Marius Pharmaceuticals seeks US FDA nod for oral testosterone therapy

Marius Pharmaceuticals LLC filed an application with the U.S. Food and Drug Administration seeking approval of oral testosterone therapy Kyzatrex to treat primary and secondary hypogonadism in adult men.

Hypogonadism is a condition in which the body does not produce enough testosterone in men.

The application, for which the company has requested a priority review, is backed by results from a late-stage study in which the medicine helped about 96% of patients to achieve normal testosterone levels after 90 days of treatment. The most common adverse event experienced by patients was hypertension.

Marius plans to seek approval from the EU for the drug in 2022.