Rani Therapeutics Announces Acceptance into U.S. FDA's Emerging Technology Program (ETP)
Key Highlights
- ➤RaniPill accepted into FDA’s Emerging Technology Program for innovative pharmaceutical technologies
- ➤FDA engagement may include pre-submission meetings and potential site visits
- ➤Program interactions can address RaniPill’s broader platform applicability beyond individual drug products
- ➤Rani plans to automate vertically integrated manufacturing ahead of broader clinical use
Expert Statements
Talat Imran, Chief Executive Officer of Rani Therapeutics
“Our acceptance into the FDA's Emerging Technology Program reflects the Agency's recognition of the RaniPill(®) platform as a novel and innovative approach to the oral delivery of biologics”
Talat Imran, Chief Executive Officer of Rani Therapeutics
“This program enables direct, collaborative access to the FDA on a technology as novel as Rani’s, and we expect that engagement to be especially valuable as we work to automate our vertically integrated manufacturing process in anticipation of broader clinical use.”
Talat Imran, Chief Executive Officer of Rani Therapeutics
“Combined with our rare disease, immunology, and obesity focused partnerships with Chugai, ProGen and PegBio, this milestone reflects our continued confidence in the RaniPill platform's potential as an alternative to injectable biologics.”
Talat Imran, Chief Executive Officer of Rani Therapeutics
“We look forward to working closely with the FDA as we continue to advance the platform.”
SAN JOSE, Calif., Oct. 05, 2026 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on oral delivery of biologics, today announced that the RaniPill(®) Capsule™ platform technology has been accepted into the U.S. Food and Drug Administration (FDA) Emerging Technology Program (ETP).
The FDA’s Emerging Technology Program, administered within the Agency’s Center for Drug Evaluation and Research (CDER), 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 provides Rani 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. Importantly, these interactions can address the broader applicability of the underlying technology rather than being limited to individual drug products.
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