Rani Therapeutics Holdings Inc（RANI）资讯与事件RANIRani Therapeutics Holdings Inc

Rani Therapeutics RaniPill Technology Accepted into FDA Program

Rani Therapeutics announced that the RaniPill Capsule platform technology has been accepted into the FDA Emerging Technology Program. The FDA's Emerging Technology Program, administered within the Agency's Center for Drug Evaluation and Research, is designed to support the development and implementation of innovative approaches to pharmaceutical product design and manufacturing.

Rani Therapeutics Reports RT-114 Oral Bioavailability Exceeds Expectations

"We made significant progress in the second quarter, as we continue to expand the RaniPill oral delivery platform," said Talat Imran, Chief Executive Officer of Rani Therapeutics. "We reported positive initial Phase 1a data for RT-114 showing oral bioavailability that exceeded matched subcutaneous dosing. These data are consistent with the bioavailability that we have seen in previous preclinical and clinical studies with the RaniPill. We have continued to advance the program in the clinic, with additional data from the dose expansion cohort expected by the end of 2026."

Rani Therapeutics Reports Initial Data on RT-114

Rani Therapeutics reported 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. 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 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. 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. Rani is expanding the Phase 1a study to include an additional cohort to further characterize the oral-to-subcutaneous pharmacokinetic relationship before advancing to the Phase 1b portion of the study. In this cohort, 15 healthy volunteers will each receive two separate 12 mg doses of PG-102 via the RaniPill. The data from this cohort are expected to inform dose selection for the planned Phase 1b portion of the study, which will assess the safety, tolerability and pharmacodynamic effect of eight weeks of repeat dosing with RT-114 in patients with obesity. The Phase 1b study is expected to begin in 2026, with data anticipated in 2027.