Cetilistat

The prevalence of obesity worldwide has increased nearly threefold in the past three decades, and the accompanying metabolic complications such as hyperlipidemia and type 2 diabetes have become a significant burden in the field of public health. Cetilistat is a weight loss drug belonging to the gastrointestinal lipase inhibitor class. It specifically inhibits the activities of gastric lipase and pancreatic lipase, reducing the hydrolysis and absorption of approximately 30% of triglycerides in the diet, and achieves weight management on the basis of energy intake control. It is clinically mainly used for obese patients with BMI ≥ 28kg/㎡, or people with BMI ≥ 24kg/㎡ combined with weight-related complications such as hypertension, hyperlipidemia and type 2 diabetes. Its action does not enter the central nervous system, adverse reactions are mostly limited to the gastrointestinal tract, and its tolerance is better than that of central weight loss drugs.

At present, the global market size of lipase inhibitor weight loss drugs has exceeded 1.2 billion US dollars, and the compound annual growth rate is maintained at around 8.2%. Compared with orlistat, which has been on the market for many years, cetilistat has lower hepatotoxicity and nephrotoxicity, and lower risk of drug interactions, and its penetration rate in elderly patients with underlying diseases is increasing year by year. The domestic market is currently in the early stage of generic drug layout. Only 3 enterprises have submitted applications for marketing registration of APIs, and the preparation varieties have not yet passed the consistency evaluation and have not been included in the scope of national centralized procurement, so the degree of market competition is relatively low.

The original research enterprise of cetilistat is Alfa Wassermann of Italy, and the original research trade name is Xenical? No, the correct original research trade name is Orlistat? No, after verification, the original research enterprise of cetilistat is Takeda Pharmaceutical of Japan, and the original research trade name is Cetilistat. The core compound patent expires in 2027 in major markets such as the European Union and the United States, and the compound patent expires in 2026 in China. The main dosage form approved by the original research is tablet, with specifications of 60mg and 120mg, which has been included in the FDA Orange Book Reference Preparation Catalog, but has not yet been included in China's *Catalog of Reference Preparations for Chemical Drugs*. At present, 4 domestic enterprises have submitted applications for marketing registration of cetilistat APIs, of which 2 have obtained A-status publicity. No original research or imported preparations have been approved for marketing in China, and domestic preparations are all in the clinical trial stage. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of cetilistat impurity reference standards. Most of the products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. They fully comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference substance use needs of pharmaceutical enterprises in various stages such as API R&D, quality research, registration and declaration.