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

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iRegene Therapeutics has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) granting Investigational New Drug (IND) approval for their innovative cell therapy, NouvNeu001, aimed at treating Parkinson’s disease. This approval marks a pivotal step forward in the fight against this debilitating neurodegenerative disorder.

A New Hope for Parkinson’s Patients

Parkinson’s disease, characterized by the loss of dopaminergic neurons, leads to severe motor and non-motor symptoms that drastically affect patients’ quality of life. Traditional treatments often focus on symptom management rather than addressing the root cause. However, iRegene’s NouvNeu001 offers a novel approach by leveraging induced pluripotent stem cells (iPSCs) to create human dopaminergic neuron precursors. These precursors are designed to replace the lost neurons and restore dopamine production in the brain.

The Science Behind NouvNeu001

NouvNeu001 is a groundbreaking therapy that utilizes iRegene’s proprietary “AI + chemical induction” platform. This platform allows for the precise reprogramming of cell fate and functions, resulting in high-purity dopaminergic neuron precursors. These cells are then delivered directly into the brain’s striatum via a guided intracerebral injection. Once transplanted, the cells differentiate into functional dopaminergic neurons, establishing connections with existing neurons and enhancing dopamine release.

Clinical Trials and Global Impact

The clinical journey of NouvNeu001 began in early 2024 with trials at Beijing Hospital and Zhongnan Hospital of Wuhan University in China. These trials have shown promising preliminary results, with significant improvements in patients’ motor function and no adverse effects related to the cell product.

The success of these trials has paved the way for the FDA’s IND approval, allowing iRegene to expand their research to the United States. The Phase 1/2 clinical trial in the U.S. will focus on evaluating the safety, tolerability, and efficacy of NouvNeu001 in patients with mid-to-late stage Parkinson’s disease.

This trial is expected to enroll around 40 participants, ranging in age from 50 to 75. Key metrics for success will include the incidence and severity of adverse events, as well as improvements in motor and non-motor functions, assessed using the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS).

Future Prospects

The FDA’s approval not only signifies a major achievement for iRegene but also brings hope to millions of Parkinson’s patients worldwide. Dr. Wei Jun, CEO of iRegene, emphasized the company’s commitment to leveraging their innovative technologies to address currently incurable diseases.

The dual approval of NouvNeu001 by both the U.S. FDA and China NMPA underscores the global recognition of iRegene’s pioneering platform and its potential to revolutionize the treatment of neurodegenerative diseases.


iRegene’s IND approval for NouvNeu001 is a testament to the company’s dedication to advancing universal cell therapy products. By harnessing the power of AI and chemical induction, iRegene is at the forefront of developing novel treatment alternatives for Parkinson’s disease and other neurodegenerative disorders.

As the clinical trials progress, the world watches with anticipation, hopeful for a future where Parkinson’s disease can be effectively treated, if not cured. Stay tuned for more updates on iRegene’s groundbreaking research and the ongoing clinical trials of NouvNeu001.

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