Lipocine Wins Health Canada Approval for TLANDO

SALT LAKE CITY, October 7, 2026

TLANDO Expands Oral Testosterone Treatment Options

The Health Canada approval of TLANDO provides Canadian physicians and eligible patients with an oral testosterone replacement option alongside existing injectable and topical approaches. According to Lipocine, men with low testosterone in Canada have traditionally been served largely by intramuscular injections and topical gels, while TLANDO offers an oral alternative with a fixed dosing regimen that does not require dose titration. The company said the approval represents an important step in expanding TLANDO’s geographic reach and supports its partnered commercial strategy. Verity Pharma, which holds exclusive commercial rights to TLANDO in North America, is responsible for regulatory and commercialization activities in the United States and Canada. The Canadian testosterone replacement therapy market represents a significant commercial opportunity. Lipocine estimates that more than 700,000 prescriptions are written annually in Canada for TRT, with approximately half of the patient population covered through private insurance. The company also points to the established use of injectable and topical testosterone products, while noting limitations associated with administration and treatment management. According to the release, injections and topical gels can require titration, while topical products may present a transference risk and can be inconvenient to apply. TLANDO’s oral formulation and fixed dosing approach are positioned by the company as potential advantages for treatment convenience and adherence.

TLANDO Targets Men With Confirmed Hypogonadism

Under its Canadian approval, TLANDO is indicated for testosterone replacement therapy in adult males with conditions associated with a deficiency or absence of endogenous testosterone. The company emphasizes that testosterone deficiency must be appropriately established before treatment. The product should not be used for nonspecific symptoms suggestive of hypogonadism when testosterone deficiency has not been demonstrated and other potential causes have not been excluded. The Canadian product information states that deficiency should be supported by clinical features and confirmed through two separate validated morning testosterone assays before testosterone replacement therapy is initiated. The approval also comes with important safety considerations for healthcare professionals. TLANDO is contraindicated in certain populations, including men with known or suspected breast or prostate cancer, as well as individuals with hypersensitivity to the drug or its ingredients. The product information also includes warnings concerning cardiovascular risk, blood pressure, hematocrit, prostate health and venous thromboembolic events. Patients receiving testosterone replacement therapy require appropriate medical assessment and ongoing monitoring to evaluate treatment response and potential adverse effects.

Verity Pharma Prepares for Canadian Commercial Launch

Lipocine and Verity Pharma entered an exclusive license agreement in January 2024, granting Verity commercial rights to TLANDO in the United States and Canada. Under the agreement, Verity Pharma is responsible for regulatory and commercialization obligations in both markets, as well as further development of the TLANDO franchise in North America. Following the Health Canada authorization, Verity plans to prepare for commercial availability in Canada by the end of 2026. TLANDO adds to Lipocine’s broader portfolio of oral therapeutic programs built around its proprietary drug-delivery technology platform. The company is developing additional candidates across areas including postpartum depression, major depressive disorder, epilepsy, essential tremor, obesity management, liver cirrhosis and prevention of preterm birth. The Canadian approval therefore represents both a regulatory milestone for TLANDO and another step in Lipocine’s strategy of advancing oral therapies and using partnerships to support commercialization.

Source: Lipocine Labs press release