KX-826 Phase III Clinical Trial Achieves Milestone Success; New Drug Application Submitted
KX-826 Clinical Results (KOSHINร)
๐ Clinically Demonstrated Efficacy
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Shown to significantly improve hair regrowth in a multicenter, randomized, double-blind, vehicle-controlled clinical study
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Consistent results observed across multiple dose groups, indicating stable and reproducible efficacy
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Achieved statistically significant improvement versus vehicle (control) group
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Demonstrated sustained efficacy in both male and female subjects with androgenetic alopecia (AGA)
๐ก Favorable Safety Profile
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Well-tolerated overall, with no treatment-related serious adverse events (SAEs) reported
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Adverse event rates were comparable to the control group
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Designed for topical scalp application with minimal systemic exposure
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Supported by favorable tolerability in clinical evaluation, including longer-term use trends
๐งฌ Mechanism of Action
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A topical androgen receptor (AR) antagonist
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Works by blocking androgen receptor activation in hair follicles
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Helps reduce follicular miniaturization associated with AGA
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Supports a healthier scalp environment and normal hair growth cycle
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Localized scalp activity helps minimize systemic side effects
๐ Clinical Overview
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Supported by multiple clinical studies conducted in China and the United States
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Represents a next-generation topical approach for androgenetic alopecia (AGA)
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Designed to complement existing standard hair loss treatment options
โจ KOSHINร Product Positioning
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KOSHINร KX-826 Series is developed based on the same core active compound and mechanism evaluated in clinical studies
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Formulated to deliver consistent topical application experience aligned with clinically studied ingredient behavior
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Designed to support visible hair density improvement and scalp health maintenance in real-world use conditions
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Clinically Proven Results from Phase III Trials
| Twice a day(BID) | 0.5% KX-826 | 1% KX-826 | Control group |
| Hair count per/ inยฒ | 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 | ๏ผ0.0001 | ๏ผ0.0001 | ๏ผ0.0001 |
ย Data sourced from officially published clinical study results.