Epalrestat

Diabetic peripheral neuropathy is one of the most common chronic complications of diabetes. The prevalence rate among patients with a disease course of more than 10 years exceeds 50%, and severe cases can lead to foot ulcers and even amputation. There has been a long-term lack of precise intervention regimens targeting the pathogenesis in clinical practice. Epalrestat is an aldose reductase inhibitor class of antidiabetic complication drug. By reversibly inhibiting the activity of aldose reductase, the key rate-limiting enzyme of the polyol pathway, it reduces the abnormal accumulation of sorbitol in tissues such as nerves and retinas, and improves the blood supply and conduction function of peripheral nerves. It is currently one of the few oral drugs that can simultaneously improve the subjective symptoms of diabetic peripheral neuropathy and objective neuroelectrophysiological indicators, and is suitable for patients with type 2 diabetes complicated with peripheral neuropathy who still have poor blood glucose control after diet therapy, exercise therapy, oral hypoglycemic drugs or insulin treatment.

At present, the global epalrestat market size is growing steadily. The market size in 2023 was approximately USD 320 million, with the Chinese market accounting for more than 60%, and the compound annual growth rate remaining at around 7%. The competition in the domestic market presents a pattern of coexistence of original research drugs and generic drugs. Since epalrestat was included in the national centralized procurement catalog in 2020, the price of generic drugs has dropped by more than 70%, clinical accessibility has been greatly improved, and the terminal drug use scale has continued to expand. At present, nearly 20 domestic enterprises have obtained approval for generic drug preparations, and the supply of active pharmaceutical ingredients is dominated by local enterprises.

The original research enterprise of epalrestat is Ono Pharmaceutical Co., Ltd. of Japan, with the original brand name "Tanglin". The expiration date of its core compound patent in Japan is 2004, and the expiration date of the compound patent in China is 2007. The main dosage form approved for the original research drug is tablet, with a specification of 50mg. This preparation has been included in the China Listed Drug Catalogue and is the reference preparation for domestic generic drug declaration. As of now, there are 19 epalrestat registration records on the API registration platform of China CDE, among which 12 have been publicized in A status. Domestically, epalrestat preparations of two dosage forms, tablets and capsules, have been approved for marketing. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for epalrestat API. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. They are compliant with multiple regulations including Chinese Pharmacopoeia and FDA, and can meet the reference standard needs of pharmaceutical enterprises in the whole process from API declaration to preparation quality research.