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Rani Therapeutics Announces Preclinical

Rani Therapeutics Announces Preclinical Data Demonstrating Successful Oral Delivery of Semaglutide via RaniPill® HC

Rani Therapeutics Holdings, Inc., a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today 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.

Semaglutide is a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor mimicking its activity. GLP-1 is an incretin hormone and enterogastrone that stimulates insulin secretion, inhibits glucagon secretion, delays gastric emptying and reduces the production of stomach acid serving as a physiological regulator of appetite and food intake.

Oral semaglutide administered via the RaniPill® HC (RT-116) demonstrated comparable bioavailability, pharmacokinetics and weight loss to subcutaneous administration. RT-116 was well tolerated with no serious adverse events. Data adds to growing body of evidence of the RaniPill® platform’s potential to enable oral delivery of multiple obesity treatments. Phase 1 study for RT-114, an oral GLP-1/GLP-2 dual agonist for the treatment of obesity, expected to initiate in 2025.

“We believe these data provide further validation of the RaniPill® oral delivery platform across a wide variety of injectable obesity treatments. We are encouraged to see that delivery of semaglutide via the RaniPill® capsule demonstrated comparable bioavailability, pharmacokinetics and weight loss to subcutaneous administration of semaglutide at the same dose,” said Talat Imran, Chief Executive Officer of Rani Therapeutics.

The target product profile of semaglutide in the RaniPill® capsule would be once-weekly oral administration of semaglutide therapy, which may be more convenient for patients and could lead to improved adherence. Overall, the totality of the preclinical data generated in the obesity space demonstrating the successful delivery of both single and triagonist incretin therapies gives confidence to continue building obesity portfolio to unlock the true value of the RaniPill® technology.

Currently, semaglutide is only available as a subcutaneous injection (SC) for the treatment of obesity and is marketed in the U.S. by Novo Nordisk as WEGOVY®. Worldwide sales for WEGOVY® were approximately $3.1 billion in the first half of 2024.

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