Vistagen, a biopharmaceutical company based in South San Francisco, California, has announced the results of its PALISADE-3 Phase 3 study concerning the use of fasedienol for the acute treatment of Social Anxiety Disorder. The company disclosed on December 17, 2025, that the trial did not achieve its primary endpoint, which measured the change in the Subjective Units of Distress Scale (SUDS).
The study aimed to determine the efficacy of intranasal fasedienol compared to a placebo. Results indicated a mean change from baseline SUDS score of 13.6 (±1.54 standard error) for fasedienol versus 14.0 (±1.51 standard error) for the placebo, resulting in a least squares mean difference of 0.4. The findings were not statistically significant (p = not significant), indicating no treatment difference between fasedienol and the placebo group.
In addition to the primary endpoint, the trial also assessed various secondary endpoints, none of which demonstrated a significant difference between the treatment and placebo groups. Despite these outcomes, Vistagen noted that the safety profile of fasedienol was favorable and aligned with data from previous clinical trials. This consistency in safety data may provide a foundation for future studies.
The PALISADE-3 study was designed to address the urgent need for effective treatments for social anxiety disorder, a condition that often leads to significant distress and impairment in daily functioning for those affected. Although the primary objectives were not met, Vistagen remains committed to exploring the potential of fasedienol and other candidates in its pipeline.
This setback comes as a disappointment to stakeholders and investors, particularly those following Vistagen’s progress on the Nasdaq under the ticker symbol VTGN. As the company analyzes the implications of these results, attention will likely turn to its next steps in addressing social anxiety disorder and enhancing its product offerings.
Vistagen’s research into pherines, a new class of intranasal product candidates, continues to represent an innovative approach in the field of neuroscience. Future updates from the company may clarify how it plans to proceed with fasedienol and its ongoing commitment to addressing mental health challenges.
