Posted by Michael Wonder on 06 Jan 2021
Marius Pharmaceuticals submits new drug application to U.S. FDA for next generation oral testosterone replacement therapy in male patients with hypogonadism
5 January 2021 - Kyzatrex new drug application includes data demonstrating less than 2 mm Hg mean SBP increase as measured by ambulatory blood pressure monitoring in clinical study participants receiving the investigational drug.
Marius Pharmaceuticals today announced that it has submitted a new drug application to the U.S. FDA seeking approval of Kyzatrex, its novel oral testosterone undecanoate soft gelatin capsule for the treatment of primary and secondary hypogonadism in adult men.
Read Marius Pharmaceuticals press release
