TNX-601 CR


Phase I

Phase II

Phase III

Depression, PTSD, Neurocognitive Dysfunction from Corticosteroids
Phase II start — targeting 1Q 2023

Phase I

TNX-601 CR is a novel oral formulation of tianeptine oxalate that is being developed as a potential treatment for major depressive disorder (MDD), posttraumatic stress disorder (PTSD) and neurocognitive dysfunction associated with corticosteroid use. Tonix’s TNX-601 CR includes tianeptine oxalate and naloxone HCl in a controlled release formulation. Naloxone has been added to the formulation to minimize potential for parenteral abuse.

Tianeptine sodium (amorphous) immediate release (IR) has been available in Europe for the treatment of depression for more than three decades, first marketed in France in 1989. Tianeptine sodium IR is also marketed in many countries in Asia and Latin America. However, to date, no tianeptine-containing product has been approved by the U.S. Food and Drug Administration (FDA).

TNX-601 CR is designed for once daily dosing, which is believed to provide an adherence advantage relative to the three times per day, or t.i.d. dosing, of the immediate-release tianeptine sodium salt products available in Europe and other jurisdictions around the world. The crystalline tianeptine oxalate of the patented compositions is believed to provide improved stability, consistency, and manufacturability as compared to the amorphous sodium salt. TNX-601 CR indirectly modulates the glutamatergic system, bypassing interactions with NMDA, AMPA or kainite receptors, and it is mechanistically different from traditional approved treatments for depression in the U.S.

TNX-601 CR is covered by a number of issued and pending worldwide patents which cover composition of matter and method of use.


TNX-601 (tianeptine oxalate and naloxone HCl controlled-release tablets) is an investigational new drug and has not been approved for any indication.