KX-826 Phase III Clinical Trial Achieves Milestone Success; New Drug A – KOSHINE
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KX-826 Phase III Clinical Trial Achieves Milestone Success; New Drug Application Submitted

KX-826 Clinical Results (KOSHINÉ)

📊 Clinically Demonstrated Efficacy

  • Shown to significantly improve hair regrowth in a multicenter, randomized, double-blind, vehicle-controlled clinical study

  • Consistent results observed across multiple dose groups, indicating stable and reproducible efficacy

  • Achieved statistically significant improvement versus vehicle (control) group

  • Demonstrated sustained efficacy in both male and female subjects with androgenetic alopecia (AGA)

🛡 Favorable Safety Profile

  • Well-tolerated overall, with no treatment-related serious adverse events (SAEs) reported

  • Adverse event rates were comparable to the control group

  • Designed for topical scalp application with minimal systemic exposure

  • Supported by favorable tolerability in clinical evaluation, including longer-term use trends

🧬 Mechanism of Action

  • A topical androgen receptor (AR) antagonist

  • Works by blocking androgen receptor activation in hair follicles

  • Helps reduce follicular miniaturization associated with AGA

  • Supports a healthier scalp environment and normal hair growth cycle

  • Localized scalp activity helps minimize systemic side effects

🌍 Clinical Overview

  • Supported by multiple clinical studies conducted in China and the United States

  • Represents a next-generation topical approach for androgenetic alopecia (AGA)

  • Designed to complement existing standard hair loss treatment options

✨ KOSHINÉ Product Positioning

  • KOSHINÉ KX-826 Series is developed based on the same core active compound and mechanism evaluated in clinical studies

  • Formulated to deliver consistent topical application experience aligned with clinically studied ingredient behavior

  • Designed to support visible hair density improvement and scalp health maintenance in real-world use conditions

 

Clinically Proven Results from Phase III Trials

Twice a day(BID) 0.5% KX-826 1% KX-826 Control group
Hair count per/ in² 93.23 hairs 98.9 hairs 30.19 hairs
Vs Control +48.70 hairs +63.09 hairs +0 hairs
Cycle 6 months 6 months 6 months
Drug adverse effects none none none
Trial site CN/US CN/US CN/US
P-value <0.0001 <0.0001 <0.0001

 Data sourced from officially published clinical study results.