Marius Pharmaceuticals Partners with Major Academic Medical Center on Education and Research Efforts for Oral Testosterone

/EIN News/ -- RALEIGH, N.C., March 03, 2025 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a pharmaceutical company dedicated to developing innovative therapies for testosterone deficiency, has partnered with Duke University School of Medicine to explore the potential of KYZATREX^® (testosterone undecanoate) CIII capsules, an FDA-approved oral testosterone therapy, in improving patient outcomes before and after surgery, critical care, and acute or chronic illness. The collaboration will specifically examine the role of testosterone replacement in patients with secondary or acquired hypogonadism resulting from trauma, major surgery, or prolonged critical illness. Dr. Paul Wischmeyer, Duke Professor of Anesthesiology and Surgery and Director of Duke Online Clinical Nutrition Fellowship will lead the research efforts.

This partnership is planned to include prospective interventional studies examining the role of KYZATREX in prehabilitation and rehabilitation for patients undergoing surgery, ICU care, and trauma recovery. KYZATREX is indicated for the treatment of adult men with hypogonadism due to certain medical conditions. Research has shown that muscle mass plays a crucial role in patient recovery, influencing survival rates, reducing hospital complications, and lowering readmission risks.^1,2 Testosterone levels decline significantly in many hospitalized patients, particularly those in the ICU, within just three to five days. This drop has been associated with higher mortality rates, prolonged ventilation needs, and extended hospital stays.³

“The reality is intensive care and surgery providers have long known the prospects for optimal recovery in the shortest time increases the sooner patients get out of bed and start moving,” said Dr. Wischmeyer.

The research collaboration will further explore the potential for testosterone therapy to preserve and rebuild muscle mass, accelerate mobility post-therapy, and support a more efficient physiological recovery process. Muscle mass and movement are key to reducing frailty and preventing muscle wasting, and healthy muscle tissue plays a critical role in secreting beneficial endorphins, growth factors, and cytokines—all of which promote recovery and mitigate the negative effects of inflammation.

“Unfortunately, major illness and injuries, such as traumatic falls and major surgery, lead to rapid muscle loss and disability from a combination of poor nutrition and protein intake, and inadequate time out of the bed moving and doing rehabilitation,” said Dr Wischmeyer. “Even when adequate nutrition is provided to patients, the rapid decline in testosterone, to sometimes undetectable levels, that we observe following illness and injury may markedly reduce the body’s ability to convert the nutrition and protein we take in to muscle mass and strength, even when aggressive rehabilitation and physical therapy is provided.”

Unlike other testosterone therapies that may be more difficult to continue after hospital discharge, an oral therapy like KYZATREX could allow patients to maintain treatment throughout their recovery, with the goal of improving muscle preservation and overall rehabilitation beyond their hospital stay, which are key endpoints in the planned research.

“Many people suffer severe disability after simple falls—not just from the fall itself, but from the resulting weakness and muscle loss due to prolonged bedrest and immobility. This decline can lead to complications such as pneumonia and blood clots, which might have been prevented if muscle mass and strength were better preserved,” said Richard Callaghan, Senior Vice President of Operations at Marius. “Through this research, we hope to explore the role of TRT in improving recovery outcomes and helping patients regain their strength more effectively.”

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, including Boxed Warning for potential increased blood pressure, or visit www.kyzatrex.com.

Important Safety Information for KYZATREX^® (Testosterone Undecanoate Capsules)

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.

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:
1. Wischmeyer PE, Puthucheary Z, San Millan I, Butz D, Grocott MPW. Muscle mass and physical recovery in ICU: innovations for targeting of nutrition and exercise. Curr Opin Crit Care. 2017 Aug;23(4):269-78.
2. Prado CM, Purcell SA, Alish C, Pereira SL, Deutz NE, Heyland DK et al. Implications of low muscle mass across the continuum of care: a narrative review. Ann Med. 2018 Dec;50(8):675-93.
3. Wischmeyer PE, Suman OE, Kozar R, Wolf SE, Molinger J, Pastva AM. Role of anabolic testosterone agents and structured exercise to promote recovery in ICU survivors. Curr Opin Crit Care. 2020 Oct;26(5):508-15.

Media Contact:
Lilly Washburn
lilly@mariuspharma.com