Renascience

What Renascience does

Renascience Inc. is a Tokyo-based, privately-held biopharmaceutical R&D company founded in 2000 by a nephrologist (with the name fusing "renal science" and "renascence") that develops first-in-class pharmaceuticals, biodesign medical devices, and AI-based Software as Medical Devices (SaMD). Its lead asset, the oral small-molecule PAI-1 inhibitor RS5614, originated from computational screening of approximately 2 million virtual compounds and is currently in Phase III trials for malignant melanoma and chronic myeloid leukemia, with additional Phase II programs across lung cancer, angiosarcoma, systemic sclerosis-ILD, COVID-19 lung injury, and pancreatic cancer. The company also develops pyridoxamine (RS8001) for women's health, a topical PAI-1 inhibitor (RS5441) for alopecia out-licensed to Eirion Therapeutics, an FDA/MHLW-relevant disposable ~1mm ultrafine endoscope for peritoneal dialysis, and a phenylketonuria home diagnostic kit.

The business model is asset-light and partnership-driven: Renascience runs investigator-initiated clinical trials through flagship university labs (TREx at Tohoku University, HiREx at Hiroshima University, plus collaborations with Kyoto, Tokyo Medical and Dental/Institute of Science Tokyo, Northwestern, and others), then out-licenses developed compounds, devices, and AI SaMD to commercialization partners (Nipro for hemodialysis AI, HI-LEX Medical for the endoscope, Chest MI for respiratory AI, Eirion for alopecia). Revenue today is generated from licensing milestones, lump-sum option payments, and AMED public research grants; long-term economics depend on royalty streams from out-licensed products and potential direct sales once approved. The company had 11-50 employees as of the most recent disclosure, is led by CEO/Chairman Toshio Miyata (a Tohoku University professor), and is undertaking governance restructuring consistent with pre-IPO positioning, including Audit Committee transition (May 2022), repeated director changes, and a capital reserve reduction (May 2026).

Renascience's AI SaMD portfolio — DM-SAiL for diabetes, the DCCN-based hemodialysis AI support system, respiratory function test AI, and breast cancer pathological image AI — is differentiated by large, real-world clinical training datasets (720,000 dialysis patient records; ~1,080,000 diabetes clinical parameters) and validated accuracy in clinical performance testing, though the underlying AI engines are largely co-developed with NEC rather than wholly proprietary. The company's primary moat is intellectual property around PAI-1 inhibition and its dense open-innovation ecosystem of 100+ research institutions, supported by Orphan Drug Designation in Japan (RS5614 melanoma, August 2024) and MHLW device approval (endoscope, December 2022).

Name

Renascience

Legal name

Renascience Inc.

Website

https://renascience.co.jp

Company type

Private

Founded year

2000

Operating status

Operating

Headcount range

11–50 employees

Short description

Renascience is a Tokyo-based clinical-stage biopharmaceutical company that develops PAI-1 inhibitor drugs, biodesign medical devices, and AI-based SaMD through investigator-initiated trials at Japanese universities, then out-licenses to pharma and medical device partners for commercialization.

Ownership category

akta.pro rank

Product category

Biopharmaceuticals

NAICS

Pharmaceutical and Medicine Manufacturing (32541), Surgical and Medical Instrument Manufacturing (339112), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Pharmaceutical Preparations (2834), Surgical & Medical Instruments & Apparatus (3841), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Primary Care & General Medicine Pharmaceuticals (HLAIAAAA)

akta.pro secondary industries

Clinical Trial Pharmacy & IMP Management at Site (HLAGACAK), Endoscopic Therapeutic & Access Devices (Trocars, dilators, biopsy/ablation tools) (HLAHADAN)

Keywords

• Pharmaceutical drug development
• Clinical trial research
• AI medical devices
• Medical device development
• Biopharmaceutical research

Headquarters

HQ city

Tokyo

HQ country

Japan

HQ region

Asia

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Licensing Royalties: Renascience develops compounds through clinical trials and licenses them to pharmaceutical companies for commercialization. The company receives milestone payments and royalties from licensees. Examples include licensing RS5441 to Eirion Therapeutics and the endoscope technology to HI-LEX Medical.
2. Collaborative Research Funding: The company receives public research funding from AMED (Japan Agency for Medical Research and Development) and other government agencies for conducting investigator-initiated clinical trials and drug development.
3. Future Pharmaceutical Sales: Once drugs receive regulatory approval, potential for direct pharmaceutical product sales or continued licensing arrangements.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

Renascience is a research-driven biopharmaceutical company that develops novel small-molecule PAI-1 inhibitors (RS5614, RS5441, RS8001), AI-based software as medical devices for diabetes, hemodialysis, respiratory diagnostics and breast cancer pathology, and a disposable ultra-fine endoscope. The company advances these through investigator-initiated clinical trials at academic medical institutions, then licenses the resulting compounds and technologies to pharmaceutical and medical-device companies for commercialization.

Product overview

Renascience is a multi-modality drug development venture focused on pharmaceutical products, medical devices, and AI-powered software as medical devices (SaMD). Their pharmaceutical portfolio includes RS5614 (PAI-1 inhibitor for anti-aging, oncology, and lung diseases), RS8001 (pyridoxamine for women's health), and RS5441 (topical treatment for hair loss). Their medical device portfolio includes a disposable ultrafine endoscope for peritoneal dialysis and a phenylketonuria diagnostic kit. Their AI SaMD portfolio includes DM-SAiL for diabetes insulin prediction, a hemodialysis AI support system, respiratory function test AI, and breast cancer pathological image AI. The company operates through open innovation partnerships with universities (Tohoku, Hiroshima, Tokyo Institute of Science) and corporations (NEC, Nipro, HI-LEX). Products span from preclinical to Phase III clinical stage.

Differentiator

Problem solved

Functional benefit

Brands

• DM-SAiL: Diabetes Skill Acquisition Learning - AI-based software as a medical device for supporting diabetes treatment
• RS5614
• RS8001
• Disposable Ultrafine Endoscope
• Phenylketonuria Diagnostic

Products and services

• RS5614 (PAI-1 Inhibitor) Oral small-molecule PAI-1 inhibitor developed through computational drug design from ~2 million virtual compounds; evaluated for anti-aging/longevity, oncology (malignant melanoma, NSCLC, cutaneous angiosarcoma, CML, pancreatic cancer), and fibrotic lung diseases (COVID-19 lung injury, systemic sclerosis ILD). RS5614 has passed non-clinical safety tests and been administered to nearly 400 subjects.
• RS8001 (Pyridoxamine / Vitamin B6) Vitamin B6 (pyridoxamine) therapeutic candidate developed for menopausal disorder (hot flashes and depression) and premenstrual syndrome / premenstrual dysphoric disorder (PMS/PMDD); works by improving balance of neurotransmitters GABA and serotonin.
• RS5441 / ET-02 Topical Alopecia Treatment Topical PAI-1 inhibitor (RS5441) for androgenetic alopecia (male pattern baldness); licensed to Eirion Therapeutics for commercialization as ET-02. Phase I completed July 2024 showing 6-fold increase in non-vellus hair count at 5% dose.
• Phenylketonuria Diagnostic Kit Home monitoring system for rapid diagnosis of phenylketonuria via blood phenylalanine concentration measurement, designed for self-management of dietary phenylalanine intake. Developed in collaboration with Tohoku University; patent filed May 2021, PMDA consultation June 2021.
• Disposable Ultrafine Endoscope Disposable endoscope with ~1mm outer diameter for non-invasive peritoneal cavity observation in peritoneal dialysis patients. Developed via biodesign methodology with Tohoku University, Juntendo University, and The Jikei University School of Medicine.
• DM-SAiL Diabetes AI AI-powered Software as Medical Device supporting intensive insulin therapy by predicting specialist-prescribed insulin dosages for non-specialists. Developed with Tohoku University, NEC and NEC Solution Innovators; clinical performance test achieved 85.46% accuracy rate (error ~2 units).
• Hemodialysis AI Support System AI Software as Medical Device based on the Dual-Channel Combiner Network (DCCN) engine co-developed with NEC, predicting optimal water removal (error ~130 ml) and hypotension probability (AUC 0.91) for dialysis patients. Trained on 720,000 patient records; partnered with Nipro for commercialization.
• Respiratory Function Test AI AI Software as Medical Device that classifies respiratory diseases (Normal/Bronchial Asthma/COPD/Interstitial Lung Disease) and spirometry measurement errors from flow-volume curve images, with per-class accuracies of 86%/95%/85%/93%.
• Breast Cancer Pathological Image AI AI Software as Medical Device that detects lesions from pathological images of breast cancer (benign, non-invasive cancer, invasive cancer), achieving 88.3% accuracy for 3-class and 90.5% for 2-class classification. Developed with Tohoku University as a women's-health initiative.

Quantifiable outcome

• Melanoma response rate: 24.1% for RS5614 + nivolumab combination vs 13.5% for nivolumab + ipilimumab (existing treatment)
• +7 more outcomes

Named customers9 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability9 records

Feature9 records

Partnerships

17 partnerships are on record, tiered core, minor and flagship.

• Northwestern UniversitycoreStrategic or Co-development Partner · 1 November 2025MOU signed November 2025 for collaboration in longevity and cancer research fields. Joint research with Northwestern's Potocsnak Longevity Institute. Potocsnak Longevity Institute laboratory opened at TREx.
• King Abdullah International Medical Research Center (KAIMRC), Saudi ArabiaminorStrategic or Co-development Partner · 1 October 2025MOU signed October 2025 and Clinical Trial Agreement (CTA) signed February 2026 for XPRIZE Healthspan clinical trial collaboration.
• Taipei Medical University (TMU)-Biotech Co., Ltd.minorStrategic or Co-development Partner · 1 November 2024Joint development agreement completed November 2024 for PAI-1 inhibitor RS5614. Also collaboration for AI-based SaMD development signed August 2024.
• Toray Medical Co., Ltd.minorOEM/ Whitelabel/ Licensing Partner · 1 December 2023Joint development agreement signed December 2023 for AI installed in hemodialysis equipment that controls water removal and blood flow during hemodialysis.
• NEC CorporationcoreTechnology or Integration · 1 June 2023Signed comprehensive collaboration agreement in June 2023 for AI-based medical device development. NEC provides basic AI engines (including DCCN for hemodialysis) that Renascience customizes for medical applications. Collaboration also covers AI for diabetes treatment support and other SaMD development.
• Chest MI Inc.coreOEM/ Whitelabel/ Licensing Partner · 1 June 2023Commercialization partnership established June 2023 for respiratory function test AI. Chest MI leading system development and practical application. Renascience received milestone payment in June 2023 and lump-sum payment in February 2025 for option exercise.
• Hiroshima UniversityflagshipStrategic or Co-development Partner · 1 April 2023Comprehensive collaboration agreement signed April 2023. Established HiREx (Hiroshima University x Renascience Open Innovation) center. Conducting non-small cell lung cancer clinical trials, cutaneous angiosarcoma trials, and other joint R&D. Phase of collaboration progressed from non-clinical to clinical stage.
• Kyoto UniversitycoreStrategic or Co-development Partner · 1 December 2022Collaboration agreement signed December 2022. Also involved in collaboration agreement with Daiichi Sankyo Company regarding preferential negotiation rights and option rights for novel coronavirus treatment.
• NEC Solution Innovators, Ltd.coreTechnology or Integration · 1 November 2022Signed MOU in November 2022 for medical AI development. Partner provides technical support for AI algorithms and system development for medical applications.
• Nipro CorporationcoreOEM/ Whitelabel/ Licensing Partner · 1 October 2022Joint research agreement signed October 2022 for commercialization of AI-based program medical device for supporting maintenance hemodialysis. Agreement amended October 2025 to extend term and include lump-sum contract payment. Joint development of system for clinical implementation.
• HI-LEX Corporation / HI-LEX MedicalcoreOEM/ Whitelabel/ Licensing Partner · 1 September 2022Collaboration agreement signed September 2022 for medical device development including guide catheter for ultra-fine endoscope. License agreement signed May 2024 with HI-LEX Medical for endoscope for medical applications including peritoneal dialysis. Also collaborating on AI for predicting blood clots in auxiliary artificial hearts.
• Juntendo University / The Jikei University School of MedicineminorStrategic or Co-development Partner · 1 September 2022Collaborative development of ultra-fine endoscope for peritoneal dialysis. Universities provided clinical expertise and needs for biodesign approach.
• Tohoku UniversityflagshipStrategic or Co-development Partner · 1 January 2022Primary research partner with established TREx (Tohoku University Renascience Open Innovation Lab) at the Medicinal Hub of Tohoku University Graduate School of Medicine. Conducting multiple investigator-initiated clinical trials including Phase III for CML and melanoma, Phase II for various indications. Collaboration spans PAI-1 inhibitor development, AI medical devices, diagnostic agents, and ultra-fine endoscope development.
• St. Luke's International HospitalcoreStrategic or Co-development Partner · 1 January 2022Collaborated on hemodialysis AI development providing 720,000 patient records from multiple medical institutions including St. Luke's for DCCN AI engine training.
• Institute of Science TokyocoreStrategic or Co-development Partner · 1 December 2021Collaboration agreement signed December 2021 for RS8001 (pyridoxamine) clinical research for menopausal disorder treatment. Institute of Science Tokyo is representative organization for AMED's Practical Research Project for Comprehensive Support of Women's Health.
• Eirion Therapeutics, Inc. (USA)coreOEM/ Whitelabel/ Licensing Partner · 31 October 2016License agreement signed October 2016 for commercialization of RS5441 (ET-02) as hair loss treatment. Eirion conducted Phase I clinical trial for male pattern baldness demonstrating safety and efficacy. Phase II trial preparation underway.
• Yamaguchi University Hospital, Sendai City Hospital, Osaki City Hospital, South Miyagi Medical Center, Tohoku Rosai HospitalcoreStrategic or Co-development PartnerMulti-center clinical performance testing for diabetes AI (DM-SAiL) in addition to Tohoku University Hospital. Validated AI accuracy across diverse patient populations.

Scale indicators12 records

Recent moves7 records

Expansion highlights7 records

Direct peers

• PeptiDream: Tokyo-listed Japanese biotech developing a deep pipeline of peptide-based therapeutics via a proprietary discovery platform, with a licensing-out business model similar to Renascience's PAI-1 inhibitor and AI SaMD licensing approach. Both are Japanese clinical-stage biotechs monetizing technology through milestone and royalty agreements with global pharma.
• J-Pharma: Japanese specialty pharmaceutical company with a strong nephrology and renal disease focus, developing drug candidates targeting transporter proteins. Highly comparable to Renascience's kidney-disease origins, founder-nephrologist heritage, and Japan-based investigator-initiated clinical trial infrastructure.
• AnGes: Tokyo-listed Japanese biotech developing DNA vaccines, gene therapies, and novel biologics with multiple programs in clinical stages. Comparable as a Japanese clinical-stage biotech with a diversified pipeline and partnership/licensing-oriented revenue model.
• Unity Biotechnology: US-based clinical-stage biotech developing therapeutics that target senescent cells to treat age-related diseases, including oncology and ophthalmology indications. Highly comparable as a longevity/anti-aging biotech pursuing similar disease areas (cancer, fibrotic disease) to Renascience's RS5614 PAI-1 inhibitor program.
• BioAge Labs: US clinical-stage biotech developing therapeutics targeting the biology of aging, with a pipeline spanning metabolic disease, muscle, and immune aging. Directly comparable to Renascience's RS5614 anti-aging/longevity positioning validated by XPRIZE Healthspan.
• Aidoc: Israel-based developer of AI-powered clinical decision support and medical imaging SaMD deployed across hospital systems globally. Directly comparable to Renascience's AI SaMD portfolio (breast cancer pathology AI, respiratory function test AI) in terms of regulatory pathway, hospital customers, and SaaS-style licensing economics.
• Viz.ai: US-based AI SaMD company specializing in clinical workflow and diagnostic imaging AI for hospitals, with FDA-cleared products and a partnership-driven commercialization model. Comparable to Renascience's AI SaMD portfolio in product category, regulatory strategy, and enterprise healthcare sales motion.

Broad incumbents

• Kyowa Kirin: Major Japanese specialty pharmaceutical company with strong nephrology and rare disease franchises (e.g., anemia, CKD). A broad incumbent operating in adjacent therapeutic areas and with the global commercial infrastructure that Renascience licenses into, making Kyowa Kirin a plausible future licensing or acquisition partner for RS5614 renal and oncology indications.
• Chugai Pharmaceutical: Tokyo-listed Japanese pharmaceutical company (Roche majority-owned) with major oncology and specialty drug franchises. Comparable as a large Japanese pharma with the global commercial reach and capital that Renascience's licensing model relies on as a counterparty.

Emerging players

• Calico Life Sciences: Alphabet-backed longevity biotech pursuing therapeutics that target the biology of aging. Comparable to Renascience's RS5614 anti-aging positioning and XPRIZE Healthspan presence, though operating from a substantially better-capitalized R&D platform rather than investigator-initiated trials.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds3 records

Investors6 records

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M&A

Investments

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Frequently asked questions about Renascience