Terizidone

The clinical treatment of drug-resistant tuberculosis has long been faced with the dilemma of limited optional drugs and high adverse reaction rate. As a second-generation oxazolidinone anti-tuberculosis drug, terizidone exerts bactericidal activity by inhibiting the protein synthesis of Mycobacterium tuberculosis, and has significant antibacterial effects against multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB) strains. It is mainly used in combination with other anti-tuberculosis drugs for the treatment of adult patients with drug-resistant tuberculosis, and is a core component of the current short-course chemotherapy regimen for drug-resistant tuberculosis, which effectively reduces the treatment failure rate and mortality of patients with drug-resistant tuberculosis.

Currently, there are about 500,000 new cases of drug-resistant tuberculosis globally every year. With lower neurotoxicity and higher safety, terizidone maintains a rapid growth trend in market size. In 2023, the global market size has exceeded 1.2 billion US dollars, with a compound annual growth rate of more than 18%. The domestic market is still dominated by original research products at present. With the increasing demand for prevention and control of drug-resistant tuberculosis in China and the accelerated R&D progress of generic drugs, the market size is expected to exceed 800 million yuan in the next 3 to 5 years.

The original research enterprise of terizidone is Bayer AG in Germany, and the original trade name is Trecator. The core compound patent expired globally in 2001. The main approved dosage form is oral tablet with a specification of 250 mg. The original research tablet has been included in the FDA Reference Listed Drug Catalogue, and no original research preparation has been approved for import in China yet. In terms of domestic API registration, a total of 3 enterprises have obtained CDE registration numbers for terizidone API, among which 2 are in "A" status and can be supplied to domestic preparation manufacturers for use, and 3 domestic enterprises have obtained approval for the marketing of terizidone tablets. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of terizidone impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for pharmaceutical enterprises in the links of API R&D, quality research and preparation declaration.