Tiopronin

The incidence of chronic liver diseases such as viral hepatitis and alcoholic liver disease is increasing year by year, and the clinical demand for drugs with anti-inflammatory, antioxidant and hepatocyte protective effects continues to grow. Tiopronin is a new type of liver-protecting drug belonging to glycine derivatives containing sulfhydryl groups. It can protect the structure and function of hepatocyte mitochondria by providing sulfhydryl groups and scavenging oxygen free radicals, while promoting hepatocyte regeneration, improving abnormal liver function and reducing transaminase levels. It is widely used clinically in the treatment of acute and chronic hepatitis, alcoholic hepatitis, drug-induced hepatitis, fatty liver and early liver cirrhosis, and can also be used to reduce the toxic and side effects of radiotherapy and chemotherapy, with applicable populations covering all types of patients with liver injury and tumor populations in need of radiotherapy and chemotherapy.

The global tiopronin market size was approximately USD 320 million in 2023, and is expected to maintain a compound annual growth rate of 4.2% from 2024 to 2030, with growth drivers mainly coming from the rising prevalence of liver diseases and the expansion of clinical demand for liver-protecting drugs. China is one of the major consumer markets of tiopronin in the world, accounting for approximately 38% of the global market. The domestic market is dominated by generic drugs. At present, more than 20 enterprises have obtained approval for the production of tiopronin preparations. After the coverage of centralized procurement, the terminal price has dropped by more than 60%, further improving clinical accessibility.

The original research enterprise of tiopronin is Santen Pharmaceutical Co., Ltd. of Japan, with the original trade name "凯西莱". Its core compound patent expired in 2013. The original research dosage forms approved for marketing in China mainly include tablets (0.1g) and injections (0.1g, 0.2g), which have been included in the China Listed Medicines Catalogue as reference preparations. As of June 2025, there are a total of 11 tiopronin registration entries on the API Registration Platform of China Center for Drug Evaluation (CDE), among which 8 have been publicized in Status A and can be used for associated preparation declaration. Multiple dosage forms of tiopronin, including tablets, injections and enteric-coated tablets, have been approved for marketing in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

In response to the R&D and quality control needs of tiopronin, CATO provides a full set of impurity reference standards for this API, covering all research dimensions such as process impurities and degradation impurities. Most 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 regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can effectively support pharmaceutical enterprises in API registration and declaration as well as quality stability research.