We believe JATENZO®, once approved by the FDA, will expand treatment options for men diagnosed with symptomatic T deficiency -- a medical condition known as hypogonadism.
We have completed two Phase 3 trials, CLAR-09007 and CLAR-12011, each of which yielded efficacy consistent with FDA guidance. However, in response to our NDA, the FDA issued a complete response letter asking Clarus to conduct another Phase 3 trial to, in part, confirm efficacy. This new trial has a lower starting dose, refined dose titration algorithm and gathers additional clinical data.
The Endocrine Society defines androgen deficiency component of hypogonadism as a clinical syndrome that results from failure of the testes to produce physiological levels of testosterone (T) (androgen deficiency) and associated signs and/or symptoms. It is caused by the disruption of 1 or more levels of hypothalamic pituitary-testicular axis.