Clarus Therapeutics is a pharmaceutical company preparing for the commercial launch of REXTORO, a first-in-class oral T formulation to treat men diagnosed with T deficiency together with an associated medical condition known as hypogonadism. REXTORO is a softgel capsule that contains a testosterone (T) prodrug, T undecanoate, or TU, formulated to foster absorption via the intestinal lymphatic pathway.

 

Jatenzo

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.

Jatenzo Phase 3 Trials

We have completed three Phase 3 trials, the inTUne trial, CLAR-09007 and CLAR-12011, each of which yielded efficacy consistent with FDA guidance.  However, in response to our original NDA, the FDA issued a complete response letter asking Clarus to conduct another Phase 3 trial to, in part, confirm efficacy.  The inTUne trial used a lower starting dose, refined dose titration algorithm and gathered additional clinical efficacy and safety data. 

Testosterone Deficiency

The Endocrine Society defines hypogonadism in men as a clinical syndrome that results from failure of the testis to produce physiological levels of testosterone (androgen deficiency) and a normal number of spermatozoa due to disruption of one or more levels of the hypothalamic-pituitary-testicular axis.