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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 is an investigational small molecule being studied for the treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D). It is a gastrointestinal therapy developed by Bausch Health Companies Inc. (BHC). The drug is currently in Phase 2 clinical development and is not yet approved for any use.
The specific molecular target of Mesalamine Granules has not been disclosed. It is a small molecule therapy being evaluated for its effects on Irritable Bowel Syndrome With Diarrhea. The mechanism of action is not publicly detailed in the available clinical trial information.
Mesalamine Granules is being developed by Bausch Health Companies Inc., which trades under the ticker symbol BHC. The company is conducting clinical research on this drug for the treatment of Irritable Bowel Syndrome With Diarrhea. It is currently in Phase 2 development.
Mesalamine Granules is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The drug is being studied for Irritable Bowel Syndrome With Diarrhea, and one Phase 2 trial has been completed.
Mesalamine Granules has one completed Phase 2 clinical trial, identified as NCT01177410, titled "Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea." The trial enrolled 148 participants in the United States, was randomized, double-blind, and placebo-controlled. It included adults aged 18 years and older.
Mesalamine Granules is a formulation of mesalamine, also known as 5-aminosalicylic acid, which is an established anti-inflammatory agent used in other gastrointestinal conditions. However, this specific granule formulation is being investigated as a new treatment for Irritable Bowel Syndrome With Diarrhea and is not yet approved.