Dayspring Pharma has announced top-line data from its phase 2 clinical trial of CG2001 foam in male patients with androgenetic alopecia (AGA). The trial met its primary endpoint and demonstrated statistically significant and clinically meaningful results, with a favourable efficacy and safety profile.
This multicentre, randomised, double-blind, placebo-controlled phase 2study enrolled 110 Chinese adult men with AGA. Led by Peking University People’s Hospital, the 30-week trial was designed to evaluate the efficacy of CG2001 and identify the recommended dosing regimen for phase 3 development.
Key findings
All CG2001 treatment groups demonstrated a markedly superior improvement trend compared to the placebo group at week 24. Most notably, the group receiving 5% minoxidil + 0.075% finasteride twice daily demonstrated the best efficacy. Compared with other registered clinical data, including published data from existing Chinese minoxidil foam studies, efficacy improved by approximately 50%. In addition, the treatment showed a rapid onset of action, surpassing the peak efficacy reported in comparator studies as early as week 12.
In terms of safety, CG2001 was well tolerated and exhibited extremely low systemic exposure. All adverse reactions observed during the study were mild, mainly pruritus and increased scaliness, and resolved spontaneously without medical intervention.
Based on the overall phase 2 results, CG2001 has demonstrated strong potential in efficacy, rapid onset of action, and safety. Dayspring Pharma will continue to advance the phase 3 clinical development of CG2001, further accelerate its research and translational efforts in hair health, and strive to bring patients more effective and accessible treatment options.
About CG2001
CG2001 is a topical combination of minoxidil and finasteride developed to harness the synergistic potential of two cornerstone therapies for androgenetic alopecia (AGA). Both are widely recognised as first-line treatments for male pattern hair loss: minoxidil promotes hair growth, while finasteride inhibits 5α-reductase and reduces dihydrotestosterone (DHT) levels.
CG2001 is formulated as a specifically designed foam with an optimised dose ratio and delivery system to improve local follicular delivery, enhance efficacy, and minimise systemic exposure associated with oral finasteride.
