NeuDirection Limited (“NeuDirection”) announced that the first healthy subject has been successfully dosed in the Phase I clinical trial for its lead pipeline candidate, Neu-001, a first-in-class small molecule drug for the treatment of amblyopia. The first dose was administered on August 30, 2025, at Shanghai General Hospital. This study aims to evaluate the safety, tolerability, and pharmacokinetic profile of Neu-001 in healthy adults, providing critical data for subsequent clinical development. The Phase Ia clinical trial of Neu-001 is a single-center, randomized, double-blind, placebo-controlled, Single Ascending Dose (SAD) study. The study plans to enroll 53 healthy adult subjects to be…

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…

The symposium “Advancing Amblyopia Care: Innovations in Clinical Trials and Multisensory Approaches in Neuroscience and Auditory Science” concluded successfully in Hong Kong on April 16,2025, with Neu-Direction playing a pivotal role in advancing the dialogue around cutting-edge therapies for amblyopia. Hosted by the Chinese Academy of Sciences Hong Kong Institute for Innovation in Regenerative Medicine and Health (CRMH), the event brought together global leaders in neuroscience and ophthalmology, including Prof. K.F. So, member of the Chinese Academy of Science, and Prof. Andrew King, Fellow of the Royal Society, and distinguished scholars from institutions such as the City University of Hong Kong, Shanghai…

Our first pipeline Neu-001,Neu-001, an innovative first-in-class small-molecule drug for treating amblyopia (commonly known as lazy eye), has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA). This milestone achievement was unveiled at a press conference held on December 17 at the Hong Kong Science Park, marking the first FDA approval for a novel chemical drug developed under Hong Kong’s prestigious InnoHK research platform. The press conference was hosted by Professor Guangjin Pan, Director of the Centre for Regenerative Medicine and  Health, Hong Kong Institute of Science & Innovation, Chinese Academy of Sciences. Key attendees…