Ridinilazole & Clostridioides difficile infection (CDI) (initial)

Regulatory status

There is currently no FDA or EMA approval for ridinilazole for the treatment of initial Clostridioides (Clostridium) difficile infection (CDI). While phase 3 clinical trials have evaluated ridinilazole as a candidate for first-line therapy for CDI, it remains an investigational drug and has not received marketing authorization from either the FDA or EMA as of late 2025.
Cho et al. 2019 Ann Gastroenterol 32(2): 134-140
Collins & Riley 2022 Lett Appl Microbiol 75(3): 526-536
Okhuysen et al. 2024 Clinical Infectious Diseases 78(6): 1462-1472

Clinical data

The randomized clinical phase III treatment trial, identified as [NCT03595566 - Ridinilaz…