NCT07114874

NBI-1117568-SCZ3032: Long-Term Evaluation of NBI-1117568 in Adults With Schizophrenia

A Global, Phase 3, Multicenter, Open-Label Study to Assess the Long-Term Safety and Tolerability of NBI-1117568 in Adults With Schizophrenia

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Neurocrine Biosciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the long-term safety of NBI-1117568 in adults with schizophrenia.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	NBI-1117568	NBI-1117568 will be administered per schedule specified in the arm description.

Timeline

• Start date: 2025-07-11
• Primary completion: 2031-12-01
• Completion: 2031-12-01
• First posted: 2025-08-11
• Last updated: 2026-04-15

Locations

53 sites across 4 countries: United States, Bulgaria, Romania, Serbia

Regulatory

• FDA-regulated drug study