Trial Profile

A Phase 2/3, Randomized, Double-blind, Parallel Group, Placebo-controlled, Flexible-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in the Treatment of Adults With Generalized Anxiety Disorder

Status: Recruiting

Phase of Trial: Phase II/III

Latest Information Update: 13 Apr 2025

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At a glance

Drugs Ulotaront (Primary)
Indications Generalised anxiety disorder
Focus Registrational; Therapeutic Use
Sponsors Otsuka Pharmaceutical Development & Commercialization; Sumitomo Pharma America; Sunovion Pharmaceuticals; Takeda Pharma

05 Feb 2025 Planned End Date changed from 8 Feb 2025 to 8 Feb 2026.
05 Feb 2025 Planned primary completion date changed from 8 Feb 2025 to 8 Feb 2026.
26 Apr 2023 According to a Sunovion Pharmaceuticals and Otsuka Pharmaceutical Development & Commercialization media release, first patient has been randomized in this study.

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