NeuroDawn Ningdan New Drug – February 19, 2025

On February 19, 2025, NeuroDawn’s product Y-3 for Injection completed the first subject administration at Tranquil Clinical Research in Texas.

This Phase I clinical study, “A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetic Profiles of Y-3 in Healthy Adult Volunteers in the United States” (NCT06770491) plans to include 20 healthy subjects in the US, aiming to evaluate the safety, tolerability, and pharmacokinetic characteristics of Y-3 for Injection.

After the Phase II results of Y-3 for Injection were presented at the 2024 European Stroke Conference (ESOC 2024), it attracted widespread attention in the industry. Currently, Phase III clinical studies are being conducted in China (NCT06517173).

Several other exploratory clinical studies are underway (NCT05849805, NCT06374667); and related articles have been published recently (Liu, W., et al., Intracalvariosseous Injection: An Approach for Central Nervous System Drug Delivery through Skull Bone Marrow with a Preclinical Research in Stroke. eBioMedicine, 2025. 112.)

Ningdan New Drug will continue to explore the clinical application of Y-3 for Injection and promote global research and development.