TAIPEI, Taiwan, May 27, 2026
Foresee Pharmaceuticals has announced the successful completion of its Casppian Phase 3 clinical trial evaluating FP-001 42 mg (leuprolide mesylate), a long-acting six-month GnRH agonist formulation developed for the treatment of Central Precocious Puberty (CPP). The company confirmed that the trial achieved its primary efficacy endpoint, with 94% of pediatric patients successfully achieving luteinizing hormone (LH) suppression following a single six-month dosing interval. The study’s topline findings further strengthen Foresee’s plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) by late 2026 while expanding future regulatory submissions globally.
The completion of the Last Patient Last Visit milestone officially concludes active patient participation in the Phase 3 study and marks a major advancement for Foresee Pharmaceuticals’ long-acting injectable platform technologies. Company executives stated that FP-001 demonstrated statistically significant efficacy, exceeding the trial’s predefined success threshold while maintaining a favorable and predictable safety profile throughout the study period. The therapy is designed to provide continuous suppression of gonadotropin secretion for six months following a single subcutaneous injection, potentially reducing treatment burden for pediatric patients and caregivers compared with currently available therapies requiring more frequent dosing.
FP-001 Demonstrates Strong Hormonal Suppression in CPP
According to Foresee Pharmaceuticals, the primary endpoint of the Casppian study measured the percentage of patients achieving serum luteinizing hormone concentrations below 4 mIU/mL at Week 24 following abbreviated GnRH agonist stimulation testing. Results demonstrated that 94% of enrolled patients achieved successful LH suppression, substantially exceeding the pre-specified efficacy target of 80% and reaching strong statistical significance with a p-value of 0.0005.
Investigators also reported that FP-001 was generally well tolerated, with no unexpected safety concerns observed during the study. The safety profile remained consistent with the established GnRH agonist therapeutic class commonly used in pediatric endocrinology. Company officials emphasized that the ability to maintain hormonal suppression over a six-month period using a single injection may significantly improve treatment convenience and long-term adherence for children undergoing therapy for CPP.
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Central Precocious Puberty is a pediatric endocrine disorder characterized by premature activation of the hypothalamic-pituitary-gonadal axis, leading to abnormally early puberty. If left untreated, CPP may result in accelerated bone maturation, reduced adult height potential, and substantial psychosocial challenges for affected children and families. GnRH agonist therapies currently represent the standard of care for suppressing premature pubertal progression.
Foresee Expands Regulatory Plans for FP-001
Foresee Pharmaceuticals confirmed that it has already initiated preparations for regulatory submissions following completion of the Phase 3 study. The company plans to finalize statistical analyses and clinical study reports during the second and third quarters of 2026 before submitting an NDA to the FDA later this year. Additional marketing authorization submissions are expected to follow across multiple global markets during 2026 and 2027.
The Casppian Phase 3 study was also accepted for presentation at the Endocrine Society’s ENDO 2026 Medical Conference, one of the world’s leading scientific meetings focused on endocrinology research and clinical medicine. The abstract presentation will highlight the study’s successful achievement of its primary endpoint and the therapy’s potential to become a new six-month treatment option for children with CPP.
Company executives stated that the strong efficacy outcomes further validate Foresee’s proprietary Stabilized Injectable Formulation (SIF) technology platform, which is designed to support extended-release injectable therapies across multiple disease areas. Foresee believes FP-001 may potentially become the first ready-to-use six-month injection specifically developed for pediatric CPP treatment
Long-Acting Injectable Therapies Gain Momentum
The successful completion of the Casppian study reflects broader pharmaceutical industry interest in long-acting injectable therapies designed to improve treatment adherence, reduce dosing frequency, and simplify chronic disease management. Long-acting formulations are increasingly being explored across endocrinology, oncology, psychiatry, and inflammatory disease markets due to their potential to enhance patient convenience and clinical outcomes.
Foresee Pharmaceuticals, headquartered in Taiwan and the United States, continues expanding its portfolio of long-acting injectable therapies and specialty pharmaceutical programs. Industry analysts believe the positive Phase 3 results position FP-001 as a potentially important addition to the growing pediatric endocrinology treatment landscape if regulatory approvals are successfully obtained in the United States and international markets.
Source: Foresee Pharmaceuticals press release
