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VQW-765

Phase 3

Social Anxiety Disorder (SAD) | Small molecule | Psychiatry |Vanda Pharmaceuticals Inc.|Last Updated: Aug 17, 2026

Target and mechanism

Molecular targetα7-nAChR
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment500

FDA Designations

No designations recorded

Clinical trial landscape

VQW-765 · 2 trials · 2 indications

Phase 3 1Phase 2 1
NCT07221578Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety DisorderSocial Anxiety Disorder (SAD)
ACTIVE NOT_RECRUITING500 Analytics
PHASE3ACTIVE NOT_RECRUITING
Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety Disorder
Social Anxiety Disorder (SAD)Unlock trial analytics

Study Endpoints

Primary Endpoints

Subjective Units of Distress Scale (SUDS)
1 day

Subjective Units of Distress Scale (SUDS) during performance phase, scored from 0-100 with a higher score indicating higher distress.

Secondary Endpoints

Subjective Units of Distress Scale (SUDS)
1 day
State-Trait Anxiety Inventory - State Anxiety Scale (STAI-S)
1 day
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
2 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
VQW-765EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
VQW-765DRUGoral capsule
PlaceboDRUGoral capsule
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites30

Inclusion Criteria: 1. Ability and willingness to provide written informed consent. 2. Male and female subjects aged 18-65 years, inclusive. 3. Current diagnosis of social anxiety disorder. 4. Liebowitz Social Anxiety Scale total score ≥60. 5. Public Speaking Anxiety Scale total score ≥60. 6. Hamil...

Countries:United States
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Recent Changes (Last 90 Days)

LOWAug 17, 2026NCT07221578lastUpdatePostDate: changed
LOWAug 17, 2026NCT07221578lastUpdatePostDate: changed
MEDIUMJul 20, 2026NCT07221578Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJul 20, 2026NCT07221578Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWJun 25, 2026NCT07221578lastUpdatePostDate: changed
LOWJun 25, 2026NCT07221578lastUpdatePostDate: changed
LOWJun 25, 2026NCT07221578lastUpdatePostDate: changed

Frequently asked questions about VQW-765

What is VQW-765 used for?

VQW-765 is an investigational small molecule being developed for the on-demand treatment of Social Anxiety Disorder (SAD) and Performance Anxiety. It is currently in clinical development and has not been approved by the FDA.

Who makes VQW-765?

VQW-765 is being developed by Vanda Pharmaceuticals Inc. (NASDAQ: VNDA). The company is conducting clinical trials to evaluate the drug's efficacy and safety for anxiety-related conditions.

What phase is VQW-765 in?

VQW-765 has completed a Phase 2 trial for Performance Anxiety and is currently in a Phase 3 trial for Social Anxiety Disorder. The Phase 3 study is active but not recruiting participants.

What clinical trials is VQW-765 in?

VQW-765 has two clinical trials: NCT04800237, a completed Phase 2 study in Performance Anxiety with 230 participants, and NCT07221578, an active Phase 3 study in Social Anxiety Disorder with 500 participants. Both trials are placebo-controlled and double-blind.

Is VQW-765 the same as any other drug?

No alternative names for VQW-765 have been reported. It is identified solely by its investigational code name in clinical trials and public records.