Isoconazole

Superficial fungal infection is a highly prevalent infectious disease globally. The annual incidence of tinea manus and pedis, tinea corporis and cruris alone exceeds 10% of the global population. The continuous emergence of drug-resistant strains puts forward higher requirements for the selection of clinical antifungal therapy. Isoconazole is an imidazole broad-spectrum antifungal drug. It inhibits the biosynthesis of ergosterol in the fungal cell membrane, destroys the structural integrity of the cell membrane and affects its permeability, while interfering with the oxidative metabolic process of fungal cells, and finally exerts bacteriostatic or bactericidal effects. This drug has good activity against common pathogenic bacteria such as Trichophyton rubrum, Trichophyton mentagrophytes and Candida albicans. It is mainly used clinically to treat tinea manus and pedis, tinea corporis and cruris, tinea versicolor and mucocutaneous candidiasis, and is applicable to superficial fungal infection patients of all age groups who have no history of imidazole drug allergy.

At present, the global market size of topical antifungal drugs has exceeded 8 billion US dollars. Among them, imidazole drugs account for nearly 40% of the topical antifungal drug market share by virtue of good safety and cost performance. As a variety with sufficient clinical evidence in this category, the annual compound growth rate of market demand for isoconazole remains at around 5%. In terms of the domestic market, with the improvement of the diagnosis and treatment penetration rate of fungal dermatosis at the grassroots level, the terminal sales growth rate of isoconazole preparations has been stable at more than 7% in the past three years. At present, a number of enterprises have submitted marketing applications for generic drugs, the overall competition pattern has not been solidified, and the demand for API supply is continuing to be released. (There is no verifiable and accurate market data source, and relevant data are for reference only)

The original research enterprise of isoconazole is Janssen Pharmaceutica N.V. of Belgium, and the original research trade name is Travogen. Its core compound patent in major global markets expired in the 1990s. At present, the commonly used dosage form in China is 1% isoconazole cream, and the specification of a single tube is mostly 10g. The original research cream has been included in the FDA Orange Book Reference Listed Drug Catalog, and also included in the China Listed Drug Catalog. According to the domestic API registration platform, no enterprise has obtained the A-status registration number of isoconazole API at present, and all isoconazole preparations approved for marketing in China are imported varieties. (Data as of September 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for isoconazole API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the reference substance use needs of pharmaceutical enterprises in the process of API R&D, quality research and generic drug consistency evaluation.