FDA approves new oral testosterone for hypogonadism

The Food and drug administration has approved a new oral testosterone undecanoate (Kyzatrex) for men with hypogonadism. The new drug being manufactured by Marius Pharmaceuticals is primarily absorbed via the lymphatic system.

KYZATREX™ is an oral testosterone replacement therapy ("TRT") indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism.

The approval of KYZATREX™ provides an important option in treating hypogonadism or more commonly known as, Testosterone Deficiency, which affects approximately 40% of men older than 45 years of age and 30-50% of men with obesity or type 2 diabetes have hypogonadism1. KYZATREX™ has been approved in three dosage strengths, 100mg, 150mg, and 200mg.

"I would like to congratulate our scientific team on this major milestone, and now it is up to our commercial team to make KYZATREX™ a leading therapy and a go-to brand for millions of hypogonadal men in the U.S. Low Testosterone affects numerous metabolic factors as well as often overlooked, true quality of life, hence annual testosterone testing should be mandatory for men over age 40," remarked Himanshu H. Shah, Chairman of Marius.

KYZATREX™ is a proprietary oral softgel capsule that is absorbed primarily via the lymphatic system, avoiding liver toxicity. The oral delivery method eliminates the risk of application site reactions common with intramuscular testosterone injections as well as potential transference to women or children that can occur with topical testosterone gels and creams.

With daily dosing in the morning and evening (with food), KYZATREX™ more closely mimics the daily rhythm of natural testosterone production compared to long-acting therapies.

"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," commented Shalin Shah, CEO of Marius.

KZAYTREX™ has the potential to become the new gold standard of care for treating patients with hypogonadism. There are at least six million symptomatic men suffering from hypogonadism in the U.S., and over 100 million men globally.

Reference:

Antares Pharma Announces FDA Approval Of TLANDO™, an Oral Treatment for Testosterone Replacement Therapy Commercial launch expected in 2Q 2022. Antares Pharma. [news release]. March 29, 2022