JATENZO is a new proprietary oral formulation of testosterone undecanoate (TU). It is the first oral TU formulation approved in the United States to treat adult males diagnosed with conditions associated with a deficiency or absence of endogenous testosterone:
JATENZO was approved based on the efficacy results from the Phase 3 inTUne trial. In this trial, 145 (87%) of the 166 hypogonadal men who received JATENZO had a mean total testosterone concentration (Cavg) within the normal eugonadal range at the end of treatment.
JATENZO will not have the potential for testosterone transference to women and children, a risk associated with the market-leading TRT gels. We believe that JATENZO's oral administration will be more convenient than currently approved TRTs thus making it more likely that men will adhere to their therapy.