iRegene's NouvSight001 Cleared for RP Trials in US and China
Chengdu, China – September 29, 2026 -- iRegene Therapeutics has secured clinical trial clearances in both China and the United States for NouvSight001, an off-the-shelf cell therapy targeting retinitis pigmentosa (RP), a retinal disease affecting roughly 1.5 million people worldwide.
China's NMPA clears Phase I/III trial while FDA grants Phase I/II clearance with special exemption
China's National Medical Products Administration authorized a Phase I/III trial to assess safety, tolerability and preliminary efficacy of NouvSight001 in RP patients. The U.S. FDA separately cleared a Phase I/II trial for the same indication and granted a special exemption, building on the Orphan Drug Designation the agency awarded the program in 2024.