Neurocrine Biosciences, Inc. (NBIX)'s M4 Agonist Shows Promise in Schizophrenia Phase 2 Trial, Phase 3 Launched

Neurocrine Biosciences, Inc. (NASDAQ:NBIX) has announced promising results from its Phase 2 trial of NBI-1117568, a first-in-class investigational oral muscarinic M4 selective agonist for schizophrenia.

Presented at the American Society of Clinical Psychopharmacology 2025 Annual Meeting, the study showed that a 20 mg once-daily dose significantly improved schizophrenia symptoms, achieving a 7.5-point greater reduction on the Positive and Negative Syndrome Scale (PANSS) than placebo at six weeks. Improvements were also seen on the Clinical Global Impression of Severity (CGI-S) scale as early as Week 2, with continued benefit through Week 6.

NBI-1117568 was generally safe and well tolerated, with somnolence and dizziness as the most common side effects and no significant weight gain or clinically meaningful cardiovascular events. Discontinuation rates due to adverse events were similar to placebo. Higher doses showed greater mean improvements but did not reach statistical significance.

These results have prompted Neurocrine Biosciences, Inc. (NASDAQ:NBIX) to launch a global Phase 3 trial to further evaluate the drug’s efficacy and safety in adults with acute schizophrenia symptoms. NBI-1117568’s novel mechanism offers hope for a more targeted and tolerable treatment option for patients.

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