Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
5-MeO-DMT · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 5-MeO-DMT arm | EXPERIMENTAL | - |
| Placebo arm | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| 5-MeO-DMT | DRUG | A single dose of 5-MeO-DMT will be administered intranasally |
| Placebo | OTHER | A single dose of placebo will be administered intranasally |
Inclusion Criteria: \* Medically healthy based on medical records and study specific assessments Exclusion Criteria: \* Presence or history of severe adverse reaction to any drug or drug excipient
5-MeO-DMT is an investigational small molecule being developed by AtaiBeckley Inc. (ticker ATAI). It is in Phase 1 clinical development, and the specific therapeutic indications being pursued have not been disclosed. The compound has been studied in a single completed Phase 1 trial conducted in the United Kingdom.
5-MeO-DMT is being developed by AtaiBeckley Inc., which trades under the ticker ATAI. The company is the sponsor of the clinical program for this investigational small molecule, which has completed one Phase 1 trial to date.
5-MeO-DMT is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The program remains investigational and has not been approved by the FDA or any other regulatory agency based on the available information.
5-MeO-DMT has been studied in one completed Phase 1 trial, NCT05032833, titled Single Ascending Dose Study With 5-MeO-DMT in Healthy Subjects. The trial enrolled 36 healthy adult volunteers in the United Kingdom, was randomized, double-blind, and placebo-controlled, and included participants aged 25 years and older.
The therapeutic indications for 5-MeO-DMT have not been disclosed. The completed Phase 1 trial evaluated the drug in healthy adult volunteers to assess pharmacokinetics rather than a specific disease population. It remains an investigational small molecule in clinical development by AtaiBeckley Inc.