Rege Nephro
Rege Nephro is a clinical-stage Japanese biotech developing iPSC-derived regenerative therapies and small-molecule drugs for refractory kidney, liver, and pancreatic diseases, with lead assets RN-014 (tamibarotene) in Phase IIa for ADPKD and RN-032 nephron progenitor cell therapy for chronic kidney disease.
- Company typePrivate
- Founded2019
- HeadquartersKyoto, Japan
- Headcount11–50
- GTM typeB2B
- OfferingServices
What Rege Nephro does
Rege Nephro Co., Ltd. is a clinical-stage Japanese biotechnology company founded in 2019 by Professor Kenji Osafune of Kyoto University's Center for iPS Cell Research and Application (CiRA) to commercialize induced pluripotent stem cell (iPSC) technology for the treatment of refractory kidney, liver, and pancreatic diseases. The company's scientific foundation is a proprietary iPSC-derived nephron progenitor cell (iNPC) platform, supplemented by patent-pending manufacturing innovations (cell aggregation inhibition, residual undifferentiated iPSC detection) and a proprietary ADPKD collecting duct organoid disease model that more accurately replicates polycystic kidney disease pathology than prior nephron-based models.
Rege Nephro's lead assets are RN-014, a small-molecule retinoic acid receptor agonist (tamibarotene) for Autosomal Dominant Polycystic Kidney Disease that completed Phase IIa enrollment in 2025 and has received both Japanese and US Orphan Drug Designation; and RN-032, an iPSC-derived nephron progenitor cell therapy for chronic kidney disease that has completed process development and is preparing for non-clinical studies. Earlier-stage programs include iPSC-derived hepatocyte therapy for liver cirrhosis, iPSC-derived pancreatic beta cell therapy for diabetes, exosome-based therapeutics developed with Mitsui Chemicals, and a high-throughput ADPKD drug screening platform that has produced commercial collaborations with Roche, AstraZeneca, and Fujifilm. The company acquired global tamibarotene development rights from Syros Pharmaceuticals in February 2025 and operates from Kyoto University campus facilities with a US business development office in Palo Alto, California.
The company is pre-revenue and pre-commercial, with no marketed products and revenue mechanics dependent on a combination of research collaboration funding from pharmaceutical partners, prospective milestone payments and royalties from out-licensing of RN-014, and eventual commercialization of RN-032 cell therapy. Total cumulative funding since inception is approximately JPY 5.7 billion across seed, Series A (JPY 1.39 billion, January 2022), Series B (JPY 2.5 billion, October 2024 led by DCI Partners), and a 2026 J-KISS bridge financing (JPY 1.22 billion first close) ahead of a planned Series C in autumn 2026. Go-to-market is built on enterprise partnerships with global pharmaceutical companies, academic medical centers such as Juntendo University Hospital, and licensing arrangements rather than direct commercial sales channels.
Rege Nephro firmographics
Firmographics- Name
- Rege Nephro
- Legal name
- Rege Nephro Co., Ltd.
- Website
- https://regenephro.co.jp
- Company type
- Private
- Founded year
- 2019
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Rege Nephro is a clinical-stage Japanese biotech developing iPSC-derived regenerative therapies and small-molecule drugs for refractory kidney, liver, and pancreatic diseases, with lead assets RN-014 (tamibarotene) in Phase IIa for ADPKD and RN-032 nephron progenitor cell therapy for chronic kidney disease.
- Ownership category
- akta.pro rank
Rege Nephro industry classification
Industry- Product category
- Regenerative Medicine
- NAICS
- Scientific Research and Development Services (5417)
- SIC
- Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836)
- akta.pro primary industry
- Nephrology & Urology Pharmaceuticals (HLAIAAAM)
- akta.pro secondary industries
- Nephrology & Urology Specialty Pharmaceuticals (HLAIACAH), Endocrinology & Reproductive Health Pharmaceuticals (incl. Women’s Health) (HLAIAAAJ)
Keywords
Where Rege Nephro is headquartered
LocationHeadquarters
- HQ city
- Kyoto
- HQ country
- Japan
- HQ region
- Asia
Offices2 records
Markets served
Rege Nephro business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales, Others
Revenue model
- Cell Therapy Products: Revenue from iPSC-derived nephron progenitor cell (RN-032) therapy for chronic kidney disease, targeting regulatory approval and commercialization.
- Small Molecule Drug Licensing: Revenue from out-licensing RN-014 (tamibarotene) for ADPKD to pharmaceutical partners, with potential for milestone payments and royalties upon regulatory approval.
- Drug Discovery Collaboration Services: Revenue from partnerships utilizing company's iPSC-derived disease models for drug discovery, including collaborations with Roche, AstraZeneca, and others.
Go-to-market motion2 records
Distribution channels1 record
Marketing channels4 records
Rege Nephro product offering
Product offeringCore offering
Rege Nephro develops iPSC-based regenerative medicine products and small-molecule therapeutics for kidney, liver, and pancreatic diseases. Its lead clinical asset RN-014 (tamibarotene) is a retinoic acid receptor agonist in Phase IIa for ADPKD, identified via proprietary ADPKD organoid drug screening. Its lead cell therapy asset RN-032 uses iPSC-derived nephron progenitor cells transplanted under the kidney capsule to deliver paracrine trophic effects for chronic kidney disease.
Product overview
Rege Nephro (Rege Nephro Co., Ltd.) is a clinical-stage iPS cell biotechnology company developing a pipeline of regenerative medicine and small-molecule drug products centered on kidney, liver, and pancreatic diseases. The company's two lead products are RN-014 (tamibarotene, a retinoic acid receptor agonist identified via iPS cell disease-model screening) in Phase IIa for ADPKD, and RN-032 (iPS cell-derived nephron progenitor cells, iNPC) for chronic kidney disease cell therapy. Broader pipeline programs include iPS-derived hepatocyte therapy for liver cirrhosis, iPS-derived pancreatic beta cell therapy for diabetes, and a high-throughput ADPKD organoid drug-screening platform. The company operates from Kyoto University CiRA-originated technology with multiple manufacturing and research partnerships globally.
Differentiator
Problem solved
Functional benefit
Products and services
- RN-014 (Tamibarotene) RN-014 is a small-molecule retinoic acid receptor (RAR) agonist identified via iPSC-derived ADPKD organoid drug screening, in Phase IIa clinical development for Autosomal Dominant Polycystic Kidney Disease (ADPKD). It suppresses cyst enlargement and renal fibrosis through a mechanism distinct from the only currently approved ADPKD treatment, tolvaptan, with orphan drug designation in both Japan and the United States.
- RN-032 (iPSC-Derived Nephron Progenitor Cell Therapy) RN-032 is an iPSC-derived nephron progenitor cell (iNPC) therapy for chronic kidney disease (CKD). Nephron progenitor cells are transplanted beneath the kidney capsule to exert a paracrine trophic effect that repairs damaged nephrons and improves renal function in CKD animal models. Enabled by proprietary cell aggregation inhibition and residual undifferentiated iPSC detection technologies.
- iPS Cell-Derived Hepatocyte Therapy (iHLC) for Liver Cirrhosis iPS cell-derived hepatocyte (iHLC) cell therapy for liver cirrhosis, targeting patients with end-stage chronic liver disease and developed under the Kyoto Prefecture Industry-Academia-Government Forest program in collaboration with Toyo Seikan Group Holdings and Kyoto University CiRA.
- iPS Cell-Derived Pancreatic Beta Cell Therapy Next-generation iPSC-derived pancreatic beta cell therapy for Type 1 and Type 2 diabetes using hypoimmunogenic (HLA homozygous) iPS cells combined with hypoantigenic modification to reduce rejection risk and minimize immunosuppressant requirements. Co-developed with Abu Dhabi Stem Cells Center.
- ADPKD Drug Discovery Screening Service High-throughput drug screening service using iPSC-derived ADPKD collecting duct organoid disease models to identify and select therapeutic candidates from compound libraries. The collecting duct organoid model more accurately replicates ADPKD pathology than prior nephron-based models and is offered to pharmaceutical partners via drug discovery collaboration agreements, including partnerships with AstraZeneca, Roche, and others.
Quantifiable outcome
- Phase 2a clinical trial enrollment completed for RN-014 in ADPKD with LPLV (Last Patient Last Visit) achieved
- +2 more outcomes
Companies that use Rege Nephro
Customer profileNamed customers2 records
Segments4 records
Ideal customer profiles3 records
Rege Nephro technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature6 records
Rege Nephro partnerships and signals
Strategic signalPartnerships
13 partnerships are on record, tiered core and minor.
- Bayer (Co.Lab Connect)coreSelected for Bayer's global incubator program providing access to US market, networks, and resources for Japanese life science startups.
- FujifilmcoreJoint research for human kidney chip development using nephron progenitor cells. Aims to create products for simple prediction of compound nephrotoxicity.
- RochecoreCollaborative research agreement for novel drug discovery using iPSC-derived human disease models. Focus on genetic rare diseases.
- Abu Dhabi Stem Cells Center (ADSCC)coreJoint research for diabetes treatment development using iPSC-derived pancreatic beta cells. International collaboration with UAE center focused on cell therapy and regenerative medicine.
- Toyo Seikan Group HoldingscoreJoint research for liver cirrhosis cell therapy using iPSC-derived hepatocytes. Collaboration with CiRA and Shimadzu.
- Mitsui ChemicalscoreJoint research to develop exosomes from nephron progenitor cell culture supernatant as a new therapeutic modality. Mitsui Chemicals developing separation and large-scale manufacturing methods for exosomes.
- AstraZenecacoreJoint research with CiRA and Kyoto University to develop kidney tissue from human iPS cells. Collaboration renewed in December 2023 with significant progress. AstraZeneca provides research funding and conducts transcriptomics and histological analysis.
- AbbiecoreJoint research for cryopreservation process development of nephron progenitor cells using Abbie's proprietary CAS (Cells Alive System) technology.
- NikkisocoreJoint research for nephron progenitor cell expansion culture process development. Nikkiso applying its fluid control and component measurement technologies.
- Kirin HoldingsminorJoint research for nephron progenitor cell manufacturing process development. Kirin providing researchers and research funding.
- Kyoto University CiRAcoreExclusive patent license and comprehensive joint research agreement for iPSC-derived nephron progenitor cell technology. Co-development of renal regeneration therapies.
- iPS Cell Foundation (CiRA-F)coreSupply of HLA homozygous iPS cell lines for nephron progenitor cell production. Collaboration for hypoimmunogenic cell development.
- Pol MedTechminorCollaboration for developing pigs with kidney hypoplasia for kidney regeneration research using cloned and gene-edited pig technology.
Scale indicators12 records
Recent moves8 records
Expansion highlights9 records
Rege Nephro competitors and assessment
Company assessmentDirect peers
- Humacyte: Clinical-stage regenerative medicine company developing bioengineered human tissues for vascular and other applications. Comparable in regenerative-medicine modality, clinical-stage profile, and focus on hard-to-treat disease areas.
- BlueRock Therapeutics: Bayer subsidiary developing iPSC-derived cell therapies including for cardiology and immunology. Comparable as a leader in iPSC-derived regenerative medicine and a relevant benchmark for platform-based iPSC development and commercialization.
- ProKidney: US-listed clinical-stage biotech developing autologous cell therapy (REACT) for chronic kidney disease. Most directly comparable to Rege Nephro's RN-032 nephron progenitor cell therapy, differing in autologous vs. allogeneic iPSC-derived approach.
- Vertex Pharmaceuticals: Global biotech with VX-880 stem cell-derived pancreatic islet therapy for Type 1 diabetes, overlapping directly with Rege Nephro's iPSC-derived pancreatic beta cell diabetes program. Demonstrates a commercial-stage benchmark for iPSC-derived cell therapy.
- Chinook Therapeutics (Novartis): Was a clinical-stage ADPKD-focused biotech (acquired by Novartis in 2023) developing atrasentan and other kidney-disease therapies. Directly comparable in therapeutic focus on ADPKD and adjacent rare kidney diseases.
- Sernova: Clinical-stage cell therapy company developing implantable cell pouch technologies for diabetes and other chronic diseases. Overlaps with Rege Nephro's iPSC-derived pancreatic beta cell program in target indication and cell-replacement modality.
- Fate Therapeutics: Clinical-stage iPSC-derived cell therapy company developing off-the-shelf NK and T-cell therapies for cancer and autoimmune disease. Comparable as a peer iPSC-platform biotech with a pipeline-driven, partnership-supported business model.
Broad incumbents
- Otsuka Holdings: Markets tolvaptan (Jynarque/Samsca), the only approved ADPKD therapy and the standard-of-care competitor that RN-014 must displace. Represents the entrenched incumbent in Rege Nephro's lead commercial opportunity.
Regional players
- Megakaryon: Japanese iPSC-derived platelet company spun out from Kyoto University. Comparable as a fellow Japanese iPSC platform company with academic-origin IP, similar regulatory pathway (PMDA), and overlapping manufacturing/process challenges.
- TikoMed: Swedish regenerative-medicine company developing cell-based therapies for kidney and inflammatory conditions, including preclinical-stage programs for CKD. Comparable in kidney regenerative-medicine focus, but operates in Europe rather than Japan/US.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
Rege Nephro social profiles
Digital presenceRege Nephro financial estimates
Financial estimateRevenue estimate
Valuation estimate
Rege Nephro leadership team
Management profileNumber of profiles
Profiles15 records
Rege Nephro funding detail
Funding detailFunding overview
Funding rounds4 records
Investors33 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Rege Nephro M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Rege Nephro
What does Rege Nephro do?
Rege Nephro develops iPSC-based regenerative medicine products and small-molecule therapeutics for kidney, liver, and pancreatic diseases. Its lead clinical asset RN-014 (tamibarotene) is a retinoic acid receptor agonist in Phase IIa for ADPKD, identified via proprietary ADPKD organoid drug screening. Its lead cell therapy asset RN-032 uses iPSC-derived nephron progenitor cells transplanted under the kidney capsule to deliver paracrine trophic effects for chronic kidney disease.
Is Rege Nephro a public or private company?
Rege Nephro is a private company. It is classified as venture growth investor backed and is currently operating.
When was Rege Nephro founded?
Rege Nephro was founded in 2019. It employs 11 to 50 people.
Where is Rege Nephro based?
Rege Nephro is headquartered in Kyoto, Japan, in the Asia region.
How does Rege Nephro make money?
Three revenue lines are on record. Cell Therapy Products are the primary driver. The others are small Molecule Drug Licensing and drug Discovery Collaboration Services.
Who are Rege Nephro's main competitors?
Direct peers on record are Humacyte, BlueRock Therapeutics, ProKidney, Vertex Pharmaceuticals, Chinook Therapeutics (Novartis), Sernova and Fate Therapeutics. Otsuka Holdings is listed as a broad incumbent. Regional players are Megakaryon and TikoMed.
Does Rege Nephro have an API?
No public API is recorded for Rege Nephro.
What industry is Rege Nephro in?
Rege Nephro's product category is Regenerative Medicine. Its primary akta.pro industry code is HLAIAAAM, Nephrology & Urology Pharmaceuticals, with a secondary code of HLAIACAH, Nephrology & Urology Specialty Pharmaceuticals. Its NAICS code is 5417 and its SIC code is 2834.