FDA Grants Fast Track Designation to Cocrystal Pharma's Norovirus Antiviral CDI-988
The FDA has granted Fast Track designation to Cocrystal Pharma's oral antiviral CDI-988 for norovirus prevention and treatment. A Phase 1b norovirus challenge study is underway at Emory University, with data to be presented at an international antiviral research conference in April 2026.
The U.S. Food and Drug Administration has granted Fast Track designation to Cocrystal Pharma's oral antiviral drug candidate CDI-988 for the prevention and treatment of norovirus infection. The designation facilitates accelerated development and expedited regulatory review for the first oral antiviral candidate being developed for norovirus, which causes an estimated 685 million global cases annually with approximately $60 billion in worldwide economic impact.
Fast Track designation enables early and frequent communication with the FDA throughout the development process, allows for rolling review of a New Drug Application, and may qualify the product for Priority Review at the time of NDA submission. CDI-988 is an oral, direct-acting protease inhibitor that targets a highly conserved 3CL protease region, supporting pan-viral targeting potential.
A Phase 1b norovirus challenge study is currently underway at Emory University School of Medicine to evaluate CDI-988 as both a potential prophylactic and therapeutic option. The company will present initial Phase 1 data and updates from this ongoing Phase 1b study at the 39th International Conference on Antiviral Research (ICAR2026) in Prague from April 27 to May 1, 2026.
CDI-988 was designed and developed using Cocrystal's proprietary structure-based drug discovery platform technology as a pan-viral protease inhibitor targeting 3CL viral proteases. Based on its novel mechanism of action and broad-spectrum antiviral activity, CDI-988 represents a potential oral treatment for both noroviruses and coronaviruses.
There are currently no approved antiviral therapies or vaccines for norovirus infections, demonstrating an immediate market need. The program has progressed through early clinical stages, with favorable single-ascending dose Phase 1 data reported in July 2024, progression into multiple-ascending dose cohorts in September 2024, and broader Phase 1 results presented in January and August 2025.