Marius Gains FDA Approval of Testosterone Replacement Therapy

Raleigh-based Marius Pharmaceuticals has received federal approval for its first drug.

The U.S. Food and Drug Administration (FDA) approved Kyzatrex, an oral testosterone replacement therapy for men who have a deficiency or absence of testosterone, also known as hypogonadism.

The approval provides an important option in treating hypogonadism, more commonly known as testosterone deficiency. The disorder affects about 40% of men older than 45 years old and 30 to 50% of men with obesity or type 2 diabetes, according to the Endocrine Society, a global organization of scientists devoted to hormone research and physicians who care for people with hormone-related conditions.

“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.,” said Himanshu H. Shah, chairman of Marius.

Shah said 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.”

Testosterone, commonly known as the male sex hormone, plays important roles in neurological, cardiovascular, urological and musculoskeletal health.

Kyzatrex, or testosterone undecanoate, is a proprietary oral softgel capsule that is absorbed primarily via the lymphatic system, avoiding liver toxicity. It was approved in three dosage strengths, 100mg, 150mg, and 200mg.

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, taken with food, Kyzatrex more closely mimics the daily rhythm of natural testosterone production compared to long-acting therapies, according to Marius.

Phase 3 study results showed that 88% of hypogonadal men who completed 90 days of Kyzatrex treatment achieved average testosterone levels in the normal range with no drug-related serious adverse effects or liver issues.

Patients who received the therapy reported improvements in quality of life, energy/fatigue, erectile function, intercourse satisfaction and positive mood.

“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,” said Shalin Shah, chief executive officer of Marius. “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.”

Marius said Kyzatrex has the potential to become the new gold standard of care for treating patients with hypogonadism. At least six million symptomatic men suffer from hypogonadism in the United States, and over 100 million men globally.

The global male hypogonadism market size was $3.1 billion in 2020 and is projected to reach $5.1 billion by 2030, expanding at a compound annual growth rate of 5.1% from 2021 to 2030, according to a 2022 report by Allied Market Research. The largest segment of that market is for hormone replacement therapies like Kyzatrex.