Drugs / Omeprazole
Omeprazole
also known as
Prilosec · Losec · OMP · ABBOTT · OME · Omeprazole (Prilosec) · omeprazole-magnesium · Prilosec (Omeprazole) · +1 more
Other / unclassified targets CYP1A2, CYP2C19, FASN via inhibition
Regulatory milestones approvals, filings & regulatory actions · 11 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (9) | US (FDA) | PRILOSEC | — | 1991-06-12 – 2016-02-03 | fda.gov ↗ |
| Filed | US (FDA) | — | frequent heartburn | 2006-06-07 | “Dexcel Pharma Technologies, Ltd. filed its New Drug Application (NDA) for Omeprazole 20 mg tablets with the U.S. Food & Drug Administration (FDA)” perrigo.com ↗ “Dexcel Pharma Technologies, Ltd. filed its NDA for 20 mg omeprazole tablets with the U.S. FDA” perrigo.com ↗ |
| Approved | US (FDA) | PRILOSEC | — | 1989-09-14 | fda.gov ↗ |
Trials 345 · started per year
today
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 09 trials · 1 met primary | ||||||
| Phase 0 | NCT06693960 | Sep 2024 → Dec 2026 expected | — | Washington State University | Recruiting | No outcome recorded |
| Phase 0 | NCT06378398 | Jun 2024 → Feb 2026 | colorectal neoplasm | University of Michigan Rogel Cancer Center | Completed | No outcome recorded |
| Phase 0 | NCT05891119 | Jun 2023 → Aug 2024 | atopic eczema | Amgen | Completed | No outcome recorded |
| Phase 0 | NCT04930991 | Sep 2021 → Mar 2026 | exocrine pancreatic carcinoma | University of Oklahoma | Terminated | No outcome recorded |
| Phase 0 | NCT05005910 | Sep 2021 → Dec 2022 | peptic ulcer disease | Uayporn Kaosombatwattana | Completed | Met primary |
| Phase 0 | NCT04170270 | Nov 2019 → Dec 2020 | active peptic ulcer disease | Assiut University | Unknown | No outcome recorded |
| Phase 0 | NCT04525664 | Oct 2018 → May 2019 | Helicobacter pylori infectious disease, dyspepsia | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 0 | NCT02844621 | May → Dec 2016 | — | The University of Texas Health Science Center at San Antonio | Completed | No outcome recorded |
| Phase 0 | NCT01824199 | Mar 2013 → Nov 2016 | esophagitis | Mayo Clinic | Withdrawn | No outcome recorded Stop: Business |
| Phase 1207 trials · 1 missed | ||||||
| Phase 1 | NCT07862114 | Oct 2026 → Jan 2027 expected | digestive system neoplasm | GlaxoSmithKline | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07700953 | Jul → Aug 2026 overdue | — | Abbisko Therapeutics Co, Ltd | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07665723 | Jun 2026 → Jul 2027 expected | ulcerative colitis | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 1 | NCT07565441 | May → Nov 2026 expected | autosomal dominant polycystic kidney disease | Jemincare | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07426042 | Apr → May 2026 overdue | — | Min Kyu Park | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07214662 | Jan 2026 → Jun 2030 expected | breast cancer | Genentech, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT07223671 | Dec 2025 → Feb 2026 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT07269756 | Dec 2025 → Mar 2026 | obesity disorder | Shandong Suncadia Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT07259330 | Oct 2025 → Mar 2026 | — | SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 1 | NCT07235748 | Oct → Dec 2025 | — | Servier | Completed | No outcome recorded |
| Show all 207 trials opens the full record — a long page | ||||||
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT02892357 | Jan 2017 → Sep 2019 | gastroesophageal reflux disease | Xiyuan Hospital of China Academy of Chinese Medical Sciences | Unknown | Mixed |
| Phase 1/2 | NCT01109381 | May 2010 → Dec 2011 | Helicobacter pylori infectious disease | Synergy Pharmaceuticals Pte. Ltd. | Terminated | No outcome recorded |
| Phase 1/2 | NCT01086722 | Feb 2010 → Feb 2013 | morbid obesity | Hospital del Mar Medical Research Institute (IMIM) | Completed | No outcome recorded |
| Phase 219 trials · 2 missed | ||||||
| Phase 2 | NCT06510010 | Dec 2024 → Dec 2026 expected | chemotherapy-induced toxicity | Sixth Affiliated Hospital, Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT06861478 | Oct 2024 → Aug 2026 overdue | — | Autonomous University of Nuevo León | Recruiting | No outcome recorded |
| Phase 2 | NCT04562116 | Dec 2021 → Jun 2023 | atopic eczema | Galderma R&D | Completed | No outcome recorded |
| Phase 2 | NCT04337580 | Mar 2021 → Feb 2028 expected | castration-resistant prostate carcinoma, refractory malignant neoplasm | Wake Forest University Health Sciences | Recruiting | No outcome recorded |
| Phase 2 | NCT03428568 | Mar 2018 → Mar 2019 | dyspepsia, gastritis | King Abdullah International Medical Research Center | Unknown | No outcome recorded |
| Phase 2 | NCT02595372 | Nov 2015 → Nov 2019 | breast cancer | Kathy Miller | Completed | No outcome recorded |
| Phase 2 | NCT02085018 | Mar 2014 → Sep 2016 | idiopathic pulmonary fibrosis | Newcastle-upon-Tyne Hospitals NHS Trust | Completed | No outcome recorded |
| Phase 2 | NCT02013453 | Dec 2013 → Dec 2016 | head and neck cancer | University of Michigan Rogel Cancer Center | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT01712711 | Sep 2012 → Feb 2013 | NAFLD1 | Tehran University of Medical Sciences | Completed | No outcome recorded |
| Phase 2 | NCT01876108 | Jul 2012 → Jul 2013 | fatty liver disease | Tehran University of Medical Sciences | Completed | No outcome recorded |
| Phase 2 | NCT01759628 | Apr 2012 → Jun 2013 | NAFLD1 | Tehran University of Medical Sciences | Completed | No outcome recorded |
| Phase 2 | NCT01654549 | Apr → Sep 2012 | NAFLD1 | Tehran University of Medical Sciences | Completed | Missed primary |
| Phase 2 | NCT01136317 | Apr → Jul 2010 | gastroesophageal reflux disease | Nantes University Hospital | Completed | Missed primary |
| Phase 2 | NCT01657578 | Jun 2007 → Dec 2010 | gastroesophageal reflux disease | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 2 | NCT00426595 | Apr → Nov 2007 | gastroesophageal reflux disease | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 2 | NCT02518373 | Apr 2000 → Feb 2001 | colorectal cancer | Cancer Advances Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00003151 | Sep 1997 → Oct 1998 | lymphoma | European Organisation for Research and Treatment of Cancer - EORTC | Completed | No outcome recorded |
| Phase 2 | NCT00002682 | Aug 1995 → Oct 2001 | lymphoma | M.D. Anderson Cancer Center | 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 | NCT02004197 | Jan 2010 → Sep 2012 | Helicobacter pylori infectious disease | Hafiz Muhammad Asif | Completed | No outcome recorded |
| Phase 331 trials · 5 met primary · 2 missed | ||||||
| Phase 3 | NCT06393868 | Nov 2024 → Dec 2027 expected | thrombotic disease, venous thromboembolism | Ottawa Hospital Research Institute | Recruiting | No outcome recorded |
| Phase 3 | NCT05646862 | Jun 2023 → Nov 2026 expected | breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 3 | NCT05680870 | Feb 2023 → Dec 2024 | chemotherapy-induced neuropathy | Aya Mohamed Sadek Elsaid | Completed | No outcome recorded |
| Phase 3 | NCT02621359 | Jan 2015 → Dec 2022 | dyspepsia | Tanta University | Unknown | No outcome recorded |
| Phase 3 | NCT02422706 | Jan 2015 → Dec 2018 | gastritis | Tanta University | Unknown | No outcome recorded |
| Phase 3 | NCT01980095 | Nov 2013 → Jun 2015 | Helicobacter pylori infectious disease, dyspepsia | RedHill Biopharma Limited | Completed | Met primary |
| Phase 3 | NCT01661101 | Jan 2013 → Mar 2018 | myocardial disorder | Population Health Research Institute | Completed | Met primary |
| Phase 3 | NCT01462318 | Nov 2011 → Jan 2016 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT01499368 | Nov 2011 → Nov 2012 | esophagitis | Boryung Pharmaceutical Co., Ltd | Completed | No outcome recorded |
| Phase 3 | NCT01493089 | Apr → Oct 2011 | gastroesophageal reflux disease | Norgine | Completed | Missed primary |
| Phase 3 | NCT00995410 | Oct 2009 → May 2011 | peptic ulcer disease | POZEN | Completed | No outcome recorded |
| Phase 3 | NCT00961350 | Oct 2009 → Feb 2012 | gastric ulcer | POZEN | Completed | Met primary |
| Phase 3 | NCT00960869 | Oct 2009 → Feb 2012 | gastric ulcer | POZEN | Completed | Met primary |
| Phase 3 | NCT01005719 | Sep 2009 → Jan 2010 | — | Bayer | Completed | Met primary |
| Phase 3 | NCT00971581 | Aug 2009 → May 2010 | — | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00634114 | Jan 2008 → May 2009 | esophagitis | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00664209 | Jan 2008 → Jun 2011 | Helicobacter pylori infectious disease, Parkinson disease | University of California, Los Angeles | Terminated | No outcome recorded |
| Phase 3 | NCT00557921 | Dec 2007 → Nov 2009 | acute coronary syndrome, coronary artery disorder, myocardial infarction | Cogentus Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT00633932 | Dec 2007 → Dec 2008 | peptic esophagitis | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00367211 | Sep 2006 → Sep 2007 | ankylosing spondylitis, osteoarthritis | POZEN | Completed | No outcome recorded |
| Phase 3 | NCT00668317 | Sep 2006 → Sep 2009 | — | Hull University Teaching Hospitals NHS Trust | Terminated | No outcome recorded |
| Phase 3 | NCT00402259 | Aug 2006 → Oct 2007 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00719420 | Apr 2006 → Feb 2007 | Helicobacter pylori infectious disease | University of North Texas Health Science Center | 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 | NCT00259051 | Jan → Aug 2004 | gastroesophageal reflux disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00259077 | Oct 2003 → Jul 2004 | gastroesophageal reflux disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00164931 | Oct 2003 → ? | active peptic ulcer disease | Chinese University of Hong Kong | Completed | No outcome recorded |
| Phase 3 | NCT00045799 | May 2002 → May 2003 | — | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00256737 | Jan 1998 → Oct 2005 | gastroesophageal reflux disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00339768 | Jul 1995 → Jun 1996 | preneoplastic lesion | National Cancer Institute (NCI) | Completed | Mixed |
| Phase 3 | NCT00003617 | Mar 1995 → ? | gastric cancer | Lymphoma Trials Office | Unknown | Missed primary |
| Phase 450 trials · 4 met primary · 1 missed | ||||||
| Phase 4 | NCT07850960 | Sep → Dec 2026 expected | gastroesophageal reflux disease, obesity disorder | Federal State Budgetary Scientific Institution | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07611162 | May 2026 → May 2030 expected | gastroesophageal reflux disease | University of Mons | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07040839 | Jul 2025 → Feb 2026 overdue | Helicobacter pylori infectious disease | Rehman Medical Institute - RMI | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06690164 | Jun → Dec 2025 overdue | — | National University Hospital, Singapore | 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 | NCT05799105 | Mar 2023 → Mar 2027 expected | ulcer disease | Stephen Firkins | Recruiting | No outcome recorded |
| Phase 4 | NCT06050824 | Jul 2022 → Jul 2023 | Helicobacter pylori infectious disease | Helwan University | Completed | No outcome recorded |
| Phase 4 | NCT04149470 | Oct 2020 → Aug 2024 overdue | eosinophilic esophagitis | University of Colorado, Denver | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03781596 | Oct 2018 → Oct 2020 | eosinophilic esophagitis | Claire Daniels | Unknown | No outcome recorded |
| Phase 4 | NCT04039412 | Jun → Dec 2018 | Helicobacter pylori infectious disease | Ayman Magd Eldin Mohammad Sadek | Completed | No outcome recorded |
| Phase 4 | NCT03347513 | Nov 2017 → Mar 2019 | Helicobacter pylori infectious disease, iron deficiency anemia, pregnancy disorder | Kasr El Aini Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02760615 | Nov 2016 → Aug 2020 | Crohn disease, ulcerative colitis | Takeda | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02794844 | Jul 2016 → Jan 2017 | gastroesophageal reflux disease | Nemours Children's Clinic | Completed | No outcome recorded |
| Phase 4 | NCT02586636 | Mar 2016 → Apr 2018 | — | NHS Tayside | Completed | No outcome recorded |
| Phase 4 | NCT02730026 | Jun 2015 → Dec 2016 | — | Luis Fernando Simoneti | Completed | No outcome recorded |
| Phase 4 | NCT02291666 | Apr 2015 → Jul 2019 | type 2 diabetes mellitus | University of Montreal Hospital Centre (CHUM) | Completed | No outcome recorded |
| Phase 4 | NCT02394340 | Feb → Apr 2015 | dermatophytosis of groin and perianal area, tinea pedis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 4 | NCT03378960 | Oct 2014 → Dec 2015 | — | Emilio Vargas Castrillón | Completed | No outcome recorded |
| Phase 4 | NCT02623816 | Aug 2014 → Dec 2015 | dyspepsia | MetroHealth Medical Center | Completed | Met primary |
| Phase 4 | NCT02635191 | Mar 2014 → Mar 2016 | Helicobacter pylori infectious disease | Beijing Children's Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02140073 | Dec 2013 → Jun 2014 | gastroesophageal reflux disease | Belarusian Medical Academy of Post-Graduate Education | Unknown | No outcome recorded |
| Phase 4 | NCT01938534 | Sep 2013 → Dec 2014 | — | Ajou University School of Medicine | Unknown | No outcome recorded |
| Phase 4 | NCT01901276 | Aug 2013 → Mar 2015 | Clostridium difficile colitis | Daniel Freedberg, MD | Completed | No outcome recorded |
| Phase 4 | NCT01795794 | Apr → Dec 2013 | congenital dyserythropoietic anemia type 1 | Soroka University Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT02685436 | Mar 2013 → May 2015 | gastroesophageal reflux disease | Mansoura University Children Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02395458 | Mar 2013 → Feb 2015 | Helicobacter pylori infectious disease | Coordinación de Investigación en Salud, Mexico | Completed | No outcome recorded |
| Phase 4 | NCT02922699 | Jan → Jun 2013 | gastroesophageal reflux disease | Dr. Reddy's Laboratories Limited | Completed | No outcome recorded |
| Phase 4 | NCT01766050 | Jan → Apr 2013 | transplant rejection | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 4 | NCT01735227 | Nov 2012 → Oct 2013 | acute coronary syndrome | Yaling Han | Unknown | No outcome recorded |
| Phase 4 | NCT03146325 | Nov 2012 → Jun 2016 | Helicobacter pylori infectious disease | The University of Texas Health Science Center, Houston | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT03650543 | Sep 2012 → Aug 2015 | Helicobacter pylori infectious disease | Javeriana University | Completed | No outcome recorded |
| Phase 4 | NCT02703896 | Jan 2012 | lung disorder | King Saud University | Completed | No outcome recorded |
| Phase 4 | NCT01587885 | Jan → Apr 2012 | dyspepsia | Bayer | Completed | Met primary |
| Phase 4 | NCT01896557 | Oct 2011 → Jun 2013 | coronary artery disorder | University of Sao Paulo General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01464060 | Sep 2011 → Dec 2012 | Helicobacter pylori infectious disease | Infante, Javier Molina, M.D. | Unknown | No outcome recorded |
| Phase 4 | NCT01335334 | Mar → Jun 2011 | Helicobacter pylori infectious disease | The University of Texas Health Science Center, Houston | Unknown | No outcome recorded |
| Phase 4 | NCT01273441 | Dec 2010 → Jun 2012 | Helicobacter pylori infectious disease | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | Completed | No outcome recorded |
| Phase 4 | NCT03086070 | Jan → Apr 2010 | chronic rhinosinusitis, gastroesophageal reflux disease | Children's Hospital Srebrnjak | 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 | NCT00903448 | Apr → Jun 2009 | — | Procter and Gamble | Completed | No outcome recorded |
| Phase 4 | NCT00861640 | Mar 2009 → Mar 2010 | — | Kaohsiung Medical University Chung-Ho Memorial Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT00808769 | Nov → Dec 2008 | — | Procter and Gamble | Completed | No outcome recorded |
| Phase 4 | NCT00582972 | Jan → Dec 2008 | achlorhydria, gastroesophageal reflux disease, osteoporosis | University of Wisconsin, Madison | Completed | Missed primary |
| Phase 4 | NCT00492622 | Jun 2007 → Dec 2008 | gastroesophageal reflux disease, gastroparesis | University of Louisville | Completed | No outcome recorded |
| Phase 4 | NCT00251030 | Nov 2005 → Jan 2006 | — | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00164866 | Feb 2004 → Sep 2005 | peptic ulcer disease | Chinese University of Hong Kong | Completed | Met primary |
| Phase 4 | NCT00641264 | May 2001 → Jun 2003 | gastroesophageal reflux disease | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT02123498 | ? → May 2015 | eustachian tube disorder, gastroesophageal reflux disease | Loma Linda University | Withdrawn | No outcome recorded |
| Phase 4 | NCT00475527 | — | Helicobacter pylori infectious disease, iron deficiency anemia | Hadassah Medical Organization | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase not applicable25 trials · 1 missed | ||||||
| — | NCT06943794 | Mar 2026 → May 2030 expected | gastric cancer | Fudan University | Not yet recruiting | No outcome recorded |
| — | NCT06917963 | Apr 2025 → Jun 2027 expected | colon carcinoma, ileus, inflammatory bowel disease | Medical University of Gdansk | Recruiting | No outcome recorded |
| — | NCT05741385 | Oct 2023 → Aug 2024 | cirrhosis of liver | Boehringer Ingelheim | Completed | No outcome recorded |
| — | NCT04394663 | Oct 2020 → May 2025 overdue | — | King Chulalongkorn Memorial Hospital | Recruiting | No outcome recorded |
| — | NCT04333407 | Apr 2020 → Nov 2021 | COVID-19 | Imperial College London | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT03337945 | Apr 2018 → Jun 2021 | cirrhosis of liver | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| — | NCT03365609 | Sep 2017 → Oct 2025 overdue | Helicobacter pylori infectious disease | Ying HUANG | Recruiting | No outcome recorded |
| — | NCT02689583 | Mar 2016 → Mar 2017 | gastric ulcer, gastritis | First Affiliated Hospital of Zhejiang University | Unknown | No outcome recorded |
| — | NCT02590185 | Dec 2015 → Dec 2019 | major depressive disorder | Assistance Publique - Hôpitaux de Paris | Unknown | No outcome recorded |
| — | NCT02789527 | Nov 2015 → Apr 2017 | — | Estella S. Poloni | Completed | No outcome recorded |
| — | NCT02788591 | Aug 2015 → Jun 2021 | gastroesophageal reflux disease | LCMC Health | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT02893709 | Jun 2015 → Jul 2016 | gastroesophageal reflux disease | Changi General Hospital | Completed | No outcome recorded |
| — | NCT02438072 | Dec 2014 → Dec 2015 | depressive disorder | University Hospital, Geneva | Unknown | No outcome recorded |
| — | NCT02016820 | Nov 2014 → Jan 2017 | Clostridium difficile colitis | Columbia University | Terminated | No outcome recorded Stop: Business |
| — | NCT01723059 | Feb 2012 → Jan 2013 | Helicobacter pylori infectious disease | Dallas VA Medical Center | Unknown | No outcome recorded |
| — | NCT03563287 | Jan 2012 → Dec 2014 | morbid obesity | University of Eastern Finland | Completed | No outcome recorded |
| — | NCT01458990 | Oct 2011 → Feb 2018 | cirrhosis of liver | Hunter Holmes Mcguire Veteran Affairs Medical Center | Completed | No outcome recorded |
| — | NCT01361217 | Sep 2011 → Jun 2012 | — | University of Washington | Completed | Missed primary |
| — | NCT01341600 | Jul 2010 → May 2011 | — | University of Maryland, Baltimore | Completed | No outcome recorded |
| — | NCT01133951 | Jun 2010 → Jan 2012 overdue | Helicobacter pylori infectious disease, gastric neoplasm | Jie-Jun Wang | Active not recruiting | No outcome recorded |
| — | NCT01122160 | May → Dec 2010 | — | USDA Beltsville Human Nutrition Research Center | Completed | No outcome recorded |
| — | NCT01061034 | Mar → Jun 2007 | — | Assaf-Harofeh Medical Center | Completed | No outcome recorded |
| — | NCT00327132 | Jul 2006 → Dec 2015 | gastric mucosa-associated lymphoid tissue lymphoma | National Health Research Institutes, Taiwan | Completed | No outcome recorded |
| — | NCT04154748 | Jun 2002 → Feb 2015 | Barrett esophagus | Maria Sklodowska-Curie National Research Institute of Oncology | Completed | No outcome recorded |
| — | NCT02039869 | ? → Dec 2015 | dyspepsia, gastroesophageal reflux disease | Virginia Commonwealth University | Withdrawn | No outcome recorded Stop: Enrollment |
| Comparator or background therapy157 trials | ||||||
| Phase 0 | NCT03105375 Comparator | Feb → Oct 2017 | — | Cinclus Pharma Holding AB | Completed | No outcome recorded |
| Phase 0 | NCT01465113 Background | May 2010 → Feb 2016 | Barrett esophagus | Case Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT07156201 Background | Aug 2025 → Mar 2026 overdue | — | Actio Biosciences, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT04199624 Background | Oct 2021 → Jun 2023 | achlorhydria | Indiana University | Completed | No outcome recorded |
| Phase 1 | NCT03100838 Comparator | Mar → Dec 2017 | — | Food and Drug Administration (FDA) | Completed | No outcome recorded |
| Show all 157 trials opens the full record — a long page | ||||||
News releases announcing trial results or a regulatory action · 32
| Date | Issuer | Release |
|---|---|---|
| 2026-05-27 | Atea Pharmaceuticals, Inc. | Results Atea Pharmaceuticals Presents New Drug-Drug Interaction Results Supporting Potential Best-in-Class Profile of the Regimen of Bemnifosbuvir and Ruzasvir for the Treatment of Hepatitis C Virus at EASL Congress 2026 ateapharma.com ↗
Co-administered BEM/RZR did not meaningfully affect the pharmacokinetic (PK) profile of omeprazole. |
| 2026-05-13 | Atea Pharmaceuticals, Inc. | Results Atea Pharmaceuticals to Present Three Abstracts at EASL 2026 Congress Highlighting Progress Across Viral Hepatitis Pipeline ateapharma.com ↗
Proton-pump inhibitor omeprazole did not affect the plasma pharmacokinetics of bemnifosbuvir and ruzasvir fixed-dose combination in healthy participants |
| 2023-10-26 | Xspray Pharma AB | Results Xspray Publication Demonstrates High Concomitant PPI and TKI Use in CML Resulting in Risk of Increased Mortality Which May be Mitigated by DASYNOC™ xspraypharma.com ↗
In healthy volunteers, neither the peak blood concentration nor the overall exposure of DASYNOC was affected by co-administration of the PPI, omeprazole; compared with DASYNOC administration alone. |
| 2023-09-18 | RedHill Biopharma Limited | Regulatory RedHill Announces FDA sNDA Approval for Talicia® redhillbio.com ↗
RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announced the U.S. Food and Drug Administration's (FDA) approval of its supplemental new drug application (sNDA) for Talicia[3], allowing a change to a more flexible three times daily (TID), taken at least 4 hours apart with food, dosing regimen for H. pylori eradication. |
| 2023-08-01 | RedHill Biopharma Limited | Regulatory RedHill Biopharma Announces Talicia Approved in the United Arab Emirates and First Commercial Order Outside the U.S. redhillbio.com ↗
RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announced that its partner, Gaelan Medical LLC ("Gaelan Medical"), a wholly owned subsidiary of the Ghassan Aboud Group (GAG), has received marketing approval from the United Arab Emirates (UAE) Ministry of Health for Talicia (omeprazole magnesium, amoxicillin and rifabutin)[3]. |
| 2023-05-09 | RedHill Biopharma Limited | Results RedHill Publishes New Talicia® Data on Generic Non-Bioequivalence in AP&T and Presents New Dosing Data at Digestive Disease Week redhillbio.com ↗
The PBPK modeling data we have presented supports bioequivalence between Talicia TID and Q8H dosing regimens for H. pylori eradication therapy showing that the overall exposures are comparable for all three Talicia-containing drugs, amoxicillin, rifabutin, and omeprazole. |
| 2022-07-12 | RedHill Biopharma Limited | Results RedHill Announces New H. pylori and COVID-19 Data Publication and Presentations at Leading Upcoming Scientific Conferences redhillbio.com ↗
Helicobacter pylori Eradication by Low-Dose Rifabutin Triple Therapy (Talicia®) is Unaffected by High Body Mass Index |
| 2022-05-26 | Perrigo Company | Regulatory PERRIGO ANNOUNCES U.S. FDA APPROVAL FOR OMEPRAZOLE MAGNESIUM DELAYED-RELEASE MINI CAPSULES perrigo.com ↗
DUBLIN , May 26, 2022 / PRNewswire / -- Perrigo Company plc (NYSE: PRGO), a leading provider of Consumer Self-Care Products, today announced that it has received final approval from the U.S. Food and Drug Administration for Omeprazole Magnesium Delayed-Release Mini Capsules, 20 mg over-the-counter (OTC). |
| 2022-05-25 | RedHill Biopharma Limited | Results RedHill Presents New Talicia® Data Analyses at DDW 2022 redhillbio.com ↗
The 293 patient-analyzable mITT population who received Talicia had pooled eradication rates of 91.7% (n=44) and 84.1% (n=206) in patients with and without DM, respectively (p=0.17). |
| 2021-12-02 | RedHill Biopharma Limited | Results RedHill Biopharma Data Published in GastroHep Shows Consistent Efficacy of Talicia Irrespective of Patient BMI redhillbio.com ↗
Talicia maintained high efficacy across all BMI groups compared to the active comparator including in obese and severely obese patients (P<0.0001). |
| 2021-10-25 | RedHill Biopharma Limited | Results RedHill Biopharma Presents New Talicia® and Movantik® Data Analyses at ACG 2021 redhillbio.com ↗
today announced the presentation of four new analyses of Phase 3 Talicia® (omeprazole magnesium, amoxicillin and rifabutin)1 and Movantik® (naloxegol)2 data at the ACG 2021 Annual Scientific Meeting, taking place October 22-27, 2021. |
| 2020-10-26 | RedHill Biopharma Limited | Results RedHill Biopharma Presents New Data from Talicia®’s Phase 3 Studies at ACG 2020 Focused on Achieving Successful First-Line Treatment in H. pylori Eradication redhillbio.com ↗
This maintenance of Talicia efficacy compares to an almost 50% reduction of eradication rates in amoxicillin/omeprazole-comparator-treated patients with BMI ≥40. |
| 2020-05-05 | RedHill Biopharma Limited | Results RedHill Biopharma Announces Publication of Talicia® Pivotal Phase 3 Study Results in Annals of Internal Medicine redhillbio.com ↗
Results demonstrated the added rifabutin benefit with 83.8% eradication of H. pylori infection with Talicia vs. 57.7% in the active comparator arm (ITT analysis, p<0.0001), showing a 26.1% benefit with Talicia. |
| 2019-11-04 | RedHill Biopharma Limited | Regulatory RedHill Biopharma Announces FDA Approval of Talicia® for Treatment of H. pylori in Adults redhillbio.com ↗ |
| 2019-10-28 | RedHill Biopharma Limited | Results RedHill Biopharma to Present New Phase 3 Data on RHB-105 and RHB-104 at the American College of Gastroenterology 2019 Annual Meeting redhillbio.com ↗
The abstract discusses the positive Phase 3 ERADICATE Hp2 study results, concluding that RHB-105 (Talicia) was found to be safe, effective and well-tolerated in H. pylori eradication, and not affected by clarithromycin or metronidazole resistance. |
| 2019-07-03 | RedHill Biopharma Limited | Regulatory RedHill Biopharma Announces FDA Acceptance of New Drug Application for Talicia® redhillbio.com ↗
RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on gastrointestinal diseases, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Talicia® (RHB-105)1 for H. pylori infection. |
| 2019-05-07 | RedHill Biopharma Limited | Regulatory RedHill Biopharma Submits New Drug Application for Talicia® for H. pylori Infection redhillbio.com ↗
The NDA was submitted under the 505(b)(2) regulatory pathway. |
| 2018-12-03 | RedHill Biopharma Limited | Results RedHill Biopharma Announces Positive Top-Line Results from Confirmatory Phase 3 Study with TALICIA® for H. pylori Infection redhillbio.com ↗
The ERADICATE Hp2 study successfully met its primary endpoint with a high degree of statistical significance, demonstrating 84% eradication of H. pylori infection with TALICIA® versus 58% in the active comparator arm in the intent-to-treat (ITT) population (p<0.0001). |
| 2017-05-04 | RedHill Biopharma Limited | Results RedHill Biopharma Announces Poster Presentation of the Positive RHB-105 Phase III Results for H. pylori Infection at Digestive Disease Week 2017 redhillbio.com ↗
The study results demonstrated 89.4% efficacy in eradicating H. pylori infection with RHB-105. |
| 2016-07-18 | Perrigo Company | Regulatory Perrigo Announces FDA Final Approval And Launch Of The Store Brand Equivalent To Zegerid OTC® Capsules perrigo.com ↗
Perrigo Company plc (NYSE: PRGO; TASE) today announced that the U.S. Food and Drug Administration has approved the company's ANDA for omeprazole and sodium bicarbonate capsules, 20mg/1100mg. |
| 2015-08-27 | Lupin Limited | Regulatory Lupin receives FDA Approval for Generic Prilosec® Capsules lupin.com ↗
it has received final approval for its Omeprazole Delayed-Release capsules 40 mg from the United States Food and Drugs Administration (FDA) |
| 2013-02-21 | Tanabe Pharma Corporation | Regulatory Helicobacter pylori Gastritis Approved as Additional Indication in Japan for Helicobacter pylori Eradication by Triple Therapy with Proton Pump Inhibitor tanabe-pharma.com ↗
Helicobacter pylori Gastritis Approved as Additional Indication in Japan for Helicobacter pylori Eradication by Triple Therapy with Proton Pump Inhibitor |
| 2012-10-16 | Perrigo Company | Regulatory Perrigo Confirms FDA Tentative Approval For OTC Version Of Omeprazole And Sodium Bicarbonate Capsules perrigo.com ↗ |
| 2012-08-31 | Tanabe Pharma Corporation | Regulatory Companies Submit Joint Application Seeking Approval for Additional Indication for Helicobacter pylori Eradication by Concomitant Therapy with Proton Pump Inhibitors, Amoxicillin Hydrate and either Clarithromycin or Metronidazole tanabe-pharma.com ↗
Companies Submit Joint Application Seeking Approval for Additional Indication for Helicobacter pylori Eradication by Concomitant Therapy with Proton Pump Inhibitors, Amoxicillin Hydrate and either Clarithromycin or Metronidazole |
| 2012-02-03 | Boehringer Ingelheim | Results Study Finds No Drug-Drug Interaction Between Aggrenox® (aspirin/extended-release dipyridamole) 25mg/200mg Capsules and Omeprazole, a Widely Used PPI prnewswire.com ↗
Boehringer Ingelheim presented results of a drug interaction study that found Aggrenox® (aspirin/extended-release dipyridamole), an antiplatelet medication, is not affected by the co-administration of omeprazole, a proton pump inhibitor (PPI), frequently used to treat several gastrointestinal conditions. |
| 2010-09-24 | Perrigo Company | Regulatory Perrigo Confirms Filing for Omeprazole/Sodium Bicarbonate and Announcement of Patent Infringement Lawsuit by Schering-Plough Healthcare Products perrigo.com ↗
Perrigo Company (Nasdaq: PRGO; TASE) announced that it has filed with the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) for omeprazole 20mg/sodium bicarbonate 1100mg |
| 2010-06-18 | Tanabe Pharma Corporation | Regulatory Approval of Additional Indications for Helicobacter pylori Eradication by Concomitant Therapy with Proton Pump Inhibitors tanabe-pharma.com ↗
they have received approval from the Japanese Ministry of Health, Labor and Welfare for additional indications for Helicobacter pylori (“H. pylori”) eradication by concomitant therapy |
| 2007-12-10 | Perrigo Company | Regulatory Perrigo Announces Final FDA Approval of Dexcel's OTC Omeprazole; Raises Full Year Earnings Guidance perrigo.com ↗
The Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) announced today that the U.S. Food & Drug Administration (FDA) has granted final approval to Dexcel Pharma Technologies, Ltd. for 20 mg Omeprazole delayed-release tablets. |
| 2007-06-20 | Perrigo Company | Regulatory Perrigo Announces Tentative FDA Approval of Dexcel's OTC Omeprazole perrigo.com ↗
The Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) announced today that the U.S. Food & Drug Administration (FDA) has granted tentative approval to Dexcel Pharma Technologies, Ltd. (Dexcel) for its new drug application (NDA) for 20 mg omeprazole delayed- release tablets. |
| 2006-12-18 | Perrigo Company | Regulatory Perrigo Announces Issue of Approvable Letter by FDA for Dexcel's OTC Omeprazole perrigo.com ↗
The Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) announced today that the U. S. Food & Drug Administration (FDA) has issued an approvable letter for Dexcel Pharma Technologies, Ltd.'s New Drug Application (NDA) for 20 mg omeprazole delayed-release tablets. |
| 2006-06-07 | Perrigo Company | Regulatory Perrigo Announces Participation in Dexcel's Filing for Generic Version of Prilosec OTC® perrigo.com ↗
Dexcel Pharma Technologies, Ltd. filed its New Drug Application (NDA) for Omeprazole 20 mg tablets with the U.S. Food & Drug Administration (FDA) and notified AstraZeneca, the NDA holder and patent owner for Prilosec OTC of its filing. |
| 2002-11-11 | Impax Laboratories, LLC | Regulatory IMPAX Receives FDA Approval for Omeprazole, a Generic Version of Prilosec amneal.com ↗
We are pleased with FDA's approval of our Omeprazole ANDA. |
All press releases naming this drug 46 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 504 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | omeprazole | “After successful hemostasis, patients with high-risk PU bleeding (Forrest class Ia/Ib, IIa/IIb) were randomized into 1:1 to receive vonoprazan (20 mg twice a day for 3 days,...” PMID 38582271 ↗ Apr 2024498“We administered the Basel phenotyping cocktail (caffeine, efavirenz, flurbiprofen, omeprazole, metoprolol, midazolam) to patients with liver cirrhosis (n = 16 Child A, n = 15...” PMID 37328712 ↗ Jun 2023 “Nirogacestat 100 mg BID will be administered orally from Day 1 through Day 17 and an oral dose of CYP cocktail (CYP2B6 [bupropion 20 mg], CYP2C8 [repaglinide 0.05 mg], CYP2C9...” NCT07259330 ↗ “Ten healthy Caucasian subjects were orally dosed with the CIME combination (caffeine-CYP1A2, repaglinide-CYP2C8, tolbutamide-CYP2C9, omeprazole-CYP2C19,...” PMID 25465228 ↗ Dec 2014 “Two equally loaded capsules containing: Melatonin (2.0 mg) Nicotine (1.0 mg) Bupropion (37.5 mg) Repaglinide (0.25 mg) Losartan (12.5 mg) Omeprazole (10 mg) Chlorzoxazone...” NCT03563287 ↗ “A CYP probe cocktail composed of approved, commercially available drugs (caffeine, flurbiprofen, omeprazole, and midazolam) will be administered concomitantly as a single-dose...” NCT07426042 ↗ “BACKGROUND: Zegerid (on demand immediate-release omeprazole and sodium bicarbonate combination therapy) has demonstrated earlier absorption and more rapid pH change compared...” PMID 25706883 ↗ Feb 2015 “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 ↗ “Ten volunteers received an oral cocktail capsule containing low doses of the probes bupropion (CYP2B6), flurbiprofen (CYP2C9), omeprazole (CYP2C19), dextromethorphan (CYP2D6),...” PMID 24722393 ↗ Apr 2014 “Group 1: (110) participants received reverse hybrid regimen in the form of clarithromycin 500mg bid, omeprazole 20 mg bid, amoxicillin 1gm bid, and metronidazole 500 mg tid for...” NCT04039412 ↗ “A Phase 1, Open-Label, Randomized, 3-Way Crossover Study to Evaluate the Relative Bioavailability of a Single Oral Dose of Aspirin Administered as PA32540 (Aspirin/Omeprazole)...” NCT00632086 ↗ |
| Known as | ABBOTT | “A capsule of omeprazole ABBOTT® 10mg” NCT02590185 ↗ |
| Known as | Losec | “BACKGROUND: Zegerid (on demand immediate-release omeprazole and sodium bicarbonate combination therapy) has demonstrated earlier absorption and more rapid pH change compared...” PMID 25706883 ↗ Feb 2015 |
| Known as | OME | “Omeprazole (OME) is the most frequently used proton pump inhibitor.” NCT01470690 ↗ |
| Known as | Omeprazole (Prilosec) | “Omeprazole (Prilosec)” NCT02039869 ↗ |
| Known as | omeprazole-magnesium | “Prilosec OTC (omeprazole-magnesium 20.6 mg) tablet to be taken with a glass of water prior to breakfast” NCT00903448 ↗ |
| Known as | OMP | “VECAM is a combination of omeprazole (OMP) and SA.” PMID 22372795 ↗ Feb 20121“Oral Omeprazole (OMP)” NCT02433457 ↗ |
| Known as | Prilosec | “This study is designed to evaluate the potential for an effect of Ritonavir (Norvir®) or omeprazole (Prilosec®) on the pharmacokinetics of samatasvir and to assess the safety...” NCT01813552 ↗7“Prilosec (omeprazole) 40 mg delayed-release capsule is opaque, hard gelatin, apricot, and amethyst colored capsules, coded 743 on cap and PRILOSEC 40 on the body for oral...” NCT02453022 ↗ “This study will attempt to determine the effectiveness of Omeprazole (Prilosec) in the treatment of patients with Zollinger-Ellison Syndrome.” NCT00001191 ↗ “complete a 14-day course of omeprazole (Prilosec®), and then complete a follow-up blood and stool sample.” NCT02844621 ↗ “one EC omeprazole (Prilosec®) 40 mg capsule” NCT01557335 ↗ “Prilosec” NCT02794844 ↗ |
| Known as | Prilosec (Omeprazole) | “Prilosec (Omeprazole)” NCT02153177 ↗ |
| Known as | Prilosec OTC | “Prilosec OTC (omeprazole-magnesium 20.6 mg) tablet to be taken with a glass of water prior to breakfast” NCT00903448 ↗ |
| Action | Inhibit | “the oral gastric acid antisecretory drug, Omeprazole, which functions as a H+ - K+ ATPase inhibitor.” NCT00001191 ↗ |
| Modality | Other / unclassified | “Omeprazole is a proton pump inhibitor” PMID 32594305 ↗ Oct 2020 |
| Route | Oral | “oral Omeprazole” NCT00001191 ↗ |
| Target | CYP2C19 | “CYP2C19 inhibition by omeprazole” NCT01269333 ↗ |