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Evaluating BNC210 for treating anxiety in social anxiety disorder

A Phase 3, Randomized, Double-blind, 2-arm, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of BNC210 for the Acute, As-needed Treatment of Anxiety in Adults With Social Anxiety Disorder

Phase 3 Interventional Bionomics Limited · NCT06510504

This study is testing if a single dose of BNC210 can help adults with social anxiety feel less anxious compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment332 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorBionomics Limited Industry-sponsored
Locations21 sites (Encino, California and 20 other locations)
Trial IDNCT06510504 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy of a single acute dose of BNC210 compared to a placebo in reducing anxiety levels in adults diagnosed with social anxiety disorder. Participants will be randomly assigned to receive either 225 mg of BNC210 or a placebo, followed by a behavioral assessment task to measure their anxiety response. The study is designed as a randomized, double-blind, placebo-controlled trial, ensuring that neither the participants nor the researchers know who receives which treatment. A follow-up assessment will be conducted one week later to monitor safety and any adverse effects.

Who should consider this trial

Good fit: Ideal candidates for this study are adults with a current diagnosis of social anxiety disorder and a Liebowitz Social Anxiety Scale score of 60 or higher.

Not a fit: Patients with a history of certain psychiatric disorders or those currently using psychotropic medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a rapid and effective option for managing acute anxiety in patients with social anxiety disorder.

How similar studies have performed: Other studies have shown promise in using similar acute treatment approaches for anxiety disorders, but the specific efficacy of BNC210 is still being evaluated.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* A current diagnosis of social anxiety disorder as defined in the DSM-5.
* A Liebowitz Social Anxiety Scale total score of ≥60.
* Suitable contraception use in line with protocol requirements.
* Ability to swallow tablets.

Exclusion Criteria:

* History of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorders, anorexia or bulimia, body dysmorphic disorder, PTSD, autism-spectrum disorder or obsessive-compulsive disorder, or any other Axis I or II disorder which is currently the primary focus of treatment over social anxiety disorder.
* Hamilton Rating Scale for Depression score of ≥18.
* Moderate or severe alcohol-use disorder, or any other substance-use disorder (any severity) in the past 12 months.
* Use of psychotropic medications within 30 days of screening. Daily use of benzodiazepines within 90 days of screening.
* Any clinically significant medical history or findings as determined by the Investigator that could interfere with the objectives of the study or put the participant at risk.

Where this trial is running

Encino, California and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Social Anxiety Disorder
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.