madman
Super Moderator
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.”
