11 March 2021 - Marius Pharmaceuticals announced today that the U.S. FDA has assigned a Prescription Drug User Fee Act goal date of 31 October 2021 for the review of the Kyzatrex new drug application for primary and secondary male hypogonadism. 

Kyzattex, an oral testosterone undecanoate softgel, had one of the most comprehensive Phase 3 trials in the testosterone space and if approved, has the potential to be the only first-action approval oral testosterone product on the market.

The company plans to launch immediately following product approval.

Read Marius Pharmaceuticals press release