Neurocrine(US:NBIX) Prnewswireยท2025-05-28 20:05Core Insights - Neurocrine Biosciences announced significant improvements in symptoms and overall severity of schizophrenia in adults from the Phase 2 study of NBI-1117568, the first oral muscarinic M4 selective orthosteric agonist in clinical development for this condition [1][2][6] Company Overview - Neurocrine Biosciences is focused on developing treatments for neurological, neuroendocrine, and neuropsychiatric disorders, with a diverse portfolio that includes FDA-approved treatments and a robust pipeline of compounds in clinical development [13] Study Details - The Phase 2 study involved 210 adults aged 18 to 55 with schizophrenia, randomized to receive either NBI-1117568 or placebo over a six-week period, followed by a two-week safety follow-up [2][9] - The primary endpoint was the change in total Positive and Negative Syndrome Scale (PANSS) score from baseline to Week 6, showing statistically significant improvements with the 20 mg dose of NBI-1117568 by Week 3 [4][6] Safety and Tolerability - NBI-1117568 was generally safe and well tolerated, with treatment discontinuation rates due to adverse events similar to placebo; common adverse events included somnolence (10.7% vs 2.9%) and dizziness (9.3% vs 1.4%) [3][6] Future Development - Based on positive Phase 2 results, a Phase 3 registrational program has been initiated to further evaluate the efficacy, safety, and tolerability of NBI-1117568, expected to enroll approximately 280 patients [6][9]