FAQ

Compass Pathways is a biopharmaceutical company working to bring rigorous, evidence-based psychedelic medicine into mainstream healthcare. Founded in 2016, we are developing a synthetic, proprietary formulation of psilocybin as an investigational treatment for mental health conditions. Our approach is defined by the same clinical standards, regulatory pathways, and scientific transparency applied to any major pharmaceutical development program. 

Compass was founded from a personal need to find better options for a loved one living with a serious mental health condition. That human imperative became an unwavering scientific mission: to address the gap between what patients in need actually require and what the field of medicine has been able to offer. Our work is grounded in rigorous clinical research dedicated to those who have exhausted current options. 

Compass Pathways is the first company to ground classic psychedelics in the rigorous development pathways of mainstream medicine—including randomized, controlled, double-blind trials, FDA regulatory engagement, and peer-reviewed journal publications. Our lead investigational compound has received Breakthrough Therapy Designation from the FDA and Innovative Licensing and Access Pathway (ILAP) designation from the UK’s MHRA for treatment-resistant depression (TRD), recognizing its potential for substantial improvement over existing treatments. 

Compass Pathways is headquartered in London and listed on the Nasdaq Global Select Market (ticker: CMPS). Our clinical research program spans 125+ sites across 13 countries in North America and Europe. 

We are investigating a synthetic, proprietary formulation of psilocybin as a potential treatment for mental health conditions. This is an investigational treatment, meaning it has not yet received regulatory approval for commercial use and is being evaluated under controlled clinical trial conditions.

Yes. Our lead investigational compound has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for treatment-resistant depression (TRD), acknowledging its potential to offer substantial improvement over currently available treatments and supporting an accelerated development process. It has also received Innovative Licensing and Access Pathway (ILAP) designation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for TRD. 

Our investigational treatment is a synthetic, proprietary formulation of psilocybin developed to meet pharmaceutical standards of purity, consistency, and stability. It is administered exclusively within a structured clinical protocol under the direct supervision of trained healthcare professionals—not in a recreational, retreat, or unsupervised setting.  

Compass Pathways leads the world’s largest classic psychedelic clinical program. To date, our research has involved 1,450+ participants across 14 completed or ongoing trials at 125+ sites in 13 countries. Our lead investigational compound is the first classic psychedelic to consistently achieve its primary endpoint in treatment-resistant depression across three late-stage trials. 

Our peer-reviewed research is widely published and can be found through major medical databases such as PubMed. Some of our publications are available on the Publications page of this website. Some third-party databases may require a subscription to access full papers. 

Treatment-resistant depression (TRD) is generally defined as a patient who has major depressive disorder and has not adequately responded to at least two courses of antidepressant treatment. TRD is associated with longer depressive episodes, increased risks to health, and significant harm to overall quality of life. Millions of people are currently living with TRD and have exhausted the options currently available to them. 

Source: “Association of Treatment-Resistant Depression with Patient Outcomes and Health Care Resource Utilization in a Population-Wide Study.” JAMA Psychiatry. 14 December 2022. jamanetwork.com/journals/jamapsychiatry/fullarticle/2799488 

PTSD is a condition that may occur in people who have experienced traumatic events—from combat or assault to accidents or natural disasters. This state of hypervigilance often complicates life with intense comorbid distress, affecting patients and those closest to them. There has been no major new approved pharmacological treatment for PTSD in decades. 

Source: “What is PTSD?” American Psychiatric Association. Accessed May 2026. psychiatry.org/patients-families/ptsd/what-is-ptsd 

Both TRD and PTSD represent significant unmet clinical needs: conditions where existing treatments have consistently failed large populations, and where the human cost of inadequate care is severe. The current standard of care for mental health has been constrained by a paradigm of chronic symptom management for decades. Compass Pathways is focused on these conditions because we believe rigorous science has a responsibility to pursue new possibilities for the people who need them most. 

Compass Pathways is a pharmaceutical company, not a treatment provider. We do not administer, prescribe, or provide access to our investigational treatment directly to patients. 

If you are looking for treatment options, please speak with your healthcare provider. They are your best resource for evaluating what may be appropriate for your specific situation and can advise you on whether any currently available options may be right for you. 

Clinicaltrials.gov is the authoritative resource for information about our ongoing trials, including locations, eligibility criteria, and how to get involved. Compass Pathways does not manage that site and cannot connect patients to trials directly—all clinical trial participation is coordinated through clinicaltrials.gov and the trial sites listed there. We strongly encourage you to involve your healthcare provider in any decision about trial participation. 

The most important step is to involve the person’s treating physician or mental health provider, who can evaluate whether a clinical trial or other options may be appropriate. You can also explore the resources listed on our Patients & Caregivers page, including organizations such as Mental Health America, the National Alliance on Mental Illness (NAMI), and the Depression and Bipolar Support Alliance (DBSA), all of which offer tools, community support, and advocacy resources. Information about independent organizations is provided as an additional resource for obtaining information related to mental health conditions. It does not indicate endorsement by Compass Pathways of an organization or its communications. 

Compass Pathways has an Expanded Access policy that governs how we manage access to our investigational treatments outside of clinical trials in limited circumstances. You can find our Expanded Access page in our footer. 

For a full range of investor resources including financial filings, SEC documents, stock information, governance materials, and investor-specific FAQ, please visit our Investor Relations site at ir.compasspathways.com. 

For general inquiries, please visit the Contact Us page on our website. For investor relations inquiries, please visit our Investor Relations site.

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