Pantoprazole
Other / unclassified targets ATP4A via inhibition
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence 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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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| Phase 1 | NCT03095547 | May → Jul 2017 | invasive aspergillosis | F2G Ltd | Withdrawn | No outcome recorded |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 1 | NCT01163903 | Jul 2010 → Mar 2014 | cancer | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 1 | NCT01129427 | Aug → Nov 2009 | — | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT00744419 | May 2009 → Apr 2012 | gastroesophageal reflux disease | University of Louisville | Completed | No outcome recorded |
| Phase 1 | NCT00938366 | Jan 2008 → Jan 2009 | multiple sclerosis | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 1 | NCT00383916 | Oct 2006 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00600041 | May 2005 → Jan 2006 | — | Herzzentrum Goettingen | Completed | No outcome recorded |
| Phase 1 | NCT00835393 | Dec 2003 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1 | NCT00835588 | Dec 2003 | — | Teva Pharmaceuticals USA | Completed | Met primary |
| Phase 1 | NCT02173730 | Nov 2002 → Feb 2003 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02170610 | Mar → May 2002 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02170623 | Feb → Apr 2002 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02170636 | Jan → Mar 2002 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02209831 | Nov 2001 → Jan 2002 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02170896 | Oct → Dec 2001 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02170805 | Apr → Jun 2001 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02170766 | Oct → Dec 2000 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02170740 | Nov 1999 → Jan 2000 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02264106 | Apr → Jun 1998 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02264119 | Apr → Jul 1998 | — | Boehringer Ingelheim | 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 | NCT00037570 | Nov 2000 → Feb 2002 | peptic ulcer disease | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00001191 | Feb 1983 → Dec 2007 | Zollinger-Ellison syndrome, gastrin-producing neuroendocrine tumor | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | 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 3 | NCT00141817 | Aug 2005 → Nov 2007 | gastroesophageal reflux disease | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00195208 | Jun → Nov 2005 | esophagitis, gastroesophageal reflux disease | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00163306 | May 2005 → ? | gastroesophageal reflux disease | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00374101 | Jan 2005 → Mar 2007 | active peptic ulcer disease | Casa Sollievo della Sofferenza IRCCS | Completed | No outcome recorded |
| Phase 3 | NCT00161096 | Mar 2004 → Sep 2005 | gastroesophageal reflux disease, peptic ulcer disease | UMC Utrecht | Unknown | No outcome recorded |
| Phase 3 | NCT00161200 | Dec 2002 → Oct 2006 | Barrett esophagus | University of Medicine and Dentistry of New Jersey | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00040495 | Apr 2001 → Jan 2003 | peptic ulcer disease | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00261300 | Oct 2000 → Sep 2007 | gastroesophageal reflux disease, peptic ulcer disease | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT01499693 | — | — | Takeda | Withdrawn | 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 4 | NCT02401035 | May 2017 → Jun 2021 | gastroesophageal reflux disease | Pfizer | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03175731 | May 2017 → Aug 2019 | cirrhosis of liver, portal hypertension | Yanjing Gao | Completed | No outcome recorded |
| Phase 4 | NCT02788123 | Mar → May 2017 | stomach disorder | Astellas Pharma Europe B.V. | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT02718261 | Feb 2016 → Sep 2018 | acute kidney injury, end stage renal failure | Insel Gruppe AG, University Hospital Bern | Completed | No outcome recorded |
| Phase 4 | NCT02467621 | Jan 2016 → Oct 2017 | duodenal ulcer | Dr. Morten Hylander Møller | Completed | Missed primary |
| Phase 4 | NCT02213887 | Sep 2014 → Nov 2020 | gastroesophageal reflux disease, psychotic disorder | University of British Columbia | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02108184 | Feb 2014 → Aug 2016 | Helicobacter pylori infectious disease | Incheon St.Mary's Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01735227 | Nov 2012 → Oct 2013 | acute coronary syndrome | Yaling Han | Unknown | No outcome recorded |
| Phase 4 | NCT01737840 | Oct 2012 → Jan 2013 | dyspepsia | Akdeniz University | Completed | No outcome recorded |
| Phase 4 | NCT01801280 | Jan 2012 → Mar 2013 | disease related to solid organ transplantation | Klemens Budde | Completed | No outcome recorded |
| Phase 4 | NCT02703896 | Jan 2012 | lung disorder | King Saud University | Completed | No outcome recorded |
| Phase 4 | NCT01214408 | Mar → Jul 2011 | peptic ulcer disease | Abbott | Completed | No outcome recorded |
| Phase 4 | NCT01281501 | Jan → Oct 2011 | dyspepsia | Chulalongkorn University | Completed | Missed primary |
| Phase 4 | NCT01769365 | Jul 2010 → Oct 2013 | Helicobacter pylori infectious disease | Kaohsiung Veterans General Hospital. | Completed | Met primary |
| Phase 4 | NCT00950339 | Aug 2009 → Jun 2011 | coronary artery disorder | Tel-Aviv Sourasky Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00930670 | Jun 2009 → Dec 2011 | coronary artery disorder | Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec | Completed | No outcome recorded |
| Phase 4 | NCT01023360 | May 2008 → Oct 2010 | — | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT00713947 | Apr 2008 → Mar 2009 | coronary thrombosis | Assistance Publique - Hôpitaux de Paris | Withdrawn | No outcome recorded |
| Phase 4 | NCT01112852 | Dec 2006 → Apr 2010 | esophageal varices, hemorrhagic disease | National Science and Technology Council, Taiwan | Completed | No outcome recorded |
| Phase 4 | NCT00410592 | Oct 2006 → May 2007 | gastroesophageal reflux disease | AstraZeneca | Completed | Met primary |
| Phase 4 | NCT00325676 | Jun 2006 → ? | gastroesophageal reflux disease | Takeda | Completed | No outcome recorded |
| Phase 4 | NCT00246909 | Nov 2005 → Nov 2006 | gastroesophageal reflux disease | Takeda | Completed | No outcome recorded |
| Phase 4 | NCT00261339 | Aug 2005 → ? | gastroesophageal reflux disease | Takeda | Completed | No outcome recorded |
| Phase 4 | NCT00206050 | Sep → Dec 2004 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00307944 | Aug 2004 → Aug 2006 | gastroesophageal reflux disease, obstructive sleep apnea syndrome | University of Cincinnati | Completed | No outcome recorded |
| Phase 4 | NCT00133770 | Jul 2004 → Jul 2006 | esophagitis | Emory University | Completed | No outcome recorded |
| Phase 4 | NCT00625274 | Jun → Nov 2004 | dyspepsia, gastroesophageal reflux disease | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00304421 | Jan 2004 → Sep 2007 | gastroesophageal reflux disease | VA Greater Los Angeles Healthcare System | Completed | No outcome recorded |
| Phase 4 | NCT00279123 | Jan 2002 → ? | peptic ulcer disease | Kwong Wah Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00237367 | ? → Apr 2005 | gastroesophageal reflux disease | PriCara, Unit of Ortho-McNeil, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT02123498 | ? → May 2015 | eustachian tube disorder, gastroesophageal reflux disease | Loma Linda University | Withdrawn | 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 |
| — | NCT00709046 | Jan 2008 → Jan 2010 | hemorrhagic disease, peptic ulcer disease | National Taiwan University Hospital | Unknown | Missed primary |
| — | NCT00247715 | Oct 2003 → Jan 2007 | dyspepsia | Radboud University Medical Center | Completed | 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 |
| Phase 1 | NCT01146483 Comparator | Apr 2010 → Dec 2011 | — | University of Montreal Hospital Centre (CHUM) | Completed | No outcome recorded |
| Phase 1 | NCT01170533 Comparator | Mar 2009 → Aug 2010 | — | University of Florida | Completed | No outcome recorded |
| Phase 1 | NCT01882296 Comparator | ? → Sep 2013 | — | Ahn-Gook Pharmaceuticals Co.,Ltd | Unknown | No outcome recorded |
| Phase 1/2 | NCT06481306 Background | Jul 2024 → Apr 2028 expected | sickle cell disease | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 2 | NCT07293910 Comparator | Feb → Dec 2026 expected | Helicobacter pylori infectious disease | Tanta University | Recruiting | No outcome recorded |
| Phase 2 | NCT06488001 Comparator | Aug 2022 → Dec 2026 expected | — | United States Naval Medical Center, Portsmouth | Recruiting | No outcome recorded |
| Phase 2 | NCT05251233 Comparator | Apr 2022 → Jun 2024 | ampulla of vater cancer, distal biliary tract carcinoma, malignant pancreatic neoplasm, pancreatic neuroendocrine tumor +1 | Washington University School of Medicine | Terminated | No outcome recorded |
| Phase 2 | NCT04821310 Comparator | Jan 2022 → Dec 2025 | esophagitis | Pfizer | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04221165 Background | Aug 2020 → Sep 2023 | head and neck cancer, mucositis | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Completed | Met primary |
| Phase 2 | NCT02637557 Background | Mar 2016 → Apr 2017 | gastroesophageal reflux disease | Ironwood Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 2 | NCT02142712 Comparator | Dec 2014 | brain edema, stroke disorder | University of Florida | Completed | No outcome recorded |
| Phase 2 | NCT00978016 Background | Sep 2009 → Dec 2010 | gastroesophageal reflux disease | XenoPort, Inc. | Completed | Missed primary |
| Phase 2/3 | NCT06531642 Comparator | Sep 2024 → Jul 2026 overdue | acute kidney injury | The University of Texas Health Science Center, Houston | Recruiting | No outcome recorded |
| Phase 2/3 | NCT06062719 Background | Aug 2023 → Sep 2024 | — | National Hepatology & Tropical Medicine Research Institute | Unknown | No outcome recorded |
| Phase 2/3 | NCT05293132 Background | Feb 2022 → Jun 2023 | infectious disease with sepsis | Ain Shams University | Completed | Met primary |
| Phase 2/3 | NCT02685748 Background | Jul 2017 → Dec 2019 | schizophrenia | Clinic for Psychiatric Disorders, Dr Laza Lazarevic | Completed | Missed primary |
| Phase 2/3 | NCT00674245 Comparator | Apr 2008 → Jul 2010 | gastroesophageal reflux disease | Southern Arizona VA Health Care System | Completed | No outcome recorded |
| Phase 2/3 | NCT00403364 Background | Jul 2003 → Feb 2006 | Helicobacter pylori infectious disease | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Completed | Met primary |
| Phase 3 | NCT07275827 Comparator | Feb → Dec 2026 expected | Helicobacter pylori infectious disease | Tanta University | Recruiting | No outcome recorded |
| Phase 3 | NCT06414707 Comparator | Oct 2023 → Apr 2024 | Helicobacter pylori infectious disease | Ain Shams University | Completed | No outcome recorded |
| Phase 3 | NCT05227833 Comparator | Feb → Nov 2022 | esophageal varices with bleeding, portal hypertension, ulcer disease | Alexandria University | Completed | No outcome recorded |
| Phase 3 | NCT04107194 Background | Jan 2020 → Feb 2021 | Helicobacter pylori infectious disease | University of Bari | Unknown | No outcome recorded |
| Phase 3 | NCT04217512 Comparator | May 2019 → Dec 2030 expected | — | Tanta University | Recruiting | No outcome recorded |
| Phase 3 | NCT03374800 Comparator | Jul 2018 → Oct 2023 | peptic ulcer disease | McMaster University | Completed | No outcome recorded |
| Phase 3 | NCT03998969 Background | Jun 2016 → Dec 2018 | esophageal disorder | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 3 | NCT02533349 Comparator | May → Dec 2016 | gastroesophageal reflux disease | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT02290327 Comparator | May 2015 → Jan 2016 | — | McMaster University | Completed | No outcome recorded |
| Phase 3 | NCT02084420 Comparator | Dec 2012 → Jan 2014 | peptic ulcer disease | Il-Yang Pharm. Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT01132638 Comparator | Aug 2011 → Jun 2012 | gastroesophageal reflux disease | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT01182597 Comparator | Aug 2010 → Aug 2013 | peptic ulcer disease | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT00857597 Comparator | Mar 2009 → Dec 2011 | gastroesophageal reflux disease | University of Pittsburgh | Terminated | No outcome recorded |
| Phase 3 | NCT00326027 Comparator | Oct 2006 → Jul 2007 | gastroesophageal reflux disease | Nycomed | Completed | No outcome recorded |
| Phase 3 | NCT00365300 Comparator | Sep 2006 → Nov 2007 | gastroesophageal reflux disease | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00336219 Comparator | Aug → Nov 2006 | gastroesophageal reflux disease | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00362609 Comparator | Jul 2006 → Dec 2007 | gastroesophageal reflux disease | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00300755 Comparator | May 2006 → Apr 2008 | gastroesophageal reflux disease | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00868296 Comparator | Mar 2006 → Mar 2008 | gastroesophageal reflux disease | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00259012 Comparator | Nov 2005 → Mar 2008 | gastroesophageal reflux disease | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT07843264 Comparator | Oct 2026 → Dec 2027 expected | peptic esophagitis | University of Florida | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06564246 Comparator | Sep 2024 → Aug 2026 overdue | gastroesophageal reflux disease | Tanta University | Recruiting | No outcome recorded |
| Phase 4 | NCT06991348 Comparator | Jul 2024 → Nov 2025 overdue | gastroesophageal reflux disease | Carnot Laboratories | Recruiting | No outcome recorded |
| Phase 4 | NCT04728516 Comparator | Apr 2023 → Jun 2026 overdue | Helicobacter pylori infectious disease, acute coronary syndrome | Qilu Hospital of Shandong University | Recruiting | No outcome recorded |
| Phase 4 | NCT04660123 Background | Dec 2020 → Dec 2021 | Helicobacter pylori infectious disease, gastric cancer | Xijing Hospital of Digestive Diseases | Completed | No outcome recorded |
| Phase 4 | NCT04410536 Background | Jun 2020 → Dec 2021 | migraine disorder | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta | Completed | No outcome recorded |
| Phase 4 | NCT03094416 Background | Jul 2018 → Jun 2020 | postsurgical hypothyroidism | IBSA Institut Biochimique SA | Completed | No outcome recorded |
| Phase 4 | NCT02987920 Background | Jan 2017 → Jan 2018 | — | University of Southern California | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02432456 Background | Sep 2015 → Aug 2018 | — | Medical College of Wisconsin | Completed | Missed primary |
| Phase 4 | NCT02466919 Background | May 2014 → Sep 2016 | Helicobacter pylori infectious disease | Chung-Tai Wu | Completed | No outcome recorded |
| Phase 4 | NCT02028234 Comparator | Feb 2014 → Mar 2015 | coronary artery disorder | University of Roma La Sapienza | Unknown | No outcome recorded |
| Phase 4 | NCT01016717 Comparator | Dec 2012 | coronary artery disorder | Sheba Medical Center | Withdrawn | No outcome recorded |
| Phase 4 | NCT01493557 Comparator | Dec 2011 → Jul 2014 | atrial fibrillation | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 4 | NCT01373970 Comparator | May 2011 → May 2013 | dyspepsia | Zealand University Hospital | Terminated | No outcome recorded |
| Phase 4 | NCT02757703 Comparator | May 2010 → Jan 2015 | esophageal varices with bleeding | Kaohsiung Veterans General Hospital. | Completed | No outcome recorded |
| Phase 4 | NCT00825630 Comparator | Nov 2008 → Nov 2009 | Helicobacter pylori infectious disease | Meridian Bioscience, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00841854 Comparator | Jun 2008 → May 2010 | Helicobacter pylori infectious disease | Asan Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00731601 Comparator | May 2008 → Mar 2009 | peptic ulcer disease | Lotung Poh-Ai Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00839488 Comparator | Apr 2008 → Mar 2009 | gastric ulcer | Far Eastern Memorial Hospital | Terminated | No outcome recorded |
| Phase 4 | NCT00449813 Comparator | Mar → Oct 2007 | gastroesophageal reflux disease | Takeda | Terminated | No outcome recorded |
| Phase 4 | NCT00863837 Comparator | Dec 2006 → Nov 2009 | esophageal varices with bleeding | National Science and Technology Council, Taiwan | Unknown | No outcome recorded |
| Phase 4 | NCT00843063 Comparator | Aug 2004 → Dec 2008 | peptic ulcer disease | Ruttonjee Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00881413 Comparator | — | peptic ulcer disease | Lotung Poh-Ai Hospital | Withdrawn | No outcome recorded Stop: Business |
| — | NCT04566250 Background | Feb 2021 → Apr 2022 | — | McMaster University | Completed | Met primary |
| — | NCT04394663 Comparator | Oct 2020 → May 2025 overdue | — | King Chulalongkorn Memorial Hospital | Recruiting | No outcome recorded |
| — | NCT04566211 Comparator | Jan 2020 → Sep 2022 | Helicobacter pylori infectious disease | Kaohsiung Veterans General Hospital. | Unknown | No outcome recorded |
| — | NCT04621487 Comparator | Jan 2019 → Jan 2020 | Helicobacter pylori infectious disease | University of Split, School of Medicine | Completed | No outcome recorded |
| — | NCT04697641 Background | Sep 2017 → May 2019 | Helicobacter pylori infectious disease, dyspepsia | Sir Ganga Ram Hospital | Completed | Missed primary |
| — | NCT03058471 Comparator | Dec 2016 → Oct 2017 | chikungunya | Post Graduate Institute of Medical Education and Research, Chandigarh | Completed | No outcome recorded |
| — | NCT02759029 Comparator | Mar 2016 → Feb 2018 | Helicobacter pylori infectious disease | Gangnam Severance Hospital | Unknown | No outcome recorded |
| — | NCT03812419 Comparator | Jan → Dec 2016 | — | Future University in Egypt | Completed | No outcome recorded |
| — | NCT02502877 Background | Jul 2015 → Mar 2016 | — | Hospital da Luz, Portugal | Completed | No outcome recorded |
| — | NCT02547038 Background | Feb 2015 → Oct 2018 | Helicobacter pylori infectious disease | Kaohsiung Veterans General Hospital. | Completed | Met primary |
| — | NCT02243618 Comparator | Jan 2015 → Apr 2016 | gastric adenoma, gastric carcinoma | Yonsei University | Completed | No outcome recorded |
| — | NCT02235311 Comparator | Oct 2014 → Aug 2015 | — | University of Missouri-Columbia | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT02167633 Background | Jul 2014 → Sep 2016 | metastatic malignant neoplasm, spinal cord disorder | Rigshospitalet, Denmark | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT01477320 Comparator | Sep 2013 → Jul 2016 | Clostridium difficile colitis | Mohamed Saad | Completed | No outcome recorded |
| — | NCT01744314 Background | Nov 2012 → Nov 2019 | — | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Unknown | No outcome recorded |
| — | NCT02359435 Background | Oct 2012 → Feb 2015 | Helicobacter pylori infectious disease | Kaohsiung Veterans General Hospital. | Completed | No outcome recorded |
| — | NCT02733640 Comparator | Oct 2012 → May 2015 | platelet aggregation, spontaneous | Seoul National University Bundang Hospital | Completed | No outcome recorded |
| — | NCT02551744 Comparator | Jul 2012 → Jul 2018 | peptic ulcer disease | Kaohsiung Veterans General Hospital. | Completed | No outcome recorded |
| — | NCT01643785 Background | Jun 2012 → Jun 2013 | Helicobacter pylori infectious disease | Chuncheon Sacred Heart Hospital | Terminated | No outcome recorded |
| — | NCT01535001 Comparator | Feb 2012 → Sep 2014 | osteoarthritis, knee | Northern Orthopaedic Division, Denmark | Completed | No outcome recorded |
| — | NCT04352062 Background | Jan 2011 → Oct 2018 | — | Medical University of Lodz | Completed | No outcome recorded |
| — | NCT01167101 Background | May 2009 → Dec 2010 | gastric ulcer | Kangdong Sacred Heart Hospital | Completed | No outcome recorded |
| — | NCT00681005 Comparator | Apr 2006 → Jan 2008 | gastroesophageal reflux disease | National Taiwan University Hospital | Completed | No outcome recorded |
| — | NCT00915239 Comparator | Jan → Oct 2006 | — | Sahlgrenska University Hospital | Completed | No outcome recorded |
| — | NCT00153725 Background | Feb 2003 → Sep 2006 | cerebrovascular disorder | Chinese University of Hong Kong | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 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
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 206 sources stand behind the page.
| Field | Value | Cited 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 2017201“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 ↗ |
| 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 ↗ |
| 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 ↗ |