drugset / Trial / NCT07759128

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

NCT07759128 ↗

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a global, phase 3, randomized, double-blind, parallel-group, 3-arm, placebo-controlled, multicenter study designed to compare the efficacy, safety, and tolerability of fixed doses of SEP-363856 (50 and 75 milligrams per day \[mg/day\]) to placebo in adults at least 18 years of age with generalized anxiety disorder (GAD) over 8 weeks.

Timeline

Start
2026-07-28
Primary completion
2028-12-06
Completion
2028-12-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Ulotaront Small molecule 50 mg Oral
Subject Ulotaront Small molecule 75 mg Oral