TAIPEI, Feb. 4, 2026 — A new treatment for children experiencing early puberty is looking promising. An independent board of experts has given the green light to continue a study evaluating a longer-lasting injection for central precocious puberty (CPP), a condition where kids start puberty too early. This could mean fewer shots and a simpler treatment plan for young patients and their families.
Six-Month Dosing Interval Shows Promise in CPP Study
Researchers are optimistic about a new approach to managing early puberty in children, potentially reducing the frequency of injections needed.
- The independent Data and Safety Monitoring Board (DSMB) recommended continuation of the Casppian Phase 3 study.
- The study is evaluating leuprolide (FP-001) 42 mg, designed for a 6-month dosing interval.
- No safety concerns have been identified with the use of leuprolide in pediatric CPP patients.
- The Phase 3 study has met its primary efficacy endpoint, demonstrating robust suppression of luteinizing hormone (LH).
The Casppian Phase 3 study, an open-label, multicenter, multinational clinical trial, is assessing the efficacy, safety, and pharmacokinetics of leuprolide (FP-001) 42 mg controlled-release in patients with central (Gonadotropin-Dependent) precocious puberty. The DSMB’s fourth positive safety review, announced today, recommended the trial proceed as planned without modifications.
What exactly is precocious puberty? It’s a condition characterized by the premature activation of the pituitary-gonadal axis, leading to early puberty. If left untreated, CPP can lead to accelerated bone maturation, potentially reducing final adult height, and can also present significant emotional and social challenges for children.
Currently, treatment typically involves GnRH agonists to halt the progression of puberty. However, the investigational FP-001 42 mg is a sustained-release formulation of a GnRH agonist designed to provide continuous suppression of gonadotropin secretion for six months following a single intramuscular injection, offering a less frequent dosing schedule.
“The unanimous safety endorsement from the independent board, following full enrollment in our Casppian Ph3 trial, is a powerful testament to the potential of our six-month treatment for children with CPP,” stated Bassem Elmankabadi, M.D., Senior Vice President, Clinical Development. “Meeting the study’s primary endpoint is a definitive signal that we are on the cusp of a potential therapy, bringing us closer to a future medicine where managing this condition is simpler and more effective for young patients with CPP.”
Yisheng Lee, M.D., Chief Medical Officer, added, “This recommendation is more than a milestone; it validates our unwavering commitment to possible alternative treatments that are both powerfully effective and well tolerated. It reinforces the promise of long-acting GnRH to fundamentally improve the journey for CPP patients. We move forward with this pivotal study, guided by our core principles of scientific rigor, patient safety, and ethical integrity.”
Dr. Ben Chien, PhD, Chairman and CEO, emphasized the impact of the DSMB’s affirmation. “With this critical DSMB affirmation, we are charging ahead in our mission to add to the existing therapies of care for children with CPP. This momentum fuels our drive as we prepare for our next regulatory step, bringing a groundbreaking new treatment option closer to reality. Our deepest gratitude goes to the courageous patients and families in our Casppian trial. Their partnership is the very heart of this progress, and together, we are raising the standard of hope.”
The injectable emulsion, 42 mg, is already approved for the treatment of adult patients with advanced prostate cancer and has shown positive efficacy and safety results in that population.
