TNX-601 is a novel oral formulation of tianeptine in the pre-IND stage of development for the treatment for posttraumatic stress disorder (PTSD). Currently there is no tianeptine-containing product approved in the U.S., but tianeptine sodium (amorphous) has been marketed in Europe, Asia, and Latin America for the treatment of depression since 1987. Tonix has discovered a novel salt and polymorph which may provide improved stability, consistency, and manufacturability relative to the known forms of tianeptine.
Like cyclobenzaprine, tianeptine shares structural similarities with classic tricyclic antidepressants, but it has unique pharmacological and neurochemical properties.1 Tianeptine modulates the glutamatergic system indirectly and reverses the inhibitory neuroplasticity observed during periods of stress and steroid use. It is a weak mu-opioid receptor (MOR) agonist, but does not have significant affinity for known neurotransmitter receptors. Tianeptine has an established safety profile based on its decades of use in many European, Asian, and Latin American countries.
Leveraging Tonix’s development expertise in PTSD, TNX-601 is being developed as a first line monotherapy for PTSD for daytime dosing. Tianeptine’s reported pro-cognitive and anxiolytic effects as well as its ability to reduce excessive stress responses suggest that it can be used to treat PTSD by a different mechanism of action than TNX-102 SL.1 Several published studies support the potential of tianeptine as a possible effective and safe therapy for patients with PTSD.2,3,4,5