Jatenzo, an oral testosterone replacement therapy designed for men with specific types of hypogonadism, was approved by the FDA in March 2019. It is indicated for men with low levels of testosterone due to genetic disorders, such as Klinefelter syndrome, or damage to the pituitary gland, such as tumors. 1 2 However, it is not indicated for treating men with age-related hypogonadism.
Jatenzo’s significance in its approval and market launch lies in its formulation. Before Jatenzo, most testosterone treatments required transdermal or injectable delivery methods. Jatenzo’s oral formulation is a novel approach, likely offering a more effective and convenient method for directly replacing testosterone. However, it can also be slightly more expensive than transdermal options. 3 Despite this, the oral formulation is a good alternative for those who have contraindications to other treatments and administration challenges with alternative treatments. 4 5 Early indications of the medication have also shown fewer side effects compared to long-lasting forms of testosterone therapy. 4
Testosterone therapies were first discovered in the 1930s, proving early on that oral testosterone did not have sufficient bioavailability for replacing other therapies due to rapid metabolism by the liver. 5 This was evident in the 1980s when there was a previous attempt at prescribing an oral testosterone therapy, which quickly fell off the market due to liver toxicity. 4 Interestingly, Jatenzo avoids liver toxicity as it bypasses the liver and is instead metabolized through the lymphatic system. Its self-emulsifying delivery system enhances absorption in the lymphatic system, ensuring therapeutic levels of testosterone in the bloodstream.
The emulsification system allows for the formation of TU-containing lipoprotein particles in the gut as the capsule contents disperse, ultimately bypassing the liver and avoiding the first-pass metabolism of testosterone. 5 The importance of having the TU-containing lipoproteins is that once in the system, endogenous esterases cleave the activated testosterone, and the fatty acid, undecanoate, can be metabolized similarly to dietary fat. This process allows it to be taken up by the lymphatic system, whereas other fatty acids, which are usually less lipophilic, are sent to the liver.
With the new generation of Jatenzo, marketing strategies have changed compared to its predecessors and other therapies. By emphasizing convenience and avoiding issues associated with injections and transdermals, Jatenzo broadens its audience and brands an image of accessibility and affordability. 1 Even with insurance challenges, given that Jatenzo is not a first-line treatment, there are savings programs where patients can receive reduced costs on their prescriptions with commercial insurance.
Furthermore, its marketing highlights its non-liver toxic formulation, which sets its safety profile apart from previous therapies, making it appealing to both healthcare providers and patients. 6 Despite the strong push for traditional testosterone therapy methods, Jatenzo has proven, through its marketing and formulation, to overcome the scientific challenges of its predecessors.
- JATENZO®. (n.d.). Retrieved May 30, 2024, from https://jatenzo.com/
- U.S. Food and Drug Administration. (2019, March 27). FDA approves new oral testosterone capsule for treatment of men with certain forms of hypogonadism. Retrieved May 30, 2024, from https://www.fda.gov/news-events/press-announcements/fda-approves-new-oral-testosterone-capsule-treatment-men-certain-forms-hypogonadism
- Neuroendocrinology. (n.d.). Two new oral testosterone products are pricey—are they worth it? Retrieved May 30, 2024, from https://neuroendocrinology.org/two-new-oral-testosterone-products-are-pricey-are-they-worth-it/
- Cleveland Clinic. (2023, January 25). Oral medication offers new option for testosterone replacement. Consult QD. Retrieved May 30, 2024, from https://consultqd.clevelandclinic.org/oral-medication-offers-new-option-for-testosterone-replacement
- Urology Times. (2023, February 1). The latest in testosterone replacement therapy. Retrieved May 30, 2024, from https://www.urologytimes.com/view/the-latest-in-testosterone-replacement-therapy
- Cleveland Clinic. (2023, January 25). Oral medication offers new option for testosterone replacement. Consult QD. Retrieved May 30, 2024, from https://consultqd.clevelandclinic.org/oral-medication-offers-new-option-for-testosterone-replacement
