Rani Therapeutics Initiates Phase 1 Study of RT-114 RaniPill® for the Treatment of Obesity in Collaboration with ProGen
Rhea-AI Summary
Rani Therapeutics (Nasdaq: RANI) initiated a Phase 1 clinical trial on Jan 8, 2026 to evaluate RT-114, an oral RaniPill® capsule delivering PG-102, a GLP-1/GLP-2 dual agonist developed by ProGen, for the treatment of obesity.
The single- and multiple-dose study will assess safety, tolerability, bioavailability, pharmacokinetics, and pharmacodynamics including weight-loss signals versus subcutaneous injection. Preclinical RT-114 data showed oral delivery with bioavailability, PK, and weight-loss comparable to subcutaneous dosing. ProGen previously reported preclinical and early clinical glucose-lowering and weight-loss signals for PG-102 at EASD 2025.
Positive
- Phase 1 trial of RT-114 officially initiated on Jan 8, 2026
- Oral delivery platform tested: RaniPill® delivers PG-102 orally
- Preclinical RT-114 showed comparable bioavailability to subcutaneous dosing
- Strategic collaboration with ProGen on PG-102 dual agonist
Negative
- Clinical program remains early-stage: Phase 1 focuses on safety and PK
- No human efficacy results yet for oral RT-114 in obesity
News Market Reaction
On the day this news was published, RANI declined NaN%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Market Reality Check
Peers on Argus
RANI gained 0.72% ahead of the Phase 1 RT-114 update, while all listed biotech peers (ESLA, ANTX, MRSN, SNTI, JSPR) also showed gains between 0.62% and 7.89%, indicating a supportive sector backdrop in addition to the company-specific catalyst.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 24 | Conference participation | Neutral | +1.8% | Management participation at Evercore healthcare conference with webcast access. |
| Nov 06 | Earnings and update | Positive | -9.2% | Q3 results, Chugai deal, private placement and RT-114 Phase 1 timing. |
| Oct 30 | Clinical data preview | Positive | -12.7% | Preclinical data on oral semaglutide via RaniPill at ObesityWeek 2025. |
| Oct 23 | Board changes, financing | Positive | -13.5% | New directors appointed and closing of a significant private placement. |
| Oct 23 | Private placement | Positive | -13.5% | Closing of oversubscribed $60.3M private placement with warrants. |
Recent RANI news with positive or strategic content has often been followed by negative price reactions, suggesting a pattern of selling into good news.
Over the last few months, Rani highlighted strategic and financing milestones, including a collaboration and license agreement potentially worth up to $1.085 billion, an oversubscribed $60.3 million private placement, and plans to initiate a Phase 1 trial of RT-114 by end of 2025. Preclinical data on oral semaglutide via the RaniPill® capsule showed bioequivalence to subcutaneous dosing with similar weight loss. Despite these developments, several announcements in October–November 2025 coincided with double‑digit percentage share price declines, contrasting with today’s modestly positive move on the RT-114 Phase 1 initiation.
Regulatory & Risk Context
An effective S-3 shelf filed on 2025-11-07 registers up to 250,000,008 Class A shares for resale by existing holders. The company itself is not selling shares and would only receive cash, up to about $60 million, if outstanding warrants at a $0.48 exercise price are exercised. This structure allows stockholders to resell shares without directly raising new primary capital for Rani.
Market Pulse Summary
This announcement marks the clinical start of RT-114, delivering ProGen’s GLP-1/GLP-2 dual agonist PG-102 orally via the RaniPill® capsule in obesity. It follows prior preclinical data suggesting oral delivery can match subcutaneous injection on bioavailability and weight loss. Recent history includes sizable financing, a Chugai collaboration, and governance changes. Investors may watch Phase 1 safety, pharmacokinetics, and weight‑loss readouts, as well as any warrant‑driven share resales under the existing S-3 registration.
Key Terms
Phase 1 medical
bioavailability medical
pharmacokinetics medical
pharmacodynamics medical
GLP-1/GLP-2 dual agonist medical
fc-fusion protein medical
subcutaneous injection medical
AI-generated analysis. Not financial advice.
- 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 -
SAN JOSE, Calif., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today announced the initiation of a Phase 1 clinical trial to evaluate the safety, tolerability, bioavailability, and pharmacokinetics and pharmacodynamics of single and multiple doses of RT-114, an orally administered RaniPill® capsule containing a GLP-1/GLP-2 dual agonist, PG-102, for the treatment of obesity.
PG-102 is a fc-fusion protein conjugated GLP-1/GLP-2 dual agonist in development by ProGen Co., Ltd. (“ProGen”). ProGen recently announced preclinical and clinical data, at the 2025 European Association for the Study of Diabetes (EASD) meeting, demonstrating glucose-lowering effects and meaningful early weight-loss signals by PG-102, reinforcing its potential as a next-generation metabolic therapy.
In preclinical testing of RT-114 in animal models, the RaniPill® delivered PG-102 orally with bioavailability, pharmacokinetics, and weight loss comparable to subcutaneous (SC) injection.
“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. “As we initiate this trial and advance RT-114 through clinical development, we view this progress as powerful validation of the modality and the unmet need it addresses. 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.”
About Rani Therapeutics
Rani Therapeutics is a clinical stage biotherapeutics company focused on advancing technologies to enable the development of orally administered biologics and drugs. Rani has developed the RaniPill® capsule, which is a novel, proprietary and patented platform technology, intended to replace subcutaneous injection or intravenous infusion of biologics and drugs with oral dosing. Rani has successfully conducted several preclinical and clinical studies to evaluate safety, tolerability and bioavailability using RaniPill® capsule technology.
About RT-114 Collaboration
RT-114 is the subject of a Collaboration Agreement between Rani and ProGen entered into in June 2024. Under the Collaboration Agreement, Rani and ProGen will collaborate to manufacture, develop, seek regulatory approvals for and, if approved, commercialize RT-114 in the field of weight management (including without limitation obesity, weight reduction and weight maintenance) in humans. Under the Collaboration Agreement, development costs, as well as operating profits and losses from the commercialization of RT-114, will be equally shared by Rani and ProGen. The parties share responsibility for the development of RT-114 worldwide, with Rani leading such development for preclinical activities through Phase 1 clinical trials. After initiation of the first Phase 2 clinical trial, Rani will lead development and commercialization of RT-114 in the United States, Canada, Europe (including the United Kingdom) and Australia, and ProGen will lead development and commercialization in all other countries.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the potential for PG-102 to be a next-generation metabolic therapy, our ability to advance RT-114 through clinical development, our belief that initiation of the Phase 1 trial of RT-114 is a powerful validation of the modality and the unmet need it addresses, our belief that a safe, effective oral option can expand access, improve patient experience, and meaningfully reshape the obesity treatment paradigm, customer acceptance of the RaniPill® capsule technology, and the potential benefits of the RaniPill® capsule technology. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “expected,” “potential,” “anticipate,” “opportunity” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Rani’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Rani’s business in general and the other risks described in Rani’s filings with the Securities and Exchange Commission, including Rani’s annual report on Form 10-K for the year ended December 31, 2024, and subsequent filings and reports by Rani. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Rani undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
Investor Contact:
investors@ranitherapeutics.com
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FAQ
What is Rani Therapeutics (RANI) studying in the Phase 1 RT-114 trial?
When did Rani Therapeutics announce the initiation of the RT-114 Phase 1 trial?
How does RT-114’s preclinical performance compare to subcutaneous PG-102?
Who is ProGen and what is their role in the RT-114 program with RANI?
What clinical endpoints will RANI evaluate in the RT-114 Phase 1 study?
