Lipocine announces Health Canada approval of TLANDO for testosterone replacement therapy

SALT LAKE CITY, Oct. 7, 2026 // -- 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(R) (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. "Men with low testosterone in Canada have been served largely by injections and topical gels, and Health Canada's approval of TLANDO means they will have access to a convenient oral option without needing dose titration," said Dr. Mahesh Patel, President and Chief Executive Officer of Lipocine. "This approval represents an important step in expanding the geographic reach of TLANDO and further validates the value of Lipocine's partnered commercial strategy. We look forward to supporting Verity as it prepares for launch in Canada." "Health Canada's approval of TLANDO gives Canadian men with hypogonadism and their physicians a new oral treatment option with a simple, fixed dosing regimen that does not require dose titration," said Dr. Neil Flesher, Chief Medical Officer of Verity Pharma. "Starting and managing testosterone therapy can be complicated for both patients and prescribers, and a fixed dose can make treatment easier to start. We value our partnership with Lipocine and look forward to making TLANDO available to patients across Canada." 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. The Canadian TRT Market More than 700,000 prescriptions are written annually in Canada for TRT, and approximately 50% of this patient population is covered through private insurance. Promotional activity surrounding currently available TRT products in Canada is limited, which Lipocine believes creates an opportunity for TLANDO to capture a meaningful share of this large and growing market. Intramuscular injections hold the largest share of TRT prescriptions. Topical gels are also widely used but carry a risk of transference to others and are messy to apply. Both injections and topical gels require titration and have been associated with compliance issues and high rates of discontinuation. Lipocine believes a safe and effective oral therapy without a titration requirement can improve patient convenience and compliance while eliminating the transference risk of gels and the injection site reactions associated with injectab