Clinical Trials
One jab, six months: Leuprolide mesylate shows strong efficacy in children with precocious puberty
The study met its primary endpoint with flying colors
- By IPP Bureau
| December 30, 2025
Pharma powerhouse Foresee Pharmaceuticals has announced positive topline results from its Phase 3 Casppian trial, testing FP-001 42 mg (leuprolide mesylate), a sustained-release GnRH agonist, in children with Central Precocious Puberty (CPP).
The study met its primary endpoint with flying colors. "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. It underscores the potential of FP-001 to offer a meaningful new treatment option, potentially improving convenience and adherence of children with CPP," said Bassem Elmankabadi, Senior Vice President, Clinical Development.
Safety findings were in line with expectations for the GnRH agonist class. "The safety profile of FP-001 42 mg observed in the study was consistent with the established class profile of GnRH agonists.
"The most common adverse events remained unchanged from those observed in earlier studies and were typically mild to moderate in severity. This outcome moves us nearer to our objective of providing safe and effective treatments for children in need," said Yisheng Lee, Chief Medical Officer.
Highlighting the potential of the therapy, Ben Chien, Chairman and CEO, added: "The consistent safety profile, coupled with the robust efficacy data, strengthens our confidence in FP-001 as a potential best-in-class therapy. We extend our sincere gratitude to the patients, families, and investigators who participated in this important study."
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