iRegene Therapeutics' Off-the-Shelf iPSC-Derived Parkinson’s Cell Therapy NouvNeu001 Granted FDA Fast Track Designation
iRegene Therapeutics
Cell Therapy Product Developer
Today (August 18), iRegene announced that its self-developed NouvNeu001 injection has been granted by the FDA.Fast Track Designation (Fast Track Designation (FTD) qualification, and the scope of application has been approved for expansion.NouvNeu001It is a universal iPSC-derived Parkinson's cell therapy product.
iRegene Therapeutics' iPSC-derived project NouvNeu001, in addition to receiving FDA Special Exemption in March 2024, has further been granted FTD accelerated pathway support by the FDA.iRegene press release stated,NouvNeu001 demonstrated statistically significant safety data over 15 months of administration in Phase 1 clinical trials. More importantly, the Phase 1 clinical data not only showed significantly superior results compared to similar cell therapy products but also outperformed existing clinical treatment methods with statistical significance. The MDS-UPDRS III scores reflected a faster improvement time window and a more pronounced improvement magnitude.
Globally, iRegene Therapeutics' iPSC-derived universal cell therapy project NouvNeu001 (chemically induced dopaminergic neural progenitor cells) has received multiple designations from the FDA. First, it obtained a Special FDA Exemption in March 2024, and on June 2024, the FDA approved its IND to initiate an international multicenter Phase 1 clinical trial in the United States and other countries. On August 15, 2025, iRegene further received Fast Track Designation (FTD) from the FDA.
Milestone Timeline for iRegene Therapeutics' NouvNeu001 Project:
In August 2023, NouvNeu001 received approval from China's NMPA to conduct a combined Phase 1/2 clinical trial in China targeting moderate to severe Parkinson's disease;
In March 2024, the U.S. FDA granted NouvNeu001 special exemption status, recognizing iRegene's breakthrough innovation platform and comprehensive quality system, and exempting NouvNeu001 from related U.S. Pharmacopeia requirements.
In June 2024, the US FDA approved its IND to initiate an international multicenter Phase 1 clinical trial in the United States and other countries;
In November 2024, NouvNeu001 completed patient enrollment for Phase 1 clinical trials in China;
In April 2025, NouvNeu001 officially launched its Phase 2 clinical trial in China;
From April to June 2025, iRegene launched the international multi-center Phase 1 clinical trial for NouvNeu001 in multiple countries;
In July 2025, the first group of patients in Phase 2 clinical trials of NouvNeu001 completed dosing;
On August 15, 2025, further granted Fast Track Designation (FTD) by the FDA.
Following the granting of FTD status, the FDA will engage in more frequent interactions with iRegene. The FDA will provide targeted one-on-one guidance to iRegene on aspects such as clinical trial design and data requirements. Additionally, iRegene has also obtained the qualification for rolling communication with the FDA without time restrictions. More importantly, the granting of this FTD also allows iRegene's NouvNeu001 to expand its intended use, applying it to other compassionate use cases. It is also worth noting that FTD can be implemented alongside Breakthrough Therapy Designation, Priority Review, and Accelerated Approval, expediting the market entry pace of iRegene's NouvNeu001, and bringing this drug, which holds significant clinical importance, to market as soon as possible.
Dr. Cai Meng, CMO of iRegene, stated: This milestone event demonstrates that the clinical value of Nouvneu001 has been recognized by regulatory authorities worldwide. Moreover, due to its breakthrough efficacy in treating Parkinson's disease, the FDA has not only provided tailored support for the regulation and market approval of Nouvneu001 but has also agreed to expand its use to other compassionate use scenarios, significantly broadening the clinical application value and commercial scope of Nouvneu001.
[1]Another Global Breakthrough! FDA Grants NouvNeu001, the World's First Universal iPSC-Derived Parkinson's Disease Cell Therapy Product Developed by iRegene, FTD Designation and Approves Expanded Indications. From https://mp.weixin.qq.com/s/jWzCShTZ84w1rNgOiuNGUQ
