FDA approves Jatenzo for certain forms of hypogonadism

The US Food and Drug Administration on Wednesday approved Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogonadism developed by privately-owned Clarus Therapeutics.

These men have low testosterone levels due to specific medical conditions, such as genetic disorders like Klinefelter syndrome or tumors that have damaged the pituitary gland. Jatenzo should not be used to treat men with “age-related hypogonadism,” in which testosterone levels decline due to aging, even if these men have symptoms that appear to be related to low testosterone. Jatenzo’s benefits do not outweigh its risks for that use, the FDA statement noted.

Jatenzo is a first-in-class proprietary softgel oral formulation, and the first oral testosterone medicine approved in more than 60 years. The FDA approval is based on Phase III inTUne clinical trial data, which showed 87% of hypogonadal men treated with Jatenzo achieved a daily average testosterone level in the normal range, with an adverse events profile generally consistent with other T replacement therapies.