Social Anxiety DisorderPhase 3NCT05030350

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

A Phase 3 study testing PH94B in people with Social Anxiety Disorder, run by VistaGen Therapeutics, Inc. at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Social Anxiety Disorder
What is being tested?: PH94B
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 481 participants
Where: 3 sitesUnited States
Study dates: 1 Oct 2021to 23 Sep 2022
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female adults, 18 through 65 years of age, inclusive.
Women of childbearing potential must be able to commit to the consistent and correct use of an effective method of birth control throughout the study, and must also have a negative urine pregnancy test result at both Screening (Visit 1) (for subjects who attend Visit 1) and Baseline (Visit 2), prior to IP administration. Effective methods of contraception include: condoms with spermicide, diaphragm with spermicide, hormonal contraceptive agents (oral, transdermal, or injectable), or implantable contraceptive devices.
Current diagnosis of social anxiety disorder
Clinician-rated HAM-D17 total score < 18 at study entry
LSAS score 50 or greater

Who cannot join

Any history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, psychosis, anorexia or bulimia, autism-spectrum disorder, or obsessive-compulsive disorder. Any other current Axis I disorder, other than SAD, which is the primary focus of treatment. Note that subjects with concurrent Generalized Anxiety Disorder are eligible for the study provided that Generalized Anxiety Disorder is not the primary diagnosis.
Subjects who meet criteria for moderate or severe alcohol or substance use disorder within the 1 year prior to study entry.
In the opinion of the Investigator, the subject has a significant risk for suicidal behavior during the course of their participation in the study.
Clinically significant nasal pathology or history of significant nasal trauma, nasal surgery, total anosmia, or nasal septum perforation that may have damaged the nasal chemosensory epithelium.
An acute or chronic condition, including an infectious illness, uncontrolled seasonal allergies at the time of the study, or significant nasal congestion that potentially could affect drug delivery to the nasal chemosensory epithelium.
Subjects using the following psychotropic medications: anticonvulsants, mood stabilizers, antipsychotic medications, gabapentin, pregabalin, opioids, naltrexone, esketamine, and ketamine at enrollment.

Show all 12Show fewer

Subjects using lower doses of atypical antipsychotics at Screening may be eligible after discussion with the Medical Monitor (e.g., quetiapine < 100 mg).
In general, subjects using antidepressants or buspirone can continue to receive these provided that they have been taking them for a minimum of 2 months, and have been on a stable dose for a minimum of 1 month.
Use of anxiolytics, such as benzodiazepines or unapproved treatments such as beta blockers, within 30 days before study entry; concomitant use is prohibited during the study. Subjects who have been taking benzodiazepines daily for 1 month or longer at the time of Visit 1 are not eligible to participate.
Use of any over-the-counter product, prescription product, or herbal preparation for treatment of the symptoms of anxiety or social anxiety within 30 days before study entry; concomitant use is prohibited during the study.
Subjects with clinically significant abnormalities in hematology, blood chemistry, urinalysis, 12-lead ECG, or physical examination identified at the Screening visit or Baseline visit that in the clinical judgment of the Investigator, could place the subject at undue risk, interfere with study participation, or confound the results of the study.
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Trial locations and contacts

3 sites in 1 country.

United States3 sites

VistaGen Investigational Site
Bellevue, Washington, 98007
VistaGen Investigational Site
New York, New York, 10128
VistaGen Investigational Site
Watertown, Massachusetts, 02472

Other trials in United States

About this study

Official title: A Phase 3 Open-label Safety Trial of PH94B Nasal Spray in the Acute Treatment of Anxiety in Adult Subjects With Social Anxiety Disorder (SAD)

This study evaluates the safety and tolerability of PH94B with repeated dosing over a period of up to 12 months. Participating subjects will use PH94B up to 4 times a day when they encounter anxiety-provoking situations in daily life. Safety and tolerability of PH94B (≤ 4 doses per day up to 12 months) will be assessed and summarized during monthly visits from baseline (Visit 2) to end of treatment (Visit 14) in AEs, laboratory values, 12-lead ECGs, physical examinations, and vital sign assessments following exposure to PH94B.

Conditions: Social Anxiety Disorder
Being tested: PH94B
Medical subject headings: Phobia, Social

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PH94BDrug
Nasal spray

Study groups in NCT05030350
Study group	Role	What they receive
PH94B 3.2 micrograms	Experimental	100 microliter nasal spray to each nostril up to four times a day as needed for acute anxiety Receives: Drug: PH94B

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Subjects with at least one Serious Adverse Event (SAE)
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 202123 Sep 2022

First posted1 Sep 2021
Study start1 Oct 2021
Primary completion23 Sep 2022
Study completion23 Sep 2022

Why it stopped: Study stopped by the sponsor for business reasons and not due to any safety concerns with PH94B

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 481 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05030350
Sponsor's protocol ID: PH94B-CL030
Status last verified: Oct 2025
First submitted: 26 Aug 2021
Last updated: 21 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Social Anxiety Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Open-label Safety Trial of PH94B Nasal Spray in the Acute Treatment of Anxiety in Adult Subjects With Social Anxiety Disorder (SAD)
ClinicalTrials.gov ID: NCT05030350
Acronym / sponsor ID: PH94B-CL030
Conditions: Social Anxiety Disorder
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study stopped by the sponsor for business reasons and not due to any safety concerns with PH94B
Enrolment: 481 participants (actual)
Lead sponsor: VistaGen Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 1 Oct 2021 (actual)
Primary completion: 23 Sep 2022 (actual)
Study completion: 23 Sep 2022 (actual)
First posted: 1 Sep 2021 (actual)
Results: Posted 21 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
PH94B 3.2 micrograms	Experimental	Drug: PH94B100 microliter nasal spray to each nostril up to four times a day as needed for acute anxiety

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male and female adults, 18 through 65 years of age, inclusive.
Women of childbearing potential must be able to commit to the consistent and correct use of an effective method of birth control throughout the study, and must also have a negative urine pregnancy test result at both Screening (Visit 1) (for subjects who attend Visit 1) and Baseline (Visit 2), prior to IP administration. Effective methods of contraception include: condoms with spermicide, diaphragm with spermicide, hormonal contraceptive agents (oral, transdermal, or injectable), or implantable contraceptive devices.
Current diagnosis of social anxiety disorder
Clinician-rated HAM-D17 total score < 18 at study entry
LSAS score 50 or greater

Key exclusion criteria (12 listed)

Any history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, psychosis, anorexia or bulimia, autism-spectrum disorder, or obsessive-compulsive disorder. Any other current Axis I disorder, other than SAD, which is the primary focus of treatment. Note that subjects with concurrent Generalized Anxiety Disorder are eligible for the study provided that Generalized Anxiety Disorder is not the primary diagnosis.
Subjects who meet criteria for moderate or severe alcohol or substance use disorder within the 1 year prior to study entry.
In the opinion of the Investigator, the subject has a significant risk for suicidal behavior during the course of their participation in the study.
Clinically significant nasal pathology or history of significant nasal trauma, nasal surgery, total anosmia, or nasal septum perforation that may have damaged the nasal chemosensory epithelium.
An acute or chronic condition, including an infectious illness, uncontrolled seasonal allergies at the time of the study, or significant nasal congestion that potentially could affect drug delivery to the nasal chemosensory epithelium.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PH94BNasal spray	Drug	PH94B 3.2 micrograms

Primary outcome

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: 12 months
Subjects with at least one Serious Adverse Event (SAE)

Results and safety

Results posted to the registry on 21 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PH94B 3.2 Micrograms	481	0

Primary outcome: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time frame: 12 months. Count of participants. Unit: Participants

Measure	PH94B n = 481
Subjects with at least one TEAE	273
Subjects with at least 1 Mild TEAE	186
Subjects with at least 1 Moderate TEAE	78
Subjects with at least 1 Severe TEAE	9
Subjects with at least 1 TEAE leading to study discontinuation	14
Subjects with at least 1 SAE	6

Adverse events

Time frame: 12 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PH94B	6 of 481 (1.2%)	137 of 481 (28.5%)	1 of 481

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Social Anxiety Disorder

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Adverse Childhood Experience, Depression / Major Depressive Disorder
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jaakko Lappalainen, MD, PhD study director

VistaGen Therapeutics

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PH94B in people with Social Anxiety Disorder, run by VistaGen Therapeutics, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05030350.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2025.