JATENZO®: Challenges in the development of oral testosterone.

Testosterone therapy (TT) for the treatment of testosterone deficiency (TD) can be administered via several routes of administration. Due to a variety of concerns such as hepatotoxicity, an oral formulation has long been absent in the United States. Recently, JATENZO® (testosterone undecanoate) oral capsules was approved by the US FDA as an oral option for men suffering from TD. In this article, we will discuss the history and challenges in the development of a viable oral formulation of exogeneous TT and examine how JATENZO® addresses these concerns.