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BPL-003

Phase 2

Alcohol Use Disorder | Small molecule | Other |AtaiBeckley Inc.|Last Updated: Aug 14, 2025

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment13
FDA Designations
BREAKTHROUGH_THERAPY
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05674929An Open-Label, Single Dose Study in Patients With Alcohol Use DisorderPHASE2 COMPLETED 13May 30, 2023Oct 2, 2024Aug 14, 20252 United Kingdom
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Study Endpoints
Primary Endpoints
Percentage of patients with treatment emergent adverse events
Up to12 weeks
Percentage of patients with clinically significant abnormal laboratory tests
Up to12 weeks
Percentage of patients with clinically significant abnormal vital signs
Up to12 weeks
Percentage of patients with suicidal ideation and changes in Columbia Suicidality Rating Scores (CSSRS)
Up to12 weeks
Readiness for discharge questionnaire
1 Day
Reactivation Questionnaire
Up to 12 weeks

Measure the frequency, emotional valence and functional impact of any re-activation events in the study

Secondary Endpoints
Effects on the Mystical Experience Questionnaire (MEQ30)
1 Day
Effects on the Ego Dissolution Inventory (EDI)
1 Day
Percentage of patients experiencing a complete mystical experience, as assessed by the Mystical Experience Questionnaire (MEQ30)
1 Day
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BPL-003 armEXPERIMENTAL -
Interventions
NameTypeDescription
BPL-003DRUGA single dose administered intranasally
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Willing and able to give informed consent. 2. Age 18 to 64 years at Screening. 3. Diagnosed with moderate to severe AUD. 4. Minimum of 4 heavy drinking days in the 28 days before Screening. 5. No more than 14 days have elapsed since the last HDD or completion of detoxificatio...

Countries:United Kingdom
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