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Ilaprazole

Phase 2

Esophagitis | Small molecule | Gastrointestinal |Takeda Pharmaceutical Company Limited|Trials Updated: Feb 2, 2012

Ilaprazole development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since May 2007

Ilaprazole target and mechanism

Molecular targetATP4A, ATP4B
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment831

FDA Designations

No designations recorded

Ilaprazole clinical trials

Ilaprazole · 1 trial · 1 indication

Phase 2 1
NCT00471094Safety and Efficacy of Ilaprazole 5, 20 and 40 mg QD and Lansoprazole 30 mg QD on Healing of Erosive EsophagitisEsophagitis
COMPLETED831 Analytics
PHASE2COMPLETED
Safety and Efficacy of Ilaprazole 5, 20 and 40 mg QD and Lansoprazole 30 mg QD on Healing of Erosive Esophagitis
EsophagitisUnlock trial analytics

Study Endpoints

Primary Endpoints

The crude healing rate of Erosive Esophagitis at week 4 of treatment as assessed by endoscopy.
Week 4

Secondary Endpoints

The crude healing rate of Erosive Esophagitis at week 8 of treatment as assessed by endoscopy.
Week 8
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Ilaprazole 5 mg QDEXPERIMENTAL -
Ilaprazole 20 mg QDEXPERIMENTAL -
Ilaprazole 40 mg QDEXPERIMENTAL -
Lansoprazole 30 mg QDACTIVE_COMPARATOR -

Interventions

NameTypeDescription
IlaprazoleDRUGIlaprazole 5 mg, capsules, orally, once daily for up to 8 weeks.
LansoprazoleDRUGLansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites94

Inclusion Criteria: * Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D). Exclusion Criteria: * Evidence of uncontrolled, clinically significant systemic disease; acquired immunodeficiency syndrome (AIDs); a condit...

Countries:United States
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Competitive Landscape -Eosinophilic Esophagitis 11 trials (matched to "Esophagitis")

Frequently asked questions about Ilaprazole

What is ilaprazole used for?

Ilaprazole is being developed for the treatment of esophagitis, specifically erosive esophagitis. It is a small molecule in the gastrointestinal therapeutic area. The clinical program has studied it for healing of erosive esophagitis, a condition where acid damage erodes the lining of the esophagus.

What does ilaprazole target?

Ilaprazole targets ATP4A and ATP4B, which together form the gastric proton pump. It acts as an inhibitor of this target. By inhibiting the proton pump, ilaprazole reduces gastric acid secretion, which is the mechanism relevant to treating erosive esophagitis.

Who is developing ilaprazole?

Ilaprazole is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor associated with the clinical development of this small molecule for gastrointestinal indications.

What phase is ilaprazole in?

Ilaprazole is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The Phase 2 program has focused on esophagitis, with one completed trial to date.

What clinical trials is ilaprazole in?

Ilaprazole has been studied in one completed clinical trial, NCT00471094. This Phase 2 trial evaluated the safety and efficacy of ilaprazole at 5, 20, and 40 mg once daily compared with lansoprazole 30 mg once daily for healing of erosive esophagitis. It enrolled 831 participants in the United States.

Is ilaprazole the same as lansoprazole?

No, ilaprazole and lansoprazole are different drugs. Ilaprazole is a distinct small molecule developed by Takeda, while lansoprazole was used as the active comparator in the Phase 2 trial NCT00471094. Both belong to the proton pump inhibitor class, but they are separate chemical entities.