TNX-102 SL

TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride, which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism.

TNX-102 SL is currently in development for Acute Stress Disorder (ASD)/Acute Stress Reaction (ASR). It is in a Phase 2 investigator-initiated OASIS study in partnership with the U.S. Department of Defense and the University of North Carolina at Chapel Hill. Topline data is expected in 2H’26.

ASD is a mental health condition that can occur within the first month of experiencing a traumatic event. The symptoms can affect both civilian and military populations.

ASR is a transient, often severe, emotional and physical response occurring minutes to days after a traumatic event, such as assault, disaster, or accident. Symptoms include anxiety, flashbacks, numbness, and insomnia, typically resolving within a few days or up to one month. No medications are currently available at or near the point of care to treat patients suffering from acute traumatic events and to support long-term health.

Additionally, TNX-102 SL is expected to begin a potentially pivotal Phase 2, Tonix-sponsored study mid-year 2026 for Major Depressive Disorder (MDD).

MDD is a prevalent and serious psychiatric illness that affects adults of all ages, races, and backgrounds. It is characterized by persistent feelings of sadness or loss of interest, along with symptoms such as sleep and appetite disturbances, fatigue, difficulty concentrating, and thoughts of worthlessness or suicide. These symptoms must last at least two weeks and significantly impair daily functioning. MDD is associated with increased risk of suicide and substantial impairment in quality of life.

TNX-102 SL is an investigational new drug and has not been approved for ASD/ASR or MDD.