VistaGen Therapeutics
Late clinical-stage biopharmaceutical company focused on development of rapid-onset, nose-to-brain intranasal therapies (microgram‑dose neuroactive molecules) and related oral prodrugs for neuropsychiatric and women’s health indications. Pipeline includes multiple clinical-stage candidates and programs for social anxiety disorder, major depressive disorder, menopausal vasomotor symptoms, PMDD, cachexia-related appetite loss, and cognitive impairment due to mental fatigue. The company pursues regulatory interactions (including FDA Fast Track designations), clinical development, publication of clinical and preclinical findings, and partnering opportunities for co-development, licensing, and commercialization.
Industries
Nr. of Employees
medium (51-250)
VistaGen Therapeutics
South San Francisco, California, United States
Patents
Products
Fasedienol (PH94B) nasal spray
Investigational intranasal agent developed for rapid-onset acute treatment of anxiety episodes in adults with social anxiety disorder; designed to activate nasal chemosensory receptors and limbic neurocircuitry without requiring systemic absorption.
Itruvone (PH10) nasal spray
Investigational intranasal neuroactive agent for rapid-onset treatment of major depressive disorder; designed to engage nasal chemosensory neurons and modulate olfactory-amygdala circuits without systemic absorption.
Refisolone (PH80) nasal spray
Investigational intranasal agent being developed for vasomotor symptoms (hot flashes) due to menopause and for acute management of premenstrual dysphoric disorder; administered at microgram doses to activate nasal receptors connected to basal forebrain circuits.
AV-101 (4-Cl-KYN) oral prodrug
Investigational oral prodrug that is metabolized to a selective antagonist of the NMDA receptor glycine binding site; evaluated in clinical and nonclinical studies for multiple CNS disorders.
PH15 (intranasal)
Investigational intranasal agent under development to improve psychomotor or cognitive impairment caused by mental fatigue; evaluated in a randomized, double‑blind, placebo‑controlled Phase 2A crossover pilot study measuring reaction time.
PH284 (intranasal)
Investigational intranasal agent evaluated for improvement of subjective appetite measures in cachexia (wasting syndrome); reported exploratory Phase 2A results showing effects on subjective feeling of hunger.
Fasedienol (PH94B) nasal spray
Investigational intranasal agent developed for rapid-onset acute treatment of anxiety episodes in adults with social anxiety disorder; designed to activate nasal chemosensory receptors and limbic neurocircuitry without requiring systemic absorption.
Itruvone (PH10) nasal spray
Investigational intranasal neuroactive agent for rapid-onset treatment of major depressive disorder; designed to engage nasal chemosensory neurons and modulate olfactory-amygdala circuits without systemic absorption.
Refisolone (PH80) nasal spray
Investigational intranasal agent being developed for vasomotor symptoms (hot flashes) due to menopause and for acute management of premenstrual dysphoric disorder; administered at microgram doses to activate nasal receptors connected to basal forebrain circuits.
AV-101 (4-Cl-KYN) oral prodrug
Investigational oral prodrug that is metabolized to a selective antagonist of the NMDA receptor glycine binding site; evaluated in clinical and nonclinical studies for multiple CNS disorders.
PH15 (intranasal)
Investigational intranasal agent under development to improve psychomotor or cognitive impairment caused by mental fatigue; evaluated in a randomized, double‑blind, placebo‑controlled Phase 2A crossover pilot study measuring reaction time.
PH284 (intranasal)
Investigational intranasal agent evaluated for improvement of subjective appetite measures in cachexia (wasting syndrome); reported exploratory Phase 2A results showing effects on subjective feeling of hunger.
Services
Co-development, regional/global licensing, out-licensing, and commercialization arrangements for clinical-stage programs and later-stage assets.
Co-development, regional/global licensing, out-licensing, and commercialization arrangements for clinical-stage programs and later-stage assets.
Expertise Areas
- Intranasal (nose-to-brain) drug development
- Clinical trial management (Phase 1–3)
- Neuropsychiatry therapeutics development
- Women’s health therapeutics (vasomotor symptoms, PMDD)
Key Technologies
- Nose-to-brain intranasal delivery
- Nasal chemosensory receptor targeting
- Microgram-level intranasal formulation
- Oral prodrug design
News & Updates
Regular corporate updates, investor conference presentations, and webcast events (examples include RBC, Stifel, TD Cowen presentations and periodic corporate update calls).
Announcement of collaboration to apply predictive AI to protocol development and resource allocation for lead clinical programs.
FDA Fast Track designations reported for multiple programs (examples cited include investigational agents for major depressive disorder, neuropathic pain, and social anxiety disorder).
Company announced achievement of minimum ICH E1 safety exposure recommendations across its clinical program for a lead intranasal candidate.
Regular corporate updates, investor conference presentations, and webcast events (examples include RBC, Stifel, TD Cowen presentations and periodic corporate update calls).
Announcement of collaboration to apply predictive AI to protocol development and resource allocation for lead clinical programs.
FDA Fast Track designations reported for multiple programs (examples cited include investigational agents for major depressive disorder, neuropathic pain, and social anxiety disorder).
Company announced achievement of minimum ICH E1 safety exposure recommendations across its clinical program for a lead intranasal candidate.