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Mesalamine Granules · 1 trial · 1 indication
A weekly responder in abdominal pain is defined as a ≥30% improvement from baseline in the weekly average abdominal pain score on a 10-point scale (0=no pain - 10= worst possible pain). A weekly responder in stool consistency is defined as ≥50% reduction in the number of days in a week with stool consistency of Type 6 or 7 compared with baseline using the Bristol Stool Scale. Monthly responders are subjects who are weekly responders in both abdominal pain and stool consistency for at least two out of four weeks.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| Mesalamine Granules 750 mg | EXPERIMENTAL | - |
| Mesalamine Granules 1500 mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | placebo capsules once daily for 12 weeks |
| Mesalamine Granules 750 mg | DRUG | 750 mg mesalamine granules once daily for 12 weeks |
| Mesalamine Granules 1500 mg | DRUG | 1500 mg mesalamine granules once daily for 12 weeks |
Inclusion Criteria: Male or non-pregnant, non-lactating female subjects Diagnosed with IBS confirmed by the Rome III criteria Meet the following IBS symptom scores in all categories during the diary eligibility period: * An average daily score of greater than or equal to 3 for abdominal pain * An...
Mesalamine granules are being studied for irritable bowel syndrome with diarrhea, or IBS-D. The formulation is mesalamine granules 750 mg, a small molecule developed by Bausch Health Companies Inc. under the ticker BHC. It is an investigational use: the drug has been tested in a Phase 2 trial in adults with IBS-D, not approved for this indication.
Mesalamine granules target ALOX5, PTGS2, PTGS1, and PPARG. The compound acts as an inhibitor across these targets, which include cyclooxygenase enzymes and the nuclear receptor PPARG. This target profile places mesalamine granules in the small molecule class being evaluated for gastrointestinal conditions, specifically irritable bowel syndrome with diarrhea.
Bausch Health Companies Inc., which trades under the ticker BHC, is developing mesalamine granules. The company is the sponsor behind the mesalamine granules 750 mg program for irritable bowel syndrome with diarrhea. Bausch Health is the developer named for this asset.
Mesalamine granules are in Phase 2 development for irritable bowel syndrome with diarrhea. The program has one completed Phase 2 trial and no active trials. Because the data do not show approval for IBS-D, mesalamine granules should be considered investigational for this indication rather than an approved therapy.
One trial has tested mesalamine granules: NCT01177410, titled Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea. It was a Phase 2, randomized, double-blind, placebo-controlled study that enrolled 148 adults aged 18 years and older in the United States. The trial is completed, and no trials are currently active.