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EMP-01

Phase 2

Social Anxiety Disorder | Small molecule | Psychiatry |AtaiBeckley Inc.|Last Updated: Jul 31, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment70

FDA Designations

No designations recorded

Clinical trial landscape

EMP-01 · 1 trial · 1 indication

Phase 2 1
NCT06693609Exploratory Safety and Efficacy of EMP-01 in Social Anxiety DisorderSocial Anxiety Disorder
COMPLETED70 Analytics
PHASE2COMPLETED
Exploratory Safety and Efficacy of EMP-01 in Social Anxiety Disorder
Social Anxiety DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence and severity of treatment emergent adverse events, adverse events of special interest and serious adverse events.
Day 1 to EOS [Day 43]

Assess the safety and tolerability of EMP-01 compared with placebo (PBO) in participants with SAD.

Incidence of clinically significant abnormalities in physical examinations, vital signs, electrocardiogram parameters, and safety laboratory results.
Day 1 [post-dose] to Day 57

Assess the safety of EMP-01 compared with placebo (PBO) in participants with SAD.

Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Baseline to Day 57

Assess the safety of EMP-01 compared with placebo (PBO) in participants with SAD.

Secondary Endpoints

Liebowitz Social Anxiety Scale (LSAS)
Baseline to EOS [Day 43]
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
EMP-01EXPERIMENTAL -
EMP-01 PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
EMP-01DRUGEMP-01 capsules
EMP-01 PlaceboDRUGEMP-01 placebo capsules
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites7

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...

Countries:United Kingdom
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Recent Changes (Last 90 Days)

MEDIUMAug 31, 2026NCT06693609TRIAL_REMOVED: changed
MEDIUMAug 31, 2026NCT06693609TRIAL_REMOVED: changed
MEDIUMAug 31, 2026NCT06693609TRIAL_REMOVED: changed
MEDIUMAug 31, 2026NCT06693609TRIAL_REMOVED: changed

Frequently asked questions about EMP-01

What is EMP-01 used for in Social Anxiety Disorder?

EMP-01 is an investigational small molecule being developed for the treatment of Social Anxiety Disorder. It is currently in Phase 2 clinical development. A completed Phase 2 trial evaluated its exploratory safety and efficacy in patients with this condition.

What does EMP-01 target?

EMP-01 is a small molecule being studied for Social Anxiety Disorder. Its specific molecular target has not been disclosed in the available information.

Who makes EMP-01?

EMP-01 is being developed by AtaiBeckley Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol ATAI.

What phase is EMP-01 in?

EMP-01 is in Phase 2 clinical development for Social Anxiety Disorder. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed.

What clinical trials is EMP-01 in?

EMP-01 has one completed Phase 2 clinical trial, identified as NCT06693609, titled 'Exploratory Safety and Efficacy of EMP-01 in Social Anxiety Disorder.' This randomized, double-blind, placebo-controlled trial enrolled 70 participants in the United Kingdom.