Vistagen, a biopharmaceutical company based in South San Francisco, announced on December 17, 2025, that its Phase 3 study, PALISADE-3, evaluating intranasal fasedienol for the acute treatment of social anxiety disorder, did not meet its primary endpoint. The trial assessed the efficacy of fasedienol by measuring changes in the Subjective Units of Distress Scale (SUDS), but results indicated no statistically significant improvement over the placebo.
The analysis revealed a least squares (LS) mean change from baseline in the SUDS score for fasedienol at 13.6 (+/-1.54 standard error, SE), while the placebo group recorded a score of 14.0 (+/-1.51 SE). This resulted in an LS mean difference of 0.4 (p = not significant), clearly indicating that fasedienol did not outperform the placebo in reducing social anxiety symptoms.
No significant treatment differences were observed in the secondary endpoints either, further emphasizing the study’s lack of efficacy for fasedienol in this context. Despite these findings, the safety profile of fasedienol remained favorable and consistent with previous clinical trials, offering some reassurance regarding the compound’s tolerability.
The PALISADE-3 study is a critical component of Vistagen’s efforts to develop a new class of intranasal products known as pherines. These candidates aim to leverage nose-to-brain neurocircuitry to address various neuropsychiatric conditions. While the outcomes of this trial are disappointing, Vistagen continues to explore other therapeutic avenues within its pipeline.
Investors and stakeholders will undoubtedly be closely monitoring Vistagen’s next steps following these results. The company trades on the Nasdaq under the ticker symbol VTGN, and its future developments in the realm of social anxiety disorder and other mental health conditions remain of significant interest.
