FDA approves Jatenzo for testosterone replacement therapy

Clarus Therapeutics announced that the FDA has approved Jatenzo (testosterone undecanoate capsules for oral use) (CIII) for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). Jatenzo is a first-in-class proprietary softgel oral formulation, and the first oral testosterone medicine approved in more than 60 years.

FDA approval is based on Phase III inTUne clinical trial data, which showed 87 percent 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. Jatenzo will be available in three dosages: 158 mg, 198 mg and 237 mg, for twice daily administration with food.

Comment: Patient adherence can be an issue with testosterone treatment. The oral delivery of Jatenzo eliminates the risks of testosterone transference to women or children that can occur with gels, application site irritation common with the transdermal testosterone patch, and discomfort associated with deep muscle injections of testosterone formulations. Jatenzo is an important addition to the class of drugs used to treat various forms of testosterone deficiency.