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Methylone Shows Rapid PTSD Symptom Improvement in Phase 2 IMPACT-1 Trial
TSND-201 (methylone) met its primary endpoint in the phase 2 IMPACT-1 trial, showing rapid, significant PTSD symptom improvement with a good safety profile.
TSND-201 (methylone) significantly improved PTSD symptoms in the phase 2 IMPACT-1 trial, announced Transcend Therapeutics on March 31, 2025. The company stated the trial met its primary endpoint—a significant improvement from baseline to day 64 in the Clinician-Administered PTSD Scale for DSM05 (CAPS-5) score.
“It has been over two decades without a new treatment for PTSD. The results of this study suggest that TSND-201 may represent a significant clinical breakthrough — demonstrating clinically meaningful efficacy with a rapid onset,” said Murray B. Stein, MD, MPH, professor of psychiatry and public health at the University of California San Diego and Staff Psychiatrist at the Veteran Affairs San Diego Healthcare System, in a statement. “Rapid-acting, episodic treatments could be a paradigm shift in the treatment of PTSD, providing hope for the many patients who have struggled to find effective relief.”
IMPACT-1, a randomized, double-blind, placebo-controlled phase 2 trial, evaluated TSND-201 for the treatment of PTSD. TSND-201 is a rapid-acting neuroplastogen with the primary site of action monoamine transporters and no activity at 5HT-2a.
The trial included 65 patients with severe PTSD who had a CAPS-5 ≥ 35 who did not respond well to other PTSD treatment. Participants were randomized to receive 4 oral doses of TSND-201 or placebo once a week and were followed for 64 days after the first dose.
On average, TSND-201 demonstrated a statistically significant CAPS-5 improvement of - 9.64 points on day 64, compared with placebo (-23.28 points vs -13.64 points; P = .0011). The improvement on TSND-201 was evident on day 10, with a mean reduction of 8.00 points (P = .012). TSND-201 also brought rapid and statistically significant improvements from baseline on the CAPS-5 total severity score.
Additionally, TSND-201 brought significant t improvements on several secondary endpoints, including response (≥ 50% from improvement from baseline on CAPS-5; 57.1% vs 19.2%; P = .002), remission (≤. 11 points on the CAPS-5; 32.1% vs 11.5%; P = .036), and a loss of PTSD diagnosis (60.7% vs 30.8%; P = .014).
As for safety, TSND-201 was well-tolerated, with most adverse events occurring only on the day of dosing, Common adverse events included headache, decreased appetite, nausea, dizziness, blood pressure increase, dry mouth, insomnia, muscle tightness, and feeling abnormal.
“We are encouraged by the positive Phase 2 results demonstrating TSND-201’s potential as a rapid-acting and durable treatment for patients with PTSD,” said Transcend Therapeutics Co-Founder and CEO Blake Mandell, in a statement. “We look forward to working with the FDA to align on a Phase 3 program in PTSD.”
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