Brand names
Testosterone undecanoate is or has been marketed under a variety of brand names, including Andriol, Androxon, Aveed, Cernos Depot, Jatenzo, Nebido, Nebido-R, Panteston, Reandron 1000, Restandol, Undecanoate 250, and Undestor. Availability
Intramuscular testosterone undecanoate is available in the United States, Canada, Europe, and elsewhere in the world. It is approved in over 100 countries worldwide. Oral testosterone undecanoate is available in Canada, Europe, Mexico, Asia, and in the United States. Intramuscular testosterone undecanoate is marketed most commonly as Nebido in Canada and Europe and as Aveed in the United States while oral testosterone undecanoate is marketed most commonly as Andriol. Legal status
Testosterone undecanoate, along with other AAS, is a schedule III controlled substance in the United States under the Controlled Substances Act and a schedule IV controlled substance in Canada under the Controlled Drugs and Substances Act.In March 2019, the US Food and Drug Administration (FDA) approved testosterone undecanoate (Jatenzo), an oral testosterone capsule to treat men with certain forms of hypogonadism. 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. The FDA granted the approval of Jatenzo to Clarus Therapeutics.In March 2022, testosterone undecanoate (Tlando) was approved for medical use in the United States. Research
Non-alcoholic steatohepatitis
In 2013, a phase II clinical trial testing intramuscular testosterone undecanoate for the treatment of non-alcoholic steatohepatitis (NASH) was initiated in the United Kingdom.
Pharmacokinetics
Testosterone undecanoate has a very long elimination half-life and mean residence time when given as a depot intramuscular injection. Its elimination half-life is 20.9 days and its mean residence time is 34.9 days in tea seed oil, while its elimination half-life is 33.9 days and its mean residence time is 36.0 days in castor oil. These values are substantially longer than those of testosterone enanthate (which, in castor oil, has values of 4.5 days and 8.5 days, respectively). Testosterone undecanoate is administered via intramuscular injection once every three months or so. Chemistry
Testosterone undecanoate, or testosterone 17β-undecanoate, is a synthetic androstane steroid and a derivative of testosterone. It is an androgen ester; specifically, it is the C17β undecylate (undecanoate) ester of testosterone. A related testosterone ester with a similarly very long duration is testosterone buciclate. History
In the late 1970s, testosterone undecanoate was introduced for oral use in Europe, although intramuscular testosterone undecanoate had already been in use in China for several years. Intramuscular testosterone undecanoate was not introduced in Europe and the United States until much later, in the early to mid 2000s and 2014, respectively. Testosterone undecanoate was approved in the United States after three previous rejections due to safety concerns. Society and culture
Generic names
Testosterone undecanoate is the generic name of the drug and its USAN and BAN. It is also referred to as testosterone undecylate.