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Fasedienol

Phase 3

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

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment238
FDA Designations
No designations recorded
Clinical trial landscape

Fasedienol · 2 trials · 2 indications

Phase 3 2
NCT06615557Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-4)Social Anxiety Disorder (SAD)
ACTIVE NOT_RECRUITING238 Analytics
NCT06358651Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-3)Social Anxiety Disorder
ACTIVE NOT_RECRUITING238 Analytics
PHASE3ACTIVE NOT_RECRUITING
Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-4)
Social Anxiety Disorder (SAD)Unlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-3)
Social Anxiety DisorderUnlock trial analytics
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)
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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
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Eligibility Criteria
Age Range18 Years to 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
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06358651primaryCompletionDate: changed
MEDIUMMay 26, 2026NCT06615557Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT06615557studyFirstPostDate: changed
LOWMay 24, 2026NCT06358651studyFirstPostDate: changed