Vistagen Therapeutics, Inc. VTGN
Vistagen Therapeutics, Inc. (Nasdaq: VTGN) is a CNS/neurology/psychiatry drug developer. Its lead program, fasedienol (PH94B) nasal spray, is in Phase 3 for acute treatment of anxiety in adults with social anxiety disorder.
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| fasedienol | social anxiety disorder (acute treatment) | small molecule | Phase 3 |
| refisolone | moderate to severe vasomotor symptoms due to menopause | small molecule | Phase 2 |
| itruvone | major depressive disorder | small molecule | Phase 2 |
| AV-101 (4-Cl-KYN) | NMDAR-related neurological disorders (levodopa-induced dyskinesia, neuropathic pain) | small molecule | Phase 2 |
| PH15 | psychomotor impairment due to mental fatigue | small molecule | Phase 1 |
| PH284 | cancer cachexia / appetite-related disorders | small molecule | Pre-clinical |
Recent results and decisions
- Sep 21, 2026positive PALISADE-4 OLE (N=322) well tolerated (1.6% AE discontinuation); LSAS improved 31.4 points at Month 4 (exploratory, uncontrolled).
today announced preliminary positive data from the open-label extension (OLE) portion of its PALISADE-4 Phase 3 study of fasedienol for the acute treatment of social anxiety disorder.
Filing - Aug 6, 2026missed Exploratory Phase 2 repeat dose study (N=61) showed numerical but not statistically significant separation on primary SUDS endpoint (p=0.2; pooled -15.0 vs -6.8 placebo); very severe subgroup nominally significant (p=0.04).
although the differences between treatment groups and placebo were not statistically significant (p=0.2)
Filing - Jun 30, 2026missed Missed primary endpoint (SUDS LS mean change -9.5 vs -11.4 placebo, diff 1.9, p=0.427, n=238); post-hoc very severe subgroup (LSAS>=95, n=123) nominal p=0.036.
In the overall trial population (n=238), fasedienol did not achieve its primary endpoint
Filing
3 more on record.
For subscribers
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