JATENZO, once approved by the FDA, will be a new proprietary oral T formulation in the United States to treat men diagnosed with symptomatic T deficiency -- a medical condition known as hypogonadism. In our three completed Phase 3 trials, JATENZO met its primary endpoint of restoring T to normal levels in at least 75% of subjects. Notably, in our recent inTUne trial, 87% of men treated with JATENZO achieved average circulating levels of T in the normal range.
JATENZO will not have the risk of T transference to women and children, a risk associated with the market-leading T gels. We believe that JATENZO's oral administration will be more convenient than currently approved T-replacement therapies thus making it more likely that men will adhere to their T therapy.
JATENZO has been evaluated in three Phase 3 clinical trials in which the primary efficacy endpoint, namely restoration of serum T to the normal range for men, was achieved in at least 75% of the subjects. Based on data from the first two trials, Clarus filed an NDA in early 2014 and received a Complete Response Letter that asked Clarus to confirm efficacy in another Phase 3 trial. Clarus worked with the FDA to design the inTUne trial that we believe will provide the basis for approval of JATENZO.
Clarus resubmitted its NDA in June 2017 and, pursuant to PDUFA guidance, anticipates a 6-month review clock at FDA.