NouvNeu001 / iRegene Therap - LARVOL DELTA

iRegene Therapeutics announced promising NouvNeu001 Phase I clinical data (The Manila Times) - "Excellent safety and tolerability were observed for up to 15 months post-transplantation, notably without the use of immunosuppressants after the sixth month...In the low-dose cohort, UPDRS-III scores improved by an average of 30.6 points in the OFF state (a 52.82% improvement from baseline) and 12.9 points in the ON state (a 54.67% improvement from baseline）at 12 months post-transplantation. Similarly, in the high-dose cohort, scores decreased by an average of 23.3 points (OFF) and 9.67 points (ON) at 9 months post-transplantation. These improvements were statistically significant, with continued improvement observed through 15 months post-treatment."

P1 data • Parkinson's Disease

Safety, Tolerability, and Preliminary Efficacy of NouvNeu001 for the Treatment of Advanced Parkinson's Disease: A Multi-center, Open Label, Phase 1 Study (MDS Congress 2025) - "The Phase 1 results of NouvNeu001 demonstrated the good safety, tolerability, and preliminary efficacy of NouvNeu001, providing supportive evidence for further development of PD treatment. A multi-center Phase II trial of NouvNeu001 is planned to start in 2025H1."

Clinical • Metastases • P1 data • CNS Disorders • Movement Disorders • Parkinson's Disease

iRegene Therapeutics Secures Series B+ Financing Following FDA Fast Track Designation for its Flagship Product NouvNeu001 (PRNewswire) - "This round builds on a series of sizable financings completed in recent months, bringing iRegene's total funding to over RMB 300 million (~USD 40M)....The proceeds will be used to accelerate iRegene's global clinical development of NouvNeu001 for Parkinson's disease (PD)..."

Financing • Parkinson's Disease

The Safety, Feasibility and Efficacy of NouvNeu001 for Parkinson's Disease (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: iRegene Therapeutics Co., Ltd. | Phase classification: P1/2 ➔ P2

Phase classification • CNS Disorders • Movement Disorders • Parkinson's Disease

A world first! The development of this "Made in Chengdu" Parkinson's cell therapy product is accelerating [Google translation] (Sohu.com) - "Chengdu-made cell therapy products have made significant progress. Recently, Ruijian Yilian Pharmaceutical Technology (Chengdu) Co., Ltd. ('Ruijian Pharmaceutical') announced that its independently developed NouvNeu001 injection for the treatment of moderate to severe Parkinson's disease has successfully dosed the first patient in a Phase II clinical trial at a Beijing hospital. Subsequently, Phase II clinical trials have officially commenced at the First Affiliated Hospital of the University of Science and Technology of China (Anhui Provincial Hospital) and the Union Hospital affiliated with Tongji Medical College of Huazhong University of Science and Technology, rapidly advancing related research."

Trial status • Parkinson's Disease

NouvNeu001-01: This Clinical Trial is Designed to Evaluate the Safety, Tolerability, Feasibility and Preliminary Efficacy of NouvNeu001 (Human Dopaminergic Progenitor Cells Injection) in Patients With Parkinson's Disease. (clinicaltrials.gov) - P1 | N=5 | Not yet recruiting | Sponsor: iRegene Therapeutics Co., Ltd.

New P1 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

iRegene Therapeutics’ NouvNeu001 Receives FDA Fast Track Designation for Parkinson’s Therapy (flcube.com) - "China-based iRegene Therapeutics announced on August 15, 2025, that its self-developed injectable product, NouvNeu001, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA)."

Fast track • Parkinson's Disease

The Safety, Feasibility and Efficacy of NouvNeu001 for Parkinson's Disease (clinicaltrials.gov) - P1/2 | N=30 | Not yet recruiting | Sponsor: iRegene Therapeutics Co., Ltd.

New P1/2 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

NouvNeu001, A Phase 1 Stage Chemically Induced Human Dopaminergic Progenitor Cell Therapy for the Treatment of Mid- to Late-stage Parkinson's Disease (MDS Congress 2024) - "These preclinical and first-in-human study results indicate that NouvNeu001 has the potential to be a safe and effective therapy for the treatment of PD patients with minimal risks."

P1 data • CNS Disorders • Parkinson's Disease

The Safety, Tolerability and Preliminary Efficacy of NouvNeu001 for Early-onset Parkinson's Disease (clinicaltrials.gov) - P1 | N=6 | Recruiting | Sponsor: iRegene Therapeutics Co., Ltd.

New P1 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

iRegene Receives IND approval from U.S. FDA to Start Clinical Trial for Parkinson's Disease (PRNewswire) - "On June 20 (UTC-4), the U.S. Food and Drug Administration (FDA) approved the IND application for NouvNeu001, a cell therapy product from iRegene therapeutics targeting Parkinson's Disease...Notably, in March 2024, iRegene was granted the exemption from the FDA, highlighting the recognition of iRegene's pioneering platform and innovative production and quality systems."

FDA event • IND • CNS Disorders • Parkinson's Disease

The Safety, Tolerability and Efficacy of NouvNeu001 for Parkinson's Disease (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: iRegene Therapeutics Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Movement Disorders • Parkinson's Disease

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 (PRNewswire) - "iRegene Therapeutics Co., Ltd...recently announced that NouvNeu001, the company's first innovative product, has completed the dosing for its first patient at Beijing Hospital, and the patient has also successfully concluded the observation period."

Trial status • CNS Disorders • Parkinson's Disease

The Safety, Tolerability and Efficacy of NouvNeu001 for Parkinson's Disease (clinicaltrials.gov) - P1/2 | N=40 | Not yet recruiting | Sponsor: iRegene Therapeutics Co., Ltd.

New P1/2 trial • CNS Disorders • Movement Disorders • Parkinson's Disease