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Also known as bismuth subsalicylate (Pepto-Bismol®)
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 in a Phase 1 trial to reduce gastrointestinal events in healthy volunteers receiving dimethyl fumarate (Tecfidera) twice daily. The trial, NCT01915901, enrolled 175 healthy adults in the United States and has been completed. The broader therapeutic indication for this development program is not publicly disclosed.
Bismuth subsalicylate targets PTGS2 and PTGS1, also known as cyclooxygenase-2 and cyclooxygenase-1. It acts as an inhibitor of these enzymes. This target profile is consistent with its classification as a small molecule and underlies its evaluation for gastrointestinal tolerability in the Phase 1 study.
Biogen Inc., which trades on the Nasdaq under the ticker BIIB, is the developer of bismuth subsalicylate. The company is evaluating the drug in a Phase 1 clinical program. Biogen is also known for its work in neurology, including dimethyl fumarate (Tecfidera), the background therapy used in the bismuth subsalicylate trial.
Bismuth subsalicylate is in Phase 1 development. It is an investigational drug and has not been approved by the FDA for the indication being studied. The single Phase 1 trial, NCT01915901, has been completed, and no active trials are currently listed for this asset.
Bismuth subsalicylate has been studied in one completed Phase 1 trial, NCT01915901, titled "PeptoBismol Use to Reduce Gastrointestinal Events in Healthy Volunteers Receiving DMF [Tecfidera] Twice Daily." The trial was randomized, double-blind, and controlled, enrolling 175 healthy volunteers aged 18 years and older in the United States.
Yes, bismuth subsalicylate is also known as Pepto-Bismol. The Phase 1 trial NCT01915901 used the Pepto-Bismol brand name in its title. This alternative name is commonly used when referring to the same active ingredient in clinical and consumer contexts.