Marius Pharmaceuticals Initiates Post-Marketing Study of Testosterone Undecanoate in Men Aged 65-80 with Hypogonadism
核心洞察
Marius Pharmaceuticals has launched a post-marketing study to evaluate testosterone undecanoate (Kyzatrex) in 50 men aged 65-80 with hypogonadism (搜索) for potential label expansion.
The six-month open-label study will assess quality of life changes and key health markers including cardiovascular parameters, body composition, strength measures, and inflammation.
Investigators will compare the drug's labeled titration protocol with a simplified once-daily dosing regimen to potentially benefit older patients with streamlined treatment plans.
Marius Pharmaceuticals has initiated a post-marketing clinical study to evaluate testosterone undecanoate (Kyzatrex) CIII capsules in men aged 65 to 80 with hypogonadism (搜索), marking a potential expansion of the drug's approved patient population. The open-label, single-site study aims to enroll 50 participants over a six-month period to assess the therapy's impact on age-related health parameters.
Study Design and Objectives
The trial will evaluate changes in overall quality of life and key health markers relevant to aging men, including cardiovascular parameters, body composition, strength-related measures, and inflammation. According to the company, these endpoints are designed to better understand how treatment with testosterone undecanoate "may support health measures that meaningfully affect day-to-day function and long-term outcomes" in older men.
A unique aspect of the study involves comparing testosterone undecanoate's labeled titration protocol with a simplified once-daily dosing regimen. Marius Pharmaceuticals suggests that a simplified regimen, if proven effective, may be especially beneficial for an older population of men who could benefit from more streamlined, easy-to-follow treatment plans.
"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, PhD, Chief Scientific Advisor and 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."
Current Approval and Efficacy Data
Testosterone undecanoate is currently approved for adult males with conditions associated with a deficiency or absence of endogenous testosterone. The initial approval was based on a multi-center phase 3 trial involving 155 men aged 18 to 65 years, all with confirmed hypogonadism (搜索) defined as a serum testosterone level below 281 ng/dL and at least one sign or symptom of testosterone deficiency.
The phase 3 study achieved its primary endpoint, demonstrating that 88% of efficacy-evaluable patients (n = 139) achieved a mean plasma total testosterone concentration over 24 hours within the normal range (222 to 800 ng/dL) at day 90, the final pharmacokinetic visit. Patients receiving testosterone undecanoate also reported improvements in symptoms of low testosterone, including quality of life, energy/fatigue, erectile function, sexual intercourse, and mood.
Safety Profile
The most common adverse event occurring in 2% or greater of patients in the testosterone undecanoate arm was increased blood pressure, reported in 2.6% of patients. The drug is formulated as a proprietary softgel oral formulation that is absorbed primarily via the lymphatic system, meaning it is not toxic to the liver.
Clinical Rationale
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 testosterone undecanoate in this older population, the study aims to generate real-world evidence around oral testosterone therapy and its role in supporting health and quality of life in older hypogonadal men.
Enrollment is currently underway following IRB approval, representing an important step in expanding knowledge around testosterone replacement therapy in an aging population where treatment considerations may differ from younger patients.