Articles from Marius Pharmaceuticals LLC

All-female advisory board to guide Marius in addressing the unmet need for safe, effective testosterone therapies for women

RALEIGH, N.C., Sept. 10, 2025 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, Inc. today announced a collaboration with Hims & Hers™, one of the largest digital health platforms for men, to make KYZATREX®, an FDA-approved oral testosterone replacement therapy for adult men with low or no testosterone levels due to certain medical conditions, available to patients through the Hims & Hers platform in the coming months. This marks the first time Hims & Hers will offer an FDA-approved oral testosterone therapy, underscoring KYZATREX’s position as a leader in the testosterone therapy space.

RALEIGH, N.C., May 28, 2025 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a pharmaceutical company focused on developing innovative therapies for testosterone deficiency, announced today that the United States Patent and Trademark Office (USPTO) for a new patent related to its oral testosterone therapy, KYZATREX® (testosterone undecanoate) CIII Capsules. This is the sixth patent in the company’s growing intellectual property portfolio protecting KYZATREX.

The U.S. Army Special Operations Veteran and Tactical Fitness Personality Champions a Non-Invasive Testosterone Solution

RALEIGH, N.C., March 25, 2025 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a pharmaceutical company focused on developing innovative therapies for testosterone deficiency, announced today that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a new patent, strengthening the company’s intellectual property protection for its proprietary oral testosterone therapy, KYZATREX® (testosterone undecanoate) CIII Capsules.

RALEIGH, N.C., March 03, 2025 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a pharmaceutical company dedicated to developing innovative therapies for testosterone deficiency, has partnered with Duke University School of Medicine to explore the potential of KYZATREX® (testosterone undecanoate) CIII capsules, an FDA-approved oral testosterone therapy, in improving patient outcomes before and after surgery, critical care, and acute or chronic illness. The collaboration will specifically examine the role of testosterone replacement in patients with secondary or acquired hypogonadism resulting from trauma, major surgery, or prolonged critical illness. Dr. Paul Wischmeyer, Duke Professor of Anesthesiology and Surgery and Director of Duke Online Clinical Nutrition Fellowship will lead the research efforts.

RALEIGH, N.C., March 03, 2025 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, is pleased to announce that the U.S. Food and Drug Administration (FDA) has implemented significant labeling changes for KYZATREX® (testosterone undecanoate) CIII capsules. This decision follows the conclusion of the TRAVERSE trial and comprehensive blood pressure monitoring studies, marking a pivotal advancement in testosterone replacement therapy (TRT).

RALEIGH, N.C., Feb. 21, 2025 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a biopharmaceutical company dedicated to redefining the treatment of testosterone deficiency, is excited to announce the launch of its new corporate website, designed to provide comprehensive education on the importance of testosterone in overall health. In conjunction with this milestone, the company is also introducing two new advisory boards—the Longevity Board and the Endocrinology Board—featuring leading experts in the fields of integrative medicine, cardiology, longevity, and endocrinology.

RALEIGH, N.C., Feb. 11, 2025 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals is pleased to announce that Thrive, a leading provider of personalized healthcare solutions and a trusted partner of O2 Fitness, now offers KYZATREX® (testosterone undecanoate) CIII capsules to its patients nationwide. KYZATREX is an FDA-approved oral testosterone therapy designed to treat adult men with low or no testosterone due to certain medical conditions. This expansion provides men with a convenient, non-invasive option for testosterone replacement therapy (TRT) through Thrive’s accessible, patient-first healthcare model.

RALEIGH, N.C., Jan. 14, 2025 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a pharmaceutical company focused on developing innovative therapies for testosterone deficiency, has partnered with USSM, an independent physician owned/controlled Management Services Organization (“MSO”) through their Urologic in-office pharmacies and dispensaries. USSM practices include Urology Partners of North Texas, Urology of St. Louis, Urology of Iowa, Arkansas Urology, and Tennessee Valley Urology. This USSM distribution model is for KYZATREX® (testosterone undecanoate) CIII capsules, an FDA approved, cash only oral prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions. 

The Deal Gives Gameday Men’s Health Patients Access to The FDA-Approved Oral Testosterone Therapy At 250+ Health Centers

New Nonprofit Founded by Leading Testosterone Experts Seeks to Provide Equal Access to Care for Both Men and Women

RALEIGH, N.C., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a pharmaceutical company focused on developing innovative therapies for testosterone deficiency, has released compelling new insights from a recent Androgen Deficiency in Aging Males (qADAM) questionnaire conducted on their KYZATREX® (testosterone undecanoate) CIII capsules website. The data collected from 779 participants highlights significant challenges faced by men regarding energy, libido, strength and overall life satisfaction, underscoring the potential impact of testosterone deficiency on quality of life and well-being.

RALEIGH, N.C., Sept. 18, 2024 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals is pleased to announce a new partnership with Numan, a leading UK-based, VC-backed digital health platform, to introduce KYZATREX® (testosterone undecanoate) CIII capsules into Numan’s product offerings. KYZATREX is FDA-approved in the US and is indicated for adult men who have low or no testosterone due to certain medical conditions. This collaboration marks a significant step forward in the treatment of testosterone deficiency, offering men a more comprehensive and patient-centered solution for managing this common yet often overlooked condition.

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. This submission marks the company's first international filing, with an anticipated approval date in Q2 of 2025.

RALEIGH, N.C., Sept. 19, 2023 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a pharmaceutical company focused on developing innovative therapies for testosterone deficiency, is proud to announce the expansion of access to its FDA-approved oral testosterone therapy, KYZATREX™, to the Department of Veteran Affairs (VA). This initiative is a significant milestone in Marius Pharmaceutical’s ongoing mission to provide accessible and life-enhancing therapies to focused communities.

RALEIGH, N.C., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals (Marius) and Smartway Pharmaceuticals (Smartway) are pleased to announce their strategic partnership, aimed at addressing the pressing global issue of hypogonadism through the launch of a comprehensive Early Access Program for KYZATREX™ (testosterone undecanoate).

RALEIGH, N.C., July 24, 2023 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a patient-centric healthcare company specializing in therapies for hypogonadism or Testosterone Deficiency, is proud to announce the launch of their disease state awareness website, ReThink Testosterone. With the aim of changing the narrative surrounding testosterone and testosterone therapy, ReThink Testosterone seeks to empower men dealing with Low T to advocate for their health by providing valuable education and debunking long-standing myths.

RALEIGH, N.C., June 20, 2023 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a patient-centric healthcare company specializing in therapies for hypogonadism or testosterone deficiency, announced today its sponsorship of the AXYS 2023 Virtual Family Conference. This conference serves as a significant platform for individuals and families affected by XY Chromosome Variations, including conditions such as Klinefelter's Syndrome.

RALEIGH, N.C., June 09, 2023 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a patient-centric healthcare company focused on therapies designed for hypogonadism or testosterone deficiency, announced that its U.S. patents related to KYZATREX™ (testosterone undecanoate), No. 11590146B2 and No. 11617758B2, are now listed in the U.S. Food and Drug Administration (FDA) publication, “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the “Orange Book.”