FDA approves oral testosterone undecanoate softgel for treatment of hypogonadism

The FDA has approved an oral testosterone undecanoate softgel for men with deficiency or absence of endogenous testosterone, or hypogonadism, according to a press release.

Oral testosterone undecanoate (Kyzatrex, Marius Pharmaceuticals) is a softgel capsule absorbed primarily via the lymphatic system. The oral delivery eliminates the risk of application site reactions common with intramuscular testosterone injections and potential transference to women or children that can occur with topical testosterone gels and creams. The FDA’s approval will allow the therapy to be prescribed in dosage strengths of 100 mg, 150 mg and 200 mg.

In a phase 3, multicenter, open-label, 6-month trial, 88% of men aged 18 to 65 years with hypogonadism treated with oral testosterone undecanoate met the study’s primary endpoint by achieving a mean plasma total testosterone concentration within the normal range of 222 ng/dL to 800 ng/dL at day 90. Men receiving oral testosterone undecanoate reported improvement in quality of life, energy, erectile function, intercourse satisfaction and positive mood, according to the release. The most common adverse event was increased blood pressure, reported in 2.6% of participants.

As Healio previously reported, the FDA accepted a new drug application for oral testosterone undecanoate softgel for the treatment of primary and secondary hypogonadism in men in March 2021.

The FDA approval is for adult men only. Oral testosterone undecanoate’s safety and efficacy has not been established in males younger than 18 years.

“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,” Shalin Shah, CEO of Marius Pharmaceuticals, said in the release. “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.”