Health Canada approves testosterone undecanoate for hypogonadism

Health Canada has approved testosterone undecanoate (Kyzatrex) CIII capsules for adult men with low or no testosterone levels due to certain medical conditions, Marius Pharmaceuticals announced in a news release.¹

According to the company, the medication will be made available through telehealth and traditional provider options in the first half of 2026. Marius plans to work closely with physicians in Canada to “ensure appropriate patient access, education, and monitoring.”

“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, in the news release.¹ “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 health care providers to bring KYZATREX to patients who may benefit.”

Testosterone undecanoate is “a softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver),” according to Marius Pharmaceuticals. The medication was approved by the FDA in August 2022 for men with conditions associated with a deficiency or absence of endogenous testosterone.

The safety and efficacy of testosterone undecanoate was demonstrated in an open-label, phase 3 extension trial, MRS-TU-2019EXT (NCT04467697). Findings from the study were recently published in Therapeutic Advances in Urology.²

In total, the 6-month trial included 155 hypogonadal men aged 18 to 65 years who received testosterone undecanoate starting at 200 mg twice daily with meals. Doses were titrated over two 28-day cycles between 100 mg and 800 mg daily.

Overall, 88% of patients in the efficacy-evaluable population (n = 139) achieved the primary end point of a mean plasma total testosterone concentration (Cavg) over 24 hours within the normal range (222 to 800 ng/dL) on the final pharmacokinetic visit of the study (day 90). Patient-reported outcomes also showed that patients who received testosterone undecanoate saw improvements in the symptoms of hypogonadism, which included improvements in quality of life, energy/fatigue, erectile function, sexual intercourse, and mood.

Treatment was well-tolerated, with no drug-related serious adverse events reported. The most common adverse event in the testosterone undecanoate arm, reported in 2.6% of patients, was hypertension.

REFERENCE

1. Marius Pharmaceuticals expands global footprint with Health Canada approval of KYZATREX (testosterone undecanoate) CIII capsules. News release. Marius Pharmaceuticals LLC. November 12, 2025. Accessed November 12, 2025. https://www.globenewswire.com/news-release/2025/11/12/3186364/0/en/Marius-Pharmaceuticals-Expands-Global-Footprint-with-Health-Canada-Approval-of-KYZATREX-testosterone-undecanoate-CIII-Capsules.html

2. Bernstein JS, Dhingra OP. A phase III, single-arm, 6-month trial of a wide-dose range oral testosterone undecanoate product. Ther Adv Urol. 2024:16:17562872241241864. doi:10.1177/17562872241241864