Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia

Summary

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, multi-arm, multi-stage inpatient study designed to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of NBI-1117568 compared with placebo in adult subjects with a primary diagnosis of schizophrenia, who are experiencing an acute exacerbation or relapse of symptoms.

Timeline

Start

2022-10-04

Primary completion

2024-07-10

Completion

2024-07-10

Outcome

Met primary endpoint

release “The NBI-1117568-SCZ2028 dose-finding study met its primary endpoint for the once-daily 20 mg dose.” nxera.life ↗

release “NBI-1117568 had delivered positive topline results from its Phase 2 clinical study in adults with schizophrenia.” nxera.life ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	NBI-1117568	Unknown	—	Oral

Indications