Foresee Pharmaceuticals Reports Positive Phase 3 Results for FP-001 in Central Precocious Puberty

Foresee Pharmaceuticals Reports Positive Phase 3 Results for FP-001 in Central Precocious Puberty

By, Admin 30 December 2025

Foresee Pharmaceuticals has announced positive topline results from its Phase 3 Casppian clinical trial. The study evaluated FP-001 42 mg (leuprolide mesylate), a six-month, sustained-release GnRH agonist for central precocious puberty (CPP).

Why This Trial Matters?

CPP causes early activation of puberty in children. If untreated, it can lead to:

  • Accelerated bone maturation
  • Reduced final adult height
  • Significant psychosocial stress

Current treatments require frequent dosing. Longer-acting options could improve adherence and quality of life.

Trial Design and Primary Endpoint

The Phase 3 Casppian trial assessed efficacy and safety of FP-001 42 mg. The primary endpoint was clear and rigorous:

  • Serum LH < 4 mIU/mL at 60 minutes
  • Measured after GnRHa stimulation at Week 24

Key Efficacy Results

FP-001 met and exceeded expectations.

  • 94% of patients achieved LH suppression below 4 mIU/mL
  • The result was statistically significant (P = 0.0005)
  • The predefined success threshold was 80%

This confirms effective suppression of the pituitary-gonadal axis for six months.

Safety Profile

FP-001 was well tolerated.

  • Safety matched the established GnRH agonist class profile
  • Most adverse events were mild to moderate
  • No new safety signals were observed

What Leadership Is Saying?

Company executives highlighted both efficacy and convenience.

  • A single injection maintained suppression for a full six months
  • Reduced dosing frequency may improve adherence in children
  • The data supports FP-001 as a potential best-in-class therapy

What’s Next for FP-001?

Foresee plans to move quickly.

  • Full results will be presented at a scientific conference
  • Regulatory discussions are planned globally
  • New Drug Application submission targeted for mid-2026

About FP-001 42 mg

FP-001 is a long-acting injectable GnRH agonist.

  • Designed for six months of continuous suppression
  • Delivered via a single intramuscular injection
  • Aims to reduce treatment burden compared to existing options

The Bigger Picture

These results position FP-001 as a strong new option in CPP management. For families and clinicians, fewer injections could mean better outcomes and less disruption.

If approved, FP-001 could redefine long-term treatment expectations for children with central precocious puberty.

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