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EMP-01 · 1 trial · 1 indication
Assess the safety and tolerability of EMP-01 compared with placebo (PBO) in participants with SAD.
Assess the safety of EMP-01 compared with placebo (PBO) in participants with SAD.
Assess the safety of EMP-01 compared with placebo (PBO) in participants with SAD.
| Arm | Type | Description |
|---|---|---|
| EMP-01 | EXPERIMENTAL | - |
| EMP-01 Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| EMP-01 | DRUG | EMP-01 capsules |
| EMP-01 Placebo | DRUG | EMP-01 placebo capsules |
Inclusion Criteria: Eligibility will be assessed at Screening and will be reconfirmed on Day -1 (Baseline) based on available information, before randomization on the following day (Day 1). Participants must meet all of the following criteria to be enrolled in this study: Age 1. Participants mus...
EMP-01 is an investigational small molecule being developed by AtaiBeckley Inc. for the treatment of social anxiety disorder. It is a psychiatric candidate that has completed a Phase 2 clinical trial. EMP-01 has not been approved by any regulatory agency and remains in clinical development.
EMP-01 is being studied for social anxiety disorder, a psychiatric condition characterized by intense fear or anxiety in social situations. Its clinical program has focused on this single indication. Because EMP-01 is still investigational, it is not available as a prescribed treatment outside of clinical research.
EMP-01 targets the 5-HT2A receptor, also written as 5-HT2AR, a serotonin receptor. The 5-HT2A receptor is a G protein-coupled receptor that mediates effects of serotonin in the brain. EMP-01 is a small molecule designed to act at this receptor target.
EMP-01 is being developed by AtaiBeckley Inc., which trades under the ticker ATAI. The company is the sponsor of the drug's clinical program in social anxiety disorder. AtaiBeckley is a psychiatry-focused biopharmaceutical company.
EMP-01 is in Phase 2 development. Its Phase 2 trial in social anxiety disorder has been completed, and no trials are currently listed as active. EMP-01 is investigational and has not received FDA approval.
EMP-01 has been evaluated in one clinical trial, NCT06693609, titled Exploratory Safety and Efficacy of EMP-01 in Social Anxiety Disorder. The Phase 2 study was completed, enrolled 70 participants, was randomized, double-blind, and placebo-controlled, and was conducted in the United Kingdom in adults aged 18 years and older.