VQW-765 · program
VQW-765 for Social anxiety disorder
Vanda's Phase 3 program for VQW-765 in social anxiety disorder evaluates a single, on-demand oral dose for acute anxiety provoked by a standardized psychosocial stress test. The pivotal study (NCT07221578) is recruiting ~500 adults with SAD; topline results are guided for end of 2026. The approach follows a Phase 2 performance-anxiety study (NCT04800237) that missed its primary endpoint overall but showed a significant effect in female participants.
Development timeline
- Phase 3 social anxiety disorder study (NCT07221578) initiated; first study start date on ClinicalTrials.gov.
Readouts
Clinical trials in Social anxiety disorder
NCT07221578Phase 3Recruitingn=500
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Acute Anxiety in Patients With Social Anxiety Disorder
NCT04800237VP-VQW-765-2201Phase 2Completedn=230
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of VQW-765 in Patients With Performance Anxiety
metsecondarySUDS during TSST performance phase, female subgroup (0.034)
Female participants (~69% of the sample) receiving VQW-765 showed a larger-magnitude and statistically significant reduction in performance-phase anxiety versus placebo (P=0.034).
missedprimarySubjective Units of Distress Scale (SUDS) during the Trier Social Stress Test performance phase (0.1443)
A single 10 mg oral dose of VQW-765 produced numerically lower distress (SUDS) than placebo during the TSST performance phase but did not reach statistical significance in the overall intention-to-treat population (P=0.1443).
Formulations
| Formulation | Route | Regimen | Pharmacokinetics |
|---|---|---|---|
| VQW-765 oral capsule 10 mg oral capsule, single on-demand dose (Phase II performance-anxiety trial VP-VQW-765-2201) | Oral | Single dose | t½ 20.75 h · Tmax 6 h |
Mechanism of action
VQW-765 is a potent and selective partial agonist of the alpha-7 nicotinic acetylcholine receptor (alpha7-nAChR, gene CHRNA7). It is being developed for on-demand acute use, leveraging fast-onset cholinergic modulation of the social-stress response.
| Target | Action | Affinity |
|---|---|---|
| alpha7 nAChRprimaryCHRNA7 | Partial agonist | EC50 7.5 uMⓘ |
← Full VQW-765 compound page (identity, identifiers, all indications)
Sources
- Efficacy and safety of an alpha7-nAChR agonist, VQW-765, in subjects with performance anxiety (RCT) - oral 10 mg single dose — The British Journal of Psychiatry (PMC)
- Evaluating the Effects of VQW-765 vs. Placebo in Performance Anxiety — ClinicalTrials.gov
- Feuerbach et al. 2015 - AQW051, a novel, potent and selective alpha7 nAChR partial agonist: pharmacological characterization and phase I evaluation — British Journal of Pharmacology (PMC)
- NCT07221578 - VQW-765 for on-demand treatment of social anxiety disorder — ClinicalTrials.gov
- Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results — Vanda Pharmaceuticals (Nasdaq)
- Vanda Pharmaceuticals Reports Results in a Phase II Clinical Study of VQW-765 in the Treatment of Acute Performance Anxiety — Vanda Pharmaceuticals (PR Newswire)