Transcend Therapeutics gains breakthrough designation for PTSD treatment

Transcend Therapeutics receives Breakthrough Therapy Designation from the USA FDA for TSND- 201 (methylone) for the treatment of PTSD, after positive results from the Phase II clinical trial, IMPACT-1. 

Transcend Therapeutics, a clinical-stage biotechnology company that develops medicines to treat neuropsychiatric diseases, today announced that the US Food & Drug Administration (FDA) has granted Breakthrough Therapy designation to TSND-201 (methylone) for the treatment of Post-Traumatic Stress Disorder (PTSD).

Breakthrough Therapy designation is granted if preliminary clinical evidence shows that it may demonstrate substantial improvement over available therapy. The Breakthrough Therapy pathway was designed to potentially expedite development and review timelines for promising investigational medicines for serious or life-threatening conditions.

The Breakthrough Therapy designation is based on the positive results from IMPACT-1, a randomised, placebo-controlled, Phase II clinical trial evaluating TSND-201, a rapid-acting neuroplastogen, for the treatment of PTSD. The IMPACT-1 study was a randomised, placebo-controlled Phase II trial of 65 patients with severe PTSD. TSND-201 achieved rapid, robust, and durable improvements in PTSD symptoms. Statistically significant and clinically meaningful symptom improvements occurred by Day 10 (-8.00 placebo-adjusted CAPS-5 improvement) with effects sustained through Day 64 (-9.64 placebo-adjusted CAPS-5 improvement). TSND-201 was well tolerated, with no hallucinations or discontinuations due to adverse events.

“This designation underscores the urgent need for new, more effective treatments for the 13 million Americans living with PTSD,” said Blake Mandell, co-founder and CEO of Transcend Therapeutics. “Only two FDA-approved medications are available today and no new PTSD treatments have been approved in over two decades. This Breakthrough Therapy designation enables us to work more closely with the FDA as we prepare to launch our Phase III programme.”

“A rapid-acting, durable treatment for PTSD would be a paradigm shift in psychiatry, and offer a potential lifeline for patients,” said Murray B Stein, Distinguished Professor of Psychiatry and Public Health at the University of California San Diego and a consultant to Transcend. “The current treatment standard, SSRIs, can take up to 12 weeks to show maximal effect and often cause side effects during that time. Even then, many patients on SSRIs don’t get adequate benefit. This designation offers new hope that faster, more effective treatment may be within reach.”

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Source: Transcend Therapeutics. Transcend Therapeutics Receives Breakthrough Therapy Designation for TSND- 201 (methylone) for the Treatment of PTSD. [Date Accessed 15/07/2025]
https://transcendtherapeutics.com/transcend-therapeutics-receives-breakthrough-therapy-designation-for-tsnd-201-methylone-for-the-treatment-of-ptsd/