NEW YORK, September 2, 2025 – Transcend Therapeutics, a clinical-stage biotechnology company developing rapid-acting treatments for neuropsychiatric conditions, today announced the publication of new preclinical data confirming the mechanism of TSND-201 (methylone) for the treatment of post-traumatic stress disorder (PTSD). The study, published in Neuropsychopharmacology, demonstrated that acute dosing of TSND-201 promotes rapid neuronal growth and long-lasting improvements in fear extinction learning, a process associated with recovery from PTSD.
The study found that TSND-201 increased both the length and branching of neurons, suggesting it directly supports brain cell growth and connectivity. These effects were mediated not only by TSND-201’s primary pharmacological targets — the norepinephrine, serotonin, and dopamine transporters — but also by neurotrophic factor signaling pathways (BDNF and mTOR) that are essential for neuronal survival and plasticity. At the behavioral level, TSND-201 reduced fear responses and helped the brain relearn safety cues in animal models. Importantly, both neurogenic and behavioral effects were rapid and persisted long after TSND-201 cleared the system.
Since TSND-201 does not directly activate 5HT2A receptors, consistent with no hallucinogenic activity in humans or animal models, the mechanism underlying its neuroplastic effects appears to be distinct from traditional psychedelics.
“These findings show how TSND-201 engages the brain’s natural growth and repair systems in ways that are both rapid and enduring,” said Jennifer Warner-Schmidt, PhD, Vice President of Scientific Affairs at Transcend Therapeutics and lead author of the study. “The ability to promote lasting neuroplasticity helps explain the long-term clinical benefits we have observed, even though the drug itself is short-acting.”
“This publication supports a mechanism of how acute treatment with no 5HT2A receptor activity can provide rapid and long-lasting effects,” said Blake Mandell, Co-Founder and CEO of Transcend Therapeutics.
In July, 2025, the U.S. Food & Drug Administration (FDA) granted Breakthrough Therapy designation to TSND-201 for the treatment of PTSD. Transcend is working to align with the FDA as Transcend prepares for the launch of a Phase 3 program in 2026.
The complete preclinical data are available in Neuropsychopharmacology.
About TSND-201
TSND-201, a rapid-acting neuroplastogen, is a proprietary formulation of methylone developed by Transcend Therapeutics. TSND-201 has well-characterized primary pharmacology, with its primary site of action at the monoamine transporters, and no activity at 5HT-2a (i.e., not hallucinogenic). Transcend is developing TSND-201 as a rapid-acting and durable treatment for PTSD and other central nervous system (CNS) indications. TSND-201 is an investigational medication.
About PTSD
PTSD is a mental health condition that can occur after experiencing or witnessing a life-threatening or traumatic event. Symptoms may include flashbacks, nightmares, severe anxiety, and uncontrollable thoughts about the event. PTSD impacts approximately 13 million Americans each year and it is estimated that nearly 7% of U.S. adults will be diagnosed with PTSD during their lifetime. Only two medications are FDA-approved for the treatment of PTSD (sertraline and paroxetine), yet their efficacy is modest at best. New treatments for PTSD are urgently needed.
About Transcend Therapeutics
Transcend Therapeutics, founded in 2021, is a clinical-stage, neuroscience-focused company developing rapid-acting treatments for neuropsychiatric diseases. The company’s mission is to develop new drugs for the millions of people for whom current psychiatric medicines have not worked. Transcend’s leadership team has made pivotal contributions to 14 FDA approvals and $7B in M&A and public company value. Transcend has raised approximately $50M to date.
