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Jatenzo, (testosterone undecanoate) has been given the FDA greenlight to be used as an oral capsule treatment for men with certain forms of hypogonadism. Jatenzo is the first treatment option for men with certain hypogonadal conditions that has an oral route of administration.
Jatenzo has only been approved to treat men that have low testosterone levels due to specific medical conditions such as genetic disorders like Klinefelter syndrome, or tumors that have damaged the pituitary gland, not for “age-related hypogonadism.” Eighty-six percent of Jatenzo-treated men achieved an average testosterone level within normal range within the four-month clinical trial.
Hylton V. Joffe, M.D, M.M.Sc., director of the Division of Bone, Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research says “It’s important to emphasize that this drug should not, like other testosterone treatments, be used to treat older men with ‘age-related hypogonadism.’ The benefits of testosterone therapy, including Jatenzo, have not been established for this use, and Jatenzo’s effects on raising blood pressure can increase the risks of heart attack, stroke and cardiovascular death in this population.” Aging patients with symptoms that appear to be related to low testosterone, are not eligible to be treated with Jatenzo.
Read the Full FDA Press Release here.