Neurocrine Biosciences, Inc. announced the initiation of a Phase 3 registrational program to evaluate the efficacy, safety, and tolerability of NBI-1117568. This investigational oral muscarinic M4 selective orthosteric agonist is a potential treatment for schizophrenia in adults.
There is a significant need for new and innovative medicines to treat schizophrenia, a disorder impacting millions globally. The Phase 3 study is a global double-blind, placebo-controlled trial expected to enroll approximately 280 patients, with the primary endpoint being a reduction from baseline in the Positive and Negative Syndrome Scale (PANSS).
This advancement is supported by positive top-line data from the Phase 2 clinical study, reported in August 2024, which met its primary endpoint for the once-daily 20 mg dose. NBI-1117568 offers a novel mechanism with potential for an improved safety profile without the need for combination therapy.
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