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VQW-765

Phase 3

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

VQW-765 development status

Highest phase Phase 3
Registered trials 2 across 1 sponsor since Mar 2021

VQW-765 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 Trials2
Total Enrollment730

FDA Designations

No designations recorded

VQW-765 clinical trials

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

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 for Performance Anxiety. It is currently in clinical development, with a Phase 2 study completed for Performance Anxiety and a Phase 3 study for Social Anxiety Disorder.

What does VQW-765 target?

VQW-765 targets the α7-nicotinic acetylcholine receptor (α7-nAChR). This receptor is a type of nicotinic acetylcholine receptor that is involved in the nervous system, and VQW-765 is designed to modulate its activity to address symptoms of anxiety.

Who makes VQW-765?

VQW-765 is being developed by Vanda Pharmaceuticals Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol VNDA. Vanda is conducting clinical trials to evaluate the drug's safety and efficacy for anxiety-related conditions.

What phase is VQW-765 in?

VQW-765 is in Phase 3 clinical development for Social Anxiety Disorder (SAD), based on a Phase 3 trial that is active but not recruiting. A Phase 2 study for Performance Anxiety has been completed. The drug is investigational and not yet approved by regulatory authorities.

What clinical trials is VQW-765 in?

VQW-765 has two clinical trials. NCT07221578 is a Phase 3 study evaluating the drug for on-demand treatment of Social Anxiety Disorder, with 500 participants, and is active but not recruiting. NCT04800237 is a completed Phase 2 study in Performance Anxiety with 230 participants. Both were conducted in the United States.

Is VQW-765 the same as any other drug?

No, VQW-765 is a unique investigational compound developed by Vanda Pharmaceuticals. It is not known to be the same as any other marketed drug. It is being studied specifically for its effects on anxiety disorders through its action on the α7-nAChR receptor.