Lipocine Inc.

Lipocine Inc. is a clinical-stage biopharmaceutical company whose core business model involves developing oral drug candidates, which inherently requires animal testing for preclinical development and regulatory compliance. The company’s public SEC filings explicitly state that its drug development process includes the “completion of preclinical laboratory tests and animal studies.” This reliance on animal models is a standard, integral component of bringing pharmaceutical products to market. Lipocine’s lead commercial product, TLANDO® (testosterone undecanoate), carries an FDA-mandated warning that its teratogenic risk assessment is “based on data from animal studies,” confirming the use of animal data in its regulatory approval and ongoing safety labeling. As a company whose pipeline and approved products are built on this research methodology, Lipocine systematically commissions and relies on animal testing.