VQW-765 / Novartis, Vanda - LARVOL DELTA

Novel and promising treatments for anxiety disorders (WFSBP 2026) - "Results / Several compounds are in development, including drugs targeting the serotonin system (toludesvenlafaxine, gepirone, FKW00GA), the trace amine-associated receptor 1 (TAAR1), , the GABA binding site (ENX-102, darigabat, and buagafuran), the nicotinic receptor (soclenitant and VQW-765), the endocannabinoid system (cannabidiol and SYT-510), pherins (fasedienol) and psychedelics (MM120, PSX-001, MSP-1014). The translation of these compounds into clinically approved treatments for anxiety disorders may take several years, potentially delaying the emergence of significant therapeutic breakthroughs."

CNS Disorders • Mood Disorders • Psychiatry

Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety Disorder (clinicaltrials.gov) - P3 | N=500 | Active, not recruiting | Sponsor: Vanda Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Mood Disorders • Psychiatry • Social Anxiety Disorder

Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety Disorder (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: Vanda Pharmaceuticals

New P3 trial • CNS Disorders • Mood Disorders • Psychiatry • Social Anxiety Disorder

Efficacy and safety of an alpha 7-nicotinic acetylcholine receptor agonist, VQW-765, in subjects with performance anxiety: randomised, double-blind, placebo-controlled trial: commentary, Baldwin et al. (PubMed, Br J Psychiatry) - No abstract available

Journal • Mood Disorders • Psychiatry

Efficacy and safety of an alpha 7-nicotinic acetylcholine receptor agonist, VQW-765, in subjects with performance anxiety: randomised, double-blind, placebo-controlled trial. (PubMed, Br J Psychiatry) - "This is the first study showing anxiolytic effect of an α7-nAChR agonist in humans. VQW-765 is a promising candidate to be developed for on-demand treatment of social anxiety disorder."

Journal • CNS Disorders • Mood Disorders • Psychiatry • Social Anxiety Disorder

Evaluating the Effects of VQW-765 vs. Placebo in Performance Anxiety (clinicaltrials.gov) - P2 | N=230 | Completed | Sponsor: Vanda Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Mood Disorders • Psychiatry

Efficacy and Safety of an Alpha 7 Nicotinic Acetylcholine Receptor Agonist, VQW-765, in Subjects with Performance Anxiety in a Randomized, Placebo-Controlled Trial (ASCP 2023) - P2 | "This is the first time that an α7-nAChR agonist has shown an anxiolytic effect in humans. VQW-765 is a promising candidate to be developed as a medicine that can be used on an as needed basis for the treatment of acute anxiety and warrants further clinical studies. Trial registration: ClinicalTrials.gov NCT04800237."

Clinical • CNS Disorders • Mood Disorders • Psychiatry • Social Anxiety Disorder

Efficacy and Safety of an Alpha 7 Nicotinic Acetylcholine Receptor Agonist, VQW-765, in Subjects with Performance Anxiety in a Randomized, Placebo-Controlled Trial (ASCP 2023) - P2 | "This is the first time that an α7-nAChR agonist has shown an anxiolytic effect in humans. VQW-765 is a promising candidate to be developed as a medicine that can be used on an as needed basis for the treatment of acute anxiety and warrants further clinical studies. Trial registration: ClinicalTrials.gov NCT04800237."

Clinical • CNS Disorders • Mood Disorders • Psychiatry • Social Anxiety Disorder

Evaluating the Effects of VQW-765 vs. Placebo in Performance Anxiety (clinicaltrials.gov) - P2 | N=220 | Active, not recruiting | Sponsor: Vanda Pharmaceuticals | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2022 ➔ Dec 2022 | Trial primary completion date: Jun 2022 ➔ Dec 2022

Enrollment closed • Trial completion date • Trial primary completion date • Mood Disorders • Psychiatry

Evaluating the Effects of VQW-765 vs. Placebo in Performance Anxiety (clinicaltrials.gov) - P2; N=220; Recruiting; Sponsor: Vanda Pharmaceuticals; Trial completion date: Oct 2021 ➔ Jun 2022; Trial primary completion date: Oct 2021 ➔ Jun 2022

Clinical • Trial completion date • Trial primary completion date • Mood Disorders • Psychiatry

Evaluating the Effects of VQW-765 vs. Placebo in Performance Anxiety (clinicaltrials.gov) - P2; N=220; Recruiting; Sponsor: Vanda Pharmaceuticals

Clinical • New P2 trial • Mood Disorders • Psychiatry

Effect of AQW051 on Cognitive Function in Patients With Chronic Stable Schizophrenia - [P2,N=32; Recruiting; Completion; Feb’11             Sep’11; Trial delayed]

Pharmacodynamic/Pharmacokinetic Study of AQW051 in Schizophrenia - P1/2,N=132; Recruiting;

Schizophrenia