Econazole

Skin fungal infection is a highly prevalent infectious disease worldwide. Due to its high recurrence rate and protracted course, it exerts a long-term impact on patients' quality of life. Econazole is an imidazole class broad-spectrum antifungal drug. It inhibits the biosynthesis of ergosterol in fungal cell membranes, damages the structure of cell membranes and alters their permeability. Meanwhile, it interferes with the activities of fungal oxidase and peroxidase, leading to the accumulation of intracellular peroxides, and ultimately exerts bacteriostatic or bactericidal effects. It has strong activity against common pathogenic bacteria such as *Trichophyton rubrum*, *Trichophyton mentagrophytes* and Candida. Clinically, it is mainly used for the treatment of tinea corporis, tinea cruris, tinea pedis and manus, tinea versicolor and cutaneous candidiasis, and the applicable population covers most patients with superficial fungal infections without contraindications.

The global market size of topical antifungal drugs reached USD 12.8 billion in 2023. Among them, imidazole drugs account for 37% of the market share due to their cost-effectiveness advantage. As a commonly used clinical variety, econazole maintains an annual growth rate of around 4.2%. In terms of the domestic market, econazole preparations have been included in the 2024 edition of the National Medical Insurance Catalog. At present, more than 20 enterprises have obtained approval for generic preparations, and the supply of API is dominated by local enterprises. The market competition is relatively sufficient, and the price system is relatively stable.

The original research enterprise of econazole is Janssen Pharmaceuticals. The compound preparation (containing econazole and triamcinolone acetonide) with the original research trade name "派瑞松" (Pevisone) was first approved for marketing in 1982, and the trade name of the single-agent preparation is "Spectazole". Its core compound patent expired in 1999, and the patent protection period has now expired. The main dosage forms of the original research include cream, powder and spray, and the conventional specification of the single-agent cream is 1% (10g:0.1g). The original research single-agent preparation has been included in the FDA Reference Listed Drug Catalog. The original research preparation is not imported into China, and domestic preparations are mainly generic. As of December 2024, there are a total of 12 econazole API registration entries on the CDE API Registration Platform, among which 7 have been publicized in Status A and can be associated with the review and approval of domestic preparations. (Data as of December 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for econazole API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They comply with the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard needs in the process of API R&D, quality research and declaration.