ReST Therapeutics, a clinical-stage biopharmaceutical company focused on developing novel therapeutics for stress and trauma-related disorders through precision neuropsychiatry, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for RST-101, its lead investigational therapeutic candidate for the early treatment of post-traumatic stress disorder (PTSD). The IND acceptance clears the way for ReST Therapeutics to initiate a first-in-human clinical trial evaluating RST-101 in healthy volunteers. “We are very pleased with the FDA acceptance of our IND application, which allow us to initiate the First-In-Human clinical trial to evaluate the safety, tolerability, pharmacokinetics and food effect characteristics of RST-101 in healthy volunteers, a pivotal step in our clinical development program to address early PTSD and potentially avoid debilitating long-term symptoms, a profound unmet medical need in mental health,” said Reina Benabou, MD, PhD, ReST Therapeutics Chief Medical Officer.
PTSD affects millions of people worldwide and is characterized by persistent psychological distress following exposure to traumatic events. Current treatment approaches typically begin a significant amount of time after trauma exposure, missing a critical early intervention window. RST-101 represents a paradigm shift in PTSD treatment by targeting the biological mechanisms of trauma response in the early phase following traumatic exposure, potentially preventing the development of chronic PTSD. “This is quite an achievement for ReST therapeutics and a tribute to the commitment of our team and partners. What started with a conviction that we could quench the consolidation of Traumatic Events into a chronic PTSD plaguing the life of millions of civilians and veterans now enters clinical phase,” said Founder and Chief Innovation Officer, Gilles Rubinstenn, PhD, MBA.
About RST-101
RST-101 is a small molecule, NMDA Antagonist designed to modulate NMDAR 2C/2D during the critical early window following trauma exposure. Unlike existing PTSD treatments that address symptoms after the disorder has become established, RST-101’s unique mechanism of action targets the pathophysiology and neurobiological processes involved in trauma memory consolidation and stress response dysregulation.
The therapeutic approach is grounded in extensive preclinical research demonstrating that early intervention during the post-trauma period can significantly alter the trajectory of stress-related pathology. By addressing the biological underpinnings of PTSD formation rather than managing chronic symptoms, RST-101 has the potential to prevent the long-term psychological and physiological consequences of trauma exposure, including depression, anxiety disorders, and substance abuse that commonly occur with PTSD.
About Post-Traumatic Stress Disorder (PTSD)
PTSD is a psychiatric disorder that can develop following exposure to traumatic events such as combat, assault, accidents, or natural disasters. It affects approximately 300M people globally, about 2 million new cases each year, with symptoms including intrusive memories, avoidance behaviors, negative alterations in mood and cognition, and hyperarousal. Current treatments primarily consist of psychotherapy and antidepressant medications initiated after PTSD diagnosis, often months after the traumatic event. Early intervention strategies that could avoid the unwanted and debilitating longer-term PTSD symptoms represent a significant unmet medical need.
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Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the clinical development of RST-101, the potential benefits of RST-101, and the company’s development plans. These statements are based on management’s current assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated. Important factors that could cause actual results to differ materially from those in the forward-looking statements include uncertainties related to clinical trial results, regulatory approvals, and other risks detailed in the company’s filings with securities regulators. ReST Therapeutics undertakes no obligation to update any forward-looking statements.
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