NeOnc Technologies Holdings announced it has received Investigational New Drug (IND) status from the Department of Health – Abu Dhabi (DOH) for its lead candidate, NEO100. NEO100 is an intranasally administered therapy for treating progressive or recurrent high-grade gliomas. This approval expands the company's global clinical development footprint ahead of an anticipated U.S. data milestone.
Key Details
- Drug Candidate: NEO100, an intranasally delivered formulation of purified perillyl alcohol for non-invasive nose-to-brain delivery.
- Authorization Scope: The UAE IND status covers Phase 1 through Phase 2 studies in adults and Phase 1/1b studies in pediatric patients for recurrent Grade III or IV gliomas.
- Upcoming Milestone: The company expects to report top-line data from its fully enrolled U.S. Phase 2a trial (NEO100-01) by the end of July 2026.
- U.S. Regulatory Status: In the United States, NEO100 already holds FDA Orphan Drug, Fast Track, and Rare Pediatric Disease designations.