Rani's 'Robotic Pill' for Obesity Enters Human Trials

SAN JOSE, CA – January 08, 2026 – In a move that could significantly alter the landscape of obesity treatment, Rani Therapeutics today announced the start of a Phase 1 clinical trial for RT-114, an oral capsule designed to deliver a next-generation weight-loss drug. The trial marks a critical step in the race to offer a convenient pill-based alternative to the blockbuster injectable medications that currently dominate the multi-billion-dollar market.

The study, initiated in collaboration with South Korean biotech ProGen, will evaluate the safety and efficacy of the RaniPill® capsule delivering PG-102, a promising GLP-1/GLP-2 dual agonist. This milestone places Rani at the forefront of innovation, aiming to solve one of the biggest challenges in modern medicine: delivering large-molecule biologic drugs orally.

The Quest for an Oral Revolution

The market for weight-loss therapies is experiencing explosive growth, largely fueled by the success of GLP-1 agonists like Novo Nordisk's Wegovy and Eli Lilly's Zepbound. These injectable drugs have proven highly effective, leading to a market projected to reach nearly $100 billion by 2030. However, their reliance on subcutaneous injections presents a significant hurdle for long-term patient adherence. Surveys have consistently shown a widespread aversion to needles, which can deter patients from starting or continuing chronic treatment.

This has ignited a fierce competition among pharmaceutical giants to develop an effective oral alternative. Novo Nordisk recently launched an oral version of its semaglutide drug, but it comes with a major caveat: it must be taken on an empty stomach with a mandatory 30-minute fast before consuming any other food or drink. This dosing inconvenience has been cited as a barrier to adoption for its diabetes counterpart, Rybelsus.

Meanwhile, Eli Lilly is advancing its own oral candidate, orforglipron, which has shown significant weight loss in late-stage trials and boasts the advantage of being taken at any time, with or without food. With a potential launch in 2026, orforglipron is poised to capture a significant share of the emerging oral market.

It is into this high-stakes environment that Rani Therapeutics introduces its unique approach. Rather than reformulating a small-molecule drug, Rani aims to deliver a complex biologic orally, a feat that has long been considered a holy grail in drug development.

A 'Robotic Pill' Meets a Dual-Action Drug

At the heart of Rani's strategy is the RaniPill®, an innovative capsule often described as a "robotic pill." Designed to withstand the harsh acidic environment of the stomach, the pill travels intact to the small intestine. Once there, it deploys a tiny, dissolvable needle to inject its drug payload directly into the highly vascular intestinal wall, a process designed to be painless. The drug is then rapidly absorbed into the bloodstream, mimicking the bioavailability of a traditional injection.

The payload for RT-114 is PG-102, a novel fc-fusion protein developed by ProGen. Unlike first-generation weight-loss drugs that target only the GLP-1 receptor, PG-102 is a dual agonist, activating both GLP-1 and GLP-2 receptors. This dual-action mechanism holds the potential for a more comprehensive therapeutic effect. While GLP-1 activation is known to regulate blood sugar and promote weight loss, GLP-2 activation has been linked in preclinical studies to reducing visceral fat—the dangerous fat surrounding internal organs—and potentially preserving lean muscle mass during weight loss.

Data presented by ProGen at the 2025 European Association for the Study of Diabetes (EASD) meeting highlighted PG-102's potential. In preclinical models, it not only demonstrated superior blood glucose-lowering effects compared to leading competitors but also showed a greater reduction in visceral fat. Furthermore, early human studies of an injectable version of PG-102 showed meaningful weight loss with a favorable side-effect profile, particularly lower rates of the gastrointestinal issues that can plague users of other GLP-1 drugs.

"The initiation of Phase 1 trial for RT-114 is an important step towards our vision of making oral biologics a reality," said Talat Imran, Chief Executive Officer of Rani, in a statement. "We believe that a tolerable and efficacious oral option has the potential to expand access, improve patient experience, and meaningfully reshape the obesity treatment paradigm."

A Strategic Alliance to Tackle a Global Epidemic

The development of RT-114 is underpinned by a strategic collaboration formed in June 2024 between Rani Therapeutics and ProGen. The partnership is a synergistic blend of Rani's groundbreaking oral delivery platform and ProGen's innovative drug candidate.

Under the terms of the agreement, the two companies will share development costs and any future profits or losses equally. This 50/50 structure, established without any upfront payments, signifies a deep, shared commitment to the program's success and a mutual belief in its transformative potential.

The collaboration also features a phased leadership model designed to leverage each company's strengths. Rani is spearheading development through the initial preclinical and Phase 1 stages. Should the program advance to Phase 2, Rani will lead development and commercialization in major Western markets, including the United States, Canada, Europe, and Australia. ProGen will take the lead in all other territories, ensuring a global strategy for the drug's rollout.

This partnership structure allows Rani to validate its RaniPill® platform in one of the most lucrative and high-profile therapeutic areas, while ProGen gains access to a revolutionary delivery system that could unlock the full potential of its lead asset.

The Path Forward and Market Hurdles

The newly initiated Phase 1 trial is the first crucial test for RT-114 in humans. Its primary goals are to establish the safety, tolerability, and pharmacokinetic profile of the oral formulation compared to a subcutaneous injection of PG-102. Success in this early stage would be a powerful signal, building on promising preclinical data where the RaniPill® achieved bioavailability comparable to an injection in animal models.

The road to market is long and fraught with challenges. The drug must still navigate larger, more complex Phase 2 and Phase 3 trials to prove its efficacy and safety in a broad population before it can seek regulatory approval. All the while, the competitive landscape will continue to evolve as established pharmaceutical giants and nimble biotechs alike pour resources into conquering the oral obesity market.

However, if RT-114 succeeds, the implications would be profound. For millions of patients, it could mean a simple, painless pill to manage a chronic condition, free from the burden of daily or weekly injections. For Rani Therapeutics, it would represent the ultimate validation of its platform technology, opening the door to applying the RaniPill® to a vast array of other biologic drugs currently limited to injectable formulations. The journey for RT-114 is just beginning, but it represents a significant leap toward a new era in the treatment of chronic disease.