Neurocrine receives FDA IND Acceptance for Alzheimer’s Ph2
Cambridge, UK-based Neurocrine Biosciences - partnered with Japan’s Nxera Pharma - has announced it has received IND Acceptance from the US Food and Drug Administration (FDA) for a Phase 2 study of NBI-1117567 (“NBI-’567”) for Alzheimer's cognition.
NBI-’567 is an investigational, orally administered, muscarinic M1 receptor preferring agonist discovered using Nxera’s proprietary NxWave drug discovery platform.
Muscarinic receptors are fundamental to activating signalling pathways in the brain. There are five muscarinic acetylcholine receptors involved in neurotransmission, and selectively targeting two of these subtypes, M1 and M4, is an approach that has been clinically evaluated, with M1 as a potential drug target for cognition and M4 for psychosis.
Nxera Pharma and Neurocrine Biosciences entered a collaboration and licensing agreement in November 2021 to develop novel muscarinic receptor agonists for the treatment of schizophrenia, dementia, and other neuropsychiatric disorders.
Under the terms of the agreement, Neurocrine is responsible for development costs associated with the programmes globally, except for M1 agonists being developed in Japan. Nxera retains rights to develop M1agonists in Japan for any indication, with Neurocrine receiving co-development and profit share options.
Nxera is eligible to receive R&D funding plus development, regulatory and commercial milestones of up to $2.6 billion, with further product royalties, provided the criteria under the agreement are satisfied.
Nxera will now receive an IND Acceptance milestone payment of $10 million from Neurocrine pursuant to the agreement.
Christopher Cargill, president and CEO of Nxera Pharma, commented: “Alzheimer's cognition remains an area of significant unmet medical need globally, including in Japan, and we believe NBI-’567 has the potential to contribute meaningfully to improving outcomes for patients.”
Nxera Pharma operates at key locations in Tokyo and Osaka (Japan), London and Cambridge (UK), Basel (Switzerland), and Seoul (South Korea), and is listed on the Tokyo Stock Exchange (ticker: 4565).
Nxera also has a partnership with UK biotech Antiverse, which raised $9.3 million to accelerate its drug discovery programmes in March this year, based on an AI-powered platform for designing antibody-based therapeutics. That partnership focuses on multiple antibodies targeting GPCRs – a complex and unstable class of proteins that play a vital role in cellular communication, making them prime targets across multiple diseases.
In April 2026, Neurocrine previously announced a $2.9 billion deal to acquire Soleno Therapeutics and its Vykat XR (diazoxide choline) medicine for Prader-Willi syndrome (PWS), which was approved by the FDA last year to treat hyperphagia, an intense and incessant urge to eat, which is the most prominent characteristic of the disorder and can lead to dangerous weight gain.
