Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Balsalazide Disodium · 2 trials · 2 indications
Incidence of treatment emergent adverse events
| Arm | Type | Description |
|---|---|---|
| balsalazide disodium tablets,3.3 g BID, | OTHER | - |
| Name | Type | Description |
|---|---|---|
| Balsalazide Disodium | DRUG | - |
Inclusion Criteria: * Subject has a documented history of UC and is either in remission or currently presents with mildly to moderately active UC symptoms as determined by the investigator upon subject interview of UC symptoms, (e.g., urgency, bowel frequency, and rectal bleeding). Additionally, th...
Balsalazide disodium is used to treat inflammatory bowel disease, specifically ulcerative colitis. It is a small molecule developed by Bausch Health Companies Inc. for gastrointestinal use. The clinical program has studied it in adults with mildly to moderately active ulcerative colitis, and it is given orally.
Balsalazide disodium acts as an agonist at PPARG and also engages ALOX5, PTGS2, and PTGS1. These targets are involved in inflammatory signaling in the gut. By interacting with this target class, the drug is designed to reduce the inflammatory activity that drives ulcerative colitis symptoms.
Bausch Health Companies Inc., which trades under the ticker BHC, is the developer of balsalazide disodium. The company has sponsored the clinical trial program for the drug in inflammatory bowel disease, including the Phase 3 studies conducted in the United States.
Balsalazide disodium has been studied in Phase 3 clinical development for inflammatory bowel disease. Two Phase 3 trials have been completed, and no trials are currently listed as active. The program enrolled a total of 843 participants across those completed studies.
Two completed Phase 3 trials have evaluated balsalazide disodium. NCT00486031 was an open-label, long-term ulcerative colitis study that enrolled 443 adults in the United States. NCT00408174 compared balsalazide disodium with mesalamine in 400 adults with mildly to moderately active ulcerative colitis, also in the United States.
Yes. The balsalazide disodium Phase 3 program used randomized, double-blind designs, and participants were adults aged 18 years and older of any sex. The studies enrolled people with ulcerative colitis rather than healthy volunteers, and the comparison trial evaluated the drug against mesalamine.