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* The trial will also evaluate KYZATREX’s labeled titration protocol alongside a simplified once-daily dosing regimen, an important consideration for older adults who may benefit from more streamlined, easy-to-follow treatment plans.
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RALEIGH, N.C., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, Inc. today announced the company will initiate a new post-marketing clinical study for potential label expansion evaluating KYZATREX® (testosterone undecanoate) CIII capsules in men ages 65–80 with hypogonadism. KYZATREX is a prescription drug used to treat adult men who have low or no testosterone levels due to certain medical conditions.
As men age, the effects of low testosterone can intersect with broader age-related changes, influencing energy, mobility, metabolic function, and overall well-being. By examining KYZATREX in this older population, the study aims to better understand how treatment may support health measures that meaningfully affect day-to-day function and long-term outcomes. The trial will also evaluate KYZATREX’s labeled titration protocol alongside a simplified once-daily dosing regimen, an important consideration for older adults who may benefit from more streamlined, easy-to-follow treatment plans.
Study Overview
This open-label, single-site study will enroll 50 men ages 65–80 with confirmed hypogonadism. Over the six-month duration, investigators will evaluate changes in overall quality of life as well as key health markers relevant to aging men, including cardiovascular parameters, body composition, strength-related measures, and inflammation. By focusing on these critical domains, the study seeks to generate insights into how KYZATREX may support broader health and functional outcomes in older hypogonadal men.
“Marius is committed to advancing the understanding of men’s health across all ages, and this study reflects our interest in evaluating outcomes that matter most to older patients,” said Om Dhingra, Chief Scientific Advisor & Board Director at Marius. “By focusing on cardiovascular markers, body composition, strength, and inflammation, we hope to generate insights that can help clinicians care for this growing patient population.”
Enrollment is now underway following IRB approval. This research represents an important step in expanding real-world knowledge around oral testosterone therapy and its role in supporting health and quality of life in older hypogonadal men.
Marius Pharmaceuticals to Initiate Study Evaluating KYZATREX® (testosterone undecanoate) CIII ...
RALEIGH, N.C., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, Inc. today announced the company will initiate a new post-marketing clinical study for potential label expansion evaluating KYZATREX® (testosterone undecanoate)
RALEIGH, N.C., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, Inc. today announced the company will initiate a new post-marketing clinical study for potential label expansion evaluating KYZATREX® (testosterone undecanoate) CIII capsules in men ages 65–80 with hypogonadism. KYZATREX is a prescription drug used to treat adult men who have low or no testosterone levels due to certain medical conditions.
As men age, the effects of low testosterone can intersect with broader age-related changes, influencing energy, mobility, metabolic function, and overall well-being. By examining KYZATREX in this older population, the study aims to better understand how treatment may support health measures that meaningfully affect day-to-day function and long-term outcomes. The trial will also evaluate KYZATREX’s labeled titration protocol alongside a simplified once-daily dosing regimen, an important consideration for older adults who may benefit from more streamlined, easy-to-follow treatment plans.
Study Overview
This open-label, single-site study will enroll 50 men ages 65–80 with confirmed hypogonadism. Over the six-month duration, investigators will evaluate changes in overall quality of life as well as key health markers relevant to aging men, including cardiovascular parameters, body composition, strength-related measures, and inflammation. By focusing on these critical domains, the study seeks to generate insights into how KYZATREX may support broader health and functional outcomes in older hypogonadal men.
“Marius is committed to advancing the understanding of men’s health across all ages, and this study reflects our interest in evaluating outcomes that matter most to older patients,” said Om Dhingra, Chief Scientific Advisor & Board Director at Marius. “By focusing on cardiovascular markers, body composition, strength, and inflammation, we hope to generate insights that can help clinicians care for this growing patient population.”
Enrollment is now underway following IRB approval. This research represents an important step in expanding real-world knowledge around oral testosterone therapy and its role in supporting health and quality of life in older hypogonadal men.
