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VQW-765

Phase 3

Social Anxiety Disorder (SAD) | Small molecule | Psychiatry |Vanda Pharmaceuticals Inc.|Last Updated: May 29, 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_CONTROLLEDDMC
Total Trials1
Total Enrollment500
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07221578Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety DisorderPHASE3 RECRUITING 500Sep 22, 2025Apr 1, 2027May 29, 202630 United States
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Study Endpoints
Primary Endpoints
Subjective Units of Distress Scale (SUDS)
1 day

Subjective Units of Distress Scale (SUDS) during performance phase, scored from 0-100 with a higher score indicating higher distress.

Secondary Endpoints
Subjective Units of Distress Scale (SUDS)
1 day
State-Trait Anxiety Inventory - State Anxiety Scale (STAI-S)
1 day
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
2 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
VQW-765EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
VQW-765DRUGoral capsule
PlaceboDRUGoral capsule
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites30

Inclusion Criteria: 1. Ability and willingness to provide written informed consent. 2. Male and female subjects aged 18-65 years, inclusive. 3. Current diagnosis of social anxiety disorder. 4. Liebowitz Social Anxiety Scale total score ≥60. 5. Public Speaking Anxiety Scale total score ≥60. 6. Hamil...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 29, 2026NCT07221578lastUpdatePostDate: changed
LOWMay 29, 2026NCT07221578lastUpdatePostDate: changed
LOWMay 29, 2026NCT07221578lastUpdatePostDate: changed
LOWMay 26, 2026NCT07221578primaryCompletionDate: changed
LOWMay 24, 2026NCT07221578studyFirstPostDate: changed