Rege Nephro

About Rege Nephro

Rege Nephro is a clinical-stage biotechnology company developing treatments for kidney, liver, and pancreas diseases using induced pluripotent stem cell (iPSC) technology. The company was established in September 2019 as a startup from Kyoto University, based on the research of Professor Kenji Osafune from the Center for iPS Cell Research and Application (CiRA). Professor Osafune, who serves as a founder and Chief Scientific Advisor, was the first to identify nephron progenitor cells (NPCs) and successfully induce their differentiation from iPS cells. The company is led by CEO Akifumi Morinaka.

Rege Nephro's business model centers on the research, development, and eventual production and sale of therapeutic drugs for renal diseases. The company's core technology enables the generation of various kidney cells from iPS cells. This technology underpins its two main product candidates. The first, RN-014 (Tamibarotene), is a small molecule drug for Autosomal Dominant Polycystic Kidney Disease (ADPKD). It is a retinoic acid receptor (RAR) agonist expected to inhibit cyst formation and improve renal function. A Phase II clinical trial for RN-014 began in December 2023. The second product, RN-032, is a cell therapy for Chronic Kidney Disease (CKD) that uses iPS cell-derived nephron progenitor cells (iNPCs). This therapy has shown in mouse models that implanting these cells can improve renal function.

The company was founded to address the significant unmet medical need in kidney disease, where treatment options are often limited to dialysis or transplantation. In Japan alone, over 13 million people suffer from CKD, with associated healthcare costs for dialysis reaching approximately 1.6 trillion yen. Rege Nephro has secured significant funding to advance its clinical trials, including a Series B round in October 2024. The company collaborates with various partners, such as Mitsui Chemicals for developing exosomes as a new treatment method and NIKKISO CO., LTD. for scaling up manufacturing processes.