Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Omeprazole bicarbonate immediate release PWD/FS · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Omeprazole sodium bicarbonate immediate release PWD/FS | EXPERIMENTAL | - |
| Cimetidine IV | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Omeprazole sodium bicarbonate immediate release PWD/FS | DRUG | - |
| Cimetidine IV | DRUG | - |
Patients will be included in the trial if they meet all of the following criteria: 1. An adult or adolescent (greater than or equal to 16 years of age) male or non-pregnant female requiring mechanical ventilation for greater than or equal to 48 hours. 2. An anticipated ICU stay of greater than or e...
Omeprazole bicarbonate immediate release PWD/FS is an investigational small molecule medicine being developed by Bausch Health Companies Inc. (ticker BHC) for the prevention of upper gastrointestinal bleeding in critically ill patients. It combines omeprazole with sodium bicarbonate in an immediate release powder or suspension formulation.
It is being studied for the prevention of upper gastrointestinal bleeding in critically ill patients. The Phase 3 trial enrolled critically ill adults at risk of upper GI bleeding. It is investigational and has not been approved for this use.
Omeprazole bicarbonate immediate release PWD/FS targets ATP4A and ATP4B, the subunits of the gastric proton pump (H+/K+ ATPase). It acts as an inhibitor of this pump, which is the mechanism that suppresses gastric acid secretion. The bicarbonate component is included to protect the omeprazole from acid degradation.
Bausch Health Companies Inc., which trades under the ticker BHC, is the developer of omeprazole bicarbonate immediate release PWD/FS. The company is studying the asset for upper gastrointestinal bleeding in critically ill patients.
Omeprazole bicarbonate immediate release PWD/FS is in Phase 3 development. It is investigational and has not been approved by the FDA. The Phase 3 trial has been completed, and no trials are currently active.
Omeprazole bicarbonate immediate release PWD/FS has been evaluated in one completed Phase 3 trial, NCT00045799, titled Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill. The randomized, double blind, active controlled trial enrolled 354 participants in the United States.