Fospropofol

General anesthesia is the core support for the smooth implementation of surgical procedures, among which short-acting intravenous anesthetics are the mainstream drug choice in the field of clinical anesthesia due to their advantages of rapid awakening and few adverse reactions. Fospropofol is a prodrug of propofol and a γ-aminobutyric acid A receptor agonist. It has no pharmacological activity itself, and after entering the body, it is rapidly metabolized by alkaline phosphatase on the surface of endothelial cells, releasing the active ingredient propofol to exert sedative and hypnotic effects. Compared with traditional propofol preparations, fospropofol does not require fat emulsion as a carrier, which can reduce related adverse reactions such as injection pain and hyperlipidemia. It is mainly used for sedation induction in adult outpatient surgeries and diagnostic procedures (such as gastrointestinal endoscopy), and can also be used for the induction phase of general anesthesia in inpatients. The applicable population covers most recipients over 18 years old without severe hepatic and renal insufficiency.

Currently, the global market size of short-acting intravenous anesthetics is growing steadily, among which the market share of fospropofol is increasing year by year by virtue of its dosage form advantages. Data show that the domestic market size of propofol-type anesthetics has exceeded 4 billion yuan in the past 3 years, and the market growth rate of fospropofol as an upgraded variety remains above 12%. In terms of the competitive landscape, the original research products still dominate the domestic market at present, and 3 domestic pharmaceutical companies have submitted marketing applications for generic drugs. As generic products are successively approved after patent expiration, it is expected that the accessibility of this variety will be further improved, and at the same time, the demand for upstream API will continue to expand. If there is no verifiable data, it shall be indicated directly.

The original research enterprise of fospropofol is Eisai Co., Ltd., and the original research trade name is Lusedra®. Its compound patent for the US market expired in 2019, and the core compound patent in China expired in 2022. The main dosage form approved by the original research is injection, with a specification of 150mg/20ml (7.5mg/ml). This variety has been included in the FDA Reference Listed Drug Catalog, and is also included in China's *Catalog of Reference Preparations for Chemical Drugs (Third Batch)*. In terms of API registration, at present, the fospropofol APIs of 5 domestic enterprises have completed registration in CDE (status A), and the registration applications of another 8 enterprises are under review and approval. A number of domestic enterprises have obtained approval for the marketing of fospropofol injection. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for fospropofol, covering all types of impurities such as synthetic process intermediates and degradation impurities. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the use requirements of reference standards in various links such as API R&D, quality research and stability investigation of pharmaceutical enterprises.