Trial intelligence / Profile preview

Phase 3 trial of SEP-363856 versus placebo in adults with generalized anxiety disorder

jRCT2031260595Phase 3Recruiting

Sponsor
Otsuka Pharmaceutical Co., Ltd.
Start
Nov 2026
Modality
Small Molecules
01

Overview

Phase 3, randomised, double-blind trial in generalized anxiety disorder (GAD) comparing SEP-363856 75 mg/day with Placebo (2 arms). Primary endpoint: Change from baseline at Week 8 in Hamilton Anxiety Rating Scale total score. Started Nov 2026; status: recruiting.

02

Drugs

ulotaront
03

Conditions

generalized anxiety disorder (GAD)

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