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News|Articles|October 20, 2026
Phase 2 Clinical Study Initiated: Evaluating NBI-'567 for the Treatment of Adults With Alzheimer Disease
Author(s)Leah Kuntz
Neurocrine launches a phase 2 trial of once-daily NBI-'567, testing a selective muscarinic agonist to boost cognition in mild to moderate Alzheimer disease.
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Neurocrine Biosciences today announced the initiation of its phase 2 clinical study of investigational compound NBI-1117567 (NBI-'567) in adults with mild to moderate Alzheimer disease.1
NBI-'567 is an orally administered, M1/M4 (M1 preferring) selective muscarinic agonist being evaluated as an adjunctive treatment for cognitive impairment in Alzheimer disease. NBI-'567 is designed to selectively activate these receptors while minimizing activity at other muscarinic receptor subtypes, with the potential to reduce off-target pharmacology-related adverse effects. The study will evaluate the potential of NBI-'567 to improve cognitive performance in adults with mild to moderate Alzheimer disease who are receiving stable treatment with an acetylcholinesterase inhibitor.
"As a defining characteristic of Alzheimer disease, cognitive impairment affects memory, attention, and other thinking abilities that significantly impact daily functioning," said Eiry W. Roberts, MD, the chief medical officer of Neurocrine Biosciences. "The advancement of NBI-'567 reflects our commitment to delivering new treatment options for this vulnerable population, in addition to our broader strategy to explore the potential of selectively targeting muscarinic receptors across a range of neurological and psychiatric conditions."
About the Study
The phase 2 randomized double-blind placebo-controlled study will enroll approximately 135 adult participants aged 50 to 85 with mild to moderate Alzheimer disease who are receiving stable treatment with an acetylcholinesterase inhibitor. Participants will be randomly assigned across a high or low dose level of NBI-'567 administered once daily. Over the 12-week treatment period, the study will assess the efficacy, safety, tolerability, and pharmacokinetics of NBI-'567 compared with placebo.
The primary efficacy endpoint is change from baseline in a Neuropsychological Test Battery composite score at week 12. Secondary endpoints include changes from baseline in ADAS-Cog13 and CDR Sum of Boxes at week 12.
IND Acceptance
Back in August 2026, Neurocrine received IND Acceptance from the US Food and Drug Administration (FDA) for a phase 2 study of NBI-'567 for Alzheimer cognition.2
References
1. Neurocrine Biosciences initiates phase 2 clinical study evaluating NBI-'567 in adults with Alzheimer's disease. News release. October 20, 2026. Accessed October 20, 2026.
2. Nxera Pharma’s partner Neurocrine Biosciences receives IND acceptance from the FDA for phase 2 study of NBI-1117567 for Alzheimer's cognition. News release. August 26, 2026. Accessed October 20, 2026.
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