Oral Testosterone Treatment for Constitutional Delay in Growth and Puberty ("CDGP") in boys
TSX-002 is a novel oral formulation of unmodified Testosterone (T) that is designed to treat boys with CDGP.
CDGP is diagnosed in approximately 100,000 adolescent boys in the USA each year exhibiting delayed growth and a transient state of hypogonadism. It is characterized by a significant fall in height and weight below the average of their peers and a lack of sexual maturation of between two to two and a half years from the population mean. The current standard of care via depot injections of testosterone is prone to poor patient acceptance and potentially harmful testosterone peaks, that may lead to closing patients’ growth platelets prematurely.
In Phase 2 clinical adult studies, TSX-002 has shown the potential to deliver the requisite levels of testosterone for the treatment of CDGP with a safe and convenient oral formulation that mimics the body’s natural physiological pattern. The company is currently preparing to conduct an investigator led study in patients as precursor to a pivotal study.
The US Food and Drug Administration (FDA) granted Orphan Drug Designation to TesoRx for its novel oral formulation in June 2016.