Marius Pharmaceuticals today announced published results from MRS-TU-2019EXT, a six-month clinical trial of 139 men with low testosterone studying the safety and efficacy of its oral testosterone replacement therapy, KYZATREX® (testosterone undecanoate) CIII Capsules in adult men with conditions associated with a deficiency or absence of endogenous testosterone.
Data Published in Therapeutic Advances in Urology Demonstrates Up to 96% Efficacy in Helping Restore Testosterone Levels to Normal at Day 901* RALEIGH, N.C., April 11, 2024 /PRNewswire/ -- Marius Pharmaceuticals, a pharmaceutical company focused on developing innovative therapies for testosterone deficiency, today announced published results from MRS-TU-2019EXT, a six-month clinical trial of 139 men with low testosterone studying the safety and efficacy of its oral testosterone replacement therapy, KYZATREX® (testosterone undecanoate) CIII Capsules in adult men with conditions associated with a deficiency or absence of endogenous testosterone. The data, published in Therapeutic Advances in Urology, demonstrated that KYZATREX was up to 96% effective at Day 90 at restoring normal testosterone levels in adult men who have low or no testosterone levels due to certain medical conditions.1* *Per label, 88% of patients had low testosterone levels at Day 90 (worst-case scenario calculation, excluding Site 104). Based on patients who completed the study (n=127), 96% of patients achieved normal testosterone levels at Day 90.1 “The world is experiencing a crisis related to men’s health, and we firmly believe that oral testosterone in the form of KYZATREX has the potential to be a critical part of the solution,” said Shalin Shah, chief executive officer of Marius Pharmaceuticals. “Not only does the data demonstrate that KYZATREX is a safe and effective form of testosterone replacement therapy, but it also shows that KYZATREX is effective at decreasing the amount of sex hormone binding globulin (SHBG) and increasing the amount of free testosterone in the body. We believe combining the convenience of our oral delivery system with the testosterone-boosting benefits of testosterone undecanoate can be transformative for men suffering from testosterone deficiency and in helping to correct the substantial drop in testosterone levels among men in the United States over the past few decades.” Select Results from MRS-TU-2019EXT
The authors of the study were James S. Bernstein, PhD, and Om Dhingra, PhD, board director and scientific advisor to Marius Pharmaceuticals. Om Dhingra commented, “The excellent safety and efficacy data can be attributable to KYZATREX’s innovative and elegant formulation. This formulation utilizes phytosterols as a first in a pharmaceutical product to help make safe and effective Oral Testosterone a reality. We have expanded the traditional framework, as well, when considering effects of SHBG and Free Testosterone, which potentially mark a new era in treatment focused on usable testosterone, not just total T. We look forward to this being the beginning of a broader research program to better understand and demonstrate real world benefits of testosterone as a metabolic hormone.” Testosterone deficiency – or hypogonadism – is a chronic disease that affects about 30 percent of men aged 20 years and older.2 In a 24-year study, researchers noted a substantial age-independent decline in testosterone levels among men in the U.S. Since the study’s inception in 1984, it was determined that men born in more recent years have lower testosterone levels than previous generations, with average levels declining by about 1% per year.3 Compounding the issue, it’s been reported that only 5-10% of men with low testosterone are being treated with testosterone replacement therapy (TRT).4 Historically, TRT has been administered through injections, pellets and gels. KYZATREX is designed to utilize lymphatic absorption to bypass first-pass metabolism to drive uptake and prevent liver damage. KYZATREX is an immediate-release formulation with twice-daily dosing that, when administered every 12 hours, closely mimics the diurnal rhythm of endogenous testosterone, as demonstrated by the pharmacokinetic data in the study article.1 This published study is part of Marius Pharmaceuticals’ comprehensive effort to develop innovative therapies for testosterone deficiency. To learn more about KYZATREX®, visit https://www.kyzatrex.com. To learn more about Marius Pharmaceuticals, visit https://www.mariuspharma.com. The full journal article can be found here. About KYZATREX® (testosterone undecanoate) Please see additional Important Safety Information below, including Boxed Warning for potential increased blood pressure, for KYZATREX or visit www.kyzatrex.com. About Marius Pharmaceuticals Important Safety Information for KYZATREX® (testosterone undecanoate) Use Important Safety Information for KYZATREX® (testosterone undecanoate) 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.
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:
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. 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 calling 1-833-949-5040. Keep KYZATREX and all medicines out of the reach of children. See Full Prescribing Information and Medication Guide for KYZATREX. References:
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