Prusogliptin

In response to the clinical treatment needs of type 2 diabetes, dipeptidyl peptidase-4 (DPP-4) inhibitors have become one of the mainstream categories in the field of oral hypoglycemic drugs, relying on their clinical advantages of stable glucose lowering, low risk of hypoglycemia, and no effect on body weight. Prusogliptin is a new long-acting DPP-4 inhibitor, which reduces the degradation of glucagon-like peptide-1 (GLP-1) by highly selectively inhibiting the activity of DPP-4, thereby promoting insulin secretion, inhibiting glucagon release, and exerting a glucose-dependent hypoglycemic effect. It can be used as monotherapy or in combination for glycemic control in adult patients with type 2 diabetes, especially suitable for elderly patient groups who require long-term stable glycemic control and have underlying comorbidities.

At present, the global market size of DPP-4 inhibitors has exceeded 15 billion US dollars. Among them, long-acting preparations, with the compliance advantage of only needing to be taken once a week, have grown 2.3 times faster than ordinary short-acting DPP-4 inhibitors in recent years. Domestic long-acting DPP-4 inhibitors are still in the early stage of market penetration. The sales volume at public medical institution terminals increased by more than 87% year-on-year in 2023, and the current market share is mainly occupied by original research products. With the acceleration of domestic generic drug research and development progress, the accessibility of this track is expected to improve rapidly.

The original research enterprise of prusogliptin is Hanmi Pharmaceutical Co., Ltd. of South Korea, with the original research brand name Zemiglo, and its Chinese compound patent will expire in 2027. The dosage form of the original research drug approved in China is tablet, with a specification of 100mg per tablet, which has been included in the *Catalogue of Reference Preparations of Chemical Drugs* issued by the National Medical Products Administration. As of now, the Chinese Listed Medicines Catalogue has not shown that any domestic prusogliptin preparation has been approved, and the API registration platform has not yet publicized any domestic API registration number that has obtained the A status. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for prusogliptin API, most of which are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. They can simultaneously meet the R&D compliance requirements under multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and provide stable and reliable reference standard support for pharmaceutical companies' generic drug consistency evaluation, quality research and declaration work.