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.

 

We believe REXTORO, if approved by the FDA, will be a first-in-class oral T formulation to treat men diagnosed with T deficiency together with an associated medical condition known as hypogonadism.  On January 3, 2014, we submitted our New Drug Application to the U.S. Food and Drug Administration and we are preparing for the commercial launch of REXTORO.

We completed two pivotal Phase 3 trials, Phase 3A trial (CLAR-09007) and Phase 3B trial (CLAR-12011), each of which yielded efficacy consistent with FDA guidance.

According to the International Journal of Clinical Practice, T deficiency affects approximately 39% of men over the age of 45.