Marius Pharmaceuticals has backed a move by the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) to update prescribing information for testosterone replacement therapies, saying the changes reflect years of accumulating scientific evidence.
Announced during Men’s Health Month, the proposed revisions would remove language stating that the safety and effectiveness of testosterone therapy for age-related low testosterone had not been established. The FDA also plans to update information on prostate cancer risk and revise warnings related to enlarged prostate conditions.
READ: Fixing metabolic health through hormones: Marius CEO on Kyzatrex and testosterone deficiency (February 21, 2025)
The agency said the changes are based on a review of newer clinical evidence, including a cardiovascular outcomes study involving more than 5,200 men that found no significant increase in serious cardiovascular events among patients receiving testosterone therapy.
The latest action follows a broader regulatory review that began in 2014, when the FDA issued a safety communication and convened an advisory committee over concerns about possible cardiovascular risks linked to testosterone therapy. In 2015, the agency added restrictions on the use of testosterone products for men with age-related low testosterone because of limited evidence available at the time.
While in February 2025, the FDA removed its boxed warning on cardiovascular risks for testosterone products after reviewing new safety data, but retained restrictions related to age-related low testosterone. The newly proposed revisions would address that 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, said the latest changes reflect the growing body of research in the field.
“What changed is not the medicine, but the strength of the evidence,” said Shalin Shah, chief executive officer of Marius Pharmaceuticals.
Kyzatrex, developed by a Raleigh, North Carolina–based company, is an FDA-approved treatment for testosterone deficiency.
READ: Testosterone doses help men ward off heart disease, prolong life: study by cardiologist Dr. Rajat Barua (August 11, 2015)
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, increasing the risk of metabolic disorders, cardiovascular disease, and a diminished quality of life. Healthcare experts say addressing testosterone deficiency is essential not only for improving patients’ well-being but also for reducing the long-term burden of chronic disease.
In the press release, Marius Pharmaceuticals said it will continue working with healthcare providers and health systems as the FDA moves to align prescribing information with current clinical evidence.