Dexrazoxane

Anthracycline chemotherapeutic drugs are the cornerstone regimen for the treatment of hematological malignancies and solid tumors, but long-term use tends to induce dose-dependent cardiotoxicity, which severely limits their clinical application scenarios. Dexrazoxane, the only approved anthracycline cardioprotective agent, is a chelator derivative. It can competitively bind to anthracycline-iron ion complexes, inhibit the production of free radicals, and block the oxidative damage pathway of cardiomyocytes. At present, it is mainly used clinically in patients with malignant lymphoma, breast cancer, lung cancer and other diseases who have received anthracyclines such as doxorubicin and epirubicin with a cumulative dose exceeding 300 mg/m². It can reduce the risk of serious cardiac adverse events such as heart failure and cardiomyopathy on the premise of not affecting the anti-tumor effect of chemotherapy.

The global market size of dexrazoxane has maintained a steady growth trend in recent years, with the market size reaching approximately USD 210 million in 2023. The growth rate of the Chinese market is significantly higher than the global average, with a compound annual growth rate of 12.7%. The domestic market is still dominated by generic drugs at present, with the original research product accounting for less than 20% of the market share. More than 10 domestic enterprises have been approved to produce dexrazoxane preparations, among which 3 enterprises have had their active pharmaceutical ingredients (APIs) passed the review of the Center for Drug Evaluation (CDE) for the quality and efficacy consistency evaluation of generic drugs. With the upgrading of the recommendation level of anthracycline cardioprotection in standardized tumor diagnosis and treatment guidelines and the increase in the penetration rate of the primary tumor chemotherapy market, there is still considerable room for the release of clinical demand for dexrazoxane.

The original research enterprise of dexrazoxane is Pfizer, with the original brand name Cardioxane®. Its core compound patent expired globally in 2009. At present, the main dosage form of the original research product marketed globally is injection, with two specifications of 250 mg/500 mg, which has been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs (Third Batch)*. In terms of the domestic market, as of now, 12 dexrazoxane APIs have been approved for marketing and completed registration with the CDE (status A), and more than 20 enterprises have obtained domestic marketing approval for dexrazoxane for injection preparations. (Data as of May 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of dexrazoxane impurity reference standards, which can cover the full-process requirements of API and preparation R&D, quality research, and consistency evaluation. 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 regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can be directly used for research related to registration and declaration.