Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Participants With Cognitive Impairment Associated With Schizophrenia

Phase 2 Terminated 216 enrolled Neurocrine Biosciences

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Study to evaluate the safety and efficacy of luvadaxistat compared with placebo on improving cognitive performance in participants with schizophrenia.

Timeline

Start: 2021-12-07
Primary completion: 2024-06-28
Completion: 2024-10-14

Outcome

Missed primary endpoint

Stopped: “Failed to meet the primary endpoint”

paper Luvadaxistat did not significantly improve performance (change from baseline) in BACS composite score versus placebo at Day 98 PMID 42032293 ↗

Publications

Khin NA, Fan RH, Ge T, Klein HS, Ballon JS, Brar S, Harvey PD, Kantrowitz JT, Keefe RSE, Asgharnejad M, Murthy V, Roberts E, Singh JB. A phase 2 randomized controlled trial of luvadaxistat in treatment of adults with cognitive impairment associated with schizophrenia: results from the ERUDITE study. Neuropsychopharmacology. 2026 Apr 24. doi: 10.1038/s41386-026-02410-5. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Luvadaxistat	Small molecule	20 mg	Oral
Subject	Luvadaxistat	Small molecule	50 mg	Oral