Rani Therapeutics Accepted into FDA’s Emerging Technology Program

SAN JOSE, Calif., Oct. 05, 2026 /CourierPR/ -- Rani Therapeutics, a clinical-stage biotherapeutics company focused on oral delivery of biologics, has announced its acceptance into the U.S. Food and Drug Administration’s (FDA) Emerging Technology Program (ETP). The RaniPill® Capsule™ platform technology, which aims to replace subcutaneous injection or intravenous infusion of biologics and drugs with oral dosing, has been selected for this program.

The FDA’s ETP is designed to support the development and implementation of innovative approaches to pharmaceutical product design and manufacturing. Technologies accepted into the program must demonstrate the potential to improve pharmaceutical product quality and incorporate novel elements for which the FDA has limited review or inspection experience. Participation in the ETP provides Rani Therapeutics with early, direct engagement with the FDA’s Emerging Technology Team to address technical and regulatory considerations related to the RaniPill platform, including through pre-submission meetings and potential site visits.

Rani Therapeutics has developed the RaniPill® Capsule™, a novel, proprietary, and patented platform technology intended to replace subcutaneous injection or intravenous infusion of biologics and drugs with oral dosing. The company has successfully conducted several preclinical and clinical studies to evaluate safety, tolerability, and bioavailability using RaniPill® Capsule technology.

The company’s acceptance into the ETP is part of a broader strategy to address unmet needs in the treatment of patients requiring injectable biologics. Rani Therapeutics is currently focused on rare disease, immunology, and obesity, with partnerships in place with Chugai, ProGen, and PegBio. These partnerships are expected to further enhance the potential of the RaniPill platform.

Forward-looking statements in the press release include the potential of Rani’s RaniPill® platform to convert injectable biologics into oral therapies and to address unmet needs in the treatment of patients requiring injectable biologics. The company also anticipates that the engagement with the FDA under the ETP will be valuable as it works to automate its vertically integrated manufacturing process in anticipation of broader clinical use. These statements are based on management’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those expressed or implied by such forward-looking statements.

Rani Therapeutics’ annual report on Form 10-K for the year ended December 31, 2025, and subsequent filings will provide further details on the company’s financial and operational performance.