Rani Therapeutics Expands Oral Biologics Push With Obesity, Immunology Pipeline

Rani Therapeutics is broadening its RaniPill platform through partnerships and selective product licensing, including an expanded Chugai collaboration covering 11 targets, primarily in rare disease and immunology.

The company reported more than 150% relative bioavailability for its oral GLP-1/GLP-2 candidate RT-114 versus subcutaneous dosing.

Rani plans additional Phase 1A testing before beginning an obesity-focused Phase 1B study, with weight-loss and safety data expected in the first half of 2027.

Rani is expanding beyond obesity into oral immunology treatments, including biosimilar versions of STELARA and HUMIRA, while scaling manufacturing from 1,500 pills per day toward 10,000 and eventually 50,000 to support larger programs.

Rani Therapeutics NASDAQ: RANI outlined its strategy to expand the use of its RaniPill oral biologic-delivery platform through a mix of technology partnerships, selectively licensed product programs and investments in manufacturing capacity.

Chief Executive Officer Talat Imran described the clinical-stage biotechnology company’s RaniPill as a “swallowable auto-injector” designed to deliver biologic medicines in the small intestine.

According to Imran, the capsule dissolves in the intestine, where an internal reaction expands a balloon and delivers a dissolvable needle through the gut wall. The remaining components are excreted.

Imran said the platform has demonstrated bioavailability and variability comparable to subcutaneous injection for biologics, including large proteins and monoclonal antibodies.

He said the company believes the technology can deliver 80% to 85% of marketed biologics in an oral dosing regimen.

The company highlighted its agreement with Chugai Pharmaceutical, which Imran said followed roughly two years of diligence and testing of Chugai molecules.

The agreement initially covered a rare-disease candidate and was later expanded after additional diligence, he said.

Imran said the collaboration now includes 11 targets, with pre-negotiated economic terms for five additional programs, primarily in high-value immunology categories.

He described the deal as validation for Rani’s platform and said partnerships can provide cash to support the company’s operating runway.

Rani expects to pursue additional agreements with drug developers, though Imran said it also sees value in selectively obtaining product licenses rather than solely licensing its technology.

The company does not plan to run late-stage studies or build a commercial organization, he said, characterizing Rani primarily as a platform company focused on oral delivery of biologics.

“We’ll have a mix of these over time,” Imran said, referring to technology and product licensing arrangements.

Rani recently reported Phase 1A bioavailability data for RT-114, an oral version of ProGen’s PG-102, a GLP-1/GLP-2 Fc-fusion protein being evaluated for obesity-related applications.

Imran said the study showed greater than 150% relative bioavailability compared with subcutaneous administration.

He said the study showed variability similar to subcutaneous dosing, with adverse events consistent with the observed exposure level and no new adverse events attributed to the RaniPill.

The company views the findings as supportive of potentially weekly oral dosing.

Rani plans to add another Phase 1A cohort to confirm the relationship between oral and subcutaneous dosing, with data expected before the end of the year.

It then expects to begin a Phase 1B study in obese patients.

Imran said that eight-week study is expected to provide data on weigh...