NeuDirection Limited is pleased to announce Neu-001 for Injection has received Investigational New Drug (IND) approval from China’s National Medical Products Administration (NMPA) on May 27, 2025. This innovative small molecule therapy is being developed for the treatment of amblyopia.
This approval represents a significant milestone for NeuDirection, following the U.S. FDA IND approval received in October 2024. The NMPA clearance enables the company to advance Neu-001’s clinical development in China, addressing the substantial unmet medical need for effective amblyopia treatments in one of the world’s largest pharmaceutical markets.
NeuDirection will initiate Phase 1 clinical studies in June 2025 to evaluate the safety, tolerability, and pharmacokinetics of Neu-001 for Injection. The company remains committed to advancing this novel therapeutic approach for patients suffering from amblyopia, a condition that affects millions of individuals worldwide and currently has limited treatment options, particularly for older children and adults.