FDA Events for VistaGen Therapeutics (VTGN)
This section highlights FDA-related milestones and regulatory updates for drugs developed by VistaGen Therapeutics (VTGN).
Over the past two years, VistaGen Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Fasedienol. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Fasedienol - FDA Regulatory Timeline and Events
Fasedienol is a drug developed by VistaGen Therapeutics for the following indication: For the acute treatment of social anxiety disorder (SAD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Fasedienol
- Announced Date:
- June 2, 2025
- Indication:
- For the acute treatment of social anxiety disorder (SAD).
Announcement
Vistagen provides an update on the timeline for the ongoing clinical trials in its U.S. registration-directed PALISADE Phase 3 Program evaluating fasedienol for acute treatment of social anxiety disorder (SAD).
AI Summary
Vistagen VTGN has provided an update on its U.S. registration-directed PALISADE Phase 3 Program for evaluating fasedienol as an acute treatment for social anxiety disorder (SAD). The company announced that its PALISADE-3 trial is progressing as planned, with topline data expected in the fourth quarter of this year. In addition, the PALISADE-4 trial is now anticipated to deliver topline results in the first half of 2026. These trials are designed similarly to earlier studies that used a public speaking challenge to trigger and measure anxiety symptoms. Vistagen is encouraged by strong patient and physician enthusiasm and remains focused on careful patient recruitment. The company believes that successful outcomes from these trials could provide substantial evidence to support a future New Drug Application for fasedienol, which may address a significant unmet need for individuals suffering from SAD.
Read Announcement- Drug:
- Fasedienol
- Announced Date:
- January 10, 2025
- Indication:
- For the acute treatment of social anxiety disorder (SAD).
Announcement
Vistagen announced enrollment of the first subject in a repeat dose study of fasedienol, its investigational neuroactive pherine nasal spray in Phase 3 development for the acute treatment of social anxiety disorder (SAD).
AI Summary
Vistagen announced the enrollment of the first subject in its repeat dose study of fasedienol, the company’s investigational neuroactive pherine nasal spray. This nasal spray is now in Phase 3 development for the acute treatment of social anxiety disorder (SAD). The study is a small, exploratory, multi-center, randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, and effectiveness of fasedienol in reducing anxiety during a public speaking challenge. In this trial, participants are divided into three groups: one receiving two doses of fasedienol, one receiving a dose of fasedienol followed by a placebo, and one receiving two doses of placebo, with the second dose given ten minutes after the first. This work is part of Vistagen’s ongoing efforts to develop a fast-acting treatment option for SAD, addressing an important unmet need in the United States.
Read Announcement- Drug:
- Fasedienol
- Announced Date:
- September 23, 2024
- Indication:
- For the acute treatment of social anxiety disorder (SAD).
Announcement
Vistagen announced enrollment of the first subject in its PALISADE-4 Phase 3 trial of fasedienol, an investigational neuroactive pherine nasal spray in U.S. registration-directed Phase 3 development for the acute treatment of social anxiety disorder (SAD).
AI Summary
Vistagen has achieved a key milestone by enrolling the first subject in its PALISADE-4 Phase 3 trial. This trial is part of the company’s U.S. registration-directed program for fasedienol, an investigational neuroactive pherine nasal spray intended for the acute treatment of social anxiety disorder (SAD). The study, designed as a randomized, double-blind, placebo-controlled trial, will assess the safety, tolerability, and effectiveness of fasedienol using a public speaking challenge in a clinical setting. SAD affects over 30 million Americans, and currently, there is no acute treatment approved by the FDA. Vistagen’s novel approach focuses on activating nose-to-brain neural circuits rapidly, with the potential to offer fast relief from the debilitating effects of SAD. This enrollment marks an important step toward a possible New Drug Application submission if the trial meets its goals.
Read Announcement- Drug:
- Fasedienol
- Announced Date:
- June 11, 2024
- Estimated Event Date Range:
- July 1, 2024 - December 31, 2024
- Target Action Date:
- 2024-H2
- Indication:
- For the acute treatment of social anxiety disorder (SAD).
Announcement
Vistagen announced that PALISADE-3 Phase 3 trial recently initiated; PALISADE-4 Phase 3 trial initiation anticipated in 2H 2024
AI Summary
Vistagen Therapeutics has made progress in its Phase 3 program for the acute treatment of social anxiety disorder. The company recently initiated the PALISADE-3 Phase 3 trial for its investigational drug fasedienol. This trial aims to evaluate the drug’s safety, efficacy, and tolerability, and mirrors the design seen in earlier studies by including up to a 12-month open-label extension. During this extension, participants may use the drug up to six times a day, particularly before facing anxiety-provoking situations.
In addition to PALISADE-3, Vistagen is preparing to launch the PALISADE-4 Phase 3 trial in the second half of 2024. The upcoming trial is expected to further support development efforts and contribute to a potential U.S. New Drug Application submission for the treatment of social anxiety disorder.
Read Announcement- Drug:
- Fasedienol
- Announced Date:
- June 11, 2024
- Indication:
- For the acute treatment of social anxiety disorder (SAD).
Announcement
Vistagen announced that "Vistagen's fiscal 2024 proved to be a year full of remarkable accomplishments. Most notably, with our PALISADE-2 trial of fasedienol, we became the first company to report positive results of a Phase 3 trial for the acute treatment of social anxiety disorder, a mental health disorder affecting the lives of over 30 million adults in the U.S for which there is no FDA-approved acute treatment option.
AI Summary
In fiscal 2024, Vistagen marked a major milestone with its PALISADE-2 Phase 3 trial of fasedienol for treating social anxiety disorder (SAD). The company became the first to report positive outcomes in a Phase 3 trial for this condition, which affects more than 30 million U.S. adults and currently has no FDA-approved acute treatment option. Administered as a rapid-onset nasal spray, fasedienol leverages a unique nose-to-brain mechanism to rapidly activate neural circuits without systemic uptake. This success underscores Vistagen's dedication to pioneering new therapies and sets the stage for ongoing registration-directed studies. With additional Phase 3 trials already initiated and planned, the company is positioning fasedienol for a potential U.S. New Drug Application submission, promising a significant step forward in addressing the unmet needs of those suffering from SAD.
Read Announcement
VistaGen Therapeutics FDA Events - Frequently Asked Questions
As of now, VistaGen Therapeutics (VTGN) has not received any FDA approvals for its therapy in the last two years.
In the past two years, VistaGen Therapeutics (VTGN) has reported FDA regulatory activity for Fasedienol.
The most recent FDA-related event for VistaGen Therapeutics occurred on June 2, 2025, involving Fasedienol. The update was categorized as "Provided Update," with the company reporting: "Vistagen provides an update on the timeline for the ongoing clinical trials in its U.S. registration-directed PALISADE Phase 3 Program evaluating fasedienol for acute treatment of social anxiety disorder (SAD)."
Currently, VistaGen Therapeutics has one therapy (Fasedienol) targeting the following condition: For the acute treatment of social anxiety disorder (SAD)..
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:VTGN) was last updated on 7/10/2025 by MarketBeat.com Staff
