LysoPE

The regulation of phospholipid metabolic pathways is an important current research direction for the treatment of inflammatory and nervous system diseases. Lysophosphatidylethanolamine, as a class of bioactive lysophospholipids, belongs to the category of endogenous lipid signaling molecules. Its mechanism of action mainly involves binding to G protein-coupled receptors such as GPR119 and GPR55 to participate in intracellular signal transduction, and it can regulate the release of inflammatory factors, neural synaptic plasticity and endothelial barrier function. At present, it has shown application potential in adjuvant intervention research for inflammatory bowel disease and Alzheimer's disease. Meanwhile, it is also a core functional excipient for food for special medical purposes and lipid delivery systems, and its applicable population covers patients with chronic inflammatory diseases, subjects with neurodegenerative diseases and the demands of high-end preparation R&D.

As a high-growth variety in the segment of lipid API, the global market size of lysophosphatidylethanolamine was approximately USD 127 million in 2023, with a compound annual growth rate of 8.3% from 2019 to 2023. The current market is characterized by "concentrated high-end customized supply and dispersed bulk production capacity". European and American enterprises dominate the supply of pharmaceutical-grade products, accounting for 62% of the global market share. Domestic enterprises in China are currently mainly focused on the production of food-grade raw materials, and there is a large gap in pharmaceutical-grade registration. With the rising R&D enthusiasm for food for special medical purposes and lipid nanoparticle preparations, it is expected that the demand growth rate of domestic pharmaceutical-grade lysophosphatidylethanolamine will remain above 12% from 2024 to 2028.

At present, there is no globally unified original or first generic preparation variety of lysophosphatidylethanolamine. The patented technologies for core pharmaceutical-grade raw materials are mainly held by lipid raw material enterprises in Germany and Japan, and the core patents related to the compound expired globally in 2018. The current mainstream pharmaceutical dosage form is injectable-grade excipient lyophilized powder, with common specifications of 10 mg/vial and 100 mg/vial. It has not yet been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China, and is only included as an excipient for liposome preparations in the FDA Reference Preparations Catalogue. As of the date of search, there is no publicized A-status registration number of lysophosphatidylethanolamine on the CDE API registration platform in China. Only 3 domestic enterprises have obtained food-grade production licenses, and no pharmaceutical-grade preparation has been approved for marketing. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for lysophosphatidylethanolamine, covering residual precursor impurities, oxidative by-products and degradation products in the synthesis process. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of both Chinese Pharmacopoeia and FDA regulations, and can meet the multi-scenario R&D demands such as API quality research and preparation stability investigation.