Breakthrough Therapy Designation
Psilocybin Therapy
The active compound in "magic mushrooms," psilocybin is being studied for depression, anxiety, and end-of-life distress. It received FDA Breakthrough Therapy Designation for treatment-resistant depression.
50Clinical Trials
15Companies
6Legal States
FDA StatusBreakthrough Therapy Designation
Legal PathwayState-by-state regulation (OR, CO, NM)
Also Known Asmagic mushrooms, COMP360, psilocin
Legal Status by State
View full legal tracker →Fully Operational
Legal, Launching
Decriminalized
Active Legislation
Research Only
No Activity
Legal & Regulated4
AZCONMOR
Decriminalized2
DCMI
Pending Legislation11
AKCACTGAMANVNJNYTXVTWA
Clinical Trials
Phase 121
Phase 217
Phase 34
Active, Not Recruiting·Phase 2·psilocybin
Psilocybin-Assisted Cognitive Processing Therapy for Chronic PTSD
Unity Health Toronto
Post Traumatic Stress DisorderPTSDChronic PTSD
Active, Not Recruiting·Phase 2·psilocybin
Group Retreat Psilocybin Therapy for the Treatment of Anxiety and Depression in Patients With Metastatic Solid Tumors or Incurable Hematologic Malignancies
University of Washington
AnxietyDepressionHematopoietic and Lymphatic System Neoplasm+1 more
Active, Not Recruiting·Phase 1·psilocybin
Safety and Preliminary Efficacy of Organic Whole Psilocybin-Containing Mushrooms to Treat Patients Suffering From PTSD
Scottsdale Research Institute
PTSD
Active, Not Recruiting·Phase 2·psilocybin
Wellcome Leap Psilocybin for OUD
Anna Rose Childress, Ph.D.
Opioid Use Disorder
Active, Not Recruiting·Phase 2·psilocybin
PsiloStudy: Psilocybin With Psychological Support (Psi-PS) for Military Veterans and First Responders With Co-occurring PTSD & Alcohol Use Disorder (AUD)
Nathan Brashares Sackett
Alcohol Use Disorder (AUD)PTSD
Active, Not Recruiting·Phase 2·psilocybin
Psilocybin in the Treatment of Cannabis Use Disorder: A-Proof-of-Concept Study
McMaster University
Cannabis Use Disorder, ModerateCannabis Use Disorder, Severe
Companies & Research
Organizations developing Psilocybin-based therapies