Vistagen introduced outcomes from the PALISADE-3 part 3 examine of intranasal fasedienol for acute remedy of social anxiousness dysfunction, displaying no statistically vital enchancment in main endpoint measures.1 The trial didn’t meet main or secondary endpoints, and confirmed favorable security information according to earlier trials.
“We’re dissatisfied by the surprising outcomes of this public talking problem trial, that are inconsistent with constructive outcomes noticed in Section 2 and our PALISADE-2 Section 3 examine,” mentioned Shawn Singh, JD, president and chief government officer of Vistagen, in a press launch. “We’re totally reviewing the outcomes of the examine, evaluating the potential influence of the outcomes on our ongoing research and plan to hunt suggestions from the [US Food and Drug Administration],” he added.
The PALISADE-3 part 3 trial was a multicenter, randomized, double-blind, placebo-controlled examine evaluating efficacy and security of single dose fasedienol. Intranasal administration of fasedienol was meant to scale back anxiousness signs throughout a simulated public talking problem. Participant anxiousness and misery signs have been evaluated utilizing the Subjective Items of Misery Scale (SUDS).
PALISADE-3 included adults aged 18 to 65 with a analysis of social anxiousness dysfunction as outlined by the DSM-5 and confirmed by a Mini-Worldwide Neuropsychiatric Interview.2 Clinician-rated Liebowitz Social Nervousness Scale rating of 70 or larger and Hamilton Despair Score Scale rating of lower than 16 have been required. Individuals additionally wanted regular olfactory perform for inclusion. Exclusion standards included any historical past of bipolar dysfunction, schizophrenia, and psychosis, amongst different psychiatric issues; average to extreme alcohol use dysfunction inside 1 yr previous to the examine and use of illicit substances or THC inside 2 months prior to check; threat for suicidal conduct; nasal pathology together with nasal trauma, nasal surgical procedure, anosmia; 2 or extra documented failed remedy trials for social anxiousness dysfunction; and receiving cognitive behavioral remedy.
Fasedienol didn’t exhibit a statistically vital enchancment within the main endpoint measurement of SUDS. There was additionally no remedy distinction for secondary endpoints. As measured by the least squares imply change from baseline on the SUDS rating for fasedienol (13.6 +/-1.54 customary error, SE) in contrast with placebo (14.0 +/-1.51 SE), least squares imply distinction of 0.4 (P not vital), the trial didn’t meet its main endpoint. The protection profile was according to earlier research, though the endpoint outcomes weren’t as constructive as earlier research of the drug.
Fasedienol modulates the olfactory-limbic amygdala concern and anxiousness neurocircuitry. The drug selectively binds as an agonist to peripheral receptors on nasal chemosensory neurons and is meant to set off olfactory bulb-to-brain neurocircuits thought to control mind areas concerned in conduct and autonomic nervous system exercise. With the intranasal type of this treatment, the design hopes to permit for therapeutic advantages with out requiring absorption into blood or uptake into the mind. The design has a definite tolerability profile as a result of neuromodulation can happen with out binding to mind neurotransmitter receptors. Vistagen famous that this formulation could have potential for a greater security profile in contrast with different pharmacological choices. Based mostly on nonclinical information, fasedienol confirmed no constructive sign of abuse potential.
Sufferers who participated within the PALISADE-3 examine could select to proceed with the open-label extension, utilizing fasedienol for as much as 12 months. The FDA has additionally granted Quick Observe designation for the event of fasedienol for acute remedy of social anxiousness dysfunction.3
References
1. Vistagen publicizes topline outcomes from PALISADE-3 part 3 public talking problem examine of fasedeniol for the acute remedy of social anxiousness. Press launch. December 17, 2025. Accessed December 17, 2025.
2. Fasedienol nasal spray for acute remedy of hysteria in adults with social anxiousness dysfunction (PALISADE-3). ClinicalTrials.gov. November 26, 2025. Accessed December 17, 2025.
3. US FDA grants VistaGen Therapeutics Quick Observe designtation for PH94B for remedy of social anxiousness dysfunction. December 10, 2019. Accessed December 17, 2025.