Rani Therapeutics Holdings, Inc. announced preclinical data supporting the safety and tolerability of the RaniPill® drug delivery platform following 60-day repeat administration. In the 60-day good laboratory practices (?GLP?) study in healthy animals, the RaniPill® capsule was well-tolerated with no treatment-related adverse events. The preclinical GLP study evaluated the safety and tolerability of the RaniPill® drug delivery platform, following 60-day repeat oral administration of the test article, RT-100.

RT-100 is an enteric-coated capsule identical to RT-102, but instead of teriparatide contains the pharmaceutical excipient mannitol. The control group received a capsule (Mock-RP) of similar weight to RT-100 but filled with potato starch. The study included males and females (1:1) divided into two groups that were administered orally either a Mock-RP (N=12) or RT-100 (N=24) once daily for 60 consecutive days with half the animals completing an additional 14-day clinical observation and safety evaluation period.

RT-100 was well-tolerated with no treatment-related adverse events and all animals remained clinically healthy throughout the study.