Tonix Doses First Patient In Phase 2 Trial Targeting Acute Stress After Trauma Exposure

Tonix Pharmaceuticals Holding Corp. announced the first patient dosing in the Phase 2 OASIS trial, which will evaluate TNX-102 SL, a sublingual formulation, for its potential to reduce the severity of acute stress reaction (ASR) and prevent the progression to acute stress disorder (ASD). The trial is sponsored by the University of North Carolina (UNC) Institute for Trauma Recovery and funded by a $3 million U.S. Department of Defense grant.

The OASIS trial targets patients who experience trauma after motor vehicle collisions (MVCs) and are admitted to emergency departments. Around 180 trauma survivors will be enrolled and randomized to receive either TNX-102 SL 5.6 mg or placebo for two weeks. The study will evaluate the drug’s impact on reducing posttraumatic neuropsychiatric symptoms during the critical early intervention window following trauma exposure.

“TNX-102 SL has been shown to improve sleep quality in PTSD, and previous trials of TNX-102 SL suggested activity on sleep and stress-related symptoms in the first several weeks of treatment. Addressing sleep disturbances is crucial in managing ASR, as poor sleep can exacerbate other symptoms and hinder recovery. There is a significant unmet need for treating ASR after traumatic events, such as civilian motor vehicle collisions or warfighter experiences in forward bases or in theater. We are encouraged by the support of TNX-102 SL’s prior data improving PTSD symptomatology in the first several weeks of treatment, which may be crucial to reducing ASR symptoms and their sequalae. We look forward to topline results in the second half of 2026,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. 

The trial builds on UNC’s AURORA initiative, a $40 million NIH-backed project aimed at improving outcomes for trauma survivors. The initiative collaborates with leading mental health organizations and tech companies like Mindstrong Health and Verily (Alphabet’s healthcare division). ASR and ASD affect both civilians and military personnel, yet no approved medications currently exist to treat these conditions immediately post-trauma, a critical period for PTSD prevention.