Omarigliptin

The global prevalence of type 2 diabetes continues to rise. With the advantages of low hypoglycemia risk and good tolerability, DPP-4 inhibitors have become one of the core categories of oral hypoglycemic drugs. Omarigliptin is a long-acting DPP-4 inhibitor. It reversibly binds to dipeptidyl peptidase-4 and reduces the degradation of glucagon-like peptide-1 (GLP-1), thereby promoting insulin secretion and inhibiting glucagon release to achieve the effect of stable glycemic control. Different from most DPP-4 inhibitors that require daily administration, omarigliptin has a long half-life of 54 hours. Only once-weekly oral administration is needed to maintain a stable plasma concentration, which greatly improves patients' medication compliance. It is indicated for blood glucose control in adult patients with type 2 diabetes, and is especially suitable for middle-aged and elderly people with poor medication compliance and multiple underlying diseases.

The global market size of DPP-4 inhibitors remains steadily above USD 12 billion, and the proportion of long-acting dosage forms has increased year by year to around 13%. At present, omarigliptin has only been approved for marketing in a small number of Asian countries such as Japan and South Korea, and has not yet entered the mainstream markets of Europe, the United States and China. It is still in the stage of exclusive supply by the originator company globally, and no generic drug has been approved for marketing yet. Although omarigliptin has not been approved for marketing in China at present, with the rapid growth of domestic demand for weekly hypoglycemic preparations, once it is approved and launched in the future, there will be a large market penetration space.

The originator company of omarigliptin is MSD K.K. (Japan), and the originator brand name is Marizev. The expiration date of its core compound patent in Japan is 2031. The main dosage form approved by the originator is tablet, with specifications of 12.5 mg and 25 mg, among which the 25 mg specification has been included in the Japanese Orange Book as the reference listed drug. Up to now, the National Medical Products Administration of China has not approved the marketing of omarigliptin preparations or active pharmaceutical ingredients, and there is no related API registration number with A status or I status in the CDE API registration database. (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 omarigliptin API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products comply with the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for the generic drug development and quality research work of relevant R&D institutions and pharmaceutical enterprises.