Testosterone

A Vital Metabolic
Hormone

Millions of people suffer from testosterone deficiency. We are dedicated to providing therapies that address this issue.
Testosterone plays a crucial role beyond sexual health. It influences…
Get a Closer Look at Testosterone

Heart function

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Bone & Muscle Strength

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Metabolic Efficiency

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Our Product

We believe that testosterone is central to overall health and well-being, which is why we have spent more than a decade developing a proprietary oral testosterone therapy.
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.
Please see additional Important Safety Information, including Boxed Warning, at the bottom of the page.
KYZATREX websitePrescribing Information
Important Safety Information for KYZATREX (testosterone undecanoate)
KYZATREX can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke.
Diagnosed Heart Conditions, Diabetes, Obesity, and Testosterone Deficiency Over 100 Years
Research

The Frontiers of
Testosterone Therapy

Evidence supports the need for research initiatives to examine hormone imbalance within other comorbidities and patient populations.
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Obesity

Testosterone deficiency is frequently encountered in obese men. Low testosterone contributes to decreased muscle mass, increased fat storage, and a decline in metabolic efficiency, creating a cycle that can be difficult to break.
Studies have shown that long-term testosterone therapy in men with testosterone deficiency produces significant weight loss, a notable reduction in waist circumference and BMI, and improvements in body composition.1
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Type 2 Diabetes

Testosterone deficiency is common in men with type 2 diabetes, contributing to insulin resistance, increased fat storage, and decreased muscle mass. This combination exacerbates metabolic challenges and makes blood sugar control more difficult.
Research has shown that testosterone therapy can lead to significant improvements in men with diabetes, including reductions in waist circumference, body fat, and fasting glucose levels.6
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Women

The benefits of testosterone therapy aren’t limited to men. Testosterone can play a crucial role in women’s health as well, particularly in reducing symptoms of menopause and improving overall well-being.
Research shows that testosterone therapy for women can effectively alleviate menopausal symptoms with minimal side effects.7
The above-referenced disease states are solely investigational and not approved uses of KYZATREX. Marius Pharmaceuticals supports continued research in the above domains. Please send Investigator Proposals and Grant requests to medical@mariuspharma.com.
Science-driven Innovation

Our Research
Pipeline

Our commitment to research drives everything we do.
From studying testosterone therapy and fertility to addressing muscle mass loss and improving women’s health, our research pushes the boundaries of what hormone therapy can achieve.
Our Research Projects

News

Learn From Our Experts

Use
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. KYZATREX is not meant for use by women.
IMPORTANT SAFETY INFORMATION FOR KYZATREX®
KYZATREX can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke.
  • If your blood pressure increases while on KYZATREX, blood pressure medicines may need to be started. If you are currently taking blood pressure medicines, they may need to be changed or new blood pressure medicines may need to be added to control your blood pressure.
  • If your blood pressure cannot be controlled, KYZATREX may need to be stopped.
  • Your healthcare provider will monitor your blood pressure while you are being treated with 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); are allergic to KYZATREX or any of its ingredients; or have low testosterone without certain medical conditions (e.g., do not take KYZATREX if you have low testosterone due to age).
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.
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.
These are not all the possible side effects of KYZATREX. For more information, ask your healthcare provider or pharmacist.
Keep KYZATREX and all medicines out of the reach of children.
See Full Prescribing Information and Medication Guide for KYZATREX.
References:
  1. Haider K, Haider A, Doros G, Traish A, Saad F. MON-091 Profound and Sustained Weight Loss in Men With Hypogonadism and Obesity Receiving Long-Term Testosterone Therapy (TTh) with Testosterone Undecanoate Injections (TU): 10-Year Data from a Registry Study in a Urological Setting. J Endocr Soc. 2019;3(Suppl 1):MON-091. Published 2019 Apr 30. doi:10.1210/js.2019-MON-091
  2. Wittert G, Bracken K, Robledo KP, et al. Testosterone treatment to prevent or revert type 2 diabetes in men enrolled in a lifestyle programme (T4DM): a randomised, double-blind, placebo-controlled, 2-year, phase 3b trial. Lancet Diabetes Endocrinol. 2021;9(1):32-45. doi:10.1016/S2213-8587(20)30367-3
  3. Mok, Charles. Testosterone: Strong Enough For A Man, Made For A Woman. Forbes Books, 2017.