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Rabeprazole

Phase 4FDA approved

Undisclosed | Small molecule | Other |Viatris Inc.|Trials Updated: Apr 24, 2024

Rabeprazole development status

FDA approval on record Mar 26, 2013 as Aciphex Sprinkle
Approval holderAytu
ApplicationNDA204736
Highest phase Phase 4 run by Janssen Korea, Ltd., Korea (NCT01008696)
Phase scored for VTRSPhase 1
Registered trials 42 across 21 sponsors since Oct 2005

Rabeprazole target and mechanism

Molecular targetATP4A, ATP4B
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment144

FDA Designations

No designations recorded

Rabeprazole clinical trials

Rabeprazole · 2 trials · 1 indication

Phase 1 2
NCT00649194Food Study of Rabeprazole Sodium Delayed-Release Tablets 20 mg to Aciphex® Tablets 20 mgHealthy
COMPLETED72 Analytics
NCT00648349Fasting Study of Rabeprazole Sodium Delayed-Release Tablets 20 mg to Aciphex® Delayed-Release Tablets 20 mgHealthy
COMPLETED72 Analytics
PHASE1COMPLETED
Food Study of Rabeprazole Sodium Delayed-Release Tablets 20 mg to Aciphex® Tablets 20 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Rabeprazole Sodium Delayed-Release Tablets 20 mg to Aciphex® Delayed-Release Tablets 20 mg
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence
within 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALRabeprazole Sodium Delayed-Release Tablets 20 mg
2ACTIVE_COMPARATORAciphex® Tablets 20 mg

Interventions

NameTypeDescription
Rabeprazole Sodium Delayed-Release Tablets 20 mgDRUG20mg, single dose fed
Aciphex® Tablets 20 mgDRUG20mg, single dose fed
Aciphex® Delayed-Release Tablets 20 mgDRUG20mg, single dose fasting
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and non-pregnant, non-lactating female 1. Women of childbearing potential must have negative serum beta-human chorionic gonadotropin (HCG) pregnancy tests performed within 14 days prior to the start of the study and the evening prior ...

Countries:United States
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Frequently asked questions about Rabeprazole

What is Rabeprazole?

Rabeprazole is a small molecule drug developed by Viatris Inc. (ticker VTRS). It is also known as Rabeprazole Sodium Delayed-Release Tablets 20 mg. The clinical trials listed for this asset were conducted in healthy adult volunteers, and the specific therapeutic indication being pursued is not disclosed.

What does Rabeprazole target?

Rabeprazole targets ATP4A and ATP4B. It is classified as an inhibitor of these targets. ATP4A and ATP4B form the gastric proton pump, and inhibiting this pump is the mechanism by which rabeprazole acts as a small molecule therapeutic.

Who makes Rabeprazole?

Rabeprazole is developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the sponsor of the clinical trials evaluating Rabeprazole Sodium Delayed-Release Tablets 20 mg.

What phase is Rabeprazole in?

Rabeprazole is in Phase 1 clinical development. It is an investigational asset and is not described as approved. Two Phase 1 trials have been completed, and no trials are currently active.

What clinical trials is Rabeprazole in?

Rabeprazole has been studied in two completed Phase 1 trials: NCT00649194, a food-effect study comparing Rabeprazole Sodium Delayed-Release Tablets 20 mg with Aciphex tablets 20 mg, and NCT00648349, a fasting study with the same comparison. Both enrolled 72 healthy volunteers in the United States, for a total enrollment of 144.