TNX-102 SL
Preclinical
Phase I
Phase II
Phase III
Acute Stress Disorder
First patient enrolled in investigator-initiated Phase 2 in May 2025
Phase II
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 a multifunctional agent with potent binding and antagonist activities at the 5-HT2A serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors. TNX-102 SL is in development for acute stress reaction (ASR)/acute stress disorder (ASD), with active IND’s (Investigational New Drug) applications for: multi-site pain associated with Long COVID (formally known as post-acute sequelae of COVID-19 [PASC]), posttraumatic stress disorder (PTSD), alcohol use disorder (AUD), and agitation in Alzheimer’s disease (AAD)*. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No.10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL with U.S. market exclusivity until 2034. Pending patent applications related to method of use could extend exclusivity until 2044.