Neurocrine Biosciences Inc. announced the presentation of data from their Phase 2 study of NBI-1117568, an investigational oral muscarinic M4 selective orthosteric agonist, at the American Society of Clinical Psychopharmacology 2025 Annual Meeting. The study involved adults with schizophrenia and demonstrated a significant improvement in symptoms and overall severity. The treatment was generally safe and well-tolerated, with adverse events such as somnolence and dizziness reported. Following these positive results, a Phase 3 registrational program has been initiated to further assess NBI-1117568's efficacy, safety, and tolerability. This global, double-blind, placebo-controlled trial is expected to enroll approximately 280 patients. The primary endpoint focuses on a reduction in the PANSS score, and additional information can be found on ClinicalTrials.gov.
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