Ciclopirox

Skin fungal infections are highly prevalent infectious diseases worldwide. The prevalence of superficial mycosis can reach 20%-25% of the total population, and intractable recurrence is the core pain point in clinical treatment. Ciclopirox is a broad-spectrum antifungal drug of the pyridone class. It exerts its effects by inhibiting fungal cytochrome oxidase, disrupting cell membrane permeability and blocking nucleic acid synthesis at the same time. It has strong antibacterial activity against dermatophytes, yeasts, molds and some Gram-positive/Gram-negative bacteria, and also has anti-inflammatory effects. It is mainly used clinically for the treatment of tinea manus and pedis, tinea corporis and cruris, onychomycosis and vaginal candidiasis. For onychomycosis with long course of disease and high recurrence tendency, its transungual absorption property is far superior to that of traditional azole drugs, and it is a common treatment option for superficial fungal infections in adults.

The global market size of topical antifungal drugs was approximately USD 8.7 billion in 2023, among which pyridone drugs account for a stable share of around 12%, with a compound annual growth rate of approximately 4.8%. In the domestic market, the size of ciclopirox-related preparations is approximately RMB 620 million. With the improvement of the awareness rate among patients with onychomycosis, the growth rate has remained above 7% in the past three years. At present, domestic preparations are mainly generic drugs, with fewer than 10 manufacturers, and the concentration of API suppliers is relatively high, so there is no excessive competition.

The original research enterprise of ciclopirox is Hexal AG of Germany, and the trade name of its original research topical cream is "Batrafen". The global core compound patent expired in 2001, and there is no surviving record of compound patent in China. The marketed dosage forms of the original drug mainly include 8% nail lacquer, 1% cream and 1% vaginal suppository. Among them, 8% ciclopirox lacquer and 1% ciclopirox cream have been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by the NMPA. Up to now, there have been 7 registration entries of ciclopirox API on the CDE API registration platform, among which 3 are in the status of "A (used in marketed preparations)". A variety of preparations including creams, lacquers and gels have been approved for marketing in China. (Data as of November 2024, please refer to the official CDE website for the latest information.)

CATO provides a full set of impurity reference standards for ciclopirox API, which can cover the full-process requirements of registration and declaration, quality research and release testing. Most 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 such as the Chinese Pharmacopoeia and FDA, and can be directly used for quality research in different declaration scenarios.