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NCT07767903 · ClinicalTrials.gov record · last posted 2026-08-17

A Trial of the Efficacy and Safety of a Fixed Dose of SEP-363856 in Adults With Generalized Anxiety Disorder

Name: A Trial of the Efficacy and Safety of a Fixed Dose of SEP-363856 in Adults With Generalized Anxiety Disorder — clinical trial record (NCT07767903)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhasePhase 3

SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.

Started2026-08-07

View on ClinicalTrials.gov ↗

from the ClinicalTrials.gov record

This is a global, phase 3, randomized, double-blind, parallel-group, 2-arm, placebo controlled, multicenter trial designed to compare the efficacy, safety and tolerability of a fixed dose of SEP-363856 (75 millligrams per day \[mg/day\]) to placebo over an 8-week double-blind treatment period in adults with generalized anxiety disorder (GAD).

Trial Details

NCT Number	NCT07767903
Lead Sponsor	Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions	Generalized Anxiety Disorder
Enrollment	384 participants
Start Date	2026-08-07
Primary Completion	2028-10-25 (estimated)
Study Completion	2028-11-01 (estimated)
Updated on ClinicalTrials.gov	2026-08-17