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# Marius Pharmaceuticals Testosterone NDA Accepted
- URL: https://www.fdaweb.com/marius-pharmaceuticals-testosterone-nda-accepted/
- Published: 2021-03-12T12:00:00.000Z
- Updated: 2026-09-14T16:50:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148872

FDA has accepted for review a Marius Pharmaceuticals NDA for Kyzatrex (oral testosterone undecanoate) for primary and secondary male hypogonadism. The company says it is seeking an indication for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). The agency has set a 10/31 user fee review action target date.  
  
The submission is based on data from the ReTUNE study where Efficacy was determined by the number of subjects in the normal, eugonadal range after 90 days of treatment. “In addition to testosterone parameters, the study collected Patient Reported Outcomes (PROs), which showed statistically significant results both from baseline and against its comparator,” the company says.