Lipocine Inc. announced on October 7, 2026, that Health Canada has approved TLANDO (testosterone undecanoate) capsules for testosterone replacement therapy in adult males. The approval covers the treatment of conditions associated with a deficiency or absence of endogenous testosterone, known as male hypogonadism. The approval was granted through Lipocine’s licensing partner, Verity Pharmaceuticals Inc.
Under an exclusive license agreement established in January 2024, Verity Pharma holds the commercial rights to TLANDO in both the United States and Canada. The company is responsible for regulatory and commercialization obligations in these markets, as well as further development of the TLANDO franchise in North America. Verity Pharma plans to launch and commercialize the product in the Canadian market by the end of 2026.
According to the filing, the Canadian testosterone replacement therapy (TRT) market involves more than 700,000 prescriptions annually, with approximately 50% of patients covered by private insurance. Lipocine and Verity note that current market options, such as intramuscular injections and topical gels, often require dose titration and are associated with compliance issues. The companies believe the fixed-dose oral option offered by TLANDO provides a convenient alternative that may improve patient adherence.
The filing includes a detailed section on safety information, noting that TLANDO is contraindicated in patients with known hypersensitivity to the drug, men with known or suspected breast or prostate carcinoma, and women who are pregnant. The document also outlines warnings regarding potential cardiovascular risks, including increases in blood pressure and the potential for venous thromboembolic events.
