RT-114 achieved systemic exposure greater than 150% relative to a matched 12mg subcutaneous dose of PG-102
No adverse events attributed to RaniPill Capsule; treatment-related adverse events were mild and consistent with the GLP-1/GLP-2 agonist class of therapeutics
Phase 1a study expanded with an additional cohort to further define the oral-to-subcutaneous pharmacokinetic relationship ahead of a planned Phase 1b repeat-dose study in patients with obesity
SAN JOSE, Calif., July 15, 2026 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on oral delivery of biologics, today reported positive initial data from the ongoing Phase 1 study of RT-114, an orally administered RaniPill® Capsule delivering PG-102, a GLP-1/GLP-2 dual agonist being developed by ProGen Co., Ltd. ("ProGen"). The initial data demonstrated that oral RT-114 achieved systemic exposure exceeding that of matched subcutaneous administration, with a safety and tolerability profile consistent with the GLP-1/GLP-2 agonist class of therapeutics.
"The safety and bioavailability findings reported today exceeded our expectations and represent an important milestone for the RaniPill® platform," said Talat Imran, Chief Executive Officer of Rani. "We have previously demonstrated that the RaniPill® can orally deliver a broad range of biologics across multiple therapeutic areas. With RT-114, we have now extended that capability into obesity and metabolic disease while achieving systemic exposure well above that of the matched subcutaneous dose. At a time when many oral biologic delivery technologies continue to produce only a small fraction of subcutaneous exposure, these data reinforce the unique potential of the RaniPill® platform."
Phase 1a Study Design and Results
The ongoing Phase 1a study is evaluating the safety, tolerability, bioavailability, pharmacokinetics and pharmacodynamics of RT-114 relative to subcutaneous PG-102. In the single-dose, open-label Phase 1a portion of the study, 30 healthy volunteers were randomized to receive an identical 12 mg dose of PG-102, delivered either orally via RT-114 or by subcutaneous injection.
Key Findings:
No serious adverse events were reported in either arm, and no adverse events were attributed to the RaniPill® Capsule itself.
Treatment-related adverse events, including nausea, vomiting and diarrhea, were mild, transient and consistent with the known profile of GLP-1/GLP-2 dual agonists.
Oral RT-114 achieved bioavailability greater than 150% relative to a matched subcutaneous dose of 12 mg PG-102.
Elimination half-life was similar between arms: 5.6 days for oral RT-114 versus 5.3 days for subcutaneous PG-102.