Drug intelligence / Profile preview

DX02 (clotrimazole)

Development stage
Phase 2
Lead developer
Hubei Dongxin Pharmaceutical
Modality
Small Molecules
Administration
Vaginal
01

Overview

DX02 is a specialized vaginal expansion suppository formulation of the imidazole antifungal agent **clotrimazole**, developed by **Hubei Dongxin Pharmaceutical**. It is primarily indicated for the treatment of **vulvovaginal candidiasis (VVC)**. The unique expansion suppository delivery system utilizes a medical-grade sponge or matrix that expands upon contact with vaginal secretions, facilitating more uniform drug distribution and prolonged contact with the vaginal mucosa compared to traditional suppositories or creams. Mechanistically, clotrimazole inhibits the fungal enzyme **lanosterol 14-alpha demethylase** (CYP51), which is essential for the biosynthesis of ergosterol. The resulting depletion of ergosterol and accumulation of methylated sterol precursors lead to structural and functional damage to the fungal cell membrane, resulting in fungistatic or fungicidal effects. DX02 has been evaluated in **Phase 3** clinical trials in China as a Class 2.2 new drug, representing an improved drug delivery system for an established active ingredient.

Other names
clotrimazole vaginal expansion suppositoryclotrimazole vaginal expanding suppository
02

Targets

CYP51A1 (Sterol 14α-demethylase)

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