NEW YORK, Feb. 18, 2026 — Transcend Therapeutics, a clinical-stage biotechnology company developing rapid-acting treatments for neuropsychiatric conditions, today announced the publication of IMPACT-1, a Phase 2 randomized, double-blind, placebo-controlled clinical trial evaluating TSND-201 (methylone) in adults with severe post-traumatic stress disorder (PTSD), in JAMA Psychiatry.
IMPACT-1 met its primary endpoint, and demonstrated rapid-acting and statistically significant improvement from baseline to Day 64 in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity score compared with placebo (LS-mean difference: 9.64; 90% CI, -16.48 to -2.80; p=0.011). The trial enrolled 65 patients (mean age: 43.7; 60.0% female) with severe PTSD (CAPS-5 total severity score ≥35) across 16 sites in the United States, United Kingdom, and Ireland. Participants received four once-weekly oral doses of TSND-201 or placebo, and were followed for six weeks after the final dose.
TSND-201 was generally well-tolerated. The most frequently reported treatment-emergent adverse events included headache, decreased appetite, nausea, dizziness, blood pressure increase, dry mouth, and insomnia. These events were typically transient, occurring on the day of dosing and resolving within a day.
“Publication in JAMA Psychiatry represents an important validation of the scientific rigor of the IMPACT-1 study and the therapeutic potential of TSND-201,” said Transcend Co-Founder and CEO Blake Mandell. “These data support continued clinical development for TSND-201 as a new, rapid-acting, and durable treatment option for patients living with PTSD.”
In July 2025, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to TSND-201 for the treatment of PTSD. Transcend is actively preparing to initiate its Phase 3 clinical program.
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 serious 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.
Contact: press@transcendtherapeutics.com
