SAN JOSE, Calif. — October 5, 2026
Rani Therapeutics Holdings, Inc. announced that its RaniPill® Capsule™ platform technology has been accepted into the U.S. Food and Drug Administration (FDA) Emerging Technology Program (ETP). The program provides early engagement with the FDA’s Emerging Technology Team to address technical and regulatory considerations for innovative pharmaceutical technologies. For Rani, the acceptance is intended to support the continued development of its oral delivery platform for biologics and drugs.
FDA Program Supports Early Regulatory Engagement
The FDA Emerging Technology Program is administered through the Center for Drug Evaluation and Research (CDER) and is designed to support innovative approaches to pharmaceutical product design and manufacturing. Technologies accepted into the program must have the potential to improve pharmaceutical product quality and include novel elements for which the FDA has limited review or inspection experience. Rani said participation will enable direct discussions with the FDA through pre-submission meetings and potential site visits, with the engagement potentially addressing the broader RaniPill technology rather than being limited to individual drug products.
RaniPill Targets Oral Delivery of Biologics
RaniPill® Capsule™ is a proprietary and patented platform designed to potentially replace subcutaneous injections or intravenous infusions with oral administration of biologics and drugs. The technology is being developed to overcome challenges associated with delivering biologic medicines orally, an area that could expand treatment options for patients who currently rely on injectable therapies. Rani has conducted multiple preclinical and clinical studies evaluating the safety, tolerability and bioavailability of medicines delivered using the RaniPill platform.
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FDA Engagement Supports Manufacturing and Partnership Strategy
Rani Therapeutics expects the FDA engagement to be particularly valuable as it works to automate its vertically integrated manufacturing process in preparation for broader clinical use. The company is also advancing partnerships involving the RaniPill platform across rare disease, immunology and obesity, including collaborations with Chugai, ProGen and PegBio. Rani said the FDA’s recognition of the platform through the Emerging Technology Program provides an opportunity to address regulatory and technical considerations as the technology progresses toward broader clinical application. The ETP acceptance represents a regulatory milestone for Rani as it seeks to establish oral delivery as an alternative to injectable administration for biologics.
Source:Rani Therapeutics, press release
