We believe JATENZO®, once approved by the FDA, has the potential to be a preferred option amongst available T-replacement therapies.
JATENZO is a proprietary softgel capsule that contains a testosterone (T) prodrug, T undecanoate, or TU, formulated to foster absorption via the intestinal lymphatic system. After oral TU is absorbed, natural enzymes in the body cause T to be released from the prodrug. This proprietary formulation enabled us to enhance the bioavailability of TU and reduce the impact of food on the absorption.
We believe JATENZO, once approved, will offer hypogonadal men and prescribing physicians a safe and effective oral T-replacement option and will have a number of advantages over the currently approved T-replacement therapies, including:
- Convenient Oral Dosing. JATENZO is one or two easy-to-swallow softgel capsules taken twice daily with a meal.
- No Inadvertent T Exposure. JATENZO is an oral product that eliminates the risk of T transfer to women and children associated with the T gels.
- Normalized T Levels. After appropriate dose adjustment, a majority (≥75%) of men treated with JATENZO in previous Phase 3 trials achieved serum T levels within the normal range, defined as 300-1,000 ng/dl. Our ongoing Phase 3 trial (the inTUne trial) which uses an improved dose titration algorithm, will define the ultimate efficacy results.
- Safety Profile. To date, JATENZO's adverse events profile is consistent with other T replacement therapies.