Concepts
Treatment-Resistant Depression (TRD)
Research notes
Context, reporting, and structured background for this dossier.
Treatment-resistant depression is generally defined as depression that has failed to respond to at least two adequate antidepressant trials. Affects roughly 30% of people with major depressive disorder. Psilocybin has shown consistent symptom reduction in open-label studies; controlled Phase 2/3 trials show meaningful but smaller effects.
Related reporting
Recent SCM reporting that overlaps this dossier’s company, program, or governance record.
- FDA Offers Faster Review Pathway for Three Psychedelic Drug Programs
FDA says three psychedelic drug programs are getting access to the CNPV accelerated-review pathway. COMPASS has directly confirmed one award; Usona and Transcend/Otsuka have not.
- Week in Review: The EPIsoDE Trial, a $1.2B Acquisition, and the State of State Policy
First full week roundup.
- Trial Tracker: What's Moving in Early 2026
Cybin's CYB003 program is recruiting in phase 3, Mount Sinai is running an MDMA therapist-training study, Brigham has a severe alcohol use disorder protocol queued up, and smaller psilocybin studies in OCD and antidepressant interaction remain active.
Related entities
Other dossiers that help connect this page to the wider reporting record.
- Psilocybin
- Compass Pathways
Compass Pathways is one of the most advanced public-company psilocybin developers, with a large Phase 3 COMP360 program in treatment-resistant depression and an FDA-authorized PTSD IND path.
- Cybin, now Helus Pharma
Cybin, now Helus Pharma, is a biopharmaceutical company developing deuterated serotonergic compounds, with HLP003/CYB003 in Phase 3 and a sudden April 2026 CEO reversal now part of the company’s live record.
- FDA
The U.S. Food and Drug Administration is the gatekeeper for psychedelic drug development in the United States, from IND clearance through advisory committee review and any eventual approval or rejection.