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pantoprazole

Generic: PANTOPRAZOLE SODIUM·Brand: PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PROTONIX, PROTONIX IV, Protonix

pantoprazole: developed by 3 companies · 3 clinical trials tracked · 4 FDA decisions.

pantoprazole evidence translation

What we can confirm

4 FDA records · 3 tracked trials

What it means

More than one developer is source-backed. Until you choose one, AI stays drug-only and does not guess ownership.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

What is verified about pantoprazole, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 2 study sponsors

Related indications

Healthy Volunteers
Development Pipeline (3)
CompanyPhase
LANNETT CO INC (LCI)Approved
DR REDDYS LABORATORIES LTD (RDY)Approved
Teva Pharmaceutical Industries Limited (TEVA)Approved
Clinical Trials (3)

A Phase 1/2a, First-in-human, Randomized, Double-blinded, Placebo-controlled, Dose-finding Study in Healthy Volunteers and Participants With Sickle Cell Disease to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, pH and Food Effect, and Preliminary Efficacy of BMS-986470

NCT06481306·Phase 1/Phase 2·BMY
Recruiting

Primary endpoint: Number of participants with adverse events (AEs)

InterventionalRandomizedquadruple224 targetStarted 2024-07Completion 2027-1132 sites · Canada, France, Italy, United Kingdom…Bristol-Myers Squibb

Preoperative Use of Pantoprazole for Prevention of Post Operative Nausea and Vomiting in Gynecologic Surgery

NCT06488001·Phase 2·UTHR
Recruiting

Primary endpoint: Postoperative Nausea and Vomiting

InterventionalRandomizedtriple132 targetStarted 2022-08Completion 2026-121 site · United StatesUnited States Naval Medical Center, Portsmouth

Open Randomised Controlled parallEl Groups Study of Gastroprotective Efficacy of Rebamipide in Patients With Atrial Fibrillation and Moderate-to-high Risk of Thromboembolic Events, Who Are Treated With Direct Oral Anticoagulants (REGATA)

NCT07354230·Phase 4
Completed

Primary endpoint: Composite endpoint

InterventionalRandomizedopen210 enrolledStarted 2022-01Completion 2024-091 site · RussiaPirogov Russian National Research Medical University
FDA Decisions4 records
Approval(LCI)FDA ↗
ANDA078281OralTablet, Delayed Release
Approval1 INDICATIONS AND USAGE Pantoprazole sodium delayed-release tablets are indicated for: Pantoprazole sodium 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 ( 1.3 ) 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal (RDY)FDA ↗
ANDA077619OralTablet, Delayed Release
Tentative Approval1 INDICATIONS AND USAGE Pantoprazole Sodium for Injection is indicated for treatment of: gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults. Limitations of Use The safety and effectiveness of Pantoprazole Sodium for Injection for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients. Pediatric use(TEVA)FDA ↗
NDA022226Type 5 - New Formulation or New ManufacturerStandardOtherInjectable
Approval1 INDICATIONS AND USAGE Pantoprazole Sodium for Injection is indicated for treatment of: gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults. Limitations of Use The safety and effectiveness of Pantoprazole Sodium for Injection for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients. Pediatric use(TEVA)FDA ↗
ANDA077056OralTablet, Delayed Release

Frequently asked questions

Who is developing pantoprazole?

pantoprazole is being developed by LANNETT CO INC, DR REDDYS LABORATORIES LTD, Teva Pharmaceutical Industries Limited.

How many clinical trials involve pantoprazole?

BioSniper tracks 3 clinical trials involving pantoprazole.

What is pantoprazole's latest FDA decision?

The most recent tracked FDA decision for pantoprazole is Approval, dated January 20, 2011.