Cocrystal Pharma Receives FDA IND Clearance for Challenge Study of Oral Broad-Spectrum Protease Inhibitor CDI-988, a Potential First Antiviral for Norovirus Prevention and Treatment
Tuesday, September 09, 2025
Cocrystal Pharma, Inc. (Nasdaq: COCP) has announced that the U.S. Food and Drug Administration (FDA) has granted clearance to proceed with a Phase 1b challenge study evaluating CDI-988, the Company’s oral broad-spectrum antiviral candidate, for the prevention and treatment of norovirus infections. The study is expected to begin before the end of 2025.
CDI-988 is a novel pan-viral 3CL protease inhibitor developed to treat both norovirus and coronavirus infections. It targets a highly conserved region of the viral protease active site, demonstrating broad-spectrum antiviral activity. Preclinical studies showed effectiveness against major norovirus proteases, including the prevalent GII.4 and GII.17 strains. In a Phase 1 study, CDI-988 was well tolerated with a favourable safety profile. Currently, no vaccines or approved therapies exist for norovirus.
Sam Lee, PhD, President and Co-CEO of Cocrystal Pharma, said:
“The FDA’s clearance of our CDI-988 study is a major milestone, marking the next step in its clinical development. CDI-988 is the first novel oral drug candidate for norovirus prevention and treatment, with encouraging data demonstrating broad antiviral activity. We look forward to initiating the Phase 1b challenge study and further assessing CDI-988’s potential efficacy in norovirus-infected patients.”
Source: globenewswire.com
