Clinical Pipeline
FDA-readiness tracker. This hub organizes the topic into a starting point, core reading, and deeper reference material so mobile readers and search systems can understand the page pathway quickly.
Get oriented first
Begin with the plain-language framing before reading narrower claims or legal and safety details.
Read the central articles
Use the core set to understand the topic before moving into edge cases and supporting references.
Education, not instruction
This section does not provide medical, dosing, sourcing, purchasing, or legal advice.
How to read psychedelic trial press releases: what MADRS, p-values, CNPV, BTD, and NDA language mean and what each source type actually establishes.
What the COMP005 and COMP006 Phase 3 results for COMP360 psilocybin in treatment-resistant depression actually show, bounded by what the data sources permit.
FDA Approval vs Oregon and Colorado Psilocybin AccessFDA approval, DEA scheduling, Oregon service centers, and Colorado Natural Medicine access are distinct regulatory pathways. This page maps the differences.
Is Psilocybin FDA Approved? Current Status ExplainedAs of mid-2026, no psilocybin drug is FDA approved. This page explains what NDA, CNPV, and rolling review mean and what is still pending.
What Phase 2 and Phase 3 mean in clinical research, why the distinction matters for interpreting psilocybin data, and how endpoints, controls, and comparators work.
Psilocybin Clinical Pipeline: Where the Research StandsA research-education overview of the psilocybin clinical trial pipeline as of mid-2026: what phases mean, which programs exist, and what is still unresolved.
Psilocybin for PTSD: Where the Evidence Actually StandsThe current state of psilocybin evidence for PTSD as of mid-2026: open-label Phase 2 publication, IND acceptance, and what differs from the TRD evidence depth.
Usona Institute Psilocybin Trial for Major DepressionThe Usona Institute psilocybin program for major depressive disorder: PSIL201 Phase 2, uAspire Phase 3 registry status, and what remains pending as of mid-2026.