Xanomeline

Cognitive impairment is a neurodegenerative disease with a high incidence in the elderly population, and damage to the cholinergic pathway is one of the core pathological mechanisms of cognitive decline in Alzheimer's disease. Xanomeline is a selective M1 muscarinic receptor agonist, which can specifically activate M1 receptors closely related to cognitive function in the central nervous system, and improve the memory, orientation and cognitive ability of Alzheimer's disease patients without significantly affecting the peripheral cholinergic system. It is mainly used for the symptomatic treatment of mild to moderate Alzheimer's disease, and the applicable population is elderly dementia patients in the early and middle stages clinically confirmed, making it an important candidate drug in the field of cholinergic replacement therapy.

The number of Alzheimer's disease patients worldwide has exceeded 55 million, with more than 10 million new cases each year, driving the continuous expansion of the cognitive-enhancing API market. As the world's first highly selective M1 receptor agonist that entered phase III clinical trials, xanomeline has gained increasing market attention year by year due to its clear clinical positioning and relatively mild side effects. At present, this drug has not been commercialized on a large scale in major global markets, there is no publicly verifiable data on market size and growth rate, and the competitive landscape is in the early layout stage. API enterprises with technical accumulation are expected to gain first-mover advantages after product approval.

The original developer of xanomeline is Eli Lilly and Company in the United States, with the original brand name Xanomeline. The initially developed dosage form is oral tablet, the expiration date of the core compound patent in the United States was 2010, and subsequent related formulation patents have expired successively. The original product has not been approved for marketing in China. At present, there is no approved xanomeline formulation on the market in China, no validly registered DMF registration number for xanomeline API has been found in the database of the Center for Drug Evaluation of the National Medical Products Administration, and it has not been included in the Chinese Reference Listed Drug Catalogue. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of xanomeline impurity reference standards, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products comply with the regulatory requirements of the Chinese Pharmacopoeia and FDA, and can fully meet various experimental needs such as structure confirmation, quality research and stability investigation in the drug development stage, providing stable reference material support for pharmaceutical enterprises in the development of xanomeline APIs and formulations.