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PH94B

Phase 3

Social Anxiety Disorder | Small molecule | Psychiatry |Vistagen Therapeutics, Inc.|Last Updated: Sep 12, 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
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment224
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04754802PH94B Nasal Spray for Anxiety Induced by a Public Speaking ChallengePHASE3 COMPLETED 224May 24, 2021Jun 22, 2022Sep 12, 202521 United States
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Study Endpoints
Primary Endpoints
Subjective Units of Distress Scale (SUDS) Score
Visit 2 (Baseline; Day 0) to Visit 3 (Day 7 ± 2 days)

The SUDS is a patient self-rated scale that is scored in the range of 0 to 100 (operationalized for participants in this study as 0=totally relaxed or no anxiety and 100=highest distress or anxiety ever felt

Secondary Endpoints
Proportions (%) of CGI-I Responders in PH94B-treated and Placebo-treated Groups at the End of Visit 3 (Treatment)
Visit 2 (Baseline; Day 0) to Visit 3 (Day 7 ± 2 days)
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PH94BEXPERIMENTALPH94B Nasal Spray - single treatment with 3.2 micrograms PH94B
PlaceboEXPERIMENTALPlacebo Nasal Spray - single treatment with placebo
Interventions
NameTypeDescription
PH94B Nasal SprayDRUGNasal spray delivered 20 minutes before the public speaking stressor
Placebo Nasal SprayDRUGNasal spray delivered 20 minutes before the public speaking stressor
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: 1. Written informed consent provided prior to conducting any study-specific assessment. 2. Male or female adult, 18 through 65 years of age, inclusive. 3. Current diagnosis of SAD as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, as confirmed ...

Countries:United States
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