Clinical Trial Phases
ClinicalThe staged process (Phase 1: safety in a small group; Phase 2: dosing and early efficacy; Phase 3: large-scale efficacy, usually the last step before an approval filing) every drug candidate has to clear.
Example: Every company in our patent series is at a different phase — Compass is finishing Phase 3, DemeRx's noribogaine program is still pre-Phase 2, and where a company sits on this ladder matters as much as its patent position.
What are the phases of a clinical trial?
Phase 1 tests safety in a small group, often healthy volunteers. Phase 2 tests dosing and early efficacy in patients. Phase 3 tests large-scale efficacy against a comparator, usually the last step before a company files for approval. Some programs also run a Phase 4 after approval, for post-market monitoring.
Which psychedelic companies are furthest along in clinical trials?
It varies by compound — Compass Pathways' COMP360 psilocybin program is finishing Phase 3, Definium's DT120 has posted two positive Phase 3 trials for anxiety, while DemeRx's noribogaine program is still pre-Phase 2. See our patent series.
Does finishing Phase 3 mean a drug is approved?
No — positive Phase 3 results support an approval filing, but the FDA still has to review it and can issue a Complete Response Letter asking for more data instead of approving it, as happened with the first MDMA therapy application.