From GlobeNewswire: 2025-04-30 19:35:00

Nxera Pharma Co., Ltd. announces the initiation of a Phase 3 clinical trial by its partner Neurocrine Biosciences Inc. for NBI-1117568 (NBI-’568), an oral muscarinic M4 selective orthosteric agonist, as a potential treatment for schizophrenia. The Phase 2 clinical study in adults with schizophrenia showed positive top-line data, leading to the advancement of NBI-’568 to Phase 3. The Phase 3 trial will enroll approximately 280 patients and aims to reduce symptoms of schizophrenia. Nxera retains rights to develop M1 agonists in Japan, while Neurocrine is focused on advancing NBI-’568 and other muscarinic agonists through clinical development for various neuropsychiatric disorders.

Positive top-line data from the Phase 2 clinical study of NBI-1117568 showed significant reduction in PANSS total score and improvement in several secondary endpoints for adults with schizophrenia. The study demonstrated the safety and tolerability of NBI-1117568, with minimal adverse events at all doses studied. Nxera and Neurocrine are collaborating on the development and commercialization of muscarinic receptor-targeting compounds, including NBI-1117567, NBI-1117569, and NBI-1117570, to address unmet needs in neuropsychiatric disorders such as schizophrenia. The Phase 3 study of NBI-1117568 is a crucial step towards providing a novel treatment option for patients with schizophrenia.

Schizophrenia affects approximately 24 million people worldwide, with significant emotional and functional burdens for patients and their families. The disorder is estimated to cost over $150 billion annually in the United States, highlighting the need for innovative treatment options like NBI-1117568. Nxera Pharma is focused on developing specialty medicines to improve the lives of patients with unmet needs, with a pipeline of over 30 active programs in areas such as neurology, metabolic diseases, and immunology. This collaboration with Neurocrine represents a significant advancement in the development of novel therapies for neuropsychiatric disorders like schizophrenia.



Read more at GlobeNewswire: Nxera Pharma’s Partner Neurocrine Biosciences Initiates