The FDA has granted Fast Track designation to CDI-988, an oral, direct-acting protease inhibitor for norovirus. CDI-988 is the first oral antiviral candidate being developed for both the treatment and prophylaxis of norovirus. The designation allows for more frequent FDA interactions, potential rolling review of the New Drug Application (NDA), and eligibility for Priority Review. A Phase 1b challenge study (NCT07198139) is currently underway at Emory University School of Medicine involving up to 40 healthy adults.