JCR Pharmaceuticals Launches Phase III Trial of Long-Acting Growth Hormone JR-142 in Japan

• JCR Pharmaceuticals initiates a Phase III clinical trial in Japan for JR-142, a long-acting growth hormone therapy, marking a key advancement in pediatric endocrinology.
• The trial will enroll 54 pediatric patients with growth hormone deficiency, comparing JR-142 to JCR's existing product, Growject®, over a 52-week period.
• JR-142 offers a potential once-weekly dosing, contrasting with the typical daily injections, which could significantly improve convenience and quality of life for children and families.
• The primary outcome will focus on growth outcomes, assessing the efficacy and safety of JR-142 in achieving non-inferior growth compared to Growject®.

JCR Pharmaceuticals Co., Ltd. has commenced a Phase III clinical trial of JR-142 (redalsomatropin alfa) in Japan, targeting pediatric growth hormone deficiency. This trial marks a significant step in developing a long-acting growth hormone therapy that could reduce the frequency of injections for affected children.

The study, registered as jRCT2031240282, is an open-label, multicenter trial involving 54 pediatric patients. It aims to compare the efficacy and safety of JR-142, administered once weekly, against JCR’s existing product, Growject®, which requires daily subcutaneous injections. The treatment duration is 52 weeks, with growth outcomes serving as the primary measure of success.

Potential Impact of JR-142

Professor Noriyuki Namba from the Division of Pediatrics and Perinatology at Tottori University Faculty of Medicine, a medical expert for the study, highlighted the potential benefits of JR-142. "Growth hormone therapy typically requires daily injections, but JR-142, as a long-acting therapy, offers the possibility of once-weekly dosing," he stated. "This advancement has the potential to significantly ease the burden on children and their families, improving both convenience and quality of care while maintaining high safety standards."

About Growject

Growject® is an injectable preparation containing recombinant human growth hormone, first launched in Japan by JCR in 1995. It is administered subcutaneously 6–7 times per week, with the dosage adjusted according to the indicated condition.

JCR Pharmaceuticals' Commitment

JCR Pharmaceuticals is dedicated to the growth hormone field, ensuring a stable supply of high-quality pharmaceuticals and expanding treatment options to meet diverse patient needs. The company's portfolio includes therapies for growth disorders, MPS II (Hunter syndrome), Fabry disease, acute graft-versus-host disease, and renal anemia.

Market Context

While JCR Pharmaceuticals is making strides with JR-142, the competitive landscape for growth hormone therapies is evolving. GlobalData’s Pharmaceutical intelligence center estimates that Growject sales peaked in 2024 at $124 million and are projected to reach $101 million by 2030. JCR's overall sales are estimated to be $285 million by the end of 2024, a decrease from $297 million in 2023.