Following the launch of a Phase III clinical trial in the US in August, Foresee Pharmaceuticals announced on 19th that its authorised partner, GeneScience Pharmaceuticals, has filed a clinical trial application with the National Medicines Regulatory Administration (NMPA) of China. The Phase III clinical trial is a multi-country, multi-centre clinical trial with an estimated enrollment of 98 patients, and applications for clinical trials in Europe and Taiwan are under preparation. Childhood central precocious puberty is a disorder of early sexual development in girls and boys, caused by the premature activation of the hypothalamic-pituitary-gonadal axis, resulting in early puberty between the ages of 2 and 9. The prevalence of the condition is about 20 times higher in girls than in boys.
According to Data Bridge Market Research, the global market for childhood central precocious puberty is estimated to be worth US$1,483 million in 2021 and is expected to reach US$2,663 million in 2029, with an estimated compound annual growth rate of approximately 7.6% over the next 8 years. Among them, leuprolide is the most widely used as a long-acting injection.
The Phase III clinical trial is an open-label, no-control-group, multi-centre clinical trial of leuprolide in children aged 2-9 years with central precocious puberty, with approximately 98 patients in the US, Europe, China and Taiwan. The clinical trial is expected to be completed in approximately 114 years, with the actual timing of implementation dependent on the status of the case.
In addition to the Phase III clinical trial of the new dosage form of FP-001 42mg in the US for the treatment of childhood central precocious puberty, which was approved in August, the authorised partner, Changchun Jinsai Pharmaceutical, filed a Phase III clinical trial application with the National Pharmaceutical Administration (NMPA) in China on 19 August, and clinical trial applications in Europe and Taiwan are under preparation.
More information please visit www.foreseepharma.com
