Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pantoprazole for approximately 9 weeks · 2 trials · 2 indications
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (0-t).
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Vz/F was calculated as the ratio of clearance (CL) to terminal disposition rate constant (λz).
| Name | Type | Description |
|---|---|---|
| pantoprazole for approximately 9 weeks. | DRUG | - |
| Pantoprazole for approximately 9 weeks | DRUG | - |
Inclusion Criteria: * Endoscopically proven GERD diagnosed within 6 months before study entry. * Weight must be equal to or over 8.3 kg; for subjects 6 years or greater, weight must be equal to or under 25 kg Exclusion Criteria: * History of GI disorders, ie, unrepaired tracheal esophageal fistul...
Pantoprazole for approximately 9 weeks is an investigational small molecule developed by Pfizer, Inc. (ticker PFE) for the treatment of gastroesophageal reflux. It is in Phase 3 clinical development. The name reflects a roughly nine-week treatment course studied in clinical trials rather than a distinct chemical entity.
Pantoprazole for approximately 9 weeks targets ATP4A and ATP4B. It acts as an inhibitor of these targets. ATP4A and ATP4B form the gastric proton pump, the enzyme responsible for secreting acid into the stomach, so inhibiting this pump reduces gastric acid production.
Pfizer, Inc. is the developer of pantoprazole for approximately 9 weeks. Pfizer trades on the New York Stock Exchange under the ticker PFE. The company is responsible for the clinical development program in gastroesophageal reflux.
Pantoprazole for approximately 9 weeks is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. Two Phase 3 trials have been completed, and no trials are currently active.
Two completed Phase 3 trials studied pantoprazole for approximately 9 weeks. NCT00195208 compared a pantoprazole formulation to the marketed tablet in adults with GERD and erosive esophagitis, enrolling 97 participants in the United States. NCT00141817 evaluated pantoprazole in children with GERD, enrolling 41 participants. Combined enrollment was 138.
Yes, pantoprazole for approximately 9 weeks refers to pantoprazole studied over a treatment period of roughly nine weeks. The full name describes the dosing duration used in the clinical program rather than a separate drug. Pantoprazole is the active small molecule being evaluated for gastroesophageal reflux.