by Barry Teater, NCBiotech writer January 6, 2021 .
RESEARCH TRIANGLE PARK – Raleigh-based Marius Pharmaceuticals, led by several former GlaxoSmithKline scientists and executives, is making progress on its first potential drug.
Marius has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of Kyzatrex, its novel treatment for hypogonadism, or testosterone deficiency, in men.
“Submission of our first NDA is an important milestone, bringing attention to the role of testosterone as a critical hormone and the multitude of effects it can have on our health system,” said
Himanshu H. Shah (Marius photo)
, founder and executive chairman of Marius, in a prepared statement. “This is the culmination of over a decade of meticulous research and dedication and is just the beginning for Marius, as our deep pipeline will continue to further the research and development in this important therapeutic area.”