Marius Pharmaceuticals Expands Global Footprint with Health Canada Approval of KYZATREX® (testosterone undecanoate) CIII Capsules

RALEIGH, N.C., Nov. 12, 2025 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, Inc. a patient-centric healthcare company committed to advancing innovative therapies for testosterone deficiency, today announced that Health Canada has approved KYZATREX ^® (testosterone undecanoate) CIII capsules. KYZATREX is a prescription drug used to treat adult men who have low or no testosterone levels due to certain medical conditions.

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. For more information, please visit www.mariuspharma.com.

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.

Please see additional Important Safety Information for KYZATREX below or visit www.kyzatrex.com.

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”).

KYZATREX^® is not meant for use by women.

Important Safety Information for KYZATREX^®

Do not take KYZATREX^® if you: have breast cancer; have or might have prostate cancer; are a woman who is pregnant (KYZATREX may harm your unborn baby); or are allergic to KYZATREX^® or any of its ingredients.

Before you take KYZATREX^®, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking KYZATREX^® with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicine and pain medicines.

KYZATREX^® may cause other serious side effects including:

Increase in red blood cell count (hematocrit) or hemoglobin, which can increase the risk of blood clots, strokes, and heart attacks. You may need to stop KYZATREX^® if your red blood cell count increases.
If you already have an enlarged prostate, your signs and symptoms may worsen while taking KYZATREX^®. These may include: increased urination at night; trouble starting your urine stream; urinating many times during the day; urge to go to the bathroom right away; a urine accident; inability to pass urine or weak urine flow.
Increased risk of prostate cancer.
Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
Abuse. Testosterone can be abused when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects.
In large doses, KYZATREX^® may lower your sperm count.
Liver problems. Symptoms of liver problems may include: nausea or vomiting; yellowing of your skin or whites of your eyes; dark urine; pain on the right side of your stomach area (abdominal pain).
Swelling of your ankles, feet, or body (edema), with or without heart failure.
Enlarged or painful breasts.
Breathing problems while you sleep (sleep apnea).

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effect of KYZATREX^® is high blood pressure. Other side effects may include: headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels.

These are not all the possible side effects of KYZATREX^®. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Marius [by visiting www.mariuspharma.com].

Keep KYZATREX and all medicines out of the reach of children.

See Full Prescribing Information and Medication Guide for KYZATREX^®.

References:

Morley, J E et al. “Validation of a screening questionnaire for androgen deficiency in aging males.” Metabolism: clinical and experimental vol. 49,9 (2000): 1239-42. doi:10.1053/meta.2000.8625
Statistics Canada. Table 17-10-0005-01, “Population estimates on July 1, by age and gender”. Release 24 Sept. 2025, doi:10.25318/1710000501-eng.

Media Contact:
Lilly Washburn
lilly@mariuspharma.com

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