NeOnc Technologies Holdings, Inc. announced it has received Investigational New Drug (IND) approval from the Department of Health – Abu Dhabi (DOH) for its brain cancer drug candidate, NEO212. This clearance allows the company to advance the drug into Phase 2 clinical trials in the United Arab Emirates, establishing its first international clinical pathway.
Key Details
- Drug: NEO212, an orally administered therapy for patients with aggressive brain tumors, such as recurrent glioblastoma (GBM).
- Regulatory Milestone: The IND approval, granted on June 16, 2026, is the first international regulatory clearance for NEO212 and follows the successful completion of a Phase 1 dose-escalation study.
- Next Steps: The company will proceed with Phase 2 development in the UAE with a recommended dose of 610 mg, while also continuing discussions with the U.S. FDA for a potential registrational pathway in the U.S.