Study Drug

What is the study drug?

The study drug in the Ri-CoDIFy 3 study is called ridinilazole. A past study in adults with CDI showed that ridinilazole was better than the existing drug vancomycin at keeping the CDI from coming back after it went away, but more testing is needed to know for sure. The Ri-CoDIFy 3 study is designed to further test how well ridinilazole works in young people compared to vancomycin.

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.