Marius Pharmaceuticals supports the FDA’s proposal to revise testosterone therapy warnings, reflecting new clinical evidence regarding safety and effectiveness for age-related low testosterone.
Marius Pharmaceuticals has expressed its support for a proposal by the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) to update the prescribing information for testosterone replacement therapies. The company believes these changes are a reflection of years of accumulating scientific evidence.
Announced during Men’s Health Month, the proposed revisions aim to remove language indicating that the safety and effectiveness of testosterone therapy for age-related low testosterone had not been established. Additionally, the FDA plans to update information regarding prostate cancer risk and revise warnings related to enlarged prostate conditions.
The FDA stated that these changes are based on a review of newer clinical evidence, which includes a cardiovascular outcomes study involving over 5,200 men. This study found no significant increase in serious cardiovascular events among patients receiving testosterone therapy.
This latest action follows a broader regulatory review that began in 2014, when the FDA issued a safety communication and convened an advisory committee due to concerns about potential cardiovascular risks associated with testosterone therapy. In 2015, the agency imposed restrictions on the use of testosterone products for men with age-related low testosterone due to the limited evidence available at that time.
In February 2025, the FDA removed its boxed warning on cardiovascular risks for testosterone products after reviewing new safety data, but it retained restrictions related to age-related low testosterone. The newly proposed revisions seek to address this remaining language and update warnings related to prostate health.
“This is a defining moment for evidence-based men’s health,” stated Shalin Shah, Chief Executive Officer of Marius Pharmaceuticals. “For years, patients and physicians lacked clear guidance because the evidence was still developing. As more data became available, the findings became increasingly clear, and these updates reflect that progress.”
Shah, who previously presented evidence supporting testosterone therapy at an FDA advisory panel meeting, emphasized that the latest changes reflect the growing body of research in the field. “What changed is not the medicine, but the strength of the evidence,” he noted.
Kyzatrex, developed by Marius Pharmaceuticals, is an FDA-approved treatment for testosterone deficiency based in Raleigh, North Carolina. An estimated 20 million men between the ages of 25 and 75 in the United States suffer from low testosterone. Despite its prevalence, hypogonadism often goes undiagnosed and untreated, which can increase the risk of metabolic disorders, cardiovascular disease, and a diminished quality of life.
Healthcare experts emphasize that addressing testosterone deficiency is crucial not only for improving patients’ well-being but also for reducing the long-term burden of chronic disease. Marius Pharmaceuticals has stated that it will continue to collaborate with healthcare providers and health systems as the FDA moves to align prescribing information with current clinical evidence.
The proposed revisions to testosterone therapy warnings represent a significant step forward in the understanding and treatment of low testosterone, aligning medical practice with the latest scientific findings, according to The American Bazaar.