The FDA’s second major labeling update in 16 months — after its February 2025 removal of the cardiovascular boxed warning — marks a historic modernization of how testosterone therapy is prescribed, bringing labeling in step with a decade of new clinical evidence. Marius CEO Shalin Shah, an invited speaker at the agency’s expert panel on the therapy, helped advance the earlier change.
RALEIGH, N.C., June 22, 2026 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a specialty pharmaceutical company advancing the science of testosterone therapy and hormone health, today welcomed an announcement by the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) requesting updates to the prescribing information for testosterone replacement therapy products — a defining moment that brings the category’s labeling in step with more than a decade of accumulated clinical evidence.
Announced during Men’s Health Month, the FDA’s requested revisions would remove the limitation of use stating that the safety and effectiveness of testosterone therapy in men with age-related low testosterone had not been established, update information related to prostate cancer risk, and revise longstanding warnings regarding enlarged prostate. The agency cited a comprehensive review of new clinical data — including a large cardiovascular outcomes trial of more than 5,200 men that found no meaningful increase in major adverse cardiovascular events — as the basis for the changes.
It is the second of two pivotal FDA labeling actions in 16 months. The first came in February 2025, when the agency removed the cardiovascular boxed warning from all testosterone products while maintaining the limitation of use tied to age-related low testosterone. This week’s requested updates address that remaining language, bringing the prescribing information fully in step with the current evidence.
“This is a defining moment for evidence-based men’s health,” said Shalin Shah, CEO of Marius Pharmaceuticals. “For years, gaps in the evidence left millions of men and their physicians without the clear guidance they deserved. As the science matured, the picture became unmistakable — and these updates reflect it. Marius has spent years building the clinical and scientific foundation for exactly this shift, and we are proud to stand at the center of the movement to put men’s health on solid ground.”
Shah carried that case directly to regulators as an invited speaker at the FDA’s expert panel on testosterone replacement therapy, where much of the evidence behind today’s changes was weighed.
A decade of evolving science
The updates now underway trace to a period of appropriate caution that began in 2014, when the FDA issued a drug safety communication and convened an advisory committee following reports of cardiovascular events in men taking testosterone. The following year, the agency added a limitation of use for men with age-related low testosterone — a prudent step given the evidence available at the time. Those measures reshaped the category at the height of its adoption and set a high bar for the data that would be needed to revisit them.
That evidence eventually arrived. In February 2025, drawing on robust new cardiovascular outcomes data, the FDA updated the class-wide labeling and removed the cardiovascular boxed warning from all testosterone products — addressing what had been a significant barrier to physician confidence and patient access. Marius helped advance that change, having petitioned the FDA in September 2024 to revisit the boxed warning in light of the mounting safety evidence.
This week’s action carries that modernization forward, addressing the remaining limitation of use and narrowing the contraindications and warnings related to prostate health, while preserving appropriate screening and monitoring.
“What changed is not the medicine — it’s the strength and clarity of the evidence,” said Shah. “We made the scientific case for revisiting the boxed warning, and that update came in early 2025. This is the next step forward. Marius has always believed testosterone is central to overall health, and that patients deserve guidance grounded in the most current science. That conviction has defined this company from the beginning, and it defines the path ahead.”
Positioned at the center of the testosterone movement
Marius was built on the conviction that testosterone deficiency is a widespread, undertreated condition whose effects reach far beyond sexual health into metabolic vitality and overall well-being. For more than a decade, the company has invested in the clinical research, intellectual property, and physician and patient education needed to modernize how the therapy is understood and delivered.
As prescribing information aligns with the latest science, Marius intends to remain the category’s standard-bearer — partnering with clinicians, health systems, and innovators to expand access to evidence-based hormone care and ensure the next chapter of men’s health is built on modern science.
About Marius Pharmaceuticals
Marius Pharmaceuticals is a specialty pharmaceutical company focused on treating conditions associated with testosterone deficiency, commonly known as hypogonadism. The company’s mission is to improve patients’ functional lives and reduce the downstream effects of endocrine imbalance by advancing science-backed approaches to hormone health for both men and women. For more information, visit www.mariuspharma.com.
Media Contact
Lilly Washburn
lilly@mariuspharma.com
