Lipocine Inc. announced that Health Canada has approved TLANDO®, an oral testosterone replacement therapy (TRT), for adult males with hypogonadism. The approval was achieved through Lipocine's exclusive North American licensing partner, Verity Pharmaceuticals Inc., which will be responsible for the commercial launch in Canada.
Key Details
- Product Approval: TLANDO® (testosterone undecanoate) is now approved for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
- Commercialization Partner: Verity Pharmaceuticals holds the exclusive commercial rights for TLANDO in Canada and the U.S. and is planning a Canadian market launch by the end of 2026.
- Market Opportunity: The approval provides an oral treatment option in the Canadian TRT market, which currently has over 700,000 annual prescriptions and is primarily served by injections and topical gels.