• About Clarus Therapeutics
• Tuclar
• Testosterone Deficiency
• Partnering and Licensing
• Investors and Media

Overview

We believe Tuclar, if approved by the FDA, will offer men and prescribing physicians a safe, effective and convenient oral testosterone (T)-replacement treatment.

Tuclar'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.  We believe Tuclar will have many advantages over currently approved T-replacement therapies, including:

• Convenient Dosing.  Tuclar is an easy-to-swallow soft gelatin capsule expected to be taken twice daily with a meal.
• No Inadvertent T Exposure.  Tuclar is an oral product and thereby avoids the safety issues related to inadvertent transference to women and children associated with the T-gels.
• Normalized T Levels.  77% and 87% of men treated with Tuclar in two of our Phase II studies, respectively, attained serum T levels within the normal range, defined as 300-1,000 ng/dL.
• No Liver Toxicity. Tuclar is comprised of TU, and during our Phase II studies, we did not observe the liver toxicity associated with methyl-T, the only currently approved oral T product in the United States.
• Safe Pharmacokinetic Profile.  In our Tuclar Phase II repeat-dose studies, the U.S. Food and Drug Administration, or FDA, guidance for acceptable peak serum T levels was met without any dose adjustment.