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Drug intelligence / Profile preview
LPCN 1021 (Tlando) is an oral formulation of testosterone undecanoate developed by Lipocine Inc. for the treatment of male hypogonadism. It utilizes the proprietary Lip'ral technology, a lipid-based drug delivery system designed to enhance the oral bioavailability of testosterone undecanoate by promoting its absorption through the intestinal lymphatic system. This mechanism bypasses first-pass hepatic metabolism and reduces the significant food effect typically seen with oral testosterone, allowing for more consistent therapeutic levels. As a prodrug, testosterone undecanoate is converted into testosterone, the primary male sex hormone, which binds to the androgen receptor to maintain male secondary sexual characteristics, bone mass, and muscle strength. Tlando was approved by the FDA in March 2022 as a twice-daily oral replacement therapy for adult males with conditions associated with a deficiency or absence of endogenous testosterone.
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