Appili Therapeutics Inc. with its partner Saptalis Pharmaceuticals LLC announced that the Food and Drug Administration accepted the ATI-1501 New Drug Application. ATI-1501 is Appili's liquid oral reformulation of the antibiotic metronidazole, which has been licensed to Saptalis. The FDA established a Prescription Drug User Fee action date of September 23, 2023.

Metronidazole is a widely used frontline oral treatment with over 10 million prescriptions written in the United States every year to help treat parasitic and anaerobic bacterial infections. The current tablet form of metronidazole is the only approved oral form on the U.S. market and its bitter taste and lack of appropriate dosage forms prove highly difficult for patients with trouble swallowing, presenting frequent treatment compliance challenges. Approval of ATI-1501 will unlock the potential to achieve relief and recovery for the millions facing these devastating infections by offering a convenient treatment option.