BioinvestGPT

BioinvestGPT ApS · Research use only

NCT06358651 (Fasedienol in Social Anxiety Disorder): BVCT ex-ante prediction vs. reported outcome

On 28 Jul 2025, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 17 Dec 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT06358651
Acronym
PALISADE-3
Drug Name
Fasedienol
Drug MoA
pherine
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Social Anxiety Disorder
Human Patients
238
Sponsor
Vistagen Therapeutics
Phase
Phase 3

Prediction of , index 2042

Prospective Prediction
Prediction Index
2042
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in SUDS/LSAS slightly-to-moderately inferior to SSRI/SNRI)
Technical Prediction
FAILURE (statistically maybe significant yet very weak clinical benefit in SUDS/LSAS compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
142 days in advance
Readout Data Interpretation
Fasedienol did not demonstrate statistically significant improvement on primary endpoint of reduction in anxiety as measured by SUDS scores compared to placebo.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
US, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Fasedienol Nasal Spray for the Acute Treatment of Anxiety Induced by a Public Speaking Challenge in Adult Subjects With Social Anxiety Disorder, With an Open-Label Extension (PALISADE-3)
Phase
Phase 3
Status
Active not recruiting
Enrollment
238
Lead sponsor
VistaGen Therapeutics, Inc.
Conditions
Social Anxiety Disorder
Interventions
DRUG: Fasedienol Nasal Spray; DRUG: Placebo Nasal Spray
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2024-03-28
Primary completion
2025-10-31
Completion
2026-10
Primary outcomes
  • Subjective Units of Distress Scale (SUDS) (7 days (Visit 2 to Visit 3))

NCT06358651 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials