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Open-label Safety Trial of PH94B in Social Anxiety Disorder (SAD)

Phase 3
Waitlist Available
Research Sponsored by VistaGen Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial tests if PH94B is safe and tolerable for people with anxiety. Participants will use it multiple times daily when anxious, and their health will be regularly monitored.

Eligible Conditions
  • Social Anxiety Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse events and other safety measures
Liebowitz Social Anxiety Scale

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: PH94B 3.2 microgramsExperimental Treatment1 Intervention
100 microliter nasal spray to each nostril up to four times a day as needed for acute anxiety
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PH94B
2014
Completed Phase 3
~70

Find a Location

Who is running the clinical trial?

VistaGen Therapeutics, Inc.Lead Sponsor
10 Previous Clinical Trials
1,338 Total Patients Enrolled
1 Trials studying Social Anxiety Disorder
236 Patients Enrolled for Social Anxiety Disorder
Jaakko Lappalainen, MD, PhDStudy DirectorVistaGen Therapeutics
~116 spots leftby Dec 2025