Neurocrine Biosciences, Inc. announced the presentation of data from the Phase 2 study of NBI-1117568 in adults with schizophrenia, which showed a significant improvement in symptoms and overall severity. The data also highlighted new information on the safety and tolerability of the treatment, presented at the American Society of Clinical Psychopharmacology 2025 Annual Meeting.
NBI-1117568 is the first and only investigational oral muscarinic M4 selective orthosteric agonist in clinical development for schizophrenia. The study demonstrated statistically significant improvements in the Positive and Negative Syndrome Scale (PANSS) total score with 20 mg of NBI-1117568 once daily by Week 3 and at all subsequent visits through Week 6.
The compound was generally safe and well tolerated at all doses studied, with treatment discontinuation rates due to adverse events similar between NBI-1117568 and placebo. Notably, no weight gain was associated with the NBI-1117568 treatment groups relative to placebo, addressing a common concern with traditional antipsychotics. Based on these positive results, a Phase 3 registrational program was recently initiated.
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