April 16 (Reuters) – The U.S. Food and Drug Administration is considering approving testosterone replacement therapy to treat low sex drive in men whose bodies do not produce enough of the hormone for no known reason, according to a federal notice filed on Thursday.
Currently, testosterone therapy is only approved for men with low hormone levels linked to a known structural or genetic cause. The proposed move would expand use to a broader group of men with low testosterone levels linked to inadequate testicular function with no known underlying cause, a condition known as idiopathic hypogonadism.
• The agency said early reviews of published medical research look promising and has invited drugmakers who sell FDA-approved testosterone products to come forward and apply for expanded approval by April 30.
• “New and emerging data suggest there may be an opportunity to help men suffering from symptoms that significantly affect quality of life,” FDA Commissioner Marty Makary said in a statement.
• The FDA held an expert panel discussion on the topic in December 2025, where specialists weighed the potential benefits and risks of widening the therapy’s use.
• The health regulator stressed that final approval would require rigorous scientific evidence and a comprehensive review of risks versus benefits.
(Reporting by Kamal Choudhury in Bengaluru)
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