Foresee Pharmaceuticals announced on the 17th that patient enrollment for the Phase III clinical trial of Casppian, a treatment for pediatric central precocious puberty (CPP), has been completed. Final results from this pivotal clinical trial are expected by the end of this year, with a complete New Drug Application (NDA) submission to regulatory authorities planned for the third quarter of 2026.
The Casppian Phase III trial is an open-label, multinational, multicenter study evaluating the efficacy, safety, and pharmacokinetics of leuprolide 42 mg (FP-001 six-month depot formulation) in patients with GnRH-dependent CPP.
The study duration is 48 weeks. The primary endpoint is the proportion of patients who achieve serum luteinizing hormone (LH) suppression—defined as a level below 4 mIU/mL within 30 minutes of a GnRH agonist stimulation test—at week 24. If more than 80% of participants achieve LH suppression at that time point, the leuprolide 42 mg formulation (FP-001 six-month depot) will be considered effective for treating CPP.
Dr. Ming-Tar Jan, founder and chairman of Foresee Pharmaceuticals, stated that with full patient enrollment completed, the final results of this pivotal study are expected by the end of 2025, and the full NDA submission will follow in Q3 2026.
Central precocious puberty (GnRH-dependent) is a condition characterized by early onset of puberty in girls and boys due to premature activation of the hypothalamic-pituitary-gonadal axis, often occurring between the ages of 2 and 9.
In addition to physical changes, children with CPP may experience social, psychological, and emotional challenges. These include low self-esteem, stress, anxiety, and depression, and can result in reduced adult height and overall quality of life.
According to the National Organization for Rare Disorders (NORD), CPP affects approximately 1 in every 5,000 to 10,000 children, with 80% to 90% of cases being idiopathic. The condition is significantly more common in girls, who are about 20 times more likely to be affected than boys. GnRH agonists—such as leuprolide—are the most widely used standard treatment for managing CPP.
Resource: 逸達兒童中樞性性早熟Casppian 三期臨床試驗收案完成
