TOKYO, Japan and CAMBRIDGE, UK, April 13, 2026
Nxera Pharma Co., Ltd. announced that its partner Neurocrine Biosciences, Inc. has successfully dosed the first patient in a Phase 2 clinical trial evaluating NBI-1117570, an investigational oral therapy for schizophrenia, marking a significant advancement in the development of next-generation neuropsychiatric treatments. The milestone also triggers a $22.5 million payment to Nxera, highlighting the strong progress of their strategic collaboration and reinforcing confidence in the program’s clinical potential.
Phase 2 Trial Targets Unmet Needs in Schizophrenia
The initiation of this Phase 2 study represents a critical step forward in addressing schizophrenia, a complex and chronic mental health disorder affecting millions globally. The trial is designed as a randomized, double-blind, placebo-controlled study enrolling approximately 120 adult patients requiring inpatient care, ensuring a robust evaluation of the therapy’s impact in a controlled clinical setting.
The primary endpoint focuses on changes in the Positive and Negative Syndrome Scale (PANSS), a widely recognized measure of symptom severity in schizophrenia, while secondary endpoints assess safety and tolerability, including treatment-emergent adverse events.
This structured approach aims to generate high-quality clinical evidence supporting the drug’s therapeutic profile. With schizophrenia remaining a leading cause of disability worldwide, the advancement of innovative therapies like NBI-1117570 is crucial to improving patient outcomes beyond current treatment limitations.
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Novel Mechanism Targets Brain Signaling Pathways
NBI-1117570 is a first-in-class investigational oral therapy that selectively targets muscarinic M1 and M4 receptors, which play a vital role in brain neurotransmission and cognitive function. Unlike traditional antipsychotics that often focus on dopamine pathways and are associated with significant side effects, this therapy is designed to modulate cholinergic signaling, offering a potentially safer and more effective treatment approach.
The compound was discovered using Nxera’s proprietary NxWave™ drug discovery platform, demonstrating the company’s strength in leveraging structure-based drug design technologies. By specifically activating M1 and M4 receptors, the drug aims to improve both cognitive deficits and psychotic symptoms, addressing key unmet needs in schizophrenia management. This targeted mechanism represents a promising shift toward precision psychiatry, where treatments are designed to intervene at the root of neurological dysfunction.
Strategic Collaboration Drives Innovation and Value
The ongoing collaboration between Nxera and Neurocrine Biosciences continues to deliver strong clinical and financial milestones, with NBI-1117570 becoming the second NxWave™-derived compound to enter Phase 2 development under their partnership.
The milestone payment of $22.5 million underscores the commercial and scientific value of the program, while also supporting Nxera’s broader pipeline expansion. Neurocrine holds the rights to develop and commercialize the therapy globally, leveraging its expertise in neurological disorders to accelerate development timelines.
This partnership reflects a growing trend in the biopharmaceutical industry, where collaborative innovation is key to advancing complex therapies in areas of high unmet need. As the trial progresses, both companies aim to generate clinically meaningful data that could pave the way for later-stage development and eventual regulatory submissions.
Schizophrenia continues to impose a significant global health and economic burden, with limited advancements in treatment innovation over recent decades. The progression of NBI-1117570 into Phase 2 clinical trials represents a renewed focus on novel therapeutic mechanisms, offering hope for more effective and tolerable treatment options. If successful, this program could reshape the future of schizophrenia care, delivering improved quality of life for patients and reducing the long-term burden on healthcare systems.
Source: Nxera Pharma press release
