BRIEF—Marius Pharmaceuticals receives FDA approval of Kyzatrex

USA-based Marius Pharmaceuticals has announced the approval of Kyzatrex (testosterone undecanoate), an oral testosterone replacement therapy, by the US Food and Drug Administration.

Kyzatrex is an oral softgel capsule that is absorbed primarily via the lymphatic system, avoiding liver toxicity. Oral delivery eliminates risks associated with traditional treatments, and mimics the daily rhythm of natural testosterone production compared to long-acting therapies due to the fact dosing occurs twice daily, according to Marius.

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