Marius Pharmaceuticals Presents KYZATREX® Phase 3 Results: FDA-Approved Testosterone Capsules' Safety and Efficacy

A recent study has shown promising results for a new oral testosterone replacement therapy. Marius Pharmaceuticals has reported that KYZATREX® (testosterone undecanoate) CIII Capsules have demonstrated effectiveness in restoring normal testosterone levels in adult men with certain medical conditions that cause low or no testosterone levels. The six-month clinical trial, which involved 139 participants, revealed that KYZATREX was highly effective, with up to 96% of the subjects achieving normal testosterone levels by Day 90.

The study, published in the journal Therapeutic Advances in Urology, highlighted the drug's safety profile as well, noting only a slight increase in systolic blood pressure and a minimal incidence of hypertension among the participants. KYZATREX is designed to be absorbed through the lymphatic system, thus avoiding liver toxicity and offering a convenient twice-daily dosing regimen that emulates the body's natural testosterone cycle.

Shalin Shah, CEO of Marius Pharmaceuticals, emphasized the potential impact of KYZATREX on men's health, suggesting that it could play a significant role in addressing the ongoing crisis of declining testosterone levels among men in the United States. The innovative formulation of KYZATREX, which includes phytosterols, is believed to contribute to its safety and efficacy, marking a new approach in testosterone therapy that focuses on usable testosterone levels.

Testosterone deficiency, also known as hypogonadism, affects a significant portion of the male population aged 20 and older. Historically, testosterone replacement therapy (TRT) has been administered through injections, pellets, or gels. KYZATREX offers a novel oral delivery system that could transform the treatment landscape for those suffering from testosterone deficiency.

While the study's findings are encouraging, it is important to consider the potential side effects, which include increased blood pressure, a risk factor for heart attack and stroke. The most common side effect reported was high blood pressure, and other potential side effects include headache, joint or back pain, and increased red blood cell count, among others. As with any medication, it is crucial for patients to discuss their medical history and current medications with their healthcare provider before starting treatment with KYZATREX.

The development of KYZATREX is part of Marius Pharmaceuticals' broader research initiative to improve therapies for testosterone deficiency, aiming to enhance metabolic health and reduce healthcare costs associated with untreated cases. The study's authors, James S. Bernstein and Om Dhingra, believe that the findings could pave the way for further research into the metabolic benefits of testosterone as a hormone.