Expanded Access Policy

Last Updated: July 1, 2026

Our mission is to bring COMP360 psilocybin treatment to patients in a way that prioritizes safety, efficacy and quality. To date, we have run a rigorous, large-scale Phase 3 clinical program in treatment-resistant depression (TRD) to generate robust data, a critical step before seeking regulatory approval. 

Compass recognizes the importance of expanded access programs; however, Compass will not provide expanded access at this time. Enrollment in our treatment-resistant depression (TRD) clinical trials has been completed, and our program is currently under NDA review, so access to COMP360 remains restricted while this process continues and as we finalize evaluation of the clinical data. While we are advancing a Phase 2b/3 program in PTSD, expanded access is not considered appropriate for that patient population given the need for controlled study conditions to further assess safety and efficacy in this indication. 

Patients and physicians are encouraged to visit ClinicalTrials.gov for information about our ongoing clinical trials.

More about Expanded Access  

As stated above, Compass does not currently provide expanded access to its investigational products. In the event that Compass may, in the future, consider a request for expanded access, each request would be evaluated in accordance with this Policy and would be required to meet the following criteria: 

• There are no adequate alternative therapies or clinical trials available. 
• A patient’s treating physician and Compass both believe there is potential for the patient to reasonably expect benefit from the treatment, and there is reasonably robust evidence to support the possibility that the patient will benefit from it.
• Adequate supply exists to support the ongoing clinical trials and approved expanded access, until and if the product becomes commercially available.
• The treatment center is adequately licensed and equipped to provide the treatment including all necessary licenses, training and facilities.
• Expanded access will not adversely impact the clinical development program, in particular, the conduct of a pivotal clinical trial that is required for regulatory approval.
• The request must be made by the patient’s treating physician, unsolicited by Compass Pathways or any other individual or organization. The treating physician should be an expert in the therapeutic area who has weighed the potential benefits and risks of providing the investigational drug to the patient and found that the potential benefit outweighs the risk. 

We use the above criteria to decide whether and when to offer expanded access to COMP360 psilocybin treatment. We cannot, however, guarantee that an expanded access program will be offered; and should a program become available, we currently cannot predict for which patients the investigational medicine could be made available. 

Any pre-approval access to an investigational product must always comply with the applicable country-specific laws and regulations, including medicine importation requirements, and approvals must be secured from relevant regulatory bodies and the Institutional Review Board or Ethics Committee of the licensed treatment center.