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BNC210

Phase 3

Social Anxiety Disorder | Small molecule | Psychiatry |Bionomics Limited - American Depository Shares|Last Updated: May 19, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment521
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06510504Efficacy of BNC210 in Acute, As-needed Treatment of Anxiety in Social Anxiety Disorder - 1PHASE3 COMPLETED 370 — — Aug 6, 2024Sep 19, 2025May 19, 202621 United States
NCT05193409A Phase 2 Study of BNC210 for the Acute Treatment of Social Anxiety DisorderPHASE2 COMPLETED 151 — — Feb 2, 2022Oct 17, 2022Mar 18, 202515 United States
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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

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 -
Interventions
NameTypeDescription
225 mg BNC210DRUG225 mg BNC210
PlaceboDRUGPlacebo
675 mg BNC210DRUG675 mg BNC210
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Eligibility Criteria
Age Range18 Years — 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 States
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