Drug intelligence / Profile preview

Sophora flavescens alkaloid gel

Development stage
Unknown
Lead developer
Xintian Pharmaceutical
Modality
Metabolically Activated Prodrugs → Prodrugs/Conditional Activator Small Molecules → Small Molecules, Classical Binding Small Molecules → Small Molecules
Administration
Vaginal
01

Overview

Sophora flavescens alkaloid gel (also known as Kushen gel or SFA gel) is a botanical extract-based hydrogel formulation derived from the roots of *Sophora flavescens* Aiton (Kushen). The active components of the gel are total alkaloids of *Sophora flavescens*, primarily consisting of matrine and oxymatrine. Developed by Guiyang Xintian Pharmaceutical, the gel is approved in China (under the brand name Kunlishu) for the treatment of gynecological inflammatory conditions, including bacterial vaginosis, trichomonal vaginitis, and senile vaginitis. It is also being evaluated in clinical trials by institutions such as Tianjin Medical University General Hospital for aerobic vaginitis combined with bacterial vaginosis. Mechanistically, the gel exhibits broad-spectrum antibacterial, anti-inflammatory, and immunomodulatory properties. It promotes the restoration of the vaginal microenvironment by enriching beneficial *Lactobacillus* species and suppressing anaerobic pathobionts. Additionally, it has been shown to activate Toll-like receptor 9 (TLR9) signaling, downregulate pro-inflammatory cytokines (such as IL-6, IL-8, and TNF-α), and enhance anti-viral immune responses (such as IFN-γ production), which also facilitates the clearance of high-risk human papillomavirus (HR-HPV) infections.

Brand names
Kunlishu
Other names
Kushen gelSFA gelSophora flavescens total alkaloid gel苦参凝胶
02

Targets

TLR9 (Toll-like receptor 9)TLR4 (Toll-like receptor 4)

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