Vistagen Therapeutics, Inc. (Nasdaq: VTGN) announced preliminary positive data from the open-label extension (OLE) portion of its PALISADE-4 Phase 3 study of fasedienol nasal spray for the acute treatment of social anxiety disorder. The data, released on September 21, 2026, and filed with the SEC on September 22, 2026, covers the safety and tolerability of the drug over a 12-month period in an everyday life setting.
The OLE portion of PALISADE-4 included 322 subjects who elected to continue the study. Participants used fasedienol as needed, up to six times per day, in anxiety-provoking social and performance situations. The study demonstrated that the drug was well-tolerated with no new drug-related safety findings. As of a July 24, 2026 data cut-off, the rate of discontinuation due to adverse events was 1.6 percent (5 out of 322 subjects), with no discontinuations attributed to fasedienol.
Adverse events reported in more than 5 percent of subjects included headache (18.0 percent), upper respiratory tract infection (9.9 percent), rhinorrhoea (7.1 percent), and oropharyngeal pain (5.3 percent). More than 95 percent of treatment-emergent adverse events were mild or moderate in severity. There were no serious adverse events related to fasedienol, and no safety signals were identified in laboratory values, electrocardiograms, physical examinations, or vital sign assessments.
Exploratory efficacy data over the first four months of treatment showed clinically relevant improvement on both clinician-administered and patient-reported scales. On the Liebowitz Social Anxiety Scale (LSAS), a score of 99.3 at baseline indicated very severe social anxiety. By Month 4, the mean improvement was 31.4 points, with 65 percent of subjects achieving an improvement of at least 20 points. The mean change in LSAS at Month 2 showed a clinically meaningful improvement of two social anxiety disorder severity categories.
Similarly, on the Social Phobia Inventory (SPIN), a score of 48.5 at baseline indicated severe social anxiety. By Month 4, the mean improvement was 14.9 points, with 59 percent of subjects improving by at least 10 points. The company noted that these results add to a growing body of evidence supporting fasedienol’s potential to address social anxiety disorder in everyday life settings.
Vistagen stated that it is preparing to meet with the U.S. Food and Drug Administration (FDA) during the current quarter to consider a proposed new registrational Phase 3 clinical trial for fasedienol. The company also noted that the randomized, double-blind, placebo-controlled portion of PALISADE-4 did not achieve its primary endpoint in the overall study population, though a post-hoc analysis of a subpopulation with very severe social anxiety showed a statistically significant difference in Subjective Units of Distress Scale (SUDS) scores.
