Protonix

(pantoprazole)

ApprovedSmall molecule

Pantoprazole reduces stomach acid to treat heartburn, acid reflux, and ulcers. It helps prevent damage to the stomach and esophagus caused by excess acid.[2] Protonix is currently approved and in use across 34 indications[4].[1]

Protonix is one of 552 small molecule programs targeting Female. It is currently in Approved.

Indications

132

Total Trials

Active Trials

551

Competitors

116

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

FemaleNot yet recruiting

Type 2 Diabetes MellitusApproved

Bacterial DiseaseApproved

HemorrhageApproved

Esophageal DiseaseApproved

Peptic UlcerCompleted

HemochromatosisActive, not recruiting

Barrett's EsophagusApproved

Ulcer DiseaseApproved

Gastrointestinal HemorrhageApproved

FemalePhase 1

Not yet recruiting

Type 2 Diabetes MellitusApproved

Approved

Bacterial DiseaseApproved

Approved

HemorrhageApproved

Approved

Esophageal DiseaseApproved

Approved

Peptic UlcerApproved

Completed

HemochromatosisPreclinical

Active, not recruiting

Barrett's EsophagusApproved

Approved

Ulcer DiseaseApproved

Approved

Gastrointestinal HemorrhageApproved

Approved

Showing 10 of 33 indications

Competition

Competitive Landscape

190 competitors in Obesity

#DrugCompanyPhaseTrials

Protonix

WWyeth-Lederle Vaccines

Approved

1 2

Cagrilintide

Novo Nordisk

Phase 3

9 3

Retatrutide

Eli Lilly

Phase 3

6 4

Gemtesa

Sumitomo Pharma America, Inc.

Phase 3

1 5

Berobenatide

Pfizer

Phase 3

3 6

Ribupatide

KKailera

Phase 3

3 7

Elecoglipron

AstraZeneca

Phase 3

1 8

PF-08653944

Pfizer

Phase 3

5 9

Survodutide

Boehringer Ingelheim

Phase 3

2 10

Semaglutide or Tirzepatide

NNational and Kapodistrian University of Athens

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Post Operative Nausea and Vomiting

NCT06488001

Phase 1Not yet recruiting

Study completion

NCT07683793

Q1 2027

Phase 1Not yet recruiting

Study completion

NCT07800897

Q4 2027

PreclinicalRecruiting

Olanzapine

NCT07743827

PreclinicalRecruiting

Anemia, Sickle Cell

NCT06481306

Q4 2029

PreclinicalNot yet recruiting

Upper Gastrointestinal Bleeding

NCT07776730

Clinical

Trials by Indication[1]

Gastroesophageal Reflux Disease13 trials

Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-339)

Completed· Takeda logo

Takeda·Phase 3·NCT00163306·1,200 enrolled

Intravenous (IV) Pantoprazole for Gastroesophageal Reflux Disease (GERD) in Neonates and Infants

Completed·UUniversity of Louisville·Phase 1·NCT00744419·24 enrolled

Efficacy of Pantoprazole in Patients Older Than 12 Years Who Have Symptoms of Non-Erosive Reflux Disease (NERD) or Erosive Gastroesophageal Reflux Disease (eGERD)

Completed·NNycomed··NCT00561730·1,995 enrolled

Show 10 more trials

Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Non-erosive Reflux or Gastroesophageal Reflux Disease (BY1023/DE-004)

Completed·NNycomed·Phase 3·NCT00326027·29 enrolled

Symptom Assessment in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) or enGERD (Endoscopic-negative GERD) After Treatment With Pantoprazole (BY1023/M3-343)

Completed· Takeda logo

Takeda·Phase 3·NCT00336219·628 enrolled

Determination of a Questionnaire After Treatment With Pantoprazole at Full Dose and Half Dose in Adult Patients With Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/UK-506)

Completed· Takeda logo

Takeda·Phase 4·NCT00261339·300 enrolled

Comparison of the Classical Healing Concept With the Complete Remission Concept After Treatment With Pantoprazole in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) (BY1023/M3-342)

Completed· Takeda logo

Takeda·Phase 4·NCT00325676·639 enrolled

Clinical Trial for the Comparative Evaluation of Acid Suppression and Symptom Management of Gastroesophageal Reflux Disease With the Administration of Tegoprazan or Pantoprazole

Recruiting·CCarnot Laboratories·Phase 4·NCT06991348·128 enrolled

Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)

Completed· Pfizer logo

Pfizer·Phase 3·NCT00365300·129 enrolled

Determination of the Minimal Clinically Important Difference After Treatment With Pantoprazole in Patients With Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-340)

Completed· Takeda logo

Takeda·Phase 4·NCT00246909·600 enrolled

Efficacy of DA-5204 on Gastroesophageal Reflux Disease

Completed·SSeoul National University Hospital·Phase 3·NCT03998969·70 enrolled

Open Label Safety Study of Enteric-Coated Spheroid Suspension in Infants Aged Less Than 12 Months With Presumed Gastroesophageal Reflux Disease (GERD)

Completed· Pfizer logo

Pfizer·Phase 3·NCT00868296·58 enrolled

Efficacy and Safety of Thread Embedding Acupuncture in Treating Gastroesophageal Reflux Disease

Completed·UUniversity of Medicine and Pharmacy at Ho Chi Minh City·N/A·NCT05353933·66 enrolled

Peptic ulcer7 trials

High Versus Standard Dose of Proton Pump Inhibitors (PPIs) in Peptic Ulcer Bleeding

Completed·CCasa Sollievo della Sofferenza IRCCS·Phase 3·NCT00374101·450 enrolled

Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage

Completed· Pfizer logo

Pfizer·Phase 2·NCT00037570·12 enrolled

Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding

Completed·LLotung Poh-Ai Hospital·Phase 4·NCT00731601·120 enrolled

Show 4 more trials

Esomeprazole Versus Pantoprazole to Prevent Peptic Ulcer Rebleeding

Withdrawn·LLotung Poh-Ai Hospital·Phase 4·NCT00881413

Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage

Completed· Pfizer logo

Pfizer·Phase 3·NCT00040495·149 enrolled

Effects of 2 Different Doses of Pantoprazole on Gastric pH and Recurrent Bleeding in Patients Who Bled From Peptic Ulcers

Completed·KKwong Wah Hospital·Phase 4·NCT00279123

Oral Versus IV Proton Pump Inhibitor in High-risk Bleeding Peptic Ulcers After Endoscopic Hemostasis

Unknown status·NNational Taiwan University Hospital·Phase 3·NCT01182597·190 enrolled

Dyspepsia5 trials

Comparison of a "Step-Up" Versus a "Step-Down" Treatment Strategy for Patients With New Onset Dyspepsia in General Practice (The DIAMOND-Study)

Completed·RRadboud University Medical Center·N/A·NCT00247715·664 enrolled

Comparison of Pantoprazole and Ranitidine in Dyspepsia

Completed·—·Phase 4·NCT01737840·66 enrolled

PPI and Microbiome in Healthy Volunteers and Functional Dyspepsia

Completed·UUniversitaire Ziekenhuizen KU Leuven·Phase 4·NCT03545243·79 enrolled

Show 2 more trials

Melatonin Supplementation in Postmenopausal Women With H. Pylori-associated Dyspepsia

Completed·MMedical University of Lodz·N/A·NCT04352062·152 enrolled

Helicobacter Pylori Eradication in Functional Dyspepsia

Completed·SSir Ganga Ram Hospital·N/A·NCT04697641·202 enrolled

Oral4 trials

Bioavailability of BIBR 953 ZW After Oral Administration of BIBR 1048 MS in Healthy Subjects

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02170636·15 enrolled

Bioavailability of Oral BIRB 796 BS Tablets With and Without Administration of Oral Pantoprazole in Healthy Male Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02209831·22 enrolled

Influence of Pantoprazole on the Pharmacokinetics of Fradafiban After Multiple Oral Doses of Lefradafiban Over 5 Days in Healthy Subjects

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02264106·12 enrolled

Show 1 more trial

Influence of Pantoprazole on the Pharmacokinetics of Fradafiban After Multiple Oral Doses of Lefradafiban in Healthy Subjects

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02264119·12 enrolled

Clopidogrel3 trials

Clopidogrel Proton-Pump Inhibitors Study

Withdrawn·SSheba Medical Center·Phase 4·NCT01016717

Does Pantoprazole Reduce the Anti-platelet Effect of Clopidogrel?

Completed·SSeoul National University Bundang Hospital·N/A·NCT02733640·42 enrolled

Platelet Inhibitory Effect of Clopidogrel in Patients Treated With Omeprazole, Pantoprazole, or Famotidine

Completed·TTel-Aviv Sourasky Medical Center·Phase 4·NCT00950339·63 enrolled

76 more indications

Helicobacter Pylori Infection2 trials

Non-invasive Test-guided Tailored Therapy Versus Empiric Treatment for Helicobacter Pylori Infection.

Unknown status·UUniversity of Bari·Phase 3·NCT04107194·362 enrolled

Quadruple vs Tailored Therapy in the Treatment of Helicobacter Pylori Infection

Completed·UUniversity of Split, School of Medicine·N/A·NCT04621487·80 enrolled

Interaction2 trials

Neuro-immune Interactions and PPI

Completed·UUniversitaire Ziekenhuizen KU Leuven·Phase 4·NCT04713969·60 enrolled

Interaction Study of Clopidogrel 300/75 mg Given Alone or Concomitantly With Pantoprazole 80 mg in Healthy Subjects

Completed· Sanofi logo

Sanofi·Phase 1·NCT01129427·66 enrolled

Medication2 trials

On-Demand Use of Pantoprazole: Determinants for Chronic Use of Acid Suppressive Medication

Unknown status·UUMC Utrecht·Phase 3·NCT00161096·276 enrolled

Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications

Withdrawn·UUniversity of British Columbia·Phase 4·NCT02213887

GastroIntestinal Bleeding2 trials

Re-Evaluating the Inhibition of Stress Erosions: Gastrointestinal Bleeding Prophylaxis In ICU

Completed·MMcMaster University·Phase 3·NCT02290327·91 enrolled

The Effect of Dual Eradication Therapy vs PPI on Gastrointestinal Bleeding in ACS Patients

Recruiting·QQilu Hospital of Shandong University·Phase 4·NCT04728516·2,600 enrolled

Gastrointestinal2 trials

Efficacy of Pantoprazole 20/40 mg Once Daily (od) in Patients Older Than 12 Years Who Have Gastrointestinal Symptoms of Reflux Disease

Completed·NNycomed··NCT00829738·4,188 enrolled

Optimal Dose of Proton Pump Inhibitors Following an Upper Gastrointestinal Bleed

Terminated·UUniversity of Missouri-Columbia·N/A·NCT02235311·3 enrolled

Sleep Disorder2 trials

Pantoprazole 20/40 mg in the Treatment of Symptomatic Reflux Disease With Focus on Sleep Disorders

Completed·NNycomed··NCT00830115·1,045 enrolled

Efficacy of Pantoprazole in Patients Older Than 12 Years With Reflux Associated Sleep Disorders (PULS)

Completed·NNycomed··NCT00562094·8,616 enrolled

Laryngopharyngeal Reflux2 trials

The Study of Eustachian Tube Dysfunction and Laryngopharyngeal Reflux

Withdrawn·LLoma Linda University·Phase 4·NCT02123498

Trial of Proton Pump Inhibitor With Prokinetics or Placebo in Patients With Laryngopharyngeal Reflux Disease

Unknown status·SSamsung Medical Center·Phase 3·NCT02533349·200 enrolled

Gastric2 trials

Study of Intragastric pH Profile After 5 Days Pantoprazole 40 mg iv Followed by Oral Esomeprazole 40 mg po or Oral Pantoprazole 40 mg po

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00206050·40 enrolled

Evaluation of 24-Hour Intragastric pH Using Esomeprazole, Lansoprazole, and Pantoprazole in Hispanic Patients With GERD

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00410592·90 enrolled

Atrial Fibrillation2 trials

A Prospective, Open Label Study Evaluating Two Management Strategies on Gastrointestinal Symptoms in Patients Newly on Treatment With Pradaxa for the Prevention of Stroke and Systemic Embolism With Non-valvular Atrial Fibrillation

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT01493557·1,067 enrolled

Gastroprotective Efficacy of Rebamipide in Patients With Atrial Fibrillation Treated With DOACs

Completed·PPirogov Russian National Research Medical University·Phase 4·NCT07354230·210 enrolled

Helicobacter Pylori2 trials

Effectiveness of the Eradication of Helicobacter Pylori and an Inhibitor of Pump With Proton Versus Control

Withdrawn·AAssistance Publique - Hôpitaux de Paris·Phase 4·NCT00713947

Compare Sequential and Quadruple Therapy for the Eradication of Helicobacter Pylori in Korea

Completed·SSeoul National University Bundang Hospital·N/A·NCT02159976·390 enrolled

Treatment2 trials

Efficacy/Safety Study as H. Pylori Eradication of Triple Therapy for 7 Days Treatment

Completed·IIl-Yang Pharm. Co., Ltd.·Phase 3·NCT02084420·323 enrolled

The CONQUEST-Study. Evaluation of Clinical Endpoints for Treatment-induced Changes in GERD-related Symptoms (BY1023/NL511)

Terminated· Takeda logo

Takeda·Phase 4·NCT00449813·40 enrolled

Function2 trials

Effect of Daily Use Proton Pump Inhibitors for One Month on Kidney Function

Unknown status·—·Phase 2·NCT03910647·200 enrolled

Effect of Proton Pump Inhibitor of Daily Use for One Month on Kidney Function Test

Unknown status·—·Phase 2·NCT04022837·200 enrolled

Pilot Study1 trial

Pharmacokinetics of Pantoprazole and CYP2C19 Activity in Children and Adolescents With GERD: A Pilot Study

Completed·—·Phase 1·NCT01887743·71 enrolled

Peripheral Neuropathy1 trial

The Role of Coenzyme Q10 in the Prophylaxis of Oxaliplatin Induced Peripheral Neuropathy in Patients With Colorectal Cancer

Recruiting·Ttoqa saad mohammed mohammed·Phase 1·NCT06856447·22 enrolled

Clinical Trial1 trial

Omeprazole and Pantoprazole Antiplatelet Effect of Clopidogrel Clinical Trials(OPEN)

Unknown status·YYaling Han·Phase 4·NCT01735227·620 enrolled

Sleep Apnea1 trial

Study of Pantoprazole for Sleepiness Associated With Acid Reflux and Sleep Apnea

Completed·UUniversity of Cincinnati·Phase 4·NCT00307944·68 enrolled

Intensive Care1 trial

Pediatric Intensive Care Ulcer Prophylaxis Pilot Trial

Completed·MMcMaster University·Phase 3·NCT02929563·116 enrolled

Coronary Artery Bypass1 trial

Proton Pump Inhibitor Prevent Dual Antiplatelet Agents Induced Gastrointestinal Ulcer After Coronary Artery Bypass Graft

Withdrawn·RRuijin Hospital·Phase 4·NCT03038009

Esophagitis1 trial

Intravenous (IV) Pantoprazole in Erosive Esophagitis

Completed·EEmory University·Phase 4·NCT00133770·20 enrolled

Injury1 trial

Proton Pump Inhibitor Preventing Upper Gastrointestinal Injury In Patients On Dual Antiplatelet Therapy After CABG

Unknown status·RRuijin Hospital·Phase 4·NCT03908593·232 enrolled

Insulin Secretion1 trial

Pantoprazole on Insulin Secretion in Diabetes

Completed·CCoordinación de Investigación en Salud, Mexico·Phase 2/3·NCT01541735·14 enrolled

Intensive Care Unit1 trial

Stress Ulcer Prophylaxis in the Intensive Care Unit

Completed·—·Phase 4·NCT02467621·3,350 enrolled

Acute Kidney Injury1 trial

Prevention of Post-Cardiac Surgery Acute Kidney Injury by Proton Pump Inhibitor

Completed·TThe University of Texas Health Science Center, Houston·Phase 2·NCT06154226·100 enrolled

Elderly1 trial

BIBR 953 ZW in Healthy Elderly Subjects

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02173730·36 enrolled

Total Knee Arthroplasty1 trial

Dextromethorphan Use in Multimodal Analgesia Regimens for Total Knee Arthroplasty

Terminated·UUniversity of Southern California·Phase 4·NCT02987920·23 enrolled

Stress1 trial

Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial

Completed·MMcMaster University·Phase 3·NCT03374800·4,800 enrolled

GERD1 trial

Comparison of the Nighttime Effects of Two Different Drugs on Subjects With GERD

Completed·VVA Greater Los Angeles Healthcare System·Phase 4·NCT00304421·23 enrolled

Reflux1 trial

A Comparative Study of Proton-pump Inhibitor Tests for Chinese Reflux Patients in Relation to the CYP2C19 Genotypes

Completed·NNational Taiwan University Hospital·N/A·NCT00681005·178 enrolled

Stroke1 trial

Histamine Glutamate Antagonism in Stroke

Completed·UUniversity of Florida·Phase 2·NCT02142712·3 enrolled

Osteosarcoma1 trial

Preventing Nephrotoxicity and Ototoxicity From Osteosarcoma Therapy

Completed·—·Phase 2·NCT01848457·13 enrolled

Rib Fracture1 trial

Ketamine Infusion Therapy for the Management of Acute Pain in Adult Rib Fracture Patients

Completed·MMedical College of Wisconsin·Phase 4·NCT02432456·153 enrolled

Intravenous1 trial

A Multiple Dose Study of Debio 1450 [Intravenous (IV) and Oral] in Healthy Volunteers

Completed·DDebiopharm International SA·Phase 1·NCT02214433·70 enrolled

Pancreaticoduodenectomy1 trial

Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy

Terminated·WWashington University School of Medicine·Phase 2·NCT05251233·56 enrolled

Cardiac1 trial

Placebo-Controlled Crossover Study for the Investigation of the Effect of Pantoprazole on Cardiac Contractility

Completed·HHerzzentrum Goettingen·Phase 1·NCT00600041·20 enrolled

Drug1 trial

Vasoactive Drugs in Real World Practice

Completed·KKaohsiung Veterans General Hospital.·Phase 4·NCT02757703·150 enrolled

Peripheral Artery Disease1 trial

Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease

Completed· Bayer logo

Bayer·Phase 3·NCT01776424·27,395 enrolled

Obese Children and Adolescents1 trial

PK Study With Pantoprazole in Obese Children and Adolescents

Completed·PPhillip Brian Smith·Phase 1·NCT02186652·41 enrolled

Pneumonia1 trial

Proton Pump Inhibitors and Risk of Community-acquired Pneumonia

Completed·CCanadian Network for Observational Drug Effect Studies, CNODES··NCT02555852·4,238,504 enrolled

Obesity1 trial

Effect of Obesity on Proton Pump Inhibitors

Completed·—·Phase 4·NCT04248335·150 enrolled

Aspirin1 trial

Aspirin in Young Psychotic Patients

Completed·CClinic for Psychiatric Disorders, Dr Laza Lazarevic·Phase 2/3·NCT02685748·60 enrolled

Type 2 Diabetes1 trial

Impact of Pantoprazole on 24-H Glycemic Control and on Post-prandial Glucose Excursion in Patients With Type 2 Diabetes

Unknown status·—·Phase 3·NCT02345239·14 enrolled

Age1 trial

A Study to Explore the Effect of Acid-reducing Agents

Completed·MMirati Therapeutics Inc.·Phase 1·NCT04935112·15 enrolled

Adult1 trial

Study Comparing 2 Different Formulations of Pantoprazole in Healthy Adults.

Completed· Pfizer logo

Pfizer·Phase 1·NCT00383916

Single Dose1 trial

Bioavailability of BIBR 1048 MS Single Doses With or Without Pantoprazole in Healthy Subjects

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02170805·24 enrolled

Congestive Heart Failure1 trial

Influence of Pantoprazole on Human Myocardial Contractility at Patients With Congestive Heart Failure

Withdrawn·JJohann Wolfgang Goethe University Hospital·Phase 3·NCT00699361

Prostate Cancer1 trial

Pantoprazole and Docetaxel for Men With Metastatic Castration-Resistant Prostate Cancer

Completed·UUniversity Health Network, Toronto·Phase 2·NCT01748500·21 enrolled

Acid Reflux1 trial

Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341)

Completed· Takeda logo

Takeda·Phase 3·NCT00312806·2,000 enrolled

Efficacy and Safety1 trial

A Study To Assess The Efficacy And Safety Of Bismuth Tripotassium Dicitrate (De-Nol) In Combination With Pantoprazole And Pantoprazole Monotherapy In Treatment Of Subjects With Nonsteroidal Anti-Inflammatory Drugs (NSAID)-Induced Gastropathy

Terminated· Astellas logo

Astellas·Phase 4·NCT02788123·9 enrolled

Chronic1 trial

Long-term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints (BY1023/VMG-708)

Completed· Takeda logo

Takeda·Phase 3·NCT00261300·100 enrolled

Clozapine1 trial

Pharmacokinetics of Clozapine and Norclozapine and the Effect of Pantoprazole

Completed·UUniversiti Sains Malaysia·Phase 1·NCT07262736·33 enrolled

ESS1 trial

Symptom Evaluation After Cessation of a Proton Pump Inhibitor in Healthy Volunteers

Completed·SSahlgrenska University Hospital·N/A·NCT00915239·50 enrolled

Islet Transplantation1 trial

Incretin Effect and Use After Clinical Islet Transplantation

Completed·UUniversity of Alberta·Phase 2·NCT00768651·8 enrolled

Helicobacter Pylori Eradication1 trial

Comparison of 7-day and 14-day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication

Completed·—·Phase 4·NCT00841854·199 enrolled

Drug Interactions1 trial

Drug/Drug Interactions With F901318

Withdrawn·FF2G Biotech GmbH·Phase 1·NCT03095547

Acute1 trial

Symptomatic Relief of Acute Dyspeptic Pain in Emergency Department With Pantoprazole

Completed·—·Phase 4·NCT01281501·87 enrolled

Gastric Acid1 trial

The Use of Oral Omeprazole and Intravenous Pantoprazole in Patients With Hypersecretion of Gastric Acid

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT00001191

Infants1 trial

Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD

Completed· Pfizer logo

Pfizer·Phase 3·NCT00362609·59 enrolled

Hereditary Hemochromatosis1 trial

Proton Pump Inhibitors in the Prevention of Iron Reaccumulation in Patient With Hereditary Hemochromatosis

Unknown status·MMaastricht University Medical Center·N/A·NCT01524757·48 enrolled

Breast Cancer1 trial

Pantoprazole Prophylaxis Against Delayed CINV for Patients Receiving Breast Cancer Chemotherapy

Completed·UUniversity of Auckland, New Zealand·Phase 2·NCT03948477·160 enrolled

Fed1 trial

Bioequivalence Study of Pantoprazole Sodium 40 mg Delayed Release Tablets Fed Study

Completed·RRanbaxy Laboratories Limited·N/A·NCT01654718·40 enrolled

Sleep1 trial

Effect of Pantoprazole 40mg Daily vs Placebo on Power Spectral Analysis of the Sleep EEG of Patients With GERD.

Completed·SSouthern Arizona VA Health Care System·Phase 2/3·NCT00674245·40 enrolled

Gastric Ulcer1 trial

Is Rebamipide Effective on the Healing of Iatrogenic Gastric Ulcer After Endoscopic Mucosal Resection?

Completed·KKangdong Sacred Heart Hospital·N/A·NCT01167101·290 enrolled

Acute Coronary Syndrome1 trial

"Pharmacodynamic Comparison of Omeprazole Versus Pantoprazole on Platelet Reactivity in Patients With Acute Coronary Syndromes on Dual Antiplatelet Therapy With New P2Y12 Inhibitors" -Trial dOPPLER-

Unknown status·UUniversity of Roma La Sapienza·Phase 4·NCT02028234·150 enrolled

Adolescent1 trial

Study Evaluating Pantoprazole in Adolescents With GERD

Completed· Pfizer logo

Pfizer·Phase 3·NCT00367614·20 enrolled

Randomized1 trial

A Randomized, Open-Label, Comparative 3-Way Treatment Crossover Study of 24-Hour Intragastric pH Profile of Once Daily Oral Administration of Esomeprazole 40mg, Lansoprazole 30mg, and Pantoprazole 40mg at Steady State in NSAID-Using Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00625274·100 enrolled

Multiple Sclerosis1 trial

Drug-Drug Interaction of Cladribine and Pantoprazole in Multiple Sclerosis Subjects

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00938366·18 enrolled

Post Operative Nausea and Vomiting1 trial

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

Recruiting·UUnited States Naval Medical Center, Portsmouth·Phase 2·NCT06488001·132 enrolled

Osteoarthritis1 trial

Structured Non-operative Treatment of Knee Osteoarthritis

Completed·NNorthern Orthopaedic Division, Denmark·N/A·NCT01535001·100 enrolled

Radiosurgery1 trial

Stereotactic Radiosurgery in Metastatic Spinal Cord Compression

Terminated·RRigshospitalet, Denmark·N/A·NCT02167633·10 enrolled

Efficacy1 trial

Vonoprazan Efficacy to Prevent Post Variceal Band Ligation Ulcer

Completed·—·Phase 3·NCT05227833·284 enrolled

Screening1 trial

Rapid Screening Phenotype Test To Evaluate CYP 2C19 Enzyme Activity Using Stable Isotope [13C]Pantoprazole

Completed·IIndiana University·N/A·NCT00668902·25 enrolled

Renal Transplantation1 trial

Esomeprazole or Pantoprazole in Renal Transplantation

Completed·FFuture University in Egypt·N/A·NCT03812419·47 enrolled

Upper Gastrointestinal Bleeding1 trial

Keverprazan Versus Pantoprazole for the Treatment of Acute Non Variceal Upper Gastrointestinal Bleeding: Protocol of a Prospective, Multicenter, Non Inferiority, Randomized Controlled Trial

Not yet recruiting·GGeneral Hospital of Shenyang Military Region·Preclinical·NCT07776730·908 enrolled

Anemia, Sickle Cell1 trial

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

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Preclinical·NCT06481306·224 enrolled

Olanzapine1 trial

Efficacy of an Olanzapine Based Dexamethasone-sparing Regimen in Breast Cancer Patients With Metabolic-risk Factors: A Randomized, Controlled Trial

Recruiting·AAlexandria University·Preclinical·NCT07743827·90 enrolled

Unspecified13 trials

Bioavailability of BIBR 953 ZW After Administration of BIBR 1048 MS in Healthy Subjects

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02170623·12 enrolled

Sup-Icu RENal (SIREN)

Completed·IInsel Gruppe AG, University Hospital Bern·Phase 4·NCT02718261·3,350 enrolled

Study of Levofloxacin-based Concomitant Therapy for H. Pylori Eradication in Diabetic Patients

Completed·CChung-Tai Wu·Phase 4·NCT02466919·114 enrolled

Show 10 more trials

Bioavailability of BIBR 1048 MS With and Without Pantoprazole Under Influence of Food in Healthy Subjects

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02170610·18 enrolled

Bioavailability of BIBR 953 ZW in Healthy Subjects

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02170766·48 enrolled

Bioequivalence Study of Pantoprazole Sodium 40 mg Delayed Release Tablets Fasting Study

Completed·RRanbaxy Laboratories Limited·N/A·NCT01654705·80 enrolled

Influence of Pantoprazole on the Bioavailability of MMF and EC-MPS

Completed·KKlemens Budde·Phase 4·NCT01801280·20 enrolled

A Bioequivalence Study of SCH 530348 2.5 mg Tablets (P06558)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01358344·173 enrolled

Bioavailability of BIBR 963 ZW After 50 mg of BIBR 1048 MS With and Without of Pantoprazole in Healthy Subjects

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02170896·16 enrolled

To Investigate PK and PD of CJ-12420, Clarithromycin, Amoxicillin After Multiple Dose Administration

Completed·HHK inno.N Corporation·Phase 1·NCT03011996·60 enrolled

13-C Urea Breath Test Using BreathID System and PPIs (Proton Pump Inhibitors)

Completed·MMeridian Bioscience, Inc.·Phase 4·NCT00825630·123 enrolled

A Phase 1, Open-label, Randomized, Pharmacokinetic Study to Assess the Drug Interactions and Food Effect of Navlimetostat (BMS-986504) in Healthy Female Participants

Not yet recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT07800897·80 enrolled

An Open-label, Fixed-sequence, Non-randomised, Drug-drug Interaction Study to Evaluate the Effect of Pantoprazole (Proton Pump Inhibitor) on the Pharmacokinetics of CHF10196 in Healthy Male Participants.

Not yet recruiting· Chiesi Farmaceutici S.p.A. logo

Chiesi Farmaceutici S.p.A.·Phase 1·NCT07683793·18 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 19, 2000

PROTONIX

NDA NDA020987

Mar 22, 2001

PROTONIX IV

NDA NDA020988

Mar 22, 2001

PROTONIX IV

NDA NDA020988

May 21, 2001

PROTONIX

NDA NDA020987

Jun 8, 2001

PROTONIX IV

NDA NDA020988

Jun 12, 2001

PROTONIX

NDA NDA020987

Jun 12, 2001

PROTONIX

NDA NDA020987

Jun 12, 2001

PROTONIX

NDA NDA020987

Jul 3, 2001

PROTONIX IV

NDA NDA020988

Jul 20, 2001

PROTONIX

NDA NDA020987

Sep 27, 2001

PROTONIX IV

NDA NDA020988

Oct 19, 2001

PROTONIX IV

NDA NDA020988

Nov 28, 2001

PROTONIX IV

NDA NDA020988

Jan 18, 2002

PROTONIX IV

NDA NDA020988

Mar 12, 2002

PROTONIX

NDA NDA020987

Apr 19, 2002

PROTONIX

NDA NDA020987

May 14, 2002

PROTONIX

NDA NDA020987

May 14, 2002

PROTONIX IV

NDA NDA020988

Jun 12, 2002

PROTONIX

NDA NDA020987

Jul 2, 2002

PROTONIX IV

NDA NDA020988

Jul 2, 2002

PROTONIX

NDA NDA020987

Jul 22, 2002

PROTONIX

NDA NDA020987

Sep 5, 2002

PROTONIX

NDA NDA020987

Oct 28, 2002

PROTONIX

NDA NDA020987

Oct 28, 2002

PROTONIX IV

NDA NDA020988

Dec 3, 2002

PROTONIX IV

NDA NDA020988

Dec 3, 2002

PROTONIX

NDA NDA020987

Dec 4, 2002

PROTONIX IV

NDA NDA020988

Dec 4, 2002

PROTONIX

NDA NDA020987

Dec 6, 2002

PROTONIX

NDA NDA020987

Feb 21, 2003

PROTONIX IV

NDA NDA020988

Oct 24, 2003

PROTONIX IV

NDA NDA020988

Nov 18, 2003

PROTONIX IV

NDA NDA020988

Dec 30, 2003

PROTONIX

NDA NDA020987

Jan 2, 2004

PROTONIX IV

NDA NDA020988

Jan 9, 2004

PROTONIX

NDA NDA020987

Jan 9, 2004

PROTONIX IV

NDA NDA020988

Mar 5, 2004

PROTONIX

NDA NDA020987

Mar 5, 2004

PROTONIX IV

NDA NDA020988

Mar 12, 2004

PROTONIX

NDA NDA020987

Apr 2, 2004

PROTONIX IV

NDA NDA020988

Apr 2, 2004

PROTONIX IV

NDA NDA020988

May 5, 2004

PROTONIX

NDA NDA020987

May 5, 2004

PROTONIX IV

NDA NDA020988

Oct 28, 2004

PROTONIX IV

NDA NDA020988

Nov 18, 2004

PROTONIX IV

NDA NDA020988

Nov 18, 2004

PROTONIX

NDA NDA020987

Dec 6, 2004

PROTONIX IV

NDA NDA020988

Aug 2, 2005

PROTONIX IV

NDA NDA020988

Aug 3, 2005

PROTONIX IV

NDA NDA020988

Jul 25, 2006

PROTONIX

NDA NDA020987

Nov 14, 2007

PROTONIX

NDA NDA022020

Nov 14, 2007

PROTONIX

NDA NDA022020

Dec 20, 2007

PROTONIX

NDA NDA020987

Dec 20, 2007

PROTONIX IV

NDA NDA020988

Nov 12, 2009

PROTONIX

NDA NDA020987

Nov 12, 2009

PROTONIX

NDA NDA022020

Nov 12, 2009

PROTONIX

NDA NDA020987

Sep 3, 2010

PROTONIX IV

NDA NDA020988

Sep 3, 2010

PROTONIX

NDA NDA022020

Sep 3, 2010

PROTONIX

NDA NDA020987

May 20, 2011

PROTONIX

NDA NDA022020

May 20, 2011

PROTONIX

NDA NDA020987

May 20, 2011

PROTONIX IV

NDA NDA020988

Jun 7, 2011

PROTONIX IV

NDA NDA020988

Oct 31, 2011

PROTONIX

NDA NDA022020

Oct 31, 2011

PROTONIX

NDA NDA020987

Dec 7, 2011

PROTONIX IV

NDA NDA020988

May 10, 2012

PROTONIX IV

NDA NDA020988

May 11, 2012

PROTONIX

NDA NDA020987

May 11, 2012

PROTONIX

NDA NDA022020

Sep 28, 2012

PROTONIX IV

NDA NDA020988

Oct 9, 2012

PROTONIX

NDA NDA022020

Oct 9, 2012

PROTONIX

NDA NDA020987

Jan 25, 2013

PROTONIX

NDA NDA020987

Dec 10, 2013

PROTONIX

NDA NDA020987

Dec 10, 2013

PROTONIX

NDA NDA022020

Dec 12, 2013

PROTONIX IV

NDA NDA020988

Mar 4, 2014

PROTONIX IV

NDA NDA020988

Sep 26, 2014

PROTONIX IV

NDA NDA020988

Sep 26, 2014

PROTONIX IV

NDA NDA020988

Nov 5, 2014

PROTONIX IV

NDA NDA020988

Dec 19, 2014

PROTONIX

NDA NDA022020

Dec 19, 2014

PROTONIX IV

NDA NDA020988

Dec 19, 2014

PROTONIX

NDA NDA020987

Nov 9, 2015

PROTONIX IV

NDA NDA020988

Oct 24, 2016

PROTONIX

NDA NDA020987

Oct 24, 2016

PROTONIX

NDA NDA022020

Oct 24, 2016

PROTONIX IV

NDA NDA020988

Jun 30, 2017

PANTOPRAZOLE SODIUM

NDA NDA209463

Jul 6, 2017

PROTONIX

NDA NDA020987

Jul 6, 2017

PROTONIX IV

NDA NDA020988

Jul 6, 2017

PROTONIX

NDA NDA022020

Dec 6, 2017

PROTONIX

NDA NDA022020

Dec 6, 2017

PROTONIX IV

NDA NDA020988

Dec 6, 2017

PROTONIX

NDA NDA020987

Dec 20, 2017

PROTONIX IV

NDA NDA020988

Dec 20, 2017

PROTONIX

NDA NDA020987

Dec 20, 2017

PROTONIX

NDA NDA022020

Jun 7, 2018

PROTONIX

NDA NDA020987

Jun 7, 2018

PROTONIX

NDA NDA022020

Jun 7, 2018

PROTONIX IV

NDA NDA020988

Apr 25, 2019

PROTONIX IV

NDA NDA020988

Apr 25, 2019

PROTONIX

NDA NDA020987

Apr 25, 2019

PROTONIX

NDA NDA022020

Nov 27, 2020

PROTONIX IV

NDA NDA020988

Nov 27, 2020

PROTONIX

NDA NDA020987

Nov 27, 2020

PROTONIX

NDA NDA022020

Mar 4, 2022

PROTONIX

NDA NDA022020

Mar 4, 2022

PROTONIX

NDA NDA020987

Mar 4, 2022

PROTONIX IV

NDA NDA020988

Jul 18, 2023

PROTONIX IV

NDA NDA020988

Jul 18, 2023

PROTONIX

NDA NDA020987

Jul 18, 2023

PROTONIX

NDA NDA022020

Feb 14, 2024

PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE

NDA NDA217512

Aug 12, 2024

PROTONIX IV

NDA NDA020988

Sources

References

[1]
ClinicalTrials.gov — 132 trial records for pantoprazole. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Protonix drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — pantoprazole compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for pantoprazole. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020988). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Protonix. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Wyeth-Lederle Vaccines company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Potassium-Transporting Atpase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: WWyeth-Lederle Vaccines

Patent Landscape[6]

Patent Cliff

Dec 7, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7544370Jun 7, 2026

7544370*PEDDec 7, 2026