase 3 evenamide study for treatment-resistant schizophrenia. The company is reviewing the feedback and preparing a response; enrollment continues outside the United States.
According to Newron’s account of the FDA communication, four deaths occurred among evenamide recipients across its clinical studies to date, versus one among placebo recipients. Investigators considered three of the four unrelated to evenamide and one possibly related.
The FDA characterized these events as a potential safety signal because a fatal arrhythmic mechanism cannot definitively be excluded. These counts alone do not establish causation or quantify comparative mortality risk; the announcement does not provide the denominators needed for that comparison.
The US enrollment hold was first reported on April 29, 2026. Newron states that no US participants have received evenamide in ENIGMA-TRS 2. The separate ENIGMA-TRS 1 trial is expected to complete enrollment by mid-October, with 12-week topline results projected for early 2027.
Source: Newron regulatory announcement, October 8, 2026.