This section highlights FDA-related milestones and regulatory updates for drugs developed by Rani Therapeutics (RANI).
Over the past two years, Rani Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
RaniPill and RT-114. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
RaniPill FDA Regulatory Events
RaniPill is a drug developed by Rani Therapeutics for the following indication: For the treatment of obesity.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- RaniPill
- Announced Date:
- July 14, 2025
- Indication:
- For the treatment of obesity
Announcement
Rani Therapeutics Holdings, Inc announced that it will present preclinical data on the RaniPill® capsule at the Endocrine Society's Annual Meeting (ENDO 2025) taking place July 12-15 in San Francisco, CA.
AI Summary
Rani Therapeutics Holdings, Inc. announced that it will showcase preclinical data on its innovative RaniPill® capsule at the Endocrine Society’s Annual Meeting (ENDO 2025) in San Francisco, CA, from July 12-15, 2025. The presentation will detail the oral delivery of a bispecific GLP-1/GLP-2 receptor agonist (PG-102) using a robotic pill (RT-114). The data demonstrates that the capsule achieves bioequivalence to subcutaneous injections in canine studies. This study was presented as a poster during the session titled “Adipose Tissue, Appetite, and Obesity: From Breakthroughs to Real-World Challenges,” scheduled on July 14, 2025, from 12:00 PM to 1:30 PM PT. The research, led by Anvesh Dasari, PhD, highlights Rani’s commitment to developing novel oral dosing solutions for biologics and drugs, potentially transforming treatment approaches and patient care.
Read Announcement- Drug:
- RaniPill
- Announced Date:
- February 5, 2025
- Indication:
- For the treatment of obesity
Announcement
Rani Therapeutics Holdings, 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.
AI Summary
Rani Therapeutics recently released new preclinical data showing that oral semaglutide delivered via the RaniPill® capsule performs comparably to the traditional subcutaneous injection method. In a small study with canines, semaglutide given in the RaniPill® was absorbed as effectively as the injection, demonstrating similar pharmacokinetic measures such as Cmax, Tmax, and overall exposure (AUC). The study also observed comparable weight loss results and reductions in serum triglycerides and cholesterol between the two groups, with the capsule proving safe and well tolerated, showing no serious adverse events.
This evidence supports the potential of the RaniPill® platform to offer a more convenient, once-weekly oral treatment option for obesity. Rani Therapeutics plans to advance its obesity portfolio with a Phase 1 clinical trial for its GLP-1/GLP-2 dual agonist, RT-114, expected to begin in 2025.
Read Announcement
RT-114 FDA Regulatory Events
RT-114 is a drug developed by Rani Therapeutics for the following indication: For the treatment of obesity.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- RT-114
- Announced Date:
- March 26, 2025
- Indication:
- For the treatment of obesity.
Announcement
Rani Therapeutics Holdings, Inc. 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").
AI Summary
Rani Therapeutics Holdings, Inc. announced promising preclinical data for its RT-114, an orally administered GLP-1/GLP-2 dual agonist (PG-102) delivered via the RaniPill® capsule. In the study, RT-114 achieved a relative bioavailability of 111% compared to PG-102 given by subcutaneous injection, with comparable pharmacokinetic profiles. Both methods resulted in similar levels of weight loss, but RT-114 demonstrated less variability in its effects.
The findings suggest that RT-114, by matching the performance of its injectable counterpart, could offer a more patient-friendly option for obesity treatment by eliminating the need for injections. These results add to the growing evidence supporting the RaniPill® platform’s potential for oral delivery of obesity treatments. Rani plans to begin a Phase 1 clinical trial for RT-114 in mid-2025 to further explore its efficacy and safety in humans.
Read Announcement- Drug:
- RT-114
- Announced Date:
- June 24, 2024
- Indication:
- For the treatment of obesity.
Announcement
Rani Therapeutics Holdings, announced that it has entered into a definitive agreement with ProGen Co., Ltd. ("ProGen")(Konex: 296160), a South Korean clinical-stage biotech company developing next generation long-acting, multi-specific fusion protein therapeutics, for the co-development and commercialization of RT-114, an oral RaniPill® capsule containing ProGen's PG-102, a GLP-1/GLP-2 dual agonist, for the treatment of obesity.
AI Summary
Rani Therapeutics Holdings has signed a definitive agreement with South Korean biotech ProGen Co., Ltd. to co-develop and commercialize RT-114, an oral anti-obesity treatment. RT-114 utilizes Rani’s innovative RaniPill® capsule to deliver ProGen’s PG-102, a GLP-1/GLP-2 dual agonist, offering a potential alternative to subcutaneous injections. The collaboration is promising as PG-102 has a long half-life that may allow for convenient weekly dosing while potentially improving body composition and nutritional health through the unique action of GLP-2.
Under the agreement, both companies will equally share development costs and revenue worldwide, with Rani Therapeutics leading in the United States, Europe, Canada, and Australia, and ProGen managing the rest of the world. This partnership aims to create a first-in-class oral therapy for obesity, improving patient compliance and delivering impactful therapeutic benefits.
Read Announcement
