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 for Inflammatory Bowel Disease, specifically mildly to moderately active ulcerative colitis. It is a small molecule being developed by Bausch Health Companies Inc. for this gastrointestinal condition. The drug has completed Phase 3 clinical trials in the United States.
Balsalazide Disodium is a small molecule that acts locally in the colon to treat ulcerative colitis. It is a prodrug that is converted to mesalamine, the active anti-inflammatory agent, in the colon. This mechanism delivers the therapeutic effect directly to the site of inflammation in the gastrointestinal tract.
Balsalazide Disodium is developed by Bausch Health Companies Inc., traded under the ticker BHC. The company has conducted Phase 3 clinical trials for this drug in the United States for the treatment of ulcerative colitis, a form of Inflammatory Bowel Disease.
Balsalazide Disodium is in Phase 3 clinical development. Two Phase 3 trials have been completed, with a total enrollment of 843 participants. The drug is investigational and has not been reported as FDA approved. It remains in clinical development for Inflammatory Bowel Disease.
Balsalazide Disodium has completed two Phase 3 trials: NCT00408174, comparing it to mesalamine in mildly to moderately active ulcerative colitis with 400 participants, and NCT00486031, an open-label long-term study with 443 participants. Both trials were conducted in the United States.
Balsalazide Disodium is not the same as mesalamine, but it is a prodrug that is converted to mesalamine in the colon. In clinical trial NCT00408174, balsalazide disodium was compared directly against mesalamine in patients with mildly to moderately active ulcerative colitis.