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NCT07786454 · ClinicalTrials.gov record · last posted 2026-08-26

A Trial of the Safety and Tolerability of SEP-363856 in Adults With Generalized Anxiety Disorder

Name: A Trial of the Safety and Tolerability of SEP-363856 in Adults With Generalized Anxiety Disorder — clinical trial record (NCT07786454)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusNot Yet Recruiting

PhasePhase 3

SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.

Started2026-10-06

View on ClinicalTrials.gov ↗

from the ClinicalTrials.gov record

This is a global, Phase 3, multicenter, open-label extension trial designed to evaluate the long-term safety, tolerability and efficacy of SEP-363856 administered at doses of 50 milligrams (mg) or 75 mg per day in adult participants with generalized anxiety disorder (GAD) over a treatment period of 26 weeks.

Trial Details

NCT Number	NCT07786454
Lead Sponsor	Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions	Generalized Anxiety Disorder
Enrollment	1,120 participants
Start Date	2026-10-06
Primary Completion	2029-05-26 (estimated)
Study Completion	2029-06-02 (estimated)
Updated on ClinicalTrials.gov	2026-08-26