Recent Updates
Recently added Catalysts

Pantoprazole

Phase 4FDA approved

FED | Small molecule | Metabolic |Dr. Reddy's Laboratories Ltd|Trials Updated: Jan 26, 2011

Pantoprazole development status

FDA approval on record Feb 2, 2000
Approval holderWyeth Pharms
ApplicationNDA020987
Highest phase Phase 4 run by Takeda (NCT00449813)
Phase scored for RDYPhase 1
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

Also known as Pantoprazole Sodium

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment94

FDA Designations

No designations recorded

Pantoprazole clinical trials

Pantoprazole · 2 trials · 2 indications

Phase 1 2
NCT01283919Bioequivalence Study of Pantoprazole Sodium DR Tablets 40 mg of Dr. Reddy's Laboratories Limited Under Fasting ConditionFasting
COMPLETED42 Analytics
NCT01283932Bioequivalence Study of Pantoprazole Sodium DR Tablets 40 mg of Dr. Reddy's Laboratories Limited Under Fed ConditionFED
COMPLETED52 Analytics
PHASE1COMPLETED
Bioequivalence Study of Pantoprazole Sodium DR Tablets 40 mg of Dr. Reddy's Laboratories Limited Under Fasting Condition
FastingUnlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of Pantoprazole Sodium DR Tablets 40 mg of Dr. Reddy's Laboratories Limited Under Fed Condition
FEDUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence on Cmax and AUC parameters
2 months
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Pantoprazole SodiumEXPERIMENTALPantoprazole Sodium DR Tablets 40 mg of Dr. Reddys Laboratories Limited
ProtonixACTIVE_COMPARATORProtonix 40 mg DR Tablets of Wyeth Laboratories

Interventions

NameTypeDescription
Pantoprazole SodiumDRUGPantoprazole Sodium DR Tablets 40 mg
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Subjects will provide written informed consent. 2. Subjects must be healthy human beings within 18-45 years of age (inclusive) weighing at least 50 kg. 3. Subjects must be within ±10% of ideal body weight in relation to height according to Life Insurance Corporation of India ...

Countries:India
Unlock Eligibility Criteria

Frequently asked questions about Pantoprazole

What is Pantoprazole?

Pantoprazole is a small molecule drug developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. It is being studied in Phase 1 clinical trials for metabolic conditions related to fed and fasting states. Pantoprazole is also known as pantoprazole sodium.

What does Pantoprazole target?

Pantoprazole targets ATP4A and ATP4B. It acts as an inhibitor of these targets. This mechanism is relevant to its development as a small molecule therapeutic.

Who makes Pantoprazole?

Pantoprazole is developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed under the ticker RDY. The company is responsible for the clinical development of this drug candidate.

What phase is Pantoprazole in?

Pantoprazole is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 trials have been completed.

What clinical trials is Pantoprazole in?

Pantoprazole has been studied in two completed Phase 1 trials: NCT01283932, a bioequivalence study under fed conditions with 52 participants, and NCT01283919, a bioequivalence study under fasting conditions with 42 participants. Both trials were conducted in India.

Is Pantoprazole the same as Pantoprazole Sodium?

Yes, Pantoprazole is also known as Pantoprazole Sodium. They refer to the same drug substance developed by Dr. Reddy's Laboratories Ltd.