Lipocine Inc. is a clinical-stage pharmaceutical company focused on the development and commercialization of oral drug delivery technologies. The company’s core expertise lies in lipid-based formulations designed to improve the bioavailability of therapeutics that traditionally require injectable administration. By leveraging proprietary technologies, Lipocine aims to offer patient-friendly alternatives with the potential for more consistent pharmacokinetic profiles and improved compliance.
The company’s lead product, TLANDO (LPCN 1021), is an oral testosterone replacement therapy approved by the U.S. Food and Drug Administration for the treatment of male hypogonadism. In parallel, Lipocine is advancing LPCN 1144, an oral formulation of testosterone undecanoate, for the treatment of nonalcoholic steatohepatitis (NASH) and related metabolic disorders. Ongoing clinical studies seek to confirm the safety and efficacy of these candidates while exploring additional indications that may benefit from Lipocine’s delivery platforms.
Headquartered in Salt Lake City, Utah, Lipocine serves a global market, conducting operations and clinical trials primarily in the United States but also engaging with partners and regulators in Europe and Asia. The organization maintains research collaborations and licensing discussions to extend the reach of its technologies and to explore new therapeutic areas. Its facilities support formulation development, analytical testing, and scale-up processes needed to transition products from the laboratory to commercial manufacture.
Since its founding in 1996, Lipocine has been led by Chief Executive Officer William D. Kaan, who has guided the company through pivotal clinical milestones and regulatory submissions. Under his leadership, Lipocine continues to pursue a strategic path toward product approvals, commercialization partnerships, and the expansion of its lipid-based delivery platforms. The company’s management team comprises experienced professionals in pharmaceutical development, regulatory affairs, and corporate strategy, all dedicated to delivering innovative therapies that improve patient outcomes.
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