Health Canada approves Lipocine's TLANDO for testosterone replacement therapy

Lipocine Inc. (NASDAQ: LPCN) said on October 7, 2026 that Health Canada has approved TLANDO (testosterone undecanoate) capsules for testosterone replacement therapy in adult males whose condition stems from a deficiency or absence of endogenous testosterone, known as male hypogonadism. The approval came through Lipocine's licensing partner, Verity Pharmaceuticals Inc (Verity Pharma).¹

Verity Pharma controls exclusive commercial rights to TLANDO across North America and is working toward bringing the product to the Canadian market before 2026 ends.¹ The companies signed an exclusive licensing deal in January 2024 that gave Verity Pharma rights to commercialize TLANDO in both the United States and Canada.¹ Under that agreement, Verity Pharma handles regulatory filings and commercialization in both countries, along with ongoing development of the TLANDO franchise across North America.¹

Lipocine CEO Mahesh Patel said the approval gives Canadian men with low testosterone a new oral option. He noted that these patients have mainly relied on injections and topical gels, and that TLANDO offers a convenient oral alternative without dose titration.¹

Describing the Canadian market opportunity, the company said more than 700,000 TRT prescriptions are written annually in Canada, with roughly half of patients covered by private insurance.¹ Injections currently hold the largest share of prescriptions, while topical gels remain widely used despite carrying transference risk and messiness.¹

TLANDO, Lipocine's oral prodrug of testosterone built on testosterone undecanoate, is already approved by the FDA for hypogonadism in adult males in the United States.¹ The Health Canada approval marks its first regulatory clearance outside the U.S. under the Verity Pharma partnership.