Baxdrostat

As a selective histone deacetylase (HDAC) inhibitor targeting isocitrate dehydrogenase (IDH) mutations, pracinostat regulates epigenetic modifications to restore the normal expression of tumor suppressor genes, and simultaneously induces differentiation and apoptosis of IDH-mutant tumor cells. At present, this drug is mainly used for the treatment of relapsed or refractory acute myeloid leukemia (AML) carrying IDH1/2 mutations, and clinical research is also being conducted in the fields of myelodysplastic syndrome, cholangiocarcinoma and other solid tumors, covering the adult patient population with IDH-mutant hematological tumors, providing a brand-new targeted option for this group of people who lack effective treatment regimens.

At present, the global market size of IDH mutation targeted drugs continues to expand. In 2023, the overall market size has exceeded 1.8 billion US dollars, with a compound annual growth rate of more than 32%. Among them, the proportion of HDAC inhibitor drugs in the AML segment is increasing year by year. As an innovative drug in this category, pracinostat is still in the period of original research exclusivity, and no generic drug has been approved for marketing worldwide. There are approximately 23,000 new annual cases of IDH-mutant AML patients in China. Due to the limited clinically available drugs, the clinical demand gap for this drug is relatively significant.

The original research enterprise of pracinostat is Bayer Healthcare, with the trade name Farydak. Its core compound patent will expire in 2027 in Europe, and the core patent in the United States will expire in 2028. At present, the main dosage form approved by the original research manufacturer is oral capsules, with specifications including 10 mg, 15 mg and 20 mg, which has been included in the FDA Reference Listed Drug Catalog. As of the retrieval time point, no preparation of this drug has been approved for marketing in China, and there is no valid API registration number available for public notification on the CDE API Registration Platform.(Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the R&D and production needs of pracinostat, CATO provides a full set of impurity reference standards for this API. Most of the products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. They comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully support the drug quality research, stability investigation and registration declaration work.

针对巴昔多司他的研发与生产需求，CATO/佳途科技提供该API全套杂质标准品，大部分产品现货供应，现货产品16:00前下单当天发货，符合中国药典、FDA等多法规合规要求，可全面支持药物的质量研究、稳定性考察及注册申报工作。