RANI THERAPEUTICS HOLDINGS INC

Rani Therapeutics Holdings, Inc. is a clinical-stage biopharmaceutical company whose core technology, the RaniPill, is a robotic pill designed to deliver biologic drugs orally. The development of this platform relies on preclinical animal testing. The company's public filings, including its 10-K and 10-Q reports, explicitly reference conducting Good Laboratory Practice (GLP) studies involving the repeat oral administration of its drug delivery platform to animals over extended periods, such as 60 days, to evaluate safety and tolerability.

This animal testing is a central and required component of the company's regulatory pathway. Rani Therapeutics states that its animal studies require pre-approval by an Institutional Animal Care and Use Committee (IACUC). As a company whose entire pipeline is predicated on bringing new drug delivery systems to market, animal testing constitutes a fundamental and ongoing part of its research and development operations.