Testosterone Replacement Therapy (TRT) has evolved from gels, patches, injections to oral formulations, offering patients another option.
This white paper summarizes answers to key questions addressed in a recently published review by Goldstein et al, Newer formulations of oral testosterone undecanoate: development and liver side effects. Sex Med Rev. 2025 Jan 31; 13(1):33‑40.
In this white paper, leading experts review breakthroughs in oral testosterone undecanoate (TU), including:
Liver safety: Clinical studies of oral TU formulations have consistently shown no clinically meaningful changes in liver function test results. No cases met Hy’s Law criteria, which are predictive of severe drug-induced liver injury (DILI). TLANDO is not a 17-alpha-alkyl androgen and is not known to produce hepatic adverse effects associated with 17-alpha-alkyl androgens. See hepatic adverse effects in the Prescribing Information for TLANDO.
Circumvention of first-pass liver metabolism: Oral TU’s are released into systemic circulation by the thoracic duct and converted to testosterone, predominantly avoiding absorption into the portal vein, and circumventing first-pass metabolism in the liver.
Enhanced absorption and bioavailability: Drug delivery systems used by TU formulations reduce reliance on high-fat meals for absorption.
Non-invasive alternative: Oral TU formulations offer a non-invasive alternative to injections and topical formulations, while eliminating the risk of transference.
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