RT-114 / Rani Therap, ProGen - LARVOL DELTA

Rani Therapeutics Reports Second Quarter 2026 Financial Results; Provides Corporate Update (The Manila Times) - "Continues to advance RT-114 in the clinic with first participants dosed in the Phase 1a expansion cohort; additional data expected by end of 2026...Rani also announced today that the first participants have been dosed in the Phase 1a study expansion cohort of RT-114, an orally administered RaniPill Capsule delivering PG-102, a GLP-1/GLP-2 dual agonist being developed by ProGen Co., Ltd. The study was expanded to enroll fifteen additional healthy volunteers to provide a comprehensive pharmacokinetic dataset for the RaniPill HC as Rani moves toward initiating a Phase 1b repeat-dose study in patients with obesity by the end of 2026, with data anticipated in 2027."

New P1 trial • P1 data • Trial status • Obesity

Study Expansion and Next Steps (GlobeNewswire) - "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 (24 mg total administered dose). 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."

P1 data • Trial status • Obesity

Rani Therapeutics Announces Positive Initial Phase 1a Data for RT-114 for the Treatment of Obesity, with Oral Bioavailability Exceeding Matched Subcutaneous Dosing (GlobeNewswire) - "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....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."

P1 data • Obesity

Rani Therapeutics Reports First Quarter 2026 Financial Results; Provides Corporate Update; Announces CFO Transition (GlobeNewswire) - "Continued advancement of the ongoing Phase 1 study of RT-114 via RaniPill for the treatment of obesity in collaboration with ProGen. Rani continued advancement of the ongoing Phase 1 clinical trial evaluating the safety, tolerability, bioavailability and pharmacokinetics and pharmacodynamics of single and multiple doses of RT-114."

Trial status • Obesity

An Early Phase Study of RT-114 (RaniPill Containing PG-102, a GLP-1/2 Dual Agonist) in Healthy Volunteers. (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: RANI Therapeutics | Not yet recruiting ➔ Recruiting | Trial completion date: Apr 2026 ➔ Jun 2027 | Trial primary completion date: Mar 2026 ➔ Dec 2026

Enrollment open • Trial completion date • Trial primary completion date • Genetic Disorders • Obesity

Rani Therapeutics Initiates Phase 1 Study of RT-114 RaniPill for the Treatment of Obesity in Collaboration with ProGen (GlobeNewswire) - "A phase 1 study to evaluate safety, tolerability, bioavailability, pharmacokinetics, and weight loss of GLP-1/GLP-2 dual agonist, PG-102, administered orally via RaniPill capsule versus subcutaneous injection."

Trial status • Obesity

Near-Term Milestone Expectations (The Manila Times) - "Initiation of Phase 1 clinical trial of RT-114, our novel oral therapy targeting obesity, by the end of 2025. The upcoming trial will evaluate safety, tolerability, and pharmacokinetics, laying the groundwork for future development phases."

New P1 trial • Obesity

Oral Delivery Of A Bispecific GLP-1/GLP-2 Receptor Agonist (PG-102) Via A Robotic Pill (RT-114) Achieves Bioequivalence To Subcutaneous Injection In Canines (ENDO 2025) - "Moreover, targeted intestinal delivery via RT-114 may better mimic physiologic incretin release, potentially enhancing gut-brain pathway engagement. Collectively, these compelling nonclinical results provide a robust rationale for initiating clinical development of RT-114 as a first in class oral anti-obesity therapy."

Late-breaking abstract • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Progen-Rani Announces Preclinical Results of Oral GLP-1/GLP-2 Dual Agonist at ENDO [Google translation] (HIT News) - "Progen...announced on the 15th that it presented the preclinical results of RPG-102 (RT-114, oral PG-102), an oral GLP-1/GLP-2 dual-action obesity treatment drug being jointly developed with Rani Therapeutics in the United States, at the Endocrine Society's annual meeting (ENDO 2025) on the 14th...According to the company, RPG-102 recorded an average bioavailability of 111% compared to the injection in the beagle dog model, and the weight loss effect was at the same level as the injection at an average of -6.7%. In particular, the standard deviation of the oral administration group was ±1.4%, which was lower than that of the injection administration group (±5.4%), indicating a more consistent expression of drug efficacy....In oral formulations, RPG-102 successfully induced in vivo exposure in 90% of the administered groups, and a positive correlation was confirmed between blood PG-102 concentrations and appetite suppression effects."

Preclinical • Obesity

Rani Therapeutics Reports First Quarter 2025 Financial Results; Provides Corporate Update (GlobeNewswire) - "Near-Term Milestone Expectations: Initiation of Phase 1 clinical trial of RT-114 for the treatment of obesity expected in mid-2025."

New P1 trial • Obesity

Rani Therapeutics Announces Preclinical Data Demonstrating Bioequivalence of RT-114, a GLP-1/GLP-2 Dual Agonist (PG-102) Delivered Orally via the RaniPill Capsule, to Subcutaneously Administered PG-102 (GlobeNewswire) - "Rani Therapeutics Holdings...today announced pharmacokinetic and pharmacodynamic data from a preclinical study evaluating RT-114, a GLP-1/GLP-2 dual agonist (PG-102). PG-102 delivered orally via the RaniPill capsule demonstrated comparable bioavailability and weight loss to subcutaneously (SC) injected PG-102 ('SC PG-102'). PG-102 is ProGen Co., Ltd’s ('ProGen') Fc-fusion protein conjugated GLP-1/GLP-2 dual agonist."

Preclinical • Obesity

Progen, 'GLP-1/GLP-2' Obesity Phase 1 "Preliminary Efficacy Confirmed" [Google translation] (Biospectator) - P1 | N=34 | "ProGen announced on the 25th that it confirmed the weight loss effect and tolerability in the phase 1 repeated dose clinical trial (Part C) of the next-generation obesity and diabetes treatment candidate 'PG-102'...Efficacy evaluation results showed that patients in Cohort 2 showed an average weight loss of 4.8% and a maximum weight loss of 8.7% at week 5...Safety assessment results showed that nausea occurred in less than 30% of patients, diarrhea in less than 20% of patients, and no cases of vomiting were reported...ProGen plans to present the safety, tolerability, and weight loss results from the Phase 1 clinical trial of PG-102 through an oral presentation at the Asian Association for the Study of Diabetes (AASD 2025)....ProGen plans to submit an Investigational New Drug (IND) phase 1 clinical trial plan for 'RPG-102 (RT-114),' an oral obesity treatment drug being jointly developed with Rani Therapeutics in the United States, in the first half of this year."

IND • New P1 trial • P1 data • Diabetes • Obesity

An Early Phase Study of RT-114 (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: RANI Therapeutics

New P1 trial • Genetic Disorders • Obesity

Rani Therapeutics Announces Preclinical Data Demonstrating Successful Oral Delivery of Semaglutide via RaniPill HC (GlobeNewswire) - "Rani Therapeutics Holdings...today announced new pharmacokinetic and pharmacodynamic data from a preclinical study evaluating the oral delivery of the glucagon-like peptide-1 receptor (GLP-1) agonist semaglutide administered via the RaniPill capsule....Eight canines were randomized into two groups who received 0.5mg of semaglutide delivered via oral administration of the RaniPill HC (N=4) or subcutaneous injection (N=4)....Semaglutide was successfully delivered in 7 of 8 canines that received the RaniPill capsule. Semaglutide administered via the RaniPill capsule was well tolerated with no serious adverse events....Initiation of Phase 1 clinical trial of RT-114 containing a GLP-1/GLP-2 dual agonist for the treatment of obesity expected in 2025."

New P1 trial • Preclinical • Metabolic Disorders • Obesity