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Pantoprazole

Phase 4FDA approved

GERD | Small molecule | Gastrointestinal |Takeda Pharmaceutical Company Limited|Trials Updated: May 7, 2012

Pantoprazole development status

FDA approval on record Feb 2, 2000
Approval holderWyeth Pharms
ApplicationNDA020987
Highest phase Phase 4 (NCT00449813)
Phase scored for TAKPhase 3
Registered trials 25 across 10 sponsors since May 2002

Label indication PROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets are indicated for: PROTONIX is a proton pump inhibitor (PPI) indicated for the following: • Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) ( 1.1 ) • Maintenance of Healing of Erosive Esophagitis ( 1.2 ) • Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome… FDA label

Pantoprazole target and mechanism

Molecular targetATP4A, ATP4B
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials4
Total Enrollment3,928

FDA Designations

No designations recorded

Pantoprazole clinical trials

Pantoprazole · 4 trials · 4 indications

Phase 3 4
NCT00336219Symptom Assessment in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) or enGERD (Endoscopic-negative GERD) After Treatment With Pantoprazole (BY1023/M3-343)GERD
COMPLETED628 Analytics
NCT00312806Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341)Gastroesophageal Reflux Disease (GERD)
COMPLETED2,000 Analytics
NCT00163306Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-339)Gastroesophageal Reflux
COMPLETED1,200 Analytics
NCT00261300Long-term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints (BY1023/VMG-708)Gastroesophageal Reflux Disease (GERD)
COMPLETED100 Analytics
PHASE3COMPLETED
Symptom Assessment in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) or enGERD (Endoscopic-negative GERD) After Treatment With Pantoprazole (BY1023/M3-343)
GERDUnlock trial analytics
PHASE3COMPLETED
Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341)
Gastroesophageal Reflux Disease (GERD)Unlock trial analytics
PHASE3COMPLETED
Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-339)
Gastroesophageal RefluxUnlock trial analytics
PHASE3COMPLETED
Long-term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints (BY1023/VMG-708)
Gastroesophageal Reflux Disease (GERD)Unlock trial analytics

Study Endpoints

Primary Endpoints

symptom assessment as measured by ReQuest™ questionnaire and investigator.
28 days
Response to treatment with pantoprazole at week 8, as measured by the questionnaire ReQuest™
8 weeks
complete reflux disease remission rate after 8 weeks of treatment defined as symptom relief assessed by reflux questionnaire (ReQuest Trademark) and endoscopically confirmed healing.
Safety (adverse events, laboratory values).
5 years

Secondary Endpoints

symptom assessment on days 7, 14, and 28 as measured by ReQuest™ questionnaire and investigator
28 days
endoscopic healing after 28 days
28 days
health-related quality of life after 28 days
28 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORPantoprazole 40 mg

Interventions

NameTypeDescription
PantoprazoleDRUGSymptom Assessment after treatment with Pantoprozole 40 mg
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites40

Main Inclusion Criteria: * Written informed consent * Outpatients * History of GERD-related symptoms for at least 6 months prior to study inclusion * Endoscopically confirmed erosive GERD or non-erosive GERD Main Exclusion Criteria: * Acute peptic ulcer and/or ulcer complications * PPIs during la...

Countries:AustraliaAustriaGermanyHungaryArgentinaBelgiumBrazilCanadaFranceHong KongIndiaItalyMalaysiaMexicoPolandPortugalSingaporeSouth AfricaSouth KoreaSpainSwitzerlandTaiwanUnited Kingdom
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Competitive Landscape -GERD 11 trials

Top 1 of 5 competitors

CompanyTickerTrialsLead PhaseDrugs
Phathom Pharmaceuticals, Inc.PHAT2PHASE3Vonoprazan
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Frequently asked questions about Pantoprazole

What is pantoprazole used for?

Pantoprazole is used to treat gastroesophageal reflux disease (GERD) and gastroesophageal reflux, and it has also been studied in patients with chronic acid peptic complaints including peptic ulcers. It is a small molecule developed by Takeda Pharmaceutical Company Limited for gastrointestinal conditions.

What does pantoprazole target?

Pantoprazole targets ATP4A and ATP4B. It acts as an inhibitor of these targets, which are components of the gastric proton pump involved in acid secretion. This mechanism underlies its use in acid-related gastrointestinal conditions such as GERD.

Who makes pantoprazole?

Pantoprazole is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the company associated with the clinical development program for pantoprazole in gastroesophageal reflux disease and related acid peptic conditions.

What phase is pantoprazole in?

Pantoprazole has been studied in Phase 3 clinical development for GERD and related gastrointestinal indications. The Phase 3 trials listed for pantoprazole are all completed, and no trials are currently active. It is an investigational asset in the context of this development program.

What clinical trials is pantoprazole in?

Pantoprazole has been evaluated in completed Phase 3 trials including NCT00336219 in erosive and endoscopic-negative GERD, NCT00312806 in acid reflux disease, NCT00261300 in chronic acid peptic complaints, and NCT00163306 in acid reflux symptoms. These trials enrolled adults and were conducted across multiple countries.

How many patients were enrolled in pantoprazole trials?

The pantoprazole clinical trials listed enrolled a total of 2100 patients across four completed Phase 3 studies. Enrollment ranged from 100 patients in the long-term chronic acid peptic complaints trial to 2000 patients in the acid reflux disease trial.