RT-114 / Rani Therap, ProGen - LARVOL DELTA

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