RT-114

July 15, 2026: Rani Therapeutics Holdings, Inc. (NASDAQ: RANI) reported positive initial data from an ongoing Phase 1 study of RT-114, an oral RaniPill Capsule delivering PG-102 (a GLP-1/GLP-2 dual agonist from ProGen) being developed for obesity. In the single-dose, open-label Phase 1a portion, 30 healthy volunteers received a 12 mg dose of PG-102 either orally via RT-114 or by subcutaneous injection. Oral RT-114 achieved systemic exposure/bioavailability >150% relative to the matched 12 mg subcutaneous dose. No serious adverse events occurred in either arm, no adverse events were attributed to the RaniPill Capsule, and treatment-related adverse events (e.g., nausea, vomiting, diarrhea) were mild, transient, and consistent with the GLP-1/GLP-2 class. Elimination half-life was similar (5.6 days oral vs 5.3 days subcutaneous).

Rani is expanding Phase 1a with an additional cohort (15 healthy volunteers) receiving two separate 12 mg oral doses (24 mg total) to further characterize oral-to-subcutaneous pharmacokinetics and inform dose selection for a planned Phase 1b repeat-dose study (8 weeks) in patients with obesity, expected to begin in 2026 with data anticipated in 2027.