fasedienol (PH94B NS) / VistaGen, EverInsight Therap - LARVOL DELTA

Fasedienol for the Acute Treatment of Social Anxiety Disorder (SAD) (VistaGen Press Release) - "The U.S. registration-directed PALISADE Program evaluating intranasal fasedienol for the acute treatment of SAD continues to progress. The PALISADE-3 Phase 3 trial remains on track for expected topline data in the fourth quarter of this year. Topline results for the PALISADE-4 Phase 3 trial are expected in the first half of 2026; Vistagen believes either PALISADE-3 or PALISADE-4, if successful, together with the positive results from PALISADE-2 reported in the second half of 2023, may establish substantial evidence of the effectiveness of fasedienol in support of a potential fasedienol New Drug Application (NDA) submission to the U.S. FDA for the acute treatment of SAD."

P3 data: top line • Social Anxiety Disorder

Vistagen Reports Fiscal Year 2025 Financial Results (VistaGen Press Release) - "R&D expenses were $39.4 million and $20.0 million for the fiscal years ended March 31, 2025, and 2024, respectively. The increase in R&D expense was primarily due to an increase in research, clinical and nonclinical development, and contract manufacturing expenses and headcount related to the U.S. registration-directed PALISADE Program for fasedienol in SAD and U.S. IND-enabling program for PH80 in women’s health."

Commercial • Pain • Social Anxiety Disorder

New Vistas in the Treatment of Mood and Anxiety Disorders: Psychedelics, Neuromodulation and More (APA 2025) - "The combination of dextromethorphan and bupropion was recently FDA approved for major depression, as was intranasal esketamine. Promising novel agents under scrutiny in clinical trials for depression include lumateperone, already approved for the treatment of schizophrenia and bipolar disorder, esmethadone, a non-mµ opiate receptor antagonist and more than one kappa opiate antagonist for the treatment of depression with prominent anhedonia, positive allosteric modulators of the GABA-A receptor for GAD and MDD (as a follow up to the approval of brexanolone and zuranolone for the treatment of post-partum depression), a novel agent that acts as a thyroid hormone receptor agonist for MDD, fasedienol for the treatment of social anxiety disorder, a novel intracellular modulator of MTORC1 in the treatment of depression, triple (DA, NE, 5HT) reuptake inhibitors for depression and an orexin antagonist for the treatment of depression. Instructional Level Intermediate;..."

Bipolar Disorder • CNS Disorders • Depression • General Anxiety Disorder • Major Depressive Disorder • Postpartum Depression • Post-traumatic Stress Disorder • Psychiatry • Schizophrenia • Social Anxiety Disorder • Vascular Neurology

Vistagen to Present at the 2025 Anxiety and Depression Association Conference (Businesswire) - "Vistagen...today announced it will present at the Anxiety and Depression Association of America (ADAA) Conference in Las Vegas, Nevada from April 3 to 5, 2025. The Company’s poster presentations will explore the age of onset of social anxiety disorder (SAD) from participants in fasedienol clinical trials, and new data on the characteristics of young adults with and without SAD."

Clinical data • Retrospective data • CNS Disorders • Social Anxiety Disorder

A U.S. Double-blind, Placebo-controlled Phase 2 Clinical Trial to Assess the Efficacy, Safety, and Tolerability of a Repeat Dose of Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults with Social Anxiety Disorder (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: VistaGen Therapeutics, Inc.

New P2 trial • CNS Disorders • Mood Disorders • Psychiatry • Social Anxiety Disorder

Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-4) (clinicaltrials.gov) - P3 | N=236 | Recruiting | Sponsor: VistaGen Therapeutics, Inc.

New P3 trial • CNS Disorders • Mood Disorders • Psychiatry • Social Anxiety Disorder

Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-3) (clinicaltrials.gov) - P3 | N=236 | Recruiting | Sponsor: VistaGen Therapeutics, Inc.

New P3 trial • CNS Disorders • Mood Disorders • Psychiatry • Social Anxiety Disorder

Results From PALISADE-2: A Phase 3 Trial of Fasedienol (PH94B) Nasal Spray for the Acute Treatment of Social Anxiety Disorder (ADAA 2024) - P3 | "Results from PALISADE-2, a Phase 3 trial of fasedienol for acute treatment of SAD, conducted in a diverse demographic group representative of the US population, demonstrated that a single dose of fasedienol prior to a stressful PSC resulted in significant anxiolysis as measured by patient-rated SUDS and PGI-C and clinician-rated CGI-I. Results support the olfactory-amygdala neural circuits as a new portal for administration of rapid-onset pherine pharmaceuticals, and the continued development of fasedienol as a first-in-class, rapid-onset, well-tolerated treatment option for acute, as-needed, treatment of SAD without addictive properties. Does this session relate to the conference theme: "Sex and Gender: Navigating the Biological and Social Constructs in Depression and Anxiety Disorders"?"

P3 data • CNS Disorders • Depression • Mood Disorders • Psychiatry • Social Anxiety Disorder

A Neuroanatomic and Pathophysiologic Framework for Novel Pharmacological Approaches to the Treatment of Post-traumatic Stress Disorder. (PubMed, Drugs) - "Indeed, investigations and drug development are proceeding in a number of these alternative, non-serotonergic pathways in an effort to improve the management of PTSD. In this manuscript, the authors introduce novel and emerging treatments for PTSD, including drugs in various stages of development and clinical testing (BI 1358894, BNC-210, PRAX-114, JZP-150, LU AG06466, NYV-783, PH-94B, SRX246, TNX-102), established agents and known compounds being investigated for their utility in PTSD (brexpiprazole, cannabidiol, doxasoin, ganaxolone, intranasal neuropeptide Y, intranasal oxytocin, tianeptine oxalate, verucerfont), and emerging psychedelic interventions (ketamine, MDMA-assisted psychotherapy, psilocybin-assisted psychotherapy), with an aim to examine and integrate these agents into the underlying pathophysiological frameworks of trauma-related disorders."

Journal • Review • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

Effect of fasedienol (PH94B) pherine nasal spray and steroidal hormones on electrogram responses and autonomic nervous system activity in healthy adult volunteers. (PubMed, Hum Psychopharmacol) - "Intranasal fasedienol, but not control or steroidal hormones, activated EGNR and rapidly reduced ANS responses, consistent with sympatholytic effects. Combined with subjective reports, results suggest fasedienol may provide acute relief in anxiety conditions."

Journal • CNS Disorders • Mood Disorders • Psychiatry • Social Anxiety Disorder

PH94B in the Treatment of Adjustment Disorder With Anxiety (clinicaltrials.gov) - P2 | N=41 | Completed | Sponsor: VistaGen Therapeutics, Inc. | Phase classification: P2a ➔ P2

Phase classification • Mood Disorders • Psychiatry

Palisade-2: PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge - 2 (clinicaltrials.gov) - P3 | N=324 | Terminated | Sponsor: VistaGen Therapeutics, Inc. | N=208 ➔ 324 | Recruiting ➔ Terminated; Study stopped by the sponsor for business reasons and not due to any safety concerns with PH94B

Enrollment change • Trial termination • CNS Disorders • Mood Disorders • Psychiatry • Social Anxiety Disorder

PH94B in the Treatment of Adjustment Disorder With Anxiety (clinicaltrials.gov) - P2a | N=41 | Completed | Sponsor: VistaGen Therapeutics, Inc. | Recruiting ➔ Completed | Trial primary completion date: Aug 2022 ➔ Dec 2022

Trial completion • Trial primary completion date • Mood Disorders • Psychiatry

Vistagen to Present Fasedienol (PH94B) Safety and Exploratory Efficacy Data from Phase 3 Open-Label Social Anxiety Disorder Study at American Society for Clinical Psychopharmacology Annual Meeting (Businesswire) - "Vistagen...today announced that safety and exploratory efficacy data from its Phase 3 open-label study of fasedienol (PH94B) nasal spray for the treatment of adults with social anxiety disorder (SAD) will be presented in a late-breaking poster presentation at the American Society for Clinical Psychopharmacology (ASCP) 2023 Annual Meeting taking place in Miami from May 30 through June 2, 2023."

Late-breaking abstract • P3 data • CNS Disorders • Social Anxiety Disorder

A Phase 3 Open-label Safety Trial of Fasedienol (PH94B) Nasal Spray in the Treatment of Anxiety in Adults with Social Anxiety Disorder (SAD) (ASCP 2023) - P2, P3 | "The study was closed early for reasons unrelated to clinical results or safety findings. 481 patients received ≥1 dose of fasedienol; 273 (56.8%) had ≥1 TEAE, of which only 9 (1.9%) were severe. TEAEs occurring in ≥5% of patients were headache (17.0%) and COVID-19 infection (11.4%)."

Clinical • Late-breaking abstract • P3 data • Addiction (Opioid and Alcohol) • CNS Disorders • Pain • Psychiatry • Social Anxiety Disorder

Vistagen Presents New Fasedienol (PH94B) Research at 2023 Anxiety and Depression Association of America Conference (Businesswire) - P3 | N=23 | NCT02622958 | Sponsor: Pherin Pharmaceuticals | "Vistagen...announced new data, presented at the 2023 Anxiety and Depression Association of America (ADAA) Conference in Washington, D.C., that further supporting the proposed mechanism of action (MOA) of fasedienol (PH94B), the Company’s rapid-onset investigational pherine nasal spray in Phase 3 development for the treatment of social anxiety disorder (SAD). Findings from the study demonstrate local metabolism and clearance of fasedienol from the nasal passages. This discovery of the local nasal clearance of fasedienol may explain prior research findings that fasedienol is absent from systemic circulation and from the brain after intranasal administration, contributing to its favorable safety profile in all clinical studies to date, which studies have involved over 30,000 doses of fasedienol administered to adults with SAD."

P3 data • CNS Disorders • Social Anxiety Disorder

"$VTGN Vistagen Advances Intellectual Property Program to Expand Patent Protection for PH94B to Include Treatment of Adjustment Disorder https://t.co/viH9WsX4sW #patent" (@stock_titan)

Open-label Safety Trial of PH94B in Social Anxiety Disorder (SAD) (clinicaltrials.gov) - P3 | N=483 | Terminated | Sponsor: VistaGen Therapeutics, Inc. | Trial completion date: Feb 2023 ➔ Sep 2022 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2022 ➔ Sep 2022; Study stopped by sponsor due to the completion of the PALISADE-1 study and the pausing of the PALISADE-2 study from which PH94B-CL030 subjects were being enrolled.

Trial completion date • Trial primary completion date • Trial termination • CNS Disorders • Mood Disorders • Psychiatry • Social Anxiety Disorder

Palisade-1: PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge (clinicaltrials.gov) - P3 | N=209 | Completed | Sponsor: VistaGen Therapeutics, Inc. | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Mood Disorders • Psychiatry • Social Anxiety Disorder

Palisade-1: PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge (clinicaltrials.gov) - P3 | N=209 | Active, not recruiting | Sponsor: VistaGen Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Mood Disorders • Psychiatry • Social Anxiety Disorder

Brain and Peripheral Distribution of Intranasal Radiolabeled PH94B in Laboratory Rats (SOBP 2022) - "The data further support the proposed mechanism of action whereby PH94B binds to peripheral sensory neuron receptors in the nasal passages, rather than neuronal receptors in the CNS, thereby limiting transport of molecules to the circulatory system, minimizing both blood brain barrier penetration and systemic exposure. DISCLOSURE Click here to read the SOBP Conflict of Interest Disclosure Policy. Financial Relationships Disclosure Yes, I do have a financial relationship(s) to disclose."

Late-breaking abstract • Preclinical • CNS Disorders • Mood Disorders • Psychiatry • Social Anxiety Disorder

Brain and Peripheral Distribution of Intranasal Radiolabeled PH94B in Laboratory Rats - "One male and one female rat was used for autoradiographic analysis at each time point. A single intranasal administration of radiolabeled 14C-PH94B was largely confined to the nasal passages, with minimal or undetectable radiolabeled 14C-PH94B uptake in either peripheral (e.g. blood plasma, kidney, and liver) or central nervous system (CNS: olfactory lobes, cerebrum, cerebellum, and spinal cord) tissue at all time points- from 15 minutes to 504 hours after intranasal administration."

Preclinical • CNS Disorders • Mood Disorders • Psychiatry • Social Anxiety Disorder

Open-label Safety Trial of PH94B in Social Anxiety Disorder (SAD) (clinicaltrials.gov) - P3; N=600; Recruiting; Sponsor: VistaGen Therapeutics, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • CNS Disorders • Mood Disorders • Psychiatry • Social Anxiety Disorder

PH94B in the Treatment of Adjustment Disorder With Anxiety (clinicaltrials.gov) - P2a; N=40; Recruiting; Sponsor: VistaGen Therapeutics, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Mood Disorders • Psychiatry

Palisade-2: PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge - 2 (clinicaltrials.gov) - P3; N=208; Recruiting; Sponsor: VistaGen Therapeutics, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • CNS Disorders • Mood Disorders • Psychiatry • Social Anxiety Disorder