US-based biopharmaceutical company Neurocrine Biosciences Inc (Nasdaq:NBIX) announced on Wednesday the initiation of a Phase 3 registrational programme to evaluate the efficacy, safety and tolerability of NBI-1117568, its investigational oral muscarinic M4 selective orthosteric agonist, as a potential treatment for schizophrenia.

In August 2024 the company reported positive top-line data for the Phase 2 clinical study in adults with schizophrenia.

The Phase 3 study is a global double-blind, placebo-controlled trial evaluating NBI-1117568 in adults with a primary diagnosis of schizophrenia who are experiencing an acute exacerbation or relapse of symptoms. It is expected to enrol approximately 280 patients. The primary endpoint is a reduction from baseline in the Positive and Negative Syndrome Scale (PANSS). The key secondary endpoint is improvement in the Clinical Global Impression of Severity (CGI-S) scale.

NBI-1117568 is claimed to be the first and only investigational oral muscarinic M4 selective orthosteric agonist in clinical development for the treatment of schizophrenia.