Drugs / Psilocybin
Psilocybin
Drug U.S. Schedule I controlled substance with no currently accepted medical use in U.S. treatment; approved in Australia for treatment-resistant depression in 2023.Serotonergic psychedelic hallucinogen; serotonin receptor agonist·First approved·2023
- Registered trials
- 173
- Ongoing
- 91/ 53%
- Completed
- 59
- Indications
- 2
Approved indications
| Indication |
|---|
| Treatment-resistant depression (approved in Australia) |
| Major depressive disorder (late-stage clinical trials in the United States) |
Clinical trial landscape
173 registered studies reference this molecule or one of its brands. The split below shows how many are ongoing versus completed per phase.
| Phase | Total | Ongoing | Completed | Split |
|---|---|---|---|---|
| Phase 2 | 81 | 45 | 22 | |
| Phase 1 | 53 | 25 | 24 | |
| Early Phase 1 | 13 | 6 | 4 | |
| Phase 1/2 | 10 | 6 | 3 | |
| Not applicable | 8 | 2 | 5 | |
| Phase 3 | 7 | 6 | 1 | |
| Unknown | 1 | 1 | 0 | |
| All phases | 173 | 91 | 59 |
Ongoing Completed Balance withdrawn, terminated, or status unreported.
Study records: ClinicalTrials.gov →
Mechanism of action
Prodrug converted to psilocin, which acts as a non-selective serotonin receptor agonist; 5-HT2A receptor activation mediates hallucinogenic effects.
Recent developments
Headlines link to the original publisher. Sources limited to a reviewed list of journals, regulators, and medical press.