Rege Nephro Co., Ltd.

Company Description

Rege Nephro is a clinical-stage biotech company utilizing induced pluripotent stem cell (iPSC)-based technology from Center for iPS Cell Research and Application (CiRA), Kyoto University. We are developing small molecule therapeutics and cell therapy for kidney, liver, and pancreas disease. We have two lead products in Phase II clinical trial and preclinical studies respectively. RN-014 is the small molecule retinoic acid receptor (RAR) agonists for autosomal dominant polycystic kidney disease (ADPKD). This has been discovered through a human disease model using disease-specific iPSCs, has better efficacy and safety profile than a currently approved drug, and could be the first-in-class and first-line therapy. We are conducting Phase IIa clinical trials and aiming to obtain a clinical proof of concept by early 2025. RN-032 is the allogeneic cell therapy for chronic kidney disease (CKD) using iPSC-derived nephron progenitor cells (iNPCs). iNPCs improved renal function when implanted into the damaged kidneys in several mouse models. We are preparing for preclinical studies and planning to enter into clinical trials in 2026. We have established collaborations with leading companies such as AstraZeneca, Otsuka Pharmaceuticals, Shimadzu, Mitsui Chemical, Fuji Film and Abu Dhabi Stem Cell Centers. These collaborations validate our technology and strategic direction.