Neurocrine Biosciences Initiates Phase 3 Registrational Program for NBI-1117568 as Potential Treatment for Adults with Schizophrenia

Core Insights - Neurocrine Biosciences has initiated a Phase 3 registrational program for NBI-1117568, an investigational oral muscarinic M4 selective orthosteric agonist aimed at treating schizophrenia, following positive Phase 2 data reported in August 2024 [1][2][3] Company Overview - Neurocrine Biosciences is a neuroscience-focused biopharmaceutical company dedicated to developing treatments for neurological, neuroendocrine, and neuropsychiatric disorders, with a diverse portfolio including FDA-approved treatments and a robust pipeline [8] Clinical Development - The Phase 3 study is a global double-blind, placebo-controlled trial targeting approximately 280 patients with schizophrenia experiencing acute exacerbation or relapse of symptoms, with primary and secondary endpoints focused on PANSS and CGI-S scale improvements [2][3] - NBI-1117568 is the first oral muscarinic M4 selective orthosteric agonist in clinical development for schizophrenia, potentially offering a novel mechanism with an improved safety profile [3][4] Market Need - Schizophrenia affects approximately 24 million people globally, with annual costs exceeding $150 billion in the U.S., highlighting the significant need for innovative treatment options [6][7] Clinical Results - The Phase 2 study demonstrated a statistically significant reduction in PANSS total score with a placebo-adjusted mean reduction of 7.5 points and an 18.2-point reduction from baseline, indicating the efficacy of NBI-1117568 [6]