This approval marks a significant milestone as Marius expands its reach beyond the U.S. market and makes the only oral testosterone replacement therapy option available under a softgel capsule dosage form in Canada. Building on Marius’s earlier submission to Health Canada in July 2024, the company is now poised to provide Canadian men and their healthcare providers with an additional treatment option.
“Today’s approval of KYZATREX by Health Canada is a major milestone for Marius Pharma and for men’s health in Canada,” said Amit Shah, Chief Operating Officer of Marius Pharmaceuticals. “We recognize the burden that testosterone deficiency places on men’s physical, cognitive, and metabolic health, and we are committed to expanding access to effective, convenient treatment options. We look forward to partnering with Canadian healthcare providers to bring KYZATREX to patients who may benefit.”
Testosterone deficiency (TD), also referred to as hypogonadism, can result from a variety of underlying medical conditions and is associated with symptoms such as low libido, fatigue, muscle weakness, mood disturbances, and metabolic dysfunction. In Canada, the crude prevalence of biochemical testosterone deficiency is estimated to be approximately 25% among men aged 40–62 years, or approximately 3 million men.1,2 This underscores a substantial patient population that may benefit from increased awareness, diagnosis, and access to effective therapies.
With Health Canada approval in hand, Marius will launch KYZATREX in the Canadian market soon, working collaboratively with Canadian providers to ensure appropriate patient access, education, and monitoring. KYZATREX will be available through multiple telehealth and traditional provider options in the first half of 2026.The availability of an oral testosterone option presents a convenient alternative to injectable or transdermal formulations.
About Marius Pharmaceuticals
Marius Pharmaceuticals strives to better the lives of patients by focusing on therapies designed for hypogonadism or Testosterone Deficiency. The company's vision is to holistically improve metabolic health and mitigate significant unnecessary costs to the global healthcare system.
About KYZATREX® (testosterone undecanoate)
KYZATREX is a proprietary softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) and indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The safety and efficacy of KYZATREX was demonstrated in a phase 3, multi-center, open-label, six-month study in 155 hypogonadal males between 18 and 65 years of age with documented hypogonadism, as defined by a below normal serum testosterone level (≤281 ng/dL) and at least one sign or symptom of testosterone deficiency. In the efficacy population (n=139), 88 percent of hypogonadal men treated with KYZATREX achieved a mean plasma total testosterone concentration (Cavg) over 24 hours within the normal range (222-800 ng/dL) on the final pharmacokinetic (PK) visit of the study at Day 90 (primary endpoint). Based on exploratory endpoints, patients who received KYZATREX reported improvements in symptoms of low testosterone, including quality of life, energy/fatigue, erectile function, sexual intercourse, and mood. The most common side effect reported in ≥2 percent of KYZATREX patients was increased blood pressure (2.6%). The safety and efficacy of KYZATREX in males less than 18 years old have not been established.
What is KYZATREX®
KYZATREX® (testosterone undecanoate) is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions.
KYZATREX® is a controlled substance (CIII) because it contains testosterone.
It is not known if KYZATREX® is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children.
It is not known if KYZATREX® is safe or effective in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”).
For more information please visit, www.MariusPharmaceuticals.com
