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EMP-01

Phase 2

Social Anxiety Disorder | Small molecule | Psychiatry |AtaiBeckley Inc.|Last Updated: Feb 17, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment70
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06693609Exploratory Safety and Efficacy of EMP-01 in Social Anxiety DisorderPHASE2 COMPLETED 70 — — Apr 15, 2025Feb 12, 2026Feb 17, 20267 United Kingdom
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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 — 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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