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
3Companies
5Legal 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 →Legal
Decriminalized
Pending
No Legislation
Legal & Regulated3
CONMOR
Decriminalized2
DCMI
Pending Legislation12
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Clinical Trials
21 trials currently recruiting
Phase 117
Phase 222
Phase 33
Recruiting·Phase 1·psilocybin
Psilocybin-assisted Treatment for Cannabis Use Disorder
Johns Hopkins University
Cannabis Use Disorder
Active, Not Recruiting·Phase 2·psilocybin
An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)
Sheppard Pratt Health System
Treatment Resistant Depression
Unknown·Phase 2·psilocybin
Evaluation of Psilocybin-Assisted Psychotherapy in Treating Severe Depression in Patients With PTSD
Apex Labs Ltd.
Post-traumatic Stress DisorderDepression
Enrolling by Invitation·Phase 1·psilocybin
PRoMiSS: Psilocybin and the Role of Music in Set and Setting
Johns Hopkins University
PsilocybinMusic Intervention
Recruiting·Phase 1·psilocybin
Digital Intervention for Psychedelic Preparation (DIPP): Comparing Meditation and Music-Based Programs
University College, London
Healthy
Completed·Phase 1·psilocybin
Psilocybin-assisted CBT for Depression
University of California, Los Angeles
Major Depressive Disorder
Companies & Research
Organizations developing Psilocybin-based therapies