Foresee Pharmaceuticals (TPEx: 6576) reported that 94% of children with central precocious puberty achieved LH suppression to prepubertal levels in its Phase III Casppian trial of FP-001 42 mg (leuprolide mesylate), a six-month subcutaneous depot formulation, with an NDA submission to the US FDA targeted for Q3–Q4 2026.
The Casppian study is an open-label, single-arm, multicenter Phase III trial enrolling children with central (gonadotropin-dependent) precocious puberty. The primary endpoint — the proportion of patients achieving serum LH suppression below prepubertal thresholds at six months following a single subcutaneous injection of FP-001 42 mg — was met with high statistical significance (p = 0.0005). The 94% suppression rate was sustained over the full six-month dosing interval. The company said the safety profile remained consistent throughout the study period, with no new or unexpected adverse events identified. Last patient last visit was completed in May 2026, and Foresee said it is now moving toward data lock, clinical study report finalization, and NDA preparation. Full results are scheduled for presentation at the Endocrine Society's ENDO 2026 conference in Chicago from June 13–16.
FP-001 is a GnRH agonist that, through continuous receptor stimulation, downregulates pituitary GnRH receptor signaling to suppress LH and FSH secretion and reduce gonadal sex steroid production — the same mechanism underlying all currently approved CPP therapies. The six-month dosing interval places FP-001 alongside Tolmar's Fensolvi (leuprolide acetate) and Azurity Pharmaceuticals' Triptodur (triptorelin), both of which are FDA-approved six-month formulations for CPP. The incumbent monthly and quarterly options, led by AbbVie's Lupron Depot-PED (leuprolide acetate), remain the most widely used agents. Cross-trial comparisons are limited given differences in trial design, patient populations, and endpoint definitions across these programs. Foresee plans to submit the NDA to the US FDA in Q3–Q4 2026, followed by marketing authorization applications in other markets through H1 2027.
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