testosterone undecanoate (Lipocine Inc, 4d94de)

LPCN 1021 (marketed as Tlando) is an oral testosterone replacement therapy (TRT) developed by Lipocine Inc. for the treatment of male hypogonadism. It is a proprietary oral formulation of testosterone undecanoate, a prodrug of testosterone. The drug utilizes Lipocine's lipid-based drug delivery technology, which is designed to enable the absorption of testosterone undecanoate via the intestinal lymphatic pathway, thereby bypassing first-pass hepatic metabolism and avoiding the need for 17-alpha alkylation. Once absorbed, testosterone undecanoate is converted into testosterone by non-specific esterases. Testosterone then binds to the androgen receptor to restore physiological levels in men with endogenous testosterone deficiency. LPCN 1021 was developed as a twice-daily oral capsule to overcome the limitations of other TRT modalities, such as the risk of secondary transfer associated with topical gels and the discomfort of injectable formulations. It received FDA approval in March 2022.

Brand names

Tlando

Other names

Oral testosterone undecanoate