Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company focused on the development of novel oral therapeutics, today announced that, through Lipocine’s licensing partner Verity Pharmaceuticals Inc (Verity Pharma), Health Canada has approved TLANDO® (testosterone undecanoate) capsules for testosterone replacement therapy in adult males for the conditions associated with a deficiency or absence of endogenous testosterone (male hypogonadism). Verity Pharma holds exclusive commercial rights to TLANDO in North America and is planning for launch and commercialization in the Canadian market by the end of 2026.

Lipocine and Verity Pharma entered into an exclusive license agreement in January 2024 under which Verity Pharma gained commercial rights to TLANDO in the United States and Canada. Verity Pharma is responsible for regulatory and commercialization obligations in both markets and for further development of the TLANDO franchise in North America.