FDA approves oral testosterone replacement therapy for hypogonadism


The FDA has approved Kyzatrex, an oral testosterone replacement therapy for the treatment of adult males with conditions associated with hypogonadism.1

The approval was based on results from the multicenter, open-label phase 3 Study MRS-TU-2019EXT (NCT04467697). The study enrolled 155 hypogonadal males. According to the study design, “The primary efficacy end point was the percentage of KYZATREX-treated patients with mean plasma total testosterone concentration over 24-hours within the normal range of 222-800 ng/dL on the final PK visit of the study at day 90.”2

Of the total patient population, 139 patients were eligible for the efficacy analysis The median patient age was 50 years (range, 22-66). Regarding race, 79% of patients were White, 16% were Black, 3% were Asian, and 2% were American Indian, Alaskan Native, or other.

Overall, 88% (122/139) of patients reached the primary study end point. The key secondary endpoints were the percentage of patients who had a maximum total testosterone

concentration that met 3 predetermined limits: ≤1.5 times the upper limit of normal range (ULN; 1200 ng/dL); 1.8-2.5 times ULN (1440-2000 ng/dL); and >2.5 times ULN (2000 ng/dL). At the final PK visit, these percentages were determined to be88%, 4%, and 0%, respectively.

The mean duration of treatment exposure was 168 days (range, 1-180). The only adverse event occurring in ≥2% of patients was hypertension, which was reported in 4 (2.6%) of 155 patients.

“With so many men suffering daily effects of Testosterone Deficiency and often abandoning or not electing to get treatment, we see FDA-approved Kyzatrex as a newly viable oral option that has demonstrated safety and effectiveness. Further, Testosterone Deficiency is a big blind spot in medicine today and our research will continue to explore the importance of testosterone in both male and female health,” Shalin Shah, CEO of Marius, the developer of Kyzatrex, stated in a news release.


1. Marius Pharmaceuticals Receives FDA Approval of KYZATREX™, an Oral Testosterone Replacement Therapy. Published online August 2, 2022. Accessed August 3, 2022. https://bit.ly/3OUA0Cx

2. FDA prescribing label for Kyzatrex (testosterone undecanoate) capsules, for oral use. Accessed August 3, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213953s000lbl.pdf

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