drugset / Trial / NCT06894212

A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia

NCT06894212 ↗

Phase 3 Active not recruiting 538 enrolled Otsuka Pharmaceutical Development & Commercialization, Inc.
RandomizedParallel-groupSingle-blindTreatment

Summary

Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia

Timeline

Start
2025-02-28
Primary completion
2026-10-20
Completion
2026-10-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Ulotaront Small molecule 75 mg —
Subject Ulotaront Small molecule 100 mg —

Indications