The “new” oral testosteorne drug will probably excite needle-phobic bodybuilders until they learn that the drug is not really very new at all.
The United States Food and Drug Administration (FDA) has announced the approval of a new oral testosterone drug called “Jatenzo” (formerly called “Rextoro”) manufactured by Claris Pharmaceuitcals in a news release published on March 27, 2019. The active ingredient is testosterone undecanoate.
The oral testosterone capsule joins the topical testosterone gels, transderal testosterone patches and injectable testosterone products that have previously been approved by the U.S. FDA.
Hylton V. Joffe, M.D, M.M.Sc., the director of the Division of Bone, Reproductive and Urologic Products for the U.S. FDA’s Center for Drug Evaluation and Research, noted the importance of the new oral delivery method.
“Jatenzo’s oral route of administration provides an important addition to current treatment options available for men with certain hypogonadal conditions who up until now have most commonly been treated with testosterone products that are applied to the skin or injected,” said Joffe.
Jatenzo has not not been approved for older men on hormone replacement therapy.
However, Joffe also emphasized that the FDA has only approved Jatenzo for very specific hypogonadal conditions. The narrowly-defined medical conditions involve low testosterone resulting from “genetic disorders like Klinefelter syndrome or tumors that have damaged the pituitary gland”.
In other words, the FDA refused to approve Jatenzo as a hormone replacement therapy (HRT) option for older men suffering from “age-related hypogonadism”. Joffe clearly warned that older men should not use Jatenzo for this purpose.
Older men will still be asked to use other FDA-approved testosterone treatments. These options include topical testosterone gels such as Androgel and Testim, topical transdermal patches such as Androderm and Testoderm, and injectable testosterone solutions such as Depo-Testosterone and Delatestryl.
While Jatenzo has been advertised as a brand new drug, the active ingredient (testosterone undecanoate) has been widely available outside the United States as an oral testosterone pill called Andriol.
Bodybuilders first experimented with Andriol testosterone pills over two decades ago. Andriol was quickly abandoned as an ineffective method of achieving supraphysiologic levels of serum testosterone.
Andriol may have worked just fine for therapeutic purposes but it was a major disappointment for bodybuilders accustomed to the high superphysiologic testosterone levels made possible with injectable testosterone products.
Jatenzo may have a new and improved oral delivery method for testosterone undecanoate but it remains to be seen if it will be of interest among bodybuilders. Unfortunately, it seems destined to go the way of Andriol.
FDA. (March 27, 2019). FDA approves new oral testosterone capsule for treatment of men with certain forms of hypogonadism. Retrieved from fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634585.htm