Marius Pharmaceuticals backs FDA proposal to revise testosterone therapy warnings

# FDA Moves to Update Testosterone Therapy Guidelines as New Evidence Reshapes Men’s Health Treatment

Marius Pharmaceuticals has welcomed a major regulatory shift by the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) that could significantly change how testosterone replacement therapies are prescribed across the United States.

Announced during Men's Health Month, the proposed revisions reflect more than a decade of accumulating scientific evidence on testosterone therapy and its long-term safety.

The FDA plans to remove longstanding language from prescribing information stating that the safety and effectiveness of testosterone therapy for age-related low testosterone had not been established.

The agency also intends to revise warnings related to prostate cancer risk and update safety information concerning enlarged prostate conditions, commonly known as benign prostatic hyperplasia.

READ: Fixing metabolic health through hormones: Marius CEO on Kyzatrex and testosterone deficiency (February 21, 2025)

The proposed changes follow an extensive review of newer clinical evidence, including a large cardiovascular outcomes trial involving more than **5,200 men**.

According to the FDA, the study found no significant increase in serious cardiovascular events among patients receiving testosterone replacement therapy compared with those who did not receive treatment.

The latest action represents the next phase of a regulatory review that began more than a decade ago.

In 2014, the FDA launched an investigation into potential cardiovascular risks associated with testosterone therapy and convened an advisory committee to evaluate available scientific evidence.

The following year, the agency introduced restrictions on testosterone products intended for men with age-related low testosterone because clinical evidence at that time remained limited.

Since then, numerous long-term clinical studies have expanded understanding of testosterone deficiency and its treatment.

Earlier in February 2025, the FDA removed its boxed warning regarding cardiovascular risks after reviewing updated safety data but maintained restrictions concerning age-related testosterone deficiency.

The newly proposed revisions would eliminate that remaining language while modernizing prescribing information to better reflect current scientific evidence.

Marius Pharmaceuticals Chief Executive Officer **Shalin Shah** described the announcement as an important milestone for evidence-based men's healthcare.

"This is a defining moment for evidence-based men's health," Shah said, adding that physicians and patients previously lacked clear guidance because research was still evolving.

He noted that the medicine itself has not fundamentally changed, but the amount and quality of clinical evidence supporting its use has grown substantially over time.

READ: Testosterone doses help men ward off heart disease, prolong life: study by cardiologist Dr. Rajat Barua (August 11, 2015)

Shah previously presented clinical evidence supporting testosterone therapy before an FDA advisory committee reviewing the treatment.

Marius Pharmaceuticals manufactures **Kyzatrex**, an FDA-approved oral testosterone replacement therapy developed for men diagnosed with testosterone deficiency.

Medical experts estimate that approximately **20 million American men between the ages of 25 and 75** experience low testosterone levels.

Despite its prevalence, healthcare professionals say hypogonadism remains significantly underdiagnosed and undertreated across the United States.

Untreated testosterone deficiency has been associated with reduced energy levels, decreased muscle mass, metabolic disorders, cardiovascular complications, diminished sexual health, and an overall decline in quality of life.

Many endocrinologists argue that appropriate diagnosis and treatment can improve both patient well-being and long-term health outcomes.

Marius Pharmaceuticals said it plans to continue working closely with healthcare providers, hospitals, and medical professionals as the FDA finalizes updated prescribing information.

If adopted, the revised guidance would represent one of the most significant regulatory updates for testosterone replacement therapy in years and could influence how physicians evaluate and treat millions of men experiencing testosterone deficiency across the country.