rabeprazole
rabeprazole: developed by 3 companies · 5 clinical trials tracked · 3 FDA decisions.
rabeprazole evidence translation
What we can confirm
3 FDA records · 5 tracked trials
What it means
What to watch
Prepared research question
What is verified about rabeprazole, and what remains unknown?
Traceable citations · Unknowns marked
See linked entities and source evidence2 indications · 5 study sponsors
Development Pipeline (3)
| Company | Phase |
|---|---|
| AYTU BIOPHARMA, INC (AYTU) | Approved |
| LANNETT CO INC (LCI) | Approved |
| DR REDDYS LABORATORIES LTD (RDY) | Approved |
Clinical Trials (5)
An Open-Label, Randomized, Four-Period, Six-Sequence Phase I Study to Evaluate the Effect of Food and Proton Pump Inhibitor Rabeprazole on the Pharmacokinetics of HMPL-760 Capsules in Healthy Participants
Primary endpoint: AUC 0-last
A PHASE 1, OPEN-LABEL, RANDOMIZED, 5-PERIOD, 6-SEQUENCE, CROSSOVER STUDY TO COMPARE THE SINGLE-DOSE PHARMACOKINETICS OF ONE IMMEDIATE RELEASE AND TWO MODIFIED-RELEASE FORMULATIONS OF PF-08049820 ADMINISTERED ORALLY UNDER FASTED AND FED CONDITIONS (PART A), AND A FIXED SEQUENCE STUDY TO ASSESS THE EFFECT OF RABEPRAZOLE ON THE PHARMACOKINETICS OF PF-08049820 (PART B), IN HEALTHY ADULTS
Primary endpoint: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
A Phase 1, Open-label, Randomized, Four-way Crossover Study to Assess the Relative Bioavailability of Two Phase 3 LY4100511 (DC-853) Tablet Formulations Compared With the Phase 2 LY4100511(DC-853) Tablet Formulation, With and Without a Proton Pump Inhibitor in Healthy Participants
Primary endpoint: Pharmacokinetic (PK): Area Under the Concentration Curve from 0 to Infinity (AUC0-∞) of LY4100511 (DC-853)
A Modular Phase I, Open-label Study to Assess the Safety, Pharmacokinetics, and Drug Interaction Potential and Relative Bioavailability of Saruparib in Patients With Advanced Solid Malignancies
Primary endpoint: Module 1: Area under plasma concentration-time curve from zero extrapolated to infinity (AUCinf) of digoxin, furosemide, metformin and rosuvastatin when dosed alone and in combination with saruparib
A Phase 1/2 Study of BMS-986408 Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors
Primary endpoint: Number of Participants With Dose Limiting Toxicities (DLTs)
FDA Decisions3 records
Frequently asked questions
Who is developing rabeprazole?
rabeprazole is being developed by AYTU BIOPHARMA, INC, LANNETT CO INC, DR REDDYS LABORATORIES LTD.
How many clinical trials involve rabeprazole?
BioSniper tracks 5 clinical trials involving rabeprazole.
What is rabeprazole's latest FDA decision?
The most recent tracked FDA decision for rabeprazole is Approval for 1 INDICATIONS AND USAGE Rabeprazole sodium delayed-release tablets is a proton pump inhibitor (PPI) indicated in adults for: Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) ( 1.1 ). Maintenance of Healing of Erosive or Ulcerative GERD ( 1.2 ). Treatment of Symptomatic GERD ( 1.3 ). Healing of Duodenal Ulcers ( 1.4 ). Helicobacter pylori Eradication to Reduce Risk of Duodenal Ulcer Recurrence ( 1.5 ). Treatment of Pathological Hypersecretory Conditions, Including Zollinger, dated November 8, 2013.