Neurocrine receives FDA IND acceptance for a Phase 2 study of NBI-1117567 in Alzheimer’s cognition, triggering a $10 million milestone to Nxera.
Written By: Creola Gonsalves, MS Biotech
Reviewed By: Pharmacally Editorial Team
Neurocrine Biosciences has received U.S. FDA acceptance of its Investigational New Drug (IND) application for a planned Phase 2 study of NBI-1117567 in Alzheimer’s cognition. The milestone advances the investigational oral M1-preferring muscarinic agonist into the next stage of clinical development and triggers a $10 million IND acceptance payment to Nxera Pharma under their 2021 collaboration. Nxera expects to recognize the payment as revenue in the third quarter of fiscal 2026.
The Phase 2 designation is important because NBI-1117567 has already undergone first-in-human testing. Neurocrine initiated a Phase 1 study in healthy adults in May 2024 to evaluate its safety, tolerability, pharmacokinetics and pharmacodynamics. Neurocrine’s current pipeline continues to list the program as Phase 1, while Nxera’s August 26 announcement states that FDA acceptance now covers a Phase 2 study.
M1-Preferring Approach Targets Cognition
NBI-1117567 is an orally administered M1/M4 muscarinic agonist with M1 preference, discovered through Nxera’s NxWave drug discovery platform. Muscarinic acetylcholine receptors regulate signaling pathways involved in neurotransmission. The M1 subtype has been investigated as a potential target for cognition, while M4 has emerged as a target for psychosis.
The program therefore occupies a distinct position within Neurocrine’s broader muscarinic portfolio, which spans selective and dual receptor agonists for neurological and psychiatric disorders.
A Differentiated Muscarinic Portfolio
The portfolio includes direclidine (NBI-1117568), an M4-selective agonist, which has advanced into Phase 3 development in schizophrenia and is also being evaluated in Phase 2 for bipolar mania. NBI-1117570 is a dual M1/M4 agonist in Phase 2 development for schizophrenia and other psychiatric indications.
NBI-1117567 instead prioritizes M1 activity and is being evaluated for Alzheimer’s cognition. This receptor differentiation reflects an effort to match distinct muscarinic mechanisms with different CNS disease biology.
$10 Million Milestone Tied to IND Acceptance
The financial milestone is also clearly defined. Nxera stated that Neurocrine’s IND acceptance itself triggers the $10 million payment, rather than first-patient dosing. The company expects to recognize the full amount in Q3 FY2026.
Under the November 2021 agreement, Neurocrine holds development and commercialization rights to a broad portfolio of Nxera-discovered M1, M4 and dual M1/M4 agonists, while Nxera retains rights to develop M1 agonists in Japan. The collaboration provides Nxera with potential development, regulatory and commercial milestones of up to $2.6 billion, plus royalties, subject to the agreement’s conditions.
Phase 2 Data Will Establish the Clinical Case
The next major test for NBI-1117567 is whether its M1-preferring pharmacology can translate into measurable cognitive benefit in patients with Alzheimer’s disease while maintaining an acceptable safety and tolerability profile.
No Phase 2 efficacy or safety results are available from the latest announcement. FDA IND acceptance permits the planned study to proceed but does not establish clinical efficacy. The program now moves toward a more definitive assessment of M1-preferring muscarinic activation as a strategy for Alzheimer’s cognition.
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About the Writer
Creola Gonsalves (Linkedin) is an M.S. Biotechnology postgraduate with a strong interest in clinical research, evidence interpretation, and healthcare writing, with a focus on translating life-science knowledge into meaningful real-world insights.
She is trained in Good Clinical Practice (GCP), clinical research principles, and critical interpretation of randomized clinical trials, with certifications from NIH and Stanford University.
Her research background in biotechnological applications and microbial research strengthens her ability to understand scientific evidence and develop clear, accurate, and research-driven healthcare content.