Propylthiouracil

Hyperthyroidism is a common autoimmune disease of the endocrine system, with a domestic prevalence rate of approximately 1.2%. More than 80% of the cases are caused by Graves' disease, and if it is not under standardized control, it can induce serious complications such as thyroid storm and liver function damage. As a core variety of thiourea antithyroid drugs, propylthiouracil reduces the synthesis of thyroid hormones by inhibiting the tyrosine iodination and coupling process mediated by thyroid peroxidase, and at the same time inhibits the conversion of T4 in peripheral tissues to T3 with stronger biological activity. It is one of the first-line treatment drugs for patients with mild to moderate Graves' disease, thyroid storm, and gestational hyperthyroidism, and is especially suitable for people intolerant to methimazole.

At present, the global market size of antithyroid drugs is stable at around US$1.2 billion, with a compound annual growth rate of approximately 3.2%. Among them, propylthiouracil, with clear clinical positioning and low price, accounts for about 18% of the market share in the segment. In terms of the domestic market, this variety has been included in the National Essential Medicine List and the Class A Medical Insurance List, with an annual procurement volume of public medical institutions exceeding 30 tons, and the market supply is dominated by generic drugs. At present, the preparations of 12 enterprises have been approved for marketing. On the API supply side, in addition to a small number of imported sources, the production capacity of domestic enterprises has been able to meet clinical needs, and there is no obvious supply gap.

The original research enterprise of propylthiouracil is Roche, with the original brand name Propyl-Thyracil, and the core compound patent expired globally in 1974. At present, the main dosage form approved in China is tablet, with specifications of 50mg and 100mg. Among them, a number of domestic tablet varieties have passed the quality and efficacy consistency evaluation of generic drugs. The original reference listed drug is not marketed in China, and the domestic reference listed drug is included in the *Catalogue of Reference Listed Drugs for Generic Chemical Drugs*. As of now, there are 13 propylthiouracil registration entries on the CDE API registration platform, 8 of which have been activated for marketing and can be associated with the review and approval of domestic preparations, and another 2 imported DMF registration numbers are in valid status. (Data as of September 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for propylthiouracil, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can provide stable reference standard support for API R&D, quality research and consistency evaluation.