RALEIGH, N.C., July 30, 2024 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a patient-centric healthcare company focused on developing innovative therapies for Testosterone Deficiency, is pleased to announce the submission of its New Drug Submission (NDS) for KYZATREX® (testosterone undecanoate) CIII capsules to Health Canada for approval.

北卡罗来纳州罗利，2024年7月30日（环球通讯社）--马吕斯制药公司是一家以患者为中心的医疗保健公司，专注于开发睾丸激素缺乏症的创新疗法，很高兴宣布将其KYZATREX®（十一酸睾酮）CIII胶囊的新药提交（NDS）提交加拿大卫生部批准。

This submission marks the company's first international filing, with an anticipated approval date in Q2 of 2025. KYZATREX is an oral testosterone replacement therapy designed to treat adult men with low or no testosterone levels due to certain medical conditions. KYZATREX offers a convenient and effective alternative in the form of a softgel capsule, which is absorbed primarily via the lymphatic system, thereby avoiding liver toxicity.

该提交文件标志着该公司首次提交国际申请，预计批准日期为2025年第二季度。KYZATREX是一种口服睾丸激素替代疗法，旨在治疗由于某些疾病导致睾丸激素水平低或无睾丸激素水平的成年男性。KYZATREX以软凝胶胶囊的形式提供了一种方便有效的替代品，该胶囊主要通过淋巴系统吸收，从而避免了肝毒性。

If approved, KYZATREX could become the only oral testosterone option available in Canada. KYZATREX received U.S. FDA approval in July 2022. “We are excited by this first international filing and look forward to helping more patients by broadening the availability of oral testosterone. Our goal is to provide men worldwide with access to effective, convenient treatment options for testosterone deficiency,” said Nita Nimmons, Director of Quality and Regulatory at Marius Pharmaceuticals.

如果获得批准，KYZATREX可能成为加拿大唯一的口服睾酮选择。KYZATREX于2022年7月获得美国FDA批准。马吕斯制药（Marius Pharmaceuticals）质量和监管总监尼塔·尼蒙斯（Nita Nimmons）表示：“我们对这一首次国际申请感到兴奋，并期待通过扩大口服睾丸激素的可用性来帮助更多患者。我们的目标是为全世界男性提供有效，方便的睾丸激素缺乏症治疗选择。”。

“Testosterone is a critical metabolic hormone that is crucial for many functions in the body. We hope that by increasing access to KYZATREX, we can become part of a solution to what has become a worldwide men’s health crisis.” KYZATREX Clinical Trial Highlights: Up to 96% Efficacy1In a six-month clinical trial of 139 men with low testosterone, 88% of patients had normal testosterone levels at Day 90 (worst-case scenario calculation, excluding Site 104).

“睾丸激素是一种关键的代谢激素，对人体的许多功能至关重要。我们希望通过增加使用KYZATREX的机会，我们可以成为解决全球男性健康危机的解决方案的一部分。”KYZATREX临床试验强调：在139名睾丸激素水平低的男性进行的为期六个月的临床试验中，88%的患者在第90天的睾丸激素水平正常（最坏情况计算，不包括104位）。

Based on patients who completed the study (n=127), 96% of patients achie.

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