VistaGen

What VistaGen does

VistaGen Therapeutics (NASDAQ: VTGN) is a late clinical-stage biopharmaceutical company headquartered in South San Francisco, California, founded in 1998 and public since May 2011. The company is developing a pipeline of intranasal pherine drug candidates built on a proprietary nose-to-brain neurocircuitry platform acquired in the December 2022 Pherin Pharmaceuticals transaction. Pherines are administered at microgram doses and activate limbic amygdala neurocircuits through olfactory chemosensory neurons without requiring systemic absorption or direct brain uptake, which the company positions as a differentiated safety and rapid-onset profile relative to benzodiazepines, conventional antidepressants, and hormone therapies. The pipeline comprises six investigational products: fasedienol (PH94B) in Phase 3 for social anxiety disorder, itruvone (PH10) in Phase 2/3 for major depressive disorder, refisolone (PH80) entering Phase 2 for menopausal vasomotor symptoms and PMDD, AV-101 (an oral NMDA glycine-site antagonist) for depression and neurological disorders, PH15 for cognitive performance, and PH284 for cachexia. FDA Fast Track designations have been granted for fasedienol, itruvone, and AV-101.

The company operates a traditional biopharmaceutical commercialization model: it generates no current product revenue and intends to commercialize approved candidates through standard pharmaceutical sales channels, specialty pharmacy networks, and potential partnerships with larger pharmaceutical companies. Target end users are patient populations across large CNS and women's health indications — approximately 30 million Americans with social anxiety disorder, 21 million US adults with major depressive episodes, and 60-80% of women entering menopause experiencing hot flashes. FY2026 Q3 revenue was $0.30 million with a full-year net loss of $69.7 million, funded by a $100 million underwritten offering completed in October 2023, leaving $45.4 million in cash, cash equivalents, and marketable securities as of March 31, 2026.

The investment profile is dominated by clinical and corporate risk events in late 2025 and early 2026: the PALISADE-3 Phase 3 trial of fasedienol failed to meet its primary endpoint in December 2025, causing an over 80% stock decline and triggering multiple securities class action lawsuits. VistaGen responded with a 20% workforce reduction in March 2026 to extend cash runway into 2027, while continuing PALISADE-4 Phase 3, advancing refisolone and other pipeline candidates, and rebuilding executive leadership with new CFO (December 2025) and CMO (May 2026) appointments. Two board resignations triggered Nasdaq Listing Rule 5605(c)(2) audit committee non-compliance, adding governance overhang to the clinical and litigation risks.

Name

VistaGen

Legal name

Vistagen Therapeutics, Inc.

Website

https://vistagen.com

Company type

Public

Founded year

1998

Operating status

Operating

Headcount range

51–100 employees

Short description

VistaGen Therapeutics is a late clinical-stage biopharmaceutical company developing intranasal pherine drug candidates for CNS disorders including social anxiety disorder, major depressive disorder, and menopausal vasomotor symptoms, with no current product revenue.

Ownership category

akta.pro rank

Product category

Clinical-stage CNS biopharmaceuticals

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Pharmaceutical and Medicine Manufacturing (3254)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Neurology & CNS Specialty Pharmaceuticals (HLAIACAC)

akta.pro secondary industry

Preclinical Development (Pharmacology, PK/PD, ADME, Toxicology) (HLAIALAC)

Keywords

• Clinical stage biopharmaceutical
• CNS therapeutics development
• Intranasal drug delivery
• Mental health therapeutics
• Pherine drug development

Headquarters

HQ city

San Francisco

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Pharmaceutical Product Sales: Pre-commercial stage biopharmaceutical company with no current revenue from product sales. Revenue will be generated through commercialization of FDA-approved pharmaceutical products upon successful completion of clinical trials and regulatory approvals.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

VistaGen is a late clinical-stage biopharmaceutical company developing a pipeline of investigational intranasal pherine drug candidates designed to treat central nervous system (CNS) disorders by activating brain neurocircuitry through the olfactory system without requiring systemic absorption or direct brain uptake. The pipeline targets social anxiety disorder (Fasedienol/PH94B), major depressive disorder (Itruvone/PH10), menopausal vasomotor symptoms (Refisolone/PH80), cognitive impairment (PH15), cachexia (PH284), and an oral NMDA receptor antagonist program (AV-101). The company is pre-commercial with no approved products and intends to commercialize post-FDA approval.

Product overview

VistaGen is a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines. The company's pipeline consists of six investigational products: Fasedienol (PH94B) for social anxiety disorder, Itruvone (PH10) for major depressive disorder, Refisolone (PH80) for menopausal hot flashes, AV-101 as an oral NMDA receptor antagonist for neurological disorders, PH15 for cognitive enhancement, and PH284 for cachexia. All pherine candidates are designed to achieve therapeutic benefits without requiring absorption into the blood or uptake into the brain, potentially offering safer alternatives to existing pharmacological options. VistaGen's pherines activate brain neurocircuitry through the olfactory system without requiring systemic absorption or binding to neurons in the brain.

Differentiator

Problem solved

Functional benefit

Products and services

• Fasedienol (PH94B) Investigational intranasal pherine nasal spray administered at microgram doses to activate nasal chemosensory neurons connected to limbic amygdala neurocircuits, in Phase 3 development for the acute treatment of adults with social anxiety disorder. Achieves pharmacological activity without requiring apparent systemic distribution or direct activity on neurons in the brain.
• Itruvone (PH10) Investigational odorless synthetic neuroactive pherine nasal spray designed to engage chemosensory neurons in the nasal cavity and activate neural circuits in the brain that produce antidepressant effects through regulation of olfactory-amygdala neural circuits and sympathetic autonomic nervous system activity. In clinical development for major depressive disorder.
• Refisolone (PH80) Investigational odorless, tasteless synthetic pherine nasal spray for menopausal vasomotor symptoms (hot flashes) and premenstrual dysphoric disorder. Activates chemosensory neurons in the nasal cavity connected to neural circuits in the brain that modulate the basal forebrain without entering the bloodstream or binding to hormone receptors. FDA "Study May Proceed" approval received for Phase 2 testing.
• AV-101 Investigational oral prodrug targeting the N-methyl-D-aspartate receptor (NMDAR). Its active metabolite 7-chloro-kynurenic acid (7-Cl-KYNA) is a potent selective full antagonist of the glycine binding site of the NMDAR without being an ion channel blocker. In clinical development for depression, levodopa-induced dyskinesia, neuropathic pain, seizures, MDD, and suicidal ideation. FDA Fast Track designation granted for MDD adjunctive treatment and non-opioid neuropathic pain treatment.
• PH15 Investigational pherine nasal spray for acute treatment to improve cognitive function. Has a novel, rapid-onset potential mechanism of action differentiated from all currently approved treatments for cognitive impairment caused by mental fatigue, with potential to improve cognitive and psychomotor performance and reaction time.
• PH284 Investigational pherine nasal spray for acute management of wasting syndrome (cachexia). Has a novel, rapid-onset mechanism of action differentiated from all currently approved treatments for loss of appetite associated with chronic disorders such as cancer, with potential for improving subjective feelings of hunger in cachexia patients.

Quantifiable outcome

• PALISADE-2 Phase 3 trial showed positive results for fasedienol in social anxiety disorder
• +2 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability1 record

Feature4 records

Partnerships

One partnership is on record.

• Pherin PharmaceuticalscoreStrategic or Co-development Partner · 21 December 2022VistaGen acquired Pherin Pharmaceuticals for approximately 12.4 million shares and cash, gaining full ownership of Pherin's pherine drug pipeline. The acquisition included advanced candidates PH94B (now fasedienol) and PH10 (now itruvone), as well as three new early-stage candidates (PH80/Refisolone, PH15, PH284). This acquisition expanded VistaGen's portfolio in CNS disorder treatments and provided the foundational technology platform for its current pipeline.

Scale indicators7 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Axsome Therapeutics: Late clinical-stage CNS biopharma developing therapeutics for depression and other CNS indications (e.g., Auvelity). Directly comparable as a small-cap CNS-focused company with similar commercialization timelines and target patient populations.
• Sage Therapeutics: CNS-focused biopharma that developed Zurzuvae for postpartum depression in partnership with Biogen. Highly comparable specialty CNS player pursuing differentiated mechanisms for depression and anxiety indications.
• Karuna Therapeutics: Was a CNS biopharma developing xanomeline-trospium for schizophrenia before being acquired by Bristol-Myers Squibb for ~$14B in 2024. VistaGen's new CMO joined from Karuna, and the small-molecule CNS specialty pharma model is closely analogous.

Emerging players

• BioXcel Therapeutics: Clinical-stage CNS biopharma using AI-based drug discovery/repurposing to develop therapies for agitation in dementia and other CNS indications. Comparable as a small-cap specialty CNS player with differentiated discovery approaches.
• Tonix Pharmaceuticals: Small-cap CNS biopharma developing treatments for depression, PTSD, and other CNS disorders. Comparable in scale, clinical-stage CNS pipeline focus, and indication overlap with VistaGen's anxiety/depression programs.
• Marinus Pharmaceuticals: Small-cap CNS biopharma developing ganaxolone for epilepsy and other seizure-related disorders. Comparable as a single-asset-focused CNS company that has navigated late-stage clinical and commercialization challenges.

Broad incumbents

• Acadia Pharmaceuticals: Established CNS specialty pharma commercializing NUPLAZID for Parkinson's disease psychosis and DAYBUE for Rett syndrome. Comparable CNS therapeutic focus with multiple approved/revenue-generating products versus VistaGen's pre-commercial stage.
• Johnson & Johnson (Janssen): Large pharmaceutical company with a substantial CNS franchise including treatments for depression, schizophrenia, and anxiety. Represents the type of large partner/acquirer that could commercialize VistaGen's pherine candidates at scale.
• Pfizer: Major pharmaceutical company with established CNS commercial infrastructure across depression, anxiety, and pain indications. Represents a potential large-pharma commercialization partner for VistaGen's pipeline.
• Eli Lilly: Leading CNS pharmaceutical company with major franchises in depression and migraine (e.g., Zepbound, Emgality). Sets the bar for commercial scale in CNS indications VistaGen is targeting.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat2 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/vistagen-therapeutics-inc-
• Xx.com/vistagen
• Facebookfacebook.com/VistaGen

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

Subsidiaries1 record

Funding overview

Funding rounds9 records

Investors10 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about VistaGen