Tokyo, Japan and Cambridge, UK — August 26, 2026
Nxera Pharma Co., Ltd. announced that its partner Neurocrine Biosciences has received FDA IND Acceptance to advance NBI-1117567 (NBI-’567) into a Phase 2 clinical study targeting cognition associated with Alzheimer’s disease. The regulatory milestone triggers a $10 million milestone payment to Nxera Pharma under the companies’ collaboration agreement, which the company expects to recognize as revenue in the third quarter of fiscal year 2026. NBI-1117567 is an investigational, orally administered muscarinic M1-preferring agonist discovered using Nxera’s proprietary NxWave™ drug discovery platform. The FDA acceptance represents another development milestone for Nxera’s muscarinic receptor agonist portfolio and expands the company’s involvement in potential treatments addressing significant unmet needs in neurodegenerative and neuropsychiatric diseases.
FDA Acceptance Advances NBI-1117567 Into Phase 2
The FDA IND Acceptance allows Neurocrine Biosciences to proceed with a planned Phase 2 study of NBI-1117567 in Alzheimer’s disease cognition. The candidate is designed to selectively target muscarinic receptors, with a preference for the M1 receptor and activity across the M1/M4 pathway. Muscarinic receptors play an important role in neurotransmission within the brain, making selective modulation of these receptors an area of interest for developing new therapies for neurological and neuropsychiatric disorders. For Nxera, the acceptance marks the third compound in its muscarinic agonist portfolio to progress into Phase 2 development or beyond, highlighting continued advancement of molecules generated through its structure-based drug discovery capabilities. NBI-1117567 was originally discovered by Nxera and is now being developed by Neurocrine under the companies’ existing collaboration. The immediate development focus is the Phase 2 evaluation of NBI-1117567 for Alzheimer’s-related cognitive impairment, with future clinical progress expected to determine its therapeutic potential.
$10 Million Milestone Highlights Partnership Progress
Under the collaboration agreement between Nxera Pharma and Neurocrine Biosciences, Nxera will receive a $10 million IND Acceptance milestone payment following the FDA regulatory milestone. The payment is expected to be fully recognized as revenue by Nxera in Q3 FY2026, providing a near-term financial benefit alongside the clinical advancement of NBI-1117567. The companies entered their collaboration and licensing agreement in November 2021 to develop novel muscarinic receptor agonists for schizophrenia, dementia and other neuropsychiatric disorders. Neurocrine obtained global development and commercialization rights to a broad portfolio of M1, M4 and dual M1/M4 receptor agonists discovered by Nxera. Nxera retains development and commercialization rights for M1 agonists in Japan, including NBI-1117567, for all indications, subject to the agreement’s provisions. The collaboration provides Nxera with continued participation in the development of its muscarinic portfolio while Neurocrine leads global development activities.
Advertisement
Nxera’s Muscarinic Portfolio Continues to Expand
NBI-1117567 joins a broader group of Nxera-discovered muscarinic agonists progressing through clinical development. Direclidine (NBI-1117568), another NxWave-designed molecule, has advanced into a Phase 3 study, while NBI-1117570 is currently in Phase 2 development. This progression provides evidence of the platform’s ability to generate multiple clinical-stage candidates targeting muscarinic receptor biology. The companies’ agreement also provides Nxera eligibility for research and development funding and development, regulatory and commercial milestone payments of up to $2.6 billion, in addition to potential product royalties, subject to achievement of applicable milestones and other conditions. For NBI-1117567, the next major development step will be the Phase 2 clinical program and its evaluation of potential effects on cognitive impairment in Alzheimer’s disease. NBI-1117567 remains investigational, and its safety and efficacy have not been established.
Source: Nxera Pharma press relese
