Cycloserine

The clinical treatment of drug-resistant tuberculosis has long faced the dilemmas of limited optional drugs and great difficulty in the management and control of adverse reactions. As a core variety among second-line anti-tuberculosis drugs, cycloserine belongs to D-alanine analogues. It competitively inhibits alanine racemase and D-alanine ligase to block the biosynthesis of Mycobacterium tuberculosis cell walls, and has significant bacteriostatic activity against multidrug-resistant Mycobacterium tuberculosis strains. Clinically, it is mainly used in combination with other anti-tuberculosis drugs for the treatment of multidrug-resistant pulmonary tuberculosis and extrapulmonary tuberculosis in adults and children, especially suitable for drug-resistant tuberculosis patients who have failed first-line drug treatment. It is a core component drug recommended in the WHO guidelines for the treatment of drug-resistant tuberculosis.

The continuous increase in the base of drug-resistant tuberculosis patients worldwide has driven the steady expansion of market demand for cycloserine. In 2023, the global market size was approximately USD 120 million, with China's market share exceeding 35%, and the compound annual growth rate remaining at around 8%. The current market supply is dominated by generic drugs. There are less than 10 domestic cycloserine preparation manufacturers that have been approved, and the number of enterprises on the API supply side is relatively small. Against the background that domestic tuberculosis prevention and control policies continue to increase the support for the diagnosis and treatment of drug-resistant tuberculosis, the demand of downstream preparation enterprises for compliant APIs is on the rise.

The original research enterprise of cycloserine is Eli Lilly and Company in the United States, and the original brand name is Seromycin. Its core US compound patent expired in the 1970s, and all core domestic patents have expired. The main dosage form approved for the original research product is oral capsule with a specification of 250 mg. The original research capsule has been included in the FDA Reference Listed Drug Catalog. The original research preparation has not been imported into China, and domestic preparations are mainly 250 mg capsules. As of October 2024, 6 domestic enterprises have obtained CDE registration numbers for cycloserine APIs, among which 3 products are registered in A status, which can be used in association with domestic preparation declaration and 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 cycloserine API. Most of the 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 compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can fully meet the needs of different scenarios such as API R&D, quality research, and registration declaration.