Home » FDA Approves Oral Testosterone Treatment for Hypogonadism
FDA Approves Oral Testosterone Treatment for Hypogonadism
March 31, 2022
The FDA has approved Antares Pharma’s oral testosterone replacement therapy Tlando (testosterone undecanoate) for adult males with hypogonadism.
The approval was based on results from a phase 3 clinical trial in 95 males with the condition who received 225 mg of Tlando orally twice daily for approximately 24 days. Eighty percent of the participants in the study achieved normal testosterone levels.
Antares acquired exclusive rights to Tlando from Salt Lake City, Utah-based Lipocine in October 2021 as part of a $21 million licensing deal.
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