Nicox Finalizes Key Data for NCX 470 NDA Submission by H1 2026

Nicox SA has announced the completion of all essential data for NCX 470 New Drug Applications (NDAs) in the U.S. and China. This milestone involves clinical trial and long-term stability data aligned with International Council for Harmonisation guidelines. Nicox is now focusing on preparing the NDA with their U.S. partner, Kowa, in time for the planned submission in H1 2026.

A pre-NDA meeting with the U.S. FDA is in preparation, ensuring all requirements for the review are met. The NDA submission in China is also expected to follow shortly after. Additionally, a Phase 3 clinical program in Japan, managed by Kowa, began in summer 2025. These steps are crucial for establishing the safety and efficacy of NCX 470, aimed at treating open-angle glaucoma and ocular hypertension.