#Canada #Salt Lake City #Lipocine #TLANDO #TRT

Lipocine Announces New Drug Submission for TLANDO® in Canada

On June 9, 2025, Lipocine Inc. (NASDAQ: LPCN), a pioneering biopharmaceutical firm, revealed that their partner, Verity Pharma, has filed a New Drug Submission (NDS) for TLANDO® in Canada. TLANDO® is set to revolutionize the testosterone replacement therapy (TRT) market in Canada as it is the first and only oral TRT approved by the US Food and Drug Administration (FDA) that does not require dose titration, which typically complicates patient management.

A Strategic Move into a Promising Market

Canada's TRT market boasts over 700,000 annual prescriptions, emphasizing a substantial commercial opportunity for TLANDO. According to Mahesh Patel, CEO of Lipocine, the NDS filing marks a significant progression toward making TLANDO available to Canadian patients. He states, "We believe that, if approved, introducing this innovative oral TRT option could lead to considerable market gains."

A notable point is that nearly 50% of the TRT patient population in Canada is covered by private insurance, indicating a ready market. Given the relatively low promotion of existing TRT options, TLANDO holds a unique position to capture significant market share in this expanding sector.

TLANDO® and Its Benefits

The approval of TLANDO® in the United States has been a game changer for men experiencing testosterone deficiency due to conditions such as primary hypogonadism and hypogonadotropic hypogonadism. It was developed leveraging Lipocine's proprietary Lip’ral drug delivery technology platform, ensuring effective oral delivery of the active ingredient, testosterone undecanoate. This development posits TLANDO as an accessible solution for men who require TRT, enhancing both convenience and adherence to treatment compared to traditional therapies that involve injections or more complex dosing.

Future Outlook

In conjunction with the NDS filing, Lipocine and Verity Pharma entered into an exclusive licensing agreement in January 2024, granting Verity the rights to market TLANDO in the United States and Canada. The partnership positions both companies to capitalize on the growing TRT market while addressing unmet medical needs for patients struggling with testosterone deficiency.

As a biopharmaceutical company, Lipocine continues to explore additional partnerships and its range of clinical development candidates. Among these are treatments for postpartum depression, epilepsy, and obesity management, indicating the company's diverse pipeline focused on delivering innovative therapies to the market and beyond.

Conclusion

Overall, Lipocine's filing for TLANDO® in Canada represents a potential breakthrough for testosterone replacement therapy in the region. If the NDS is approved, it is expected to not only broaden the treatment options available to Canadian men suffering from testosterone deficiency but also to establish Lipocine as a frontrunner in the biopharmaceutical landscape, showcasing the impact of innovative oral therapeutic delivery methods. For more information regarding TLANDO and Lipocine's initiatives, please visit Lipocine.com.