Study Drug

What is the study drug?

There are 2 drugs in the Ri-CoDIFy 3 study: the study drug (ridinilazole) and an existing CDI drug (vancomycin), which is an antibiotic often used as
standard therapy for CDI .

Participants will be assigned at random (like a coin flip) to receive either ridinilazole or vancomycin. For every 4 participants in the study, 3 will receive ridinilazole, and 1 will receive vancomycin. Neither you nor the study staff will know which you receive.

Here is some more information about each drug in the study:

STUDY DRUG EXISTING CDI DRUG
Name Ridinilazole Vancomycin
Status Investigational, which means it is not approved by the U.S. Food and Drug Administration (FDA), or the regulatory authority in any country, to be used outside of clinical research Approved by the U.S. Food and Drug Administration (FDA) to be used in people with CDI
Form Tablet Capsule
Action Designed to target and destroy only C. difficile bacteria, leaving other bacteria alone Designed to destroy C. difficile bacteria in the intestines, but also destroys good bacteria in the process
Result A healthy balance of bacteria remains in the intestines, which may prevent C. difficile from taking over again Loss of good bacteria in the intestines creates an imbalance, which can allow C. difficile to eventually take over again

Have other people used the study drug?

Yes, the study drug has been tested in Phase 1 and 2 studies in adults and was found to be generally safe and well tolerated.