Marius’ Kyzatrex (testosterone undecanoate) Receives the US FDA’s Approval for the Treatment of Hypogonadism
Shots:
- The US FDA has approved Kyzatrex, an oral testosterone replacement therapy in adult males with hypogonadism. The product is supplied as 100/150/200mg
- The approval was based on the P-III (MRS-TU-2019EXT) study that evaluated Kyzatrex in 155 hypogonadal males aged b/w 18 & 65yrs. which showed that 88% of patients achieved a 24hr. mean plasma total testosterone concentration within the normal range of 222-800ng/dL on the final PK visit @90 day & had a maximum total testosterone concentration threshold ≤1200ng/dL b/w 1400 & 2000ng/dL, & ≥2000ng/dL at the final PK visit were 88%, 4% & 0%, respectively
- In exploratory EPs, improvements in QoL, energy/fatigue, erectile function, intercourse satisfaction, and positive mood were observed
Ref: GlobeNewswire | Image: Marius Pharmaceuticals
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