What are the next regulatory milestones and timelines for RT-114's Phase 1 trial expected by late 2025?

Rani Therapeutics (US:RANI) anticipates initiating the Phase 1 clinical trial for RT-114, its oral bispecific GLP-1/GLP-2 receptor agonist for obesity, by the end of 2025.1 This timeline has been consistently communicated in recent corporate updates, evolving from an initial expectation of "mid-2025" to "second half of 2025," and finally to "by the end of 2025" in their latest filings.2

The primary regulatory milestone expected within this timeframe is the commencement of the trial itself. The Phase 1 study is designed to evaluate the safety, tolerability, and pharmacokinetics of RT-114.1

Key points regarding RT-114 and its Phase 1 trial:

• Preclinical Success: Rani Therapeutics has reported compelling preclinical data demonstrating that RT-114, delivered via the RaniPill® capsule, achieved comparable bioavailability, pharmacokinetics, and weight loss to subcutaneous administration of PG-102, the GLP-1/GLP-2 dual agonist it contains.2 This preclinical evidence provides the rationale for advancing RT-114 into clinical development.3
• Partnership: RT-114 is being co-developed with ProGen Co., Ltd., which supplies the PG-102 compound.4
• Focus: The company aims for RT-114 to be a first-in-class oral GLP-1/GLP-2 dual agonist, offering a potentially more convenient dosing regimen than current options for obesity treatment.2

As of early January 2026, the initiation of the Phase 1 trial remains the key regulatory event expected from late 2025. No specific timelines for data readouts or completion of the Phase 1 trial have been disclosed for within 2025.

Analyze Fintel's news feed for any press releases or announcements regarding the actual commencement of the RT-114 Phase 1 trial.