NouvNeu001 / iRegene Therap - LARVOL DELTA

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

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