Vistagen Reports Phase 3 Study Results for Fasedienol in Social Anxiety Treatment

Vistagen, a biopharmaceutical company based in South San Francisco, has announced the results of its PALISADE-3 Phase 3 study, which evaluated the efficacy of fasedienol for the acute treatment of social anxiety disorder. The trial, which was conducted to assess the drug’s effectiveness, did not achieve statistically significant improvements on its primary endpoint.

The primary endpoint of the study focused on changes in the Subjective Units of Distress Scale (SUDS). The results showed that the least squares mean change from baseline in SUDS scores for fasedienol was 13.6 +/- 1.54 standard error (SE), compared to 14.0 +/- 1.51 SE for the placebo group. The calculated least squares mean difference of 0.4 was found to be statistically insignificant (p = not significant).

Secondary Endpoint Results and Safety Profile

In addition to the primary endpoint, the study also evaluated several secondary endpoints. However, the trial found no meaningful treatment differences between fasedienol and the placebo in these measures.

Despite the lack of efficacy demonstrated in the trial, the safety profile of fasedienol remained favorable. According to Vistagen, these safety data align with findings from earlier clinical trials, suggesting that the drug may still hold potential for future development.

December 17, 2025 marks a significant date for Vistagen as the company continues to navigate the complexities of developing innovative therapies for mental health conditions. As part of its commitment to neuroscience, Vistagen is focused on pioneering new intranasal product candidates, known as pherines, to address unmet needs in the treatment landscape.

Investors and stakeholders will be watching closely as Vistagen evaluates these results and considers next steps for fasedienol and its ongoing research initiatives. The company trades on the Nasdaq under the ticker symbol VTGN.