Expanded Access Policy

At Transcend Therapeutics, our mission is to develop rapid-acting treatments for neuropsychiatric conditions such as post-traumatic stress disorder (PTSD). Our lead investigational medicine, TSND-201 (methylone), is being evaluated in clinical trials and has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA).

We understand that some patients may wish to access investigational therapies outside of clinical trials. In certain circumstances, the FDA may allow this through what is called Expanded Access or Compassionate Use. These programs are intended for individuals with serious or life-threatening conditions who have exhausted all approved treatment options and are not eligible for ongoing clinical trials.

At this time, we do not offer an Expanded Access or Compassionate Use program for TSND-201. We believe that participation in clinical trials is the most appropriate way to access our investigational therapy at this stage. Clinical trials allow us to generate the data necessary to determine whether our therapy is safe and effective, and to make it broadly available to patients as quickly as possible.

We will review this policy periodically and may revisit the availability of expanded access as more clinical data becomes available, particularly as we advance toward potential regulatory submission and approval. If we initiate an Expanded Access Program in the future, we will update this page with eligibility criteria and instructions for physicians.

Patients and physicians are encouraged to visit clinicaltrials.gov listings for information about our ongoing trials.

 

Last Updated: July 22nd, 2025