Itraconazole

The mortality rate of invasive fungal disease can be as high as 40%. In recent years, with the widespread use of immunosuppressants and broad-spectrum antibiotics, the size of the high-risk susceptible population has continued to expand, and there is an urgent demand for clinical antifungal therapy. Itraconazole is a triazole broad-spectrum antifungal drug. It exerts bacteriostatic or bactericidal effects ultimately by highly selectively inhibiting the fungal cytochrome P450-dependent 14α-lanosterol demethylase and blocking the synthesis of ergosterol in fungal cell membranes. Its antibacterial spectrum covers a variety of pathogenic fungi such as Candida, Aspergillus, and Cryptococcus. It can be used to treat superficial fungal infections (such as tinea manus and pedis, onychomycosis) and systemic fungal infections. Meanwhile, it is also a commonly used drug for immunocompromised people to prevent invasive fungal infections, and the applicable population includes adults and pediatric patients weighing more than 35 kg.

At present, the global market size of antifungal drugs has exceeded 15 billion US dollars, among which triazole drugs account for nearly 40%. As one of the core varieties of this category of drugs, itraconazole has a stable global annual sales volume of around 1.2 billion US dollars. In terms of the domestic market, the annual sales of itraconazole preparations exceed 1.8 billion yuan, with a compound growth rate of 7.2% in the past 3 years. The growth momentum mainly comes from the increased demand for antifungal prevention among immunodeficient people. In terms of the competitive landscape, the original research product still accounts for nearly 60% of the market share, and 12 domestic enterprises have been approved to produce generic preparations. As the fifth batch of national centralized drug procurement included itraconazole oral regular-release dosage forms in the procurement scope, the market penetration rate of generic preparations is continuously increasing.

The original research enterprise of itraconazole is Janssen Pharmaceutica N.V. of Belgium, with the original research brand name "Sporanox". Its core compound patent expired globally in 2005, and the crystal form patent in China also expired in 2017. At present, the dosage forms of the original research product approved in China include capsules (100mg), oral solution (150ml:1.5g) and injection (25ml:250mg). The above dosage forms have all been included in the China Listed Drug Catalogue as reference preparations, and are also included in the FDA Reference Preparations Catalogue. In terms of API registration, as of now, there are 27 registration entries of itraconazole API on the CDE platform, among which 11 are in status A (approved for use in marketed preparations), including the original research import registration and the registration numbers of 6 domestic enterprises. More than 30 itraconazole preparation varieties have been approved for marketing in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for itraconazole API. Most products are in stock. Orders for in-stock products 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 fully meet the reference standard use needs of pharmaceutical enterprises in all links of R&D, quality research and production, helping enterprises efficiently promote the relevant generic drug consistency evaluation and marketing declaration work.