tianeptine hemioxalate extended-release (TNX-601 ER) / Tonix - LARVOL DELTA

UPLIFT: Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD) (clinicaltrials.gov) - P2 | N=132 | Completed | Sponsor: Tonix Pharmaceuticals, Inc. | Active, not recruiting ➔ Completed | N=300 ➔ 132 | Trial completion date: May 2024 ➔ Sep 2023 | Trial primary completion date: May 2024 ➔ Sep 2023

Enrollment change • Monotherapy • Trial completion • Trial completion date • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

UPLIFT: Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD) (clinicaltrials.gov) - P2 | N=300 | Active, not recruiting | Sponsor: Tonix Pharmaceuticals, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Monotherapy • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Tonix Pharmaceuticals Announces Presentation of Data Supporting Development of Racemic and Single (S)-Isomer Tianeptine, Plastogen Anti-Depressants, at the American Society of Clinical Psychopharmacology Meeting (GlobeNewswire) - "TNX-601 ER is being tested in a potentially pivotal Phase 2 trial for the treatment of major depressive disorder (MDD) for which results of a preplanned interim analysis are expected in the fourth quarter of 2023....The findings reported at the meeting show how the pharmacokinetics of oral TNX-601 ER in humans differ from intraperitoneal (i.p.) tianeptine in mice. In humans, after an oral dose of TNX-601 ER the half-life of tianeptine in the blood is approximately 5-7 hours. In contrast, in mice after an i.p. dose of tianeptine the half-life of tianeptine in the blood has been reported to be less than approximately 30 minutes and the behavioral effects appear dominated by the longer-lasting MC5 metabolite, which maintains µ-opioid receptor activity. The data Tonix presented also show that the (R)-isomer of tianeptine is responsible for the decrease in immobility in the mouse forced swim test after i.p. administration."

P2 data • Preclinical • Alzheimer's Disease • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Parkinson's Disease

Tonix Pharmaceuticals Announces Poster Presentation at the 2023 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting (GlobeNewswire) - "Tonix Pharmaceuticals...today announced that Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals, will present a poster at the 2023 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting being held May 30 – June 2, 2023, at the Loews Miami Beach Hotel in Miami Beach, Florida. The poster will provide an update on the status of the Phase 2 UPLIFT study of TNX-601 ER (tianeptine hemioxalate extended-release tablets) for the treatment of major depressive disorder (MDD). The poster will also highlight advances in the understanding of tianeptine’s mechanism of action and provide new details regarding the preclinical development of the (S)-isomer of tianeptine, TNX-4300 (estianeptine) for MDD, Alzheimer’s disease, and Parkinson’s disease."

P2 data • Preclinical • Alzheimer's Disease • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Parkinson's Disease

A Randomized Placebo-Controlled Multicenter Trial of Monotherapy with TNX-601 ER* (Tianeptine Hemioxalate Extended-Release Tablets) for Treatment of Major Depressive Disorder (MDD) (ASCP 2023) - P2 | "Learning Objectives Discuss the development of a novel antidepressant for the US market under an IND. Describe the protocol of a Phase 2b registration-quality industry trial of a new once-daily formulation of tianeptine."

Clinical • Monotherapy • Alzheimer's Disease • Anorexia • Bipolar Disorder • CNS Disorders • Cognitive Disorders • Depression • Insomnia • Major Depressive Disorder • Mood Disorders • Obsessive-Compulsive Disorder • Personality Disorder • Post-traumatic Stress Disorder • Psychiatry • Sleep Disorder • Substance Abuse

UPLIFT: Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD) (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Tonix Pharmaceuticals, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

UPLIFT: Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD) (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: Tonix Pharmaceuticals, Inc.

Monotherapy • New P2 trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry