FDA greenlights Marius' oral hypogonadism pill; VBL Therapeutics makes cuts to its workforce
The FDA has approved Marius’ testosterone replacement treatment for adult males with hypogonadism, or testosterone deficiency.
The oral drug, to be marketed as Kyzatrex, will be available at three different doses — 100, 150 and 200mg — and the pill would be taken twice daily. The drug was approved on the back of a Phase III program with 155 males with hypogonadism. Of the men who got Kyzatrex, 88% had an average testosterone level within a normal range by the three-month mark.