Recent Updates
Recently added Catalysts

Fasedienol

Phase 3

Social Anxiety Disorder (SAD) | Small molecule | Psychiatry |Vistagen Therapeutics, Inc.|Last Updated: May 22, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment238
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06615557Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-4)PHASE3 ACTIVE NOT_RECRUITING 238Sep 16, 2024Apr 1, 2027May 22, 202626 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Subjective Units of Distress Scale (SUDS)
7 days (Visit 2 to Visit 3)

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
Global Impression Scale of Improvement (CGI-I)
7 days (Visit 2 to Visit 3)
Patient Global Impression of Change (PGI-C)
7 days (Visit 2 to Visit 3)
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Fasedienol Nasal SprayEXPERIMENTAL -
Placebo Nasal SprayEXPERIMENTAL -
Interventions
NameTypeDescription
Fasedienol Nasal SprayDRUGNasal spray delivered 20 minutes before the PSC
Placebo Nasal SprayDRUGNasal spray delivered 20 minutes before the PSC
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites26

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

Countries:United States
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06615557Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT06615557studyFirstPostDate: changed