Nicox Completes Key Data Package to Support NCX 470 NDA Submissions in the US and China
Nicox SA said it has completed generation and analysis of all key data required to support the submission of new drug applications (NDAs) for its glaucoma drug candidate NCX 470 in the United States and China.
The completed data package includes all clinical trial results and long-term stability data on batches of both the NCX 470 drug substance and the finished drug product. In addition to data from the NCX 470 clinical trials, the package includes standard NDA elements designed to support manufacturing processes, establish shelf-life for the drug and finished product, and evaluate drug metabolism.
In October, Nicox completed additional pre-planned analyses from its NCX 470 Denali phase 3 clinical trial. The results confirm an efficacy profile consistent with the Mont Blanc phase 3 trial subgroup analyses and demonstrate sustained IOP reduction through 12 months of treatment with no new safety signals.
“We have achieved this milestone through close collaboration of our committed and dedicated team with our clinical and manufacturing partners and specialist research organisations,” said Doug Hubatsch, Executive Vice President and Chief Scientific Officer of Nicox. “It marks a major step towards generating long-term value from NCX 470 and positioning Nicox for the future. Focus for the development team is now on accompanying our licensing partner for the US, Kowa, with preparation for our upcoming meeting with the Food and Drug Administration, and subsequent submission of the New Drug Application.”
Key Future Milestones
NCX 470 NDA submission in the US: Expected in the first half of 2026
NCX 470 NDA submission in China: Expected shortly after the U.S. submission
NCX 470 phase 3 clinical program in Japan: Initiated in summer 2025; managed and financed by Kowa