Drugs / Pantoprazole
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Pantoprazole

Other / unclassified targets ATP4A via inhibition

Developed for
gastroesophageal reflux disease · peptic ulcer disease · Helicobacter pylori infectious disease · dyspepsia · active peptic ulcer disease · acute kidney injury · hemorrhagic disease · chemotherapy-induced toxicity
+27 more · cirrhosis of liver · coronary artery disorder · esophageal varices · esophagitis · atrial fibrillation · autoimmune thrombocytopenic purpura · Barrett esophagus · cancer · congestive heart failure · diabetes mellitus · duodenal ulcer · end stage renal failure · esophageal varices with bleeding · gastrocutaneous syndrome · hereditary hemochromatosis · lung disorder · obstructive sleep apnea syndrome · platinum-induced ototoxicity · prostate cancer · stomach disorder · type 1 diabetes mellitus · type 2 diabetes mellitus · Zollinger-Ellison syndrome · gastric ulcer · osteoarthritis, knee · peptic esophagitis · ulcer disease
Investigated by
Boehringer Ingelheim · Wyeth is now a wholly owned subsidiary of Pfizer · Takeda · AstraZeneca · Kaohsiung Veterans General Hospital. · Assiut University
+108 more · Bristol-Myers Squibb · Children's Mercy Hospital Kansas City · Eisai Inc. · GlaxoSmithKline · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · National Taiwan University Hospital · Piramal Clinical Research (Hyderabad, India) · PriCara, Unit of Ortho-McNeil, Inc. · Rigshospitalet, Denmark · Ruijin Hospital · Seoul National University Hospital · Teva Pharmaceuticals USA · The University of Texas Health Science Center, Houston · Universitaire Ziekenhuizen KU Leuven · University Health Network, Toronto · University of British Columbia · Abbott · Akdeniz University · Annadal stichting · Asofarma de México S.A de C.V. · Assistance Publique - Hôpitaux de Paris · Astellas Pharma Europe B.V. · Autonomous University of Nuevo León · Bayer · Bio-Kinetic Europe, Ltd. · Canadian Institutes of Health Research (CIHR) · Casa Sollievo della Sofferenza IRCCS · Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec · Centro InmunoQ, Mexico City · Centro Médico ABC Observatorio, Mexico City · Chiesi Farmaceutici S.p.A. · Children's Hospital of Philadelphia · Chong Kun Dang Pharmaceutical · Chulalongkorn University · Coordinación de Investigación en Salud, Mexico · Copenhagen Trial Unit, Center for Clinical Intervention Research · Dr. Morten Hylander Møller · EMS · Emory University · Eurofarma Laboratorios S.A. · F2G Ltd · Gastroenterology and Endocrinology, University Medicine of Goettingen · Gateway for Cancer Research · General Hospital of Shenyang Military Region · Green Cross Corporation · HK inno.N Corporation · Haemonetics Corporation · Hallym University Medical Center · Helwan University · Herzzentrum Goettingen · Hospital Ángeles Metropolitano, Mexico City · Hospital Ángeles, Clínica Londres, Mexico City · Incheon St.Mary's Hospital · Insel Gruppe AG, University Hospital Bern · Janssen Research & Development, LLC · Johann Wolfgang Goethe University Hospital · Juvenile Diabetes Research Foundation · King Saud University · Klemens Budde · Kwong Wah Hospital · LCMC Health · Loma Linda University · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Maastricht University Medical Center · McGill University · McMaster University · Medical Statistics, University Medicine of Goettingen · Medical University of Vienna · Merck KGaA, Darmstadt, Germany · Merck Serono S.A., Geneva · Mirati Therapeutics Inc. · Montreal Children's Hospital of the MUHC · National Institutes of Health (NIH) · National Science and Technology Council, Taiwan · all 114 on the full record

Regulatory milestones approvals, filings & regulatory actions · 9 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (3) US (FDA) PROTONIX IV — 2001-10-19 – 2024-08-12 fda.gov ↗
Label expansions (3) US (FDA) PROTONIX — 2001-06-12 – 2009-11-12 fda.gov ↗
Approved EU (EMA) Pantozol Control — 2009-06-11 europa.eu ↗
Approved US (FDA) PROTONIX — 2000-02-02 fda.gov ↗
Filed US (FDA) — — —

“Sun Pharma filed its abbreviated new drug application for pantoprazole.” sunpharma.com ↗

Trials 115 · started per year

today
US approved 2000
EU approved 2009
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial · 1 met primary
Phase 0 NCT05005910 Sep 2021 → Dec 2022 peptic ulcer disease Uayporn Kaosombatwattana Completed Met primary
Phase 129 trials · 1 met primary
Phase 1 NCT07683793 Oct → Dec 2026 expected — Chiesi Farmaceutici S.p.A. Not yet recruiting No outcome recorded
Phase 1 NCT07800897 Aug 2026 → Mar 2027 expected — Bristol-Myers Squibb Recruiting No outcome recorded
Phase 1 NCT04935112 Jul → Aug 2021 — Mirati Therapeutics Inc. Completed No outcome recorded
Phase 1 NCT03095547 May → Jul 2017 invasive aspergillosis F2G Ltd Withdrawn No outcome recorded
Phase 1 NCT02186652 Jun 2014 → Sep 2015 gastroesophageal reflux disease Phillip Brian Smith Completed No outcome recorded
Phase 1 NCT01887743 Jun 2013 → Oct 2015 gastroesophageal reflux disease, obesity disorder Children's Mercy Hospital Kansas City Completed No outcome recorded
Phase 1 NCT01847417 May → Jul 2013 peptic ulcer disease GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT01847404 May → Jun 2013 peptic ulcer disease GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT01703858 Sep 2012 → Jan 2013 — Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT01857609 Aug → Dec 2012 — Seoul National University Hospital Completed No outcome recorded
Phase 212 trials · 1 met primary
Phase 2 NCT07076914 Oct 2025 → Jan 2028 expected non-small cell lung carcinoma, small cell lung carcinoma London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Not yet recruiting No outcome recorded
Phase 2 NCT06706258 Jan 2025 → Dec 2026 expected acute kidney injury The University of Texas Health Science Center, Houston Recruiting No outcome recorded
Phase 2 NCT06861478 Oct 2024 → Aug 2026 overdue — Autonomous University of Nuevo León Recruiting No outcome recorded
Phase 2 NCT06154226 Jan → Sep 2024 acute kidney injury The University of Texas Health Science Center, Houston Completed No outcome recorded
Phase 2 NCT03910647 Dec 2019 → Dec 2020 drug pseudoallergy Assiut University Unknown No outcome recorded
Phase 2 NCT04022837 Nov 2019 → Nov 2020 drug pseudoallergy Assiut University Unknown No outcome recorded
Phase 2 NCT03948477 Jun 2019 → Oct 2021 breast cancer, chemotherapy-induced toxicity University of Auckland, New Zealand Completed Met primary
Phase 2 NCT01848457 Apr 2013 → Jan 2016 chemotherapy-induced toxicity, osteosarcoma, platinum-induced ototoxicity Children's Hospital of Philadelphia Completed No outcome recorded
Phase 2 NCT01748500 Jan 2013 → Mar 2021 prostate cancer University Health Network, Toronto Completed No outcome recorded
Phase 2 NCT00768651 Oct 2008 → Jul 2011 type 1 diabetes mellitus University of Alberta Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT01541735 Jan 2012 → Mar 2013 type 2 diabetes mellitus Coordinación de Investigación en Salud, Mexico Completed No outcome recorded
Phase 319 trials · 3 met primary
Phase 3 NCT03177629 May 2017 → Jun 2020 Helicobacter pylori infectious disease, autoimmune thrombocytopenic purpura Seoul National University Hospital Unknown Met primary
Phase 3 NCT02929563 Jan 2017 → Jan 2020 — McMaster University Completed No outcome recorded
Phase 3 NCT01670552 Feb → Oct 2016 dyspepsia EMS Completed Met primary
Phase 3 NCT02345239 Feb → Jun 2015 diabetes mellitus McGill University Unknown No outcome recorded
Phase 3 NCT01710462 Aug 2013 → ? gastroesophageal reflux disease Eurofarma Laboratorios S.A. Withdrawn No outcome recorded Stop: Business
Phase 3 NCT01776424 Feb 2013 → Jul 2017 — Bayer Completed No outcome recorded
Phase 3 NCT02726269 Jun 2012 → Mar 2014 Helicobacter pylori infectious disease Asofarma de México S.A de C.V. Completed Met primary
Phase 3 NCT00699361 Aug → Dec 2008 congestive heart failure Johann Wolfgang Goethe University Hospital Withdrawn No outcome recorded Stop: Business
Phase 3 NCT00367614 Jan → Aug 2007 gastroesophageal reflux disease Wyeth is now a wholly owned subsidiary of Pfizer Completed No outcome recorded
Phase 3 NCT00312806 May 2006 → Mar 2007 gastroesophageal reflux disease Takeda Completed No outcome recorded
Phase 441 trials · 2 met primary · 2 missed
Phase 4 NCT07611162 May 2026 → May 2030 expected gastroesophageal reflux disease University of Mons Not yet recruiting No outcome recorded
Phase 4 NCT05624229 Oct 2023 → Dec 2025 overdue esophageal varices with bleeding West China Hospital Not yet recruiting No outcome recorded
Phase 4 NCT06050824 Jul 2022 → Jul 2023 Helicobacter pylori infectious disease Helwan University Completed No outcome recorded
Phase 4 NCT07354230 Jan 2022 → Sep 2024 atrial fibrillation Pirogov Russian National Research Medical University Completed No outcome recorded
Phase 4 NCT04713969 Mar 2021 → Jan 2024 dyspepsia Universitaire Ziekenhuizen KU Leuven Completed No outcome recorded
Phase 4 NCT03908593 Oct 2019 → Dec 2023 peptic ulcer disease Ruijin Hospital Unknown No outcome recorded
Phase 4 NCT03920306 Apr 2019 → Sep 2024 gastrocutaneous syndrome University of British Columbia Completed No outcome recorded
Phase 4 NCT03038009 Oct 2018 → Sep 2020 active peptic ulcer disease Ruijin Hospital Withdrawn No outcome recorded
Phase 4 NCT04248335 Jul 2018 → Dec 2024 gastroesophageal reflux disease, metabolic dysfunction-associated steatotic liver disease Children's Mercy Hospital Kansas City Completed No outcome recorded
Phase 4 NCT03545243 Apr 2018 → Mar 2020 immune dysregulation, neurodevelopmental defects, and colitis Universitaire Ziekenhuizen KU Leuven Completed No outcome recorded
Phase not applicable12 trials · 2 met primary · 2 missed
— NCT07248722 Mar 2026 → Dec 2027 expected cirrhosis of liver, esophageal varices General Hospital of Shenyang Military Region Enrolling by invitation No outcome recorded
— NCT06710600 Sep 2022 → Apr 2024 photosensitivity disease Medical University of Vienna Completed No outcome recorded
— NCT05353933 May → Jul 2022 gastroesophageal reflux disease University of Medicine and Pharmacy at Ho Chi Minh City Completed Met primary
— NCT03321773 Jan 2017 → Dec 2020 Helicobacter pylori infectious disease Kaohsiung Veterans General Hospital. Unknown No outcome recorded
— NCT03814421 Apr 2016 → Dec 2018 active peptic ulcer disease Samsung Changwon Hospital Unknown No outcome recorded
— NCT02788591 Aug 2015 → Jun 2021 gastroesophageal reflux disease LCMC Health Terminated No outcome recorded Stop: Enrollment
— NCT02159976 Jul 2014 → May 2015 Helicobacter pylori infectious disease Seoul National University Bundang Hospital Completed Missed primary
— NCT02541864 Jul 2013 → Aug 2015 Helicobacter pylori infectious disease Kaohsiung Veterans General Hospital. Completed No outcome recorded
— NCT01524757 Mar 2012 → Aug 2013 hereditary hemochromatosis Maastricht University Medical Center Unknown Met primary
— NCT01179724 Jul 2009 → Sep 2010 hemorrhagic disease Samsung Medical Center Unknown No outcome recorded
Comparator or background therapy91 trials
Phase 1 NCT06856447 Background Jun 2024 → May 2025 overdue colorectal cancer toqa saad mohammed mohammed Recruiting No outcome recorded
Phase 1 NCT07262736 Comparator Feb 2021 → Feb 2022 — Universiti Sains Malaysia Completed No outcome recorded
Phase 1 NCT03011996 Comparator May 2016 → Feb 2017 — HK inno.N Corporation Completed No outcome recorded
Phase 1 NCT02214433 Background Aug 2014 → Feb 2015 bacterial infectious disease Debiopharm International SA Completed No outcome recorded
Phase 1 NCT01821521 Comparator Jun → Aug 2013 — Ahn-Gook Pharmaceuticals Co.,Ltd Unknown No outcome recorded

News releases announcing trial results or a regulatory action · 6

DateIssuerRelease
2025-04-01 Alembic Pharmaceuticals Ltd. Regulatory Press Release FA for Pantoprazole Sodium injection 40 mgvial (Single Dose Vial) alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDAPantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial).
2022-11-28 HK inno.N Corporation Results HK inno.N presents K-CAB big data hepatotoxicity inno-n.com ↗
The study showed that K-CAB had a 27% lower risk of hepatotoxicity compared to six competitor PPI drugs.
2011-01-21 Wockhardt Regulatory Wockhardt launches generic version of Protonix tablets in the US wockhardt.com ↗
Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing 20mg and 40mg Pantoprazole Delayed Release tablets of Pantoprazole (Protonix) that is used for treatment of GI Ulcers and hyperacidity.
2007-09-11 Sun Pharmaceutical Industries, Inc. Regulatory Sun Pharma announces USFDA approval to market generic Protonix Tablets - Company gets its first 180 day marketing exclusivity on a first-to-file ANDA with para IV certification sunpharma.com ↗
Sun Pharmaceutical Industries Ltd. announced that USFDA has granted final approval for the company’s Abbreviated New Drug Applicat ion (ANDA) to market its generic version of Wyeth’s Protonix ®, pantoprazole tablets.
2007-08-02 Teva Branded Pharmaceutical Products R&D, Inc. Regulatory Teva Announces Approval Of Generic Protonix® Delayed Release Tablets, 20 Mg And 40 Mg tevapharm.com ↗
the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA)
2006-04-23 Teva Branded Pharmaceutical Products R&D, Inc. Regulatory Teva Receives Tentative Approval for Generic Protonix® Delayed Release Tablets, 20 Mg And 40 Mg tevapharm.com ↗
the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Wyeth's Protonix® (Pantoprazole Sodium) Delayed Release (DR) Tablets, 20 mg and 40 mg.

All press releases naming this drug 21 releases

DateIssuerRelease

Evidence & citations 15 cited values

Every value below carries the sentence it was read from. 206 sources stand behind the page.

FieldValueCited text
Known as Pantoprazole “14-day bismuth quadruple therapy (pantoprazole, bismuth subcitrate, tetracycline, and metronidazole for 14 days) or 14-day hybrid therapy (a 7-day dual therapy with...” PMID 28807915 ↗ Oct 2017
201

“Allowable PPIs : Rabeprazole Sodium 20 mg QD, Esomeprazole Magnesium 20 mg or 40 mg QD, Lansoprazole 15 mg or 30 mg QD, Pantoprazole 20 mg or 40 mg QD, Omeprazole 20 mg or 40...” NCT00978016 ↗

“Group 2 will receive azithromycin 500 mg once daily (od) (Truxa®, Laboratorios Monte Verde SA, Argentina), levofloxacin 500 mg od (Laboratorios Asofarma de México SA de CV,...” NCT02726269 ↗

“All participants were taking a standard dose QD PPI (dexlansoprazole, esomeprazole, esomeprazole magnesium, lansoprazole, omeprazole, pantoprazole, pantoprazole sodium...” NCT02637557 ↗

“Oral anti-reflux therapy of either Pantoprazole 20-40mg PO OD, or Ranitidine 5-10mg/kg/day PO divided twice daily or 150mg PO BID, for either 4 weeks or until gastrocutaneous...” NCT03920306 ↗

“The aim of the study is to investigate whether intravenous infusion of pantoprazole (Pantoloc) is effective in preventing recurrent bleeding in patients who present with acute...” NCT00153725 ↗

“patients will receive concomitant therapy comprising of pantoprazole (40 mg twice daily), amoxicillin (1 gm twice a day), clarithromycin (500 mg twice a day) and metronidazole...” NCT06050824 ↗

“The investigators will administer to every patient: cefazolin 2g iv bolus, ketorolac 30 mg iv bolus, pantoprazole 40 mg iv bolus, paracetamol 1g iv perfusion (initiated 30...” NCT02502877 ↗

“versus continuous (40mg as a bolus injection followed by continuous infusion at 8mg/hr for 72hours) intravenous pantoprazole for prevention of bleeding after endoscopic therapy...” NCT03814421 ↗

“(pantoprazole 40 mg + amoxicillin 1.0 g) bid for the first 5 days, subsequently (pantoprazole 40 mg + clarithromycin 500 mg + metronidazole 500 mg ) bid for the next 5 days :...” NCT02108184 ↗

“pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg, amoxicillin 1 g for another 5 days” NCT02359435 ↗

Show 191 more sources

Known as Antopral “Pantoprazole (Controloc 40 mg OR Antopral 40 mg OR Perloc 40 mg), tablets” NCT05227833 ↗
Known as Controloc “Pantoprazole (Controloc 40 mg OR Antopral 40 mg OR Perloc 40 mg), tablets” NCT05227833 ↗
Known as Magnesium Pantoprazole ClinicalTrials.gov intervention name — accepted as the source's own label NCT01499693 ↗
Known as Pantoloc “The aim of the study is to investigate whether intravenous infusion of pantoprazole (Pantoloc) is effective in preventing recurrent bleeding in patients who present with acute...” NCT00153725 ↗
6

“Pantoprazole 40 mg (Pantoloc) and placebo of vonoprazan (vonseca) daily for 8 weeks” NCT06564246 ↗

“Pantoprazole (Pantoloc) 3.3mg/hr for 72hrs” NCT01182597 ↗

“Drugs - Pantoloc 40mg, PO, BID, 1wk” NCT02759029 ↗

“pantoprazole (Pantoloc) 40mg” NCT06710600 ↗

NCT01112852 ↗

NCT00863837 ↗

Known as Pantomed “Pantoprazole (Pantomed®) 40mg once daily during 4 weeks” NCT03545243 ↗
Known as pantoprazole sodium “pantoprazole sodium enteric-coated spheroid suspension” NCT00259012 ↗
1

“pantoprazole sodium enteric-coated spheroid” NCT00300755 ↗

Known as pantoprazole sodium sesquihydrate “All participants were taking a standard dose QD PPI (dexlansoprazole, esomeprazole, esomeprazole magnesium, lansoprazole, omeprazole, pantoprazole, pantoprazole sodium...” NCT02637557 ↗
Known as Pantostad 40 CAP “Oral pantoprazole 40 mg capsules (Pantostad 40 CAP, Stellapharm J.V. Co., Ltd, Binh Duong, Vietnam)” NCT05353933 ↗
Known as Perloc “Pantoprazole (Controloc 40 mg OR Antopral 40 mg OR Perloc 40 mg), tablets” NCT05227833 ↗
Known as PROTONIX “This Phase IV study is intended to compare intragastric acid suppression of oral esomeprazole (NEXIUM ® Delayed-Release Capsules) with that of oral pantoprazole (PROTONIX ®...” NCT00206050 ↗
3

“Pantoprazole (Protonix) will be given at 6 different timepoints:” NCT06706258 ↗

“Protonix (Pantoprazole) 40 mg q 12 hrs for 2 days” NCT06531642 ↗

“Protonix” NCT02432456 ↗

Action Inhibit “Also investigated is the ability of the parenteral H+-K+ ATPase inhibitor, pantoprazole to control acid secretion short-term, when oral Omeprazole cannot be used.” NCT00001191 ↗
Modality Other / unclassified “Proton pump inhibitor” NCT03948477 ↗
Route Intravenous “intravenous pantoprazole” NCT00001191 ↗
Target ATP4A “Proton pump inhibitors (PPIs) block the ATP hydrolysis of the H+/K+ ATPase via binding its active site of ATP4A” NCT06706258 ↗