FDA Backs Israeli Firm RedHill’s New Crohn’s Drug Trial

Jerusalem, 21 July, 2025 (TPS-IL) — Israeli biopharma company RedHill has received positive feedback from the U.S. FDA for its planned Phase 2 trial of RHB-204, a new oral treatment for Crohn’s disease. The trial will be the first to focus on patients with a specific bacterial infection (MAP-positive), believed to be a possible cause of the disease.

Developed in Tel Aviv, the drug aims to treat both the infection and Crohn’s symptoms. Using advanced MAP testing, the study is expected to be quicker and less costly. RHB-204 builds on earlier clinical success and could qualify for fast-track FDA approval, showcasing Israeli innovation in global biotech.