Foresee Pharmaceuticals announces the Casppian Phase 3 Study Meets Primary Efficacy Endpoint, Demonstrating Robust LH Suppression with 6-Month Dosing Interval of leuprolide mesylate
The proportion of patients with serum luteinizing hormone (LH) suppression to < 4 mIU/mL at 60 minutes following a GnRHa stimulation test at Week 24 was 94%, and the results were statistically significant (P-value = 0.0005), which exceeded the pre-specified success criterion.
· Leuprolide mesylate 42mg injection (FP-001) was well tolerated in patients with Central Precocious Puberty (CPP)
Excerpt from the Press Release:
TAIPEI, December 24, 2025 – Foresee Pharmaceuticals (TPEx: 6576), (“Foresee”) today announced positive topline results from its Phase 3 Casppian clinical trial evaluating the efficacy and safety of FP-001 42 mg (leuprolide mesylate), an investigational, sustained-release GnRH agonist, administered every six months in children with Central Precocious Puberty (CPP).
The study’s primary endpoint was defined as the percentage of patients with serum LH concentrations < 4 mIU/mL at 60 minutes following an abbreviated GnRHa stimulation test at Visit 5 (Week 24). The study successfully met its primary efficacy endpoint, with statistically significant results (P-value = 0.0005), demonstrating that 94% of patients had serum luteinizing hormone (LH) suppression to < 4 mIU/mL at 60 minutes following a GnRHa stimulation test at Week 24, and exceeded the pre-specified success criterion.
FP-001 42 mg injection was well tolerated and considered effective for the treatment of CPP if ≥80% of patients exhibited this level of LH suppression. The study results convincingly achieved this threshold.
“We are incredibly encouraged by these pivotal results, which confirm the ability of a single injection of FP-001 42 mg (GnRHa) to provide effective and sustained suppression of the pituitary-gonadal axis for a full six months. Meeting this rigorous primary endpoint with such a high threshold of 94% is a significant milestone.
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