Marius submits Kyzatrex NDA

Specialty biopharma Marius Pharmaceuticals has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval of Kyzatrex, its oral testosterone undecanoate soft gelatin capsule for the treatment of primary and secondary hypogonadism in men.

Kyzatrex has generated strong results in both safety and efficacy studies for treatment of primary and secondary hypogonadism in men. Marius has requested a Priority Review that, if granted, would result in an anticipated six-month review period.

Himanshu Shah, founder and executive chairman of Marius, said: “Submission of our first NDA is an important milestone, which is the culmination of over a decade of meticulous research and dedication and is just the beginning for Marius, as our pipeline will continue to advance research and development in this important therapeutic area that has a multitude of effects on our health system.”