Clarus Therapeutics is a pharmaceutical company developing CLR-610, our Phase 3-ready oral testosterone (T) replacement therapy. If approved by the Food and Drug Administration (FDA), Tuclar will be a first-in-class oral T-replacement therapy in the United States. CLR-610 contains f a T prodrug, namely, T undecanoate (TU) that is acted upon by natural substances in the body to release T.
 

We believe CLR-610, if approved by the FDA, will offer men and prescribing physicians a safe, effective and convenient oral testosterone (T)-replacement treatment. CLR-610's unique formulation enables us to increase the amount of testosterone undecanoate (TU) per softgel capsule, enhance rapid solubilization and bioavailability of TU and reduce the impact of food effects.

Based upon input from the Food and Drug Administration (FDA), we are conducting a single pivotal Phase 3 study to support the filing of a New Drug Application, or NDA.

We conducted an extensive Phase 2 clinical program for CLR-610.  The full program included four separate studies and enrolled 77 men with low testosterone (T). In our 30-day and seven-day repeat-dose Phase 2 studies, we treated men twice daily with the same CLR-610 dose that we are evaluating in our pivotal Phase 3 study.