iRegene

Our Vision

Re-defining
Medicine for the Coming
Generation

Curing incurable diseases by re-programming cell fate or function.

Passionate

Reliable

Achievers

Committed

Team players

Innovative

Courageous

Engaged

Values in PRACTICE

iRegene's
mission

We are a passionate team committed
to developing first-in-class therapies
for patients suffering from major
incurable diseases. Making fast-acting
and disease-reversing therapies accessible
to patients in the greatest extent
possible is our priority.

Passionate

Achievers

Team players

Courageous

Reliable

Committed

Innovative

Engaged

Next Generation R&D Eco-system, Made by iRegene

iReMeta

Discovering Omics, Powered by AI

iReChem

Deep Learning Assisted Virtual Screening

iReXam

Compounds Validation

iReDita

Gene Editing & Reporter Cell Lines

iReCena

Designing Exosomes for Therapeutics Delivery

Pipelines

Project

Indication

IND Phase I Phase II Phase III

RIGHT

NouvNeu001

Parkinson′s Disease

Completed Phase II dosing in China Q1 2026 ;
US Phase lla, Received both "FTD" and "RMAT" from the FDA

NouvNeu003

Early-onset
Parkinson's Disease

IND approved by the NMPA on Dec 11th 2023;
Finished Phase I dosing in Mar 2025

NouvNeu004

Multiple System
Atrophy (MSA-P)

Phase I/IIl trial approved by NMPA in October 2025;
Phase I trial and "special exemption" approved by the FDA in November 2023

NouvSight001

Retinal Degenerative
Diseases

FDA ODD approved on Mar 20th 2024.
IND application will be submitted around Q3 2026

NouvNeu002

Ischemic Stroke

IND application will be submitted around Q4 2026

Contact

Wuhan Suzhou Denmark Singapore Australia Chengdu

News

iRegene Hits Dual Global Firsts: U.S. Patient Dosed in Phase IIa for NouvNeu001 in Parkinson’s and First Enrollment in China’s Randomized MSA Trial for NouvNeu004

2026-02-23

FDA Grants Regenerative Medicine Advanced Therapy (RMAT) Designation to iRegene’s NouvNeu001, Making It the World’s First iPSC Therapy with Both FTD and RMAT Recognitions

2026-01-19

FDA Grants RMAT Designation to iRegene’s NouvNeu001, Cementing its Lead as the World’s First iPSC Therapy with Both FTD and RMAT Recognitions

2026-01-19

Designing for scalability from day one: iRegene's foundational tech unlocks commercial cell therapies

2025-11-03

Designing for Scalability from Day One: iRegene's Foundational Tech Unlocks Commercial Cell Therapies

2025-10-27

iRegene Therapeutics announced promising NouvNeu001 Phase I clinical data

2025-10-14

iRegene Therapeutics Secures Series B+ Financing Following FDA Fast Track Designation for its Flagship Product NouvNeu001

2025-09-10

iRegene Secures Over RMB 300 Million in Landmark Series B+ Financing to Advance First-in-Class iPSC Cell Therapies

2025-09-10

Frost & Sullivan: iRegene Therapeutics Honored as

2025-06-09

iRegene Receives IND approval from U.S. FDA to Start Clinical Trial for Parkinson’s Disease

2024-06-24

NouvNeu001 Achieves Milestone with Successful Dosing of First Patient, Signaling Smooth Progress in iRegene Therapeutics’ Multicenter Clinical Trial for Innovative Novel Parkinson’s Disease Therapy

2024-02-05