Foresee Pharmaceuticals (逸達) announced on the 25th positive topline results from the Phase III clinical trial of FP-001 (42 mg), a long-acting controlled-release formulation for Central Precocious Puberty (CPP). The trial met its primary efficacy endpoint with results significantly exceeding the pre-defined threshold. The company plans to submit a New Drug Application (NDA) to the US FDA by mid-2026.

The trial evaluated FP-001 42 mg (Leuprolide Mesylate), a GnRH agonist administered once every six months. The primary endpoint was the proportion of patients achieving serum Luteinizing Hormone (LH) levels below 4 mIU/mL at week 24 (Visit 5), 60 minutes after a GnRHa stimulation test.

Key Clinical Data:

• Efficacy: 94% of subjects achieved the LH suppression target, significantly higher than the 80% success threshold (P-value = 0.0005).
• Safety: The drug was well-tolerated, with a safety profile consistent with existing GnRH agonists. Most adverse events were mild to moderate.

Dr. Bassem Elmankabadi, Senior VP of Clinical Development, and Dr. Yi-Sheng Lee, Chief Medical Officer, noted that maintaining effective suppression for a full six months with a single injection will significantly improve treatment compliance and convenience for pediatric patients. Founder and Chairman Ben Chien expressed confidence that FP-001 is on track to become a "best-in-class" therapy.

Resource: 逸達FP-001六個月長效針劑三期報捷 CPP主要療效達標、94％患者LH成功抑制