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BNC210

Phase 3

Social Anxiety Disorder | Small molecule | Psychiatry |Neuphoria Therapeutics Inc.|Last Updated: May 19, 2026

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment521

FDA Designations

No designations recorded

Clinical trial landscape

BNC210 · 5 trials · 3 indications

Phase 3 1Phase 2 4
NCT06510504Efficacy of BNC210 in Acute, As-needed Treatment of Anxiety in Social Anxiety Disorder - 1Social Anxiety Disorder
COMPLETED370 Analytics
PHASE3COMPLETED
Efficacy of BNC210 in Acute, As-needed Treatment of Anxiety in Social Anxiety Disorder - 1
Social Anxiety DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline to the Average Subjective Units of Distress Scale (SUDS) Score of the 5-minute Performance Phase of a Public Speaking Challenge
Assessed over a single visit: On the treatment day at Baseline (approximately 5 minutes pre-dose) and during the Public Speaking Challenge Performance Phase conducted at 65 to 70 minutes post-dose (following the Anticipation Phase that started at 60 min).

The SUDS is a self reported measure of the intensity of distress currently experienced by an individual. The range is 0-100, with a higher score indicating a higher level of anxiety/greater distress

Change From Baseline on the Clinician Administered Post-Traumatic Stress Disorder (PTSD) Scale for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) Total Symptom Severity Scores After 12 Weeks
Baseline, 4 weeks, 8 weeks,12 weeks

The CAPS-5 is a 30-item structured interview used to diagnose PTSD and assess PTSD symptoms over the past month. Information about the frequency and intensity of each item is combined into a severity rating, and the CAPS-5 total symptom severity score is calculated by adding the severity scores for the 20 PTSD symptoms in the DSM-5. Scores range from 0 to 80, with higher scores indicating greater severity of PTSD symptoms.

Absolute change in agitation, as measured by the Pittsburgh Agitation Scale (PAS).
5 days
Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5), Total Symptom Severity Score
12 weeks.

Investigator-rated PTSD symptom severity. The range for the Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5)Total Symptom Severity Score is 0-80, with a higher score meaning a higher severity of disease.

Secondary Endpoints

Change From Baseline to the Average SUDS Score of the 2-minute Anticipation Phase of a Public Speaking Challenge
Assessed over a single visit: On the treatment day at Baseline (approximately 5 minutes pre-dose) and during the Public Speaking Challenge Anticipation Phase conducted at 60 to 62 minutes post-dose (the first 2 minutes of the Public Speaking Challenge).
Change From Baseline to the End of the 5-minute Performance Phase of a Public Speaking Challenge in the Clinical Global Impressions-Severity (CGI-S) Score
Assessed over a single visit: On the treatment day at Baseline (approximately 5 minutes pre-dose) and at the end of the Public Speaking Challenge Performance Phase at 70 minutes post-dose (following the Anticipation Phase that started at 60 min).
Difference at the End of the 5-minute Performance Phase of a Public Speaking Challenge in the Patient Global Impressions-Improvement (PGI-I) Score
Assessed over a single visit: On the treatment day at the end of the Public Speaking Challenge Performance Phase at 70 minutes post-dose (following the Anticipation Phase that started at 60 min).
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
225 mg BNC210EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
675 mg BNC210EXPERIMENTAL -
BNC210EXPERIMENTAL -
BNC210 600 mg b.i.d.EXPERIMENTALSuspension administered orally for 12 weeks.
BNC210 300 mg b.i.d.EXPERIMENTALSuspension administered orally for 12 weeks.
BNC210 150 mg b.i.d.EXPERIMENTALSuspension administered orally for 12 weeks.
Placebo b.i.d.PLACEBO_COMPARATORSuspension administered orally for 12 weeks.

Interventions

NameTypeDescription
225 mg BNC210DRUG225 mg BNC210
PlaceboDRUGPlacebo
675 mg BNC210DRUG675 mg BNC210
BNC210DRUGBNC210 900 mg twice daily (b.i.d.) for 12 weeks
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites21

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, sc...

Countries:United StatesUnited KingdomAustralia
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Recent Changes (Last 90 Days)

MEDIUMJun 19, 2026NCT06510504TRIAL_REMOVED: changed
MEDIUMJun 19, 2026NCT06510504TRIAL_REMOVED: changed
MEDIUMJun 19, 2026NCT06510504TRIAL_REMOVED: changed

Frequently asked questions about BNC210

What is BNC210 used for?

BNC210 is an investigational small molecule being developed for Post-Traumatic Stress Disorder (PTSD), Social Anxiety Disorder, and Agitation in the Elderly. It is currently in clinical development and has not been approved by the FDA.

Who makes BNC210?

BNC210 is being developed by Bionomics Limited, which trades under the ticker NEUP. The company is conducting clinical trials to evaluate the drug's safety and efficacy in several psychiatric conditions.

What phase is BNC210 in?

BNC210 has completed Phase 2 trials for PTSD and Social Anxiety Disorder, and a Phase 3 trial for Social Anxiety Disorder has also been completed. The drug remains investigational and is not yet approved for any use.

What clinical trials is BNC210 in?

BNC210 has been studied in several completed trials, including NCT02933606 and NCT04951076 for PTSD, NCT05193409 for Social Anxiety Disorder, and NCT06510504 for Social Anxiety Disorder. These trials were randomized, double-blind, and placebo-controlled.

Is BNC210 the same as any other drug?

BNC210 is not known to have any alternative names. It is a distinct investigational compound being developed by Bionomics Limited for psychiatric conditions.