#United States #FDA #Salt Lake City #Testosterone #Lipocine

Lipocine Inc. Announces Regulatory Progress in Testosterone Therapy

SALT LAKE CITY, March 12, 2025 – Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical firm that specializes in innovative oral delivery systems for drug therapies, is celebrating a significant regulatory milestone. The U.S. Food and Drug Administration (FDA) has communicated pivotal labeling changes for approved testosterone products, a crucial development for the industry and patient care.

The FDA's decision stems from extensive evaluations related to the TRAVERSE clinical trial, which investigated the impacts of Testosterone Replacement Therapy on cardiovascular health among hypogonadal men. Following a thorough review, it has been determined that the previous Boxed Warning regarding heightened cardiovascular risks can now be eliminated from the labels of testosterone products.

This update marks a transformative moment for both Lipocine and its prospective patients. The decision is not merely about reducing warnings but also encompasses a broader reintegration of positive trial findings into the subject products' marketing materials. This involves the incorporation of the TRAVERSE trial results in all testosterone product labels while keeping the limitations of use language focused on age-related hypogonadism. Furthermore, specific labeling concerning blood pressure increases from recent ambulatory blood pressure monitoring studies will now be mandatory.

Dr. Mahesh Patel, President and CEO of Lipocine, expressed enthusiasm about these changes, stating, “We are excited about these label modifications and the removal of the Boxed Warning. We foresee these updates benefiting not just our approved testosterone replacement therapy product but also advancing our candidates focused on obesity and liver disease treatments.” He emphasized that this development will ensure all stakeholders, including drug developers and regulators, are informed about the current evidence-based approaches to testosterone therapies.

Lipocine recently entered into an exclusive licensing agreement with Verity Pharma, allowing the latter to market Lipocine's testosterone product across the United States and, contingent upon approval, in Canada as well. This partnership marks a strategic move towards expanding the availability and acceptance of Lipocine's innovative therapeutic products.

In addition to their testosterone-based therapies, Lipocine is actively developing several unique products aimed at addressing various health concerns. These include LPCN 2401, which focuses on obesity management; LPCN 1148 intended for liver cirrhosis management; and LPCN 1144, which is being developed for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).

Lipocine's ambition extends into numerous therapeutic areas, with other clinical candidates being explored such as LPCN 1154, aimed at treating postpartum depression, and LPCN 2101, which targets epilepsy treatment.

This proactive approach not only enhances the therapeutic landscape but showcases Lipocine’s commitment to addressing significant unmet medical needs through better patient-centric solutions. The company’s ongoing exploration of partnership opportunities signals a strong belief in the potential of its innovations alongside a tangible strategy for success.

As Lipocine embraces this momentous regulatory change, they continue their mission to refine and redefine the possibilities within oral drug delivery systems. Their efforts reflect a broader trend within the pharmaceutical industry – focusing on not only meeting patient needs but also ensuring that advancements in regulations and technology support optimal patient outcomes.

For more information about Lipocine and its portfolio of products, please visit www.lipocine.com.

Conclusion

With the FDA's recent adjustments to labeling regulations, Lipocine stands poised for remarkable growth within the testosterone market and beyond. This clarity in product safety and efficacy will undoubtedly amplify confidence among patients and healthcare providers, paving the way for enhanced therapeutic adoption and success in managing complex health issues like hormonal imbalances.