Shuttle Pharmaceuticals Holdings, Inc. announced receipt of written responses to questions submitted for a Type B pre-Investigational New Drug Application (PIND) meeting with the U.S. Food and Drug Administration (FDA). The FDA's positive feedback and guidance on the Company's Chemistry, Manufacturing, and Controls (CMC) and clinical protocol design for Ropidoxuridine provides a pathway to IND application submission in the fourth quarter of 2023 to initiate the Phase 2 clinical trial. Ropidoxuridine (IPdR) is Shuttle's lead candidate radiation sensitizer for use in combination with RT to treat brain tumors (glioblastoma), a deadly malignancy of the brain with no known cure.

Shuttle has received Orphan Drug Designation from the FDA, providing potential marketing exclusivity upon first FDA approval for the disease.