Approval Probability
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Adjusted LOA
ML Risk
bismuth subsalicylate · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| bismuth subsalicylate (Pepto-Bismol®) + DMF | EXPERIMENTAL | Subjects will receive dimethyl fumarate (DMF) and bismuth subsalicylate (Pepto-Bismol®). |
| Placebo + DMF | EXPERIMENTAL | Subjects will receive dimethyl fumarate (DMF) and placebo. |
| Name | Type | Description |
|---|---|---|
| bismuth subsalicylate (Pepto-Bismol®) | DRUG | 524 mg bismuth subsalicylate twice a day (BID) |
| matching placebo (bismuth subsalicylate) | DRUG | placebo twice a day (BID) |
| dimethyl fumarate (DMF) | DRUG | dimethyl fumarate (DMF) twice a day (BID) |
Key Inclusion Criteria: * Must be in good health as determined by the Principal Investigator (PI) based on medical history and Screening evaluations (clinical laboratory evaluations, 12-lead electrocardiogram (ECG), and vital signs; see below for specific exclusion criteria). * Must have a body mas...
Bismuth subsalicylate is being studied for use in healthy volunteers to reduce gastrointestinal events in people receiving dimethyl fumarate (Tecfidera) twice daily. It is a small molecule being developed by Biogen Inc. (BIIB) and is currently in Phase 1 clinical development.
Bismuth subsalicylate is being developed by Biogen Inc. (NASDAQ: BIIB). The company is conducting a Phase 1 clinical trial to evaluate its use in healthy volunteers to reduce gastrointestinal events associated with dimethyl fumarate (Tecfidera) treatment.
Bismuth subsalicylate is in Phase 1 clinical development. It is an investigational drug being studied in a completed Phase 1 trial (NCT01915901) that enrolled 175 healthy volunteers in the United States. It is not yet approved and remains in clinical development.
Bismuth subsalicylate has one completed Phase 1 clinical trial, NCT01915901, titled 'PeptoBismol® Use to Reduce Gastrointestinal Events in Healthy Volunteers Receiving DMF [Tecfidera®] Twice Daily.' The trial enrolled 175 healthy volunteers in the United States and was randomized, double-blind, and controlled.
Bismuth subsalicylate is the active ingredient in Pepto-Bismol, as indicated by the clinical trial title referencing PeptoBismol®. The study evaluates its use to reduce gastrointestinal events in healthy volunteers receiving dimethyl fumarate (Tecfidera) twice daily.