Vistagen Therapeutics, Inc.
For the period ended May 12, 2026. Filed May 12, 2026.
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May 12, 2026 · Filed May 12, 2026
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EX-99.1 · Preliminary Safety Data
Preliminary Safety Data
In the OLE portion of PALISADE-3, as of May 8, 2026, fasedienol nasal spray, taken as-needed, up to six times a day, was observed to be well-tolerated in adults with social anxiety disorder.
The rate of discontinuation due to adverse events was 2.6% (9/341), with no discontinuations attributed to fasedienol.
Substantially all (>95%) of TEAEs were mild or moderate in severity.
The only TEAEs occurring in > 5% of subjects were headache (10.9%, 37/341) and upper respiratory infection (11.4%, 39/341).
There were no Serious Adverse Events related to fasedienol.
No safety signals of concern were identified related to laboratory values, ECGs, physical examinations, and vital sign assessments following exposure to fasedienol.
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