2022-08-03| Trials & Approvals

KYZATREX’s FDA Approval Adds to the Lineup of New Oral Testosterone Treatments

by Reed Slater
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Raleigh, North Carolina-based Marius Pharmaceuticals received notice from the FDA that its oral hypogonadism treatment, KYZATREX, received approval for commercialization. The drug is Marius’ first approved treatment and will add to the list of lymph-absorbed orally-administered testosterone replacement therapy (TRT) options available to consumers. 

Providing Another Oral TRT For Males in Need

Marius spent years developing an oral TRT, and all its hard work is beginning to pay off with the announcement of KYZATREX’s FDA approval. The company’s soft gel capsule is the third lymph-absorbed oral TRT to receive FDA approval in recent years, following Clarus’ JATENZO and Antares’ TLANDO.

KYZATREX is indicated for adult males with little or no testosterone due to hypogonadism, commonly known as testosterone deficiency. Hypogonadism occurs in about 40% of men over 45 and can increase the risk of developing type 2 diabetes. Low levels or lack of testosterone can lead to symptoms like low energy, low libido, poor cognition, and other mood disorders. At least six million men in the US struggle with symptoms caused by testosterone levels.

Marius designed KYZATREX as a soft gel oral capsule absorbed through the lymphatic system, meaning it is not toxic to the liver. The drug demonstrated positive results in a six-month Phase 3 clinical trial of 155 participants with hypogonadism. During the study, 88% of participants achieved a plasma total testosterone concentration within the normal range. 

The FDA approved three dosages of KYZATREX; 100mg, 150mg, and 200mg. Like other oral TRT options, Marius designed KYZATREX to be taken in the morning and evening with food to simulate the natural daily rhythm of testosterone production. 

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

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Sizing Up the Competition in the Oral TRT Space

While injection testosterone treatments have been available for nearly a hundred years, safe and effective oral treatments are a fairly new rendition of TRT. Now that researchers and companies have cracked the code for safe and effective oral TRT options, several companies are following suit to capitalize on the extra TRT alternative. 

Researchers have long sought an oral formulation for TRT but ran into issues around drugs’ toxicity to the liver. Methyltestosterone, one of the earliest forms of testosterone treatment, is approved for oral use, but due to the risks of liver damage, doctors seldom prescribe it as an oral treatment.

Even Bayer, with all its money and resources, ran into troubles converting its injectable TRT, NEBIDO, into an oral form. In 2011, the company found that, while the oral version maintained a tolerable safety profile, the efficacy just could not match up to the injectable form. 

Instead of formulating a drug that is well-tolerated by the liver, researchers searched for a way to bypass the liver entirely and succeeded by designing a drug that is absorbed by the lymphatic system. Clarus’ JATENZO was the first to achieve the feat, gaining approval in 2019, followed by Antares’ TLANDO in March this year, and now Marius is entering the scene with KYZATREX. 

With some stiff competition alongside it, Marius has its work cut out to become a leader in the oral TRT realm. However, it is early days for safe and effective oral TRTs, and the coming years will reflect the market’s reaction to the broadening field. 

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