VistaGen Therapeutics (VTGN) FDA Approvals

VistaGen Therapeutics' Drug in the FDA Approval Process

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.

Positive Data - May 12,2026

• Drug: Fasedienol
• Announced Date: May 12, 2026
• Indication: For the acute treatment of social anxiety disorder (SAD).

Vistagen announced preliminary positive data from the ongoing open-label extension (OLE) portion of its PALISADE-3 Phase 3 study of fasedienol for the acute treatment of social anxiety disorder.

Vistagen reported preliminary positive data from the open-label extension of its PALISADE-3 Phase 3 study of fasedienol nasal spray for acute social anxiety disorder. In adults using the spray as needed in daily life, up to six times a day, the treatment was well-tolerated for as long as 12 months, with no new drug-related safety findings. The company also said early data from the first four months showed clinically relevant improvement in social anxiety over time.

These improvements were seen on both clinician-rated and patient-reported measures, including the Liebowitz Social Anxiety Scale and the Social Phobia Inventory. The findings suggest that fasedienol may help reduce fear, avoidance, and physical symptoms linked to social anxiety while maintaining a favorable safety profile during real-world use.

Provided Update - May 8,2026

Phase 3

• Drug: Fasedienol
• Announced Date: May 8, 2026
• Indication: For the acute treatment of social anxiety disorder (SAD).

Vistagen announced that the last patient has completed the last visit in the randomized, double-blind, placebo-controlled portion of PALISADE-4, the Company's Phase 3 clinical trial evaluating fasedienol nasal spray for the acute treatment of social anxiety disorder.

Vistagen announced that the last patient has completed the final visit in the randomized, double‑blind, placebo‑controlled portion of PALISADE‑4, its Phase 3 trial of fasedienol nasal spray for the acute treatment of social anxiety disorder. That milestone means the randomized part of the study has finished enrolling and collecting required patient data under blinded conditions, allowing the company to move into data analysis for those randomized results.

Topline results for the randomized portion of PALISADE‑4 are expected in the second quarter of 2026. The company said it will analyze the blinded data to determine safety and efficacy outcomes compared with placebo, and then report the findings. This completion is a key step toward evaluating whether fasedienol can provide an effective, fast-acting nasal option for people experiencing acute social anxiety symptoms.

Provided Update - December 17,2025

Phase 3

• Drug: Fasedienol
• Announced Date: December 17, 2025
• Indication: For the acute treatment of social anxiety disorder (SAD).

Vistagen announced that the PALISADE-3 Phase 3 study of intranasal fasedienol for the acute treatment of social anxiety disorder did not demonstrate a statistically significant improvement on the primary endpoint of change on the Subjective Units of Distress Scale (SUDS).

Vistagen announced that its PALISADE-3 Phase 3 study of intranasal fasedienol for acute treatment of social anxiety disorder did not meet the primary endpoint. The change in Subjective Units of Distress Scale (SUDS) scores showed a least squares mean change of 13.6 (±1.54 SE) for fasedienol versus 14.0 (±1.51 SE) for placebo, a LS mean difference of 0.4 (p = not significant).

There were no treatment differences on secondary endpoints. Safety and tolerability data were favorable and consistent with prior clinical trials, with no new safety signals reported in this study.

Vistagen said it is reviewing the unexpected results, evaluating next steps for its clinical program, and has put company-wide cash preservation measures in place to improve efficiency and extend cash runway into 2027. The company thanked patients and investigators who participated in the trial.

Clinical Trial - November 3,2025

Phase 3

• Drug: Fasedienol
• Announced Date: November 3, 2025
• Indication: For the acute treatment of social anxiety disorder (SAD).

Vistagen announced that the last patient has completed the randomized, double-blind, placebo-controlled portion of the PALISADE-3 Phase 3 clinical trial evaluating fasedienol for the acute treatment of social anxiety disorder.

Vistagen announced that the final patient has now completed the randomized, double-blind, placebo-controlled portion of its PALISADE-3 Phase 3 trial evaluating fasedienol for the acute treatment of social anxiety disorder. The study’s open-label extension is underway, allowing participants to use fasedienol for up to twelve months. Topline results from PALISADE-3 are expected by year end.

Like the earlier PALISADE-2 trial, PALISADE-3 uses a simulated public speaking challenge and measures anxiety reduction with the Subjective Units of Distress Scale. A successful outcome in PALISADE-3, together with the upcoming PALISADE-4 readout, could provide strong evidence to support a potential New Drug Application for fasedienol.

Vistagen aims to offer the first acute treatment option for the more than 30 million Americans living with social anxiety disorder. The company thanked study volunteers, investigators, site staff, and research partners for their contributions.

Provided Update - June 2,2025

Phase 3

• Drug: Fasedienol
• Announced Date: June 2, 2025
• Indication: For the acute treatment of social anxiety disorder (SAD).

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).

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.

Enrollment Update - January 10,2025

Phase 3

• Drug: Fasedienol
• Announced Date: January 10, 2025
• Indication: For the acute treatment of social anxiety disorder (SAD).

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).

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.

Enrollment Update - September 23,2024

Phase 3

• Drug: Fasedienol
• Announced Date: September 23, 2024
• Indication: For the acute treatment of social anxiety disorder (SAD).

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).

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.

Clinical Trial - June 11,2024

Phase 3

• Drug: Fasedienol
• Announced Date: June 11, 2024
• Target Action Date: H2 2024
• Estimated Target Date Range: July 1, 2024 - December 31, 2024
• Indication: For the acute treatment of social anxiety disorder (SAD).

Vistagen announced that PALISADE-3 Phase 3 trial recently initiated; PALISADE-4 Phase 3 trial initiation anticipated in 2H 2024

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.

Provided Update - June 11,2024

• Drug: Fasedienol
• Announced Date: June 11, 2024
• Indication: For the acute treatment of social anxiety disorder (SAD).

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.

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.