On April 2, 2026, Cocrystal Pharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its oral, direct-acting protease inhibitor, CDI-988. This designation is significant as it supports the accelerated development and expedites regulatory review for drugs that treat serious conditions and address unmet medical needs. CDI-988 is the first oral antiviral candidate being developed for the treatment and prophylaxis of norovirus infection, which is responsible for an estimated 685 million global cases each year and incurs approximately $60 billion in worldwide economic impact. The Fast Track designation allows for early and frequent communication with the FDA throughout the development process, enables rolling review of a New Drug Application (NDA), and may qualify the product for Priority Review at the time of NDA submission. Cocrystal is currently conducting a Phase 1b norovirus challenge study at Emory University School of Medicine to evaluate CDI-988's efficacy in preventing and treating norovirus infection. The company believes that CDI-988 has the potential to significantly impact the treatment landscape for norovirus infections, which can cause severe gastrointestinal symptoms and are particularly dangerous for immunocompromised individuals. This milestone marks a critical step for Cocrystal in its mission to develop innovative antiviral therapies.

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