Drugs / Esomeprazole
Esomeprazole
also known as
Nexium · esomeprazole magnesium · HIP1601 · D961H · Esomeprazole magnesium dihydrate · esomeprazole magnesium trihydrate · Esomeprazole sodium · HGP1705 · +12 more
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | NEXIUM IV | — | 2011-04-29 – 2014-03-04 | fda.gov ↗ |
| Approved | EU (EMA) | Nexium Control | — | 2013-08-26 | europa.eu ↗ |
| Label expansions (5) | US (FDA) | NEXIUM | — | 2004-11-24 – 2011-12-15 | fda.gov ↗ |
| Approved | US (FDA) | NEXIUM | — | 2001-02-20 | fda.gov ↗ |
| Filed | EU (EMA) | NEXIUM | — | — | “A Marketing Authorisation Application for OTC NEXIUM in a 20mg tablet form was filed with the European Medicines Agency in June 2012.” astrazeneca.com ↗ |
Trials 267 · started per year
today
US approved 2001
EU approved 2013
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 169 trials · 2 met primary | ||||||
| Phase 1 | NCT07294846 | Sep → Dec 2025 | — | Jiangsu Sinorda Biomedicine Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT07018635 | Jul → Sep 2025 | — | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT06793943 | Jan → Mar 2025 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT06733675 | Jan 2025 → Dec 2026 expected | — | Basilea Pharmaceutica | Recruiting | No outcome recorded |
| Phase 1 | NCT06717269 | Nov 2024 → Apr 2026 overdue | — | Nurix Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT06233149 | Oct → Nov 2024 | — | Bio-innova Co., Ltd | Unknown | No outcome recorded |
| Phase 1 | NCT06233097 | Aug → Sep 2024 | — | Bio-innova Co., Ltd | Unknown | No outcome recorded |
| Phase 1 | NCT06419660 | May → Jul 2024 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT06366243 | May → Jun 2024 | — | Cerevel Therapeutics, LLC | Completed | No outcome recorded |
| Phase 1 | NCT06378658 | Mar → Jun 2024 | non-small cell lung carcinoma | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT06213818 | Mar 2024 → Aug 2025 | — | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT06275841 | Feb → May 2024 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT06193811 | Jan → Mar 2024 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT06164834 | Dec 2023 → Nov 2024 | — | HK inno.N Corporation | Unknown | No outcome recorded |
| Phase 1 | NCT05845645 | May 2023 → Apr 2024 | — | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 1 | NCT05826574 | May → Jul 2023 | — | Insmed Incorporated | Completed | No outcome recorded |
| Phase 1 | NCT05232994 | Mar 2023 → Dec 2024 | severe pre-eclampsia | Christiana Care Health Services | Unknown | No outcome recorded |
| Phase 1 | NCT05688124 | Feb → Oct 2023 | — | Innovent Biologics (Suzhou) Co. Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05586568 | Nov 2022 → Apr 2023 | — | Xuanzhu Biopharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT05467475 | Oct 2022 → Jan 2023 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT05061563 | Sep → Dec 2021 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT04942652 | Jul → Aug 2021 | achlorhydria | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 1 | NCT04568772 | Nov 2020 → Jul 2021 | gastroesophageal reflux disease | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 1 | NCT05513625 | Jul → Oct 2020 | herpes simplex infectious disease | AiCuris Anti-infective Cures AG | Completed | No outcome recorded |
| Phase 1 | NCT04468815 | Jul → Oct 2020 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT04324905 | Apr → Oct 2020 | — | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 1 | NCT04204629 | Jan → Feb 2020 | — | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 1 | NCT04156646 | Nov → Dec 2019 | autism spectrum disorder | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT04142762 | Oct 2019 → Jan 2020 | chronic hepatitis B virus infection | Assembly Biosciences | Completed | No outcome recorded |
| Phase 1 | NCT04138836 | Sep → Nov 2019 | — | Bridge Biotherapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03978143 | Jun → Oct 2019 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03980756 | Jun 2019 → Apr 2020 | gastritis | Addpharma Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03882112 | Apr → Aug 2019 | — | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 1 | NCT03708211 | Mar → Dec 2019 | neoplasm | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03849690 | Feb → Apr 2019 | — | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03814642 | Jan → Jul 2019 | — | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 1 | NCT03372850 | Feb → Jun 2018 | — | Hanmi Pharmaceutical Company Limited | Unknown | No outcome recorded |
| Phase 1 | NCT03383042 | Dec 2017 → Nov 2018 | active peptic ulcer disease | Jeil Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03558477 | Sep 2017 → Feb 2018 | gastroesophageal reflux disease | Yooyoung Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03137134 | Jun → Sep 2017 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03127046 | Mar → Apr 2017 | — | Dong Wha Pharmaceutical Co. Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT02361619 | Feb 2015 → Sep 2016 | — | Turku University Hospital | Completed | No outcome recorded |
| Phase 1 | NCT02128893 | Jan → Feb 2014 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02023125 | Dec 2013 → Mar 2014 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01964131 | Oct → Dec 2013 | duodenal ulcer, gastric ulcer, peptic esophagitis | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01844583 | Jun 2013 → Aug 2014 | cancer, lymphoma | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01549574 | May 2012 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01358383 | May → Jun 2011 | juvenile idiopathic arthritis | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01210339 | Nov 2010 → Aug 2011 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01163630 | Jun → Sep 2010 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01147588 | May 2010 → May 2011 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01135472 | Mar 2010 → Apr 2012 | — | City of Hope Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT01094483 | Mar → May 2010 | platelet aggregation, spontaneous | AstraZeneca | Completed | Met primary |
| Phase 1 | NCT00942175 | Dec 2009 → Jun 2010 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT00992381 | Sep → Oct 2009 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00963027 | Sep → Oct 2009 | pulmonary arterial hypertension | United Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT00849329 | Mar → Nov 2009 | breast neoplasm | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00692055 | Jun → Jul 2008 | arthritic joint disease | POZEN | Completed | No outcome recorded |
| Phase 1 | NCT00676442 | May → Jun 2008 | arthritic joint disease | POZEN | Completed | No outcome recorded |
| Phase 1 | NCT00688428 | Apr 2008 | dyspepsia, ulcer disease | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00676117 | Apr → Jul 2008 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00665743 | Mar → Jun 2008 | arthritic joint disease | POZEN | Completed | No outcome recorded |
| Phase 1 | NCT00684190 | Mar → Jun 2008 | gastroesophageal reflux disease | AstraZeneca | Completed | Met primary |
| Phase 1 | NCT00599404 | Jan → Feb 2008 | — | POZEN | Completed | No outcome recorded |
| Phase 1 | NCT02141698 | Oct 2007 → Feb 2008 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT00474019 | Oct 2007 → Oct 2009 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00687245 | Aug 2006 → May 2008 | gastroesophageal reflux disease | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00216788 | Jan 2006 | Barrett esophagus, esophagitis, gastroesophageal reflux disease | Main Line Health | Unknown | No outcome recorded |
| Phase 1 | NCT01820143 | Feb → Apr 2005 | — | Il-Yang Pharm. Co., Ltd. | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT06302049 | Jun 2024 → May 2025 | metabolic dysfunction-associated steatohepatitis | Sadat City University | Unknown | No outcome recorded |
| Phase 1/2 | NCT05269160 | Apr → Jun 2023 | breast cancer, radiodermatitis | Baylor College of Medicine | Terminated | No outcome recorded |
| Phase 1/2 | NCT02473640 | Jun 2015 → Apr 2016 | — | Theriva Biologics, Inc. | Completed | No outcome recorded |
| Phase 29 trials · 1 met primary · 2 missed | ||||||
| Phase 2 | NCT06120803 | Mar 2024 → Dec 2027 expected | non-small cell lung carcinoma, radiation-induced disorder | Rush University Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT03488147 | Jul 2020 | arthropathy, gastroesophageal reflux disease | Icahn School of Medicine at Mount Sinai | Withdrawn | No outcome recorded |
| Phase 2 | NCT03866668 | May 2019 → Dec 2028 expected | autism | Stanford University | Recruiting | No outcome recorded |
| Phase 2 | NCT02743949 | Jul 2016 → Oct 2018 | gastroesophageal reflux disease | Takeda | Completed | Missed primary |
| Phase 2 | NCT01069081 | Aug 2009 → Feb 2012 | breast cancer, metastatic neoplasm | Fudan University | Completed | Met primary |
| Phase 2 | NCT00723502 | Sep 2008 → Apr 2009 | Helicobacter pylori infectious disease, dyspepsia | MerLion Pharmaceuticals GmbH | Completed | No outcome recorded |
| Phase 2 | NCT00405119 | May 2006 → Mar 2007 | gastroesophageal reflux disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00317044 | Apr 2006 → Jul 2008 | asthma, gastroesophageal reflux disease | AstraZeneca | Completed | Missed primary |
| Phase 2 | NCT00628953 | Oct 2002 → Apr 2004 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 2/34 trials · 1 met primary | ||||||
| Phase 2/3 | NCT05297695 | Apr 2022 → Oct 2023 | Helicobacter pylori infectious disease, generalized epilepsy | Sohag University | Completed | Met primary |
| Phase 2/3 | NCT05861687 | Aug → Dec 2021 | Helicobacter pylori infectious disease | Finni Kollins | Completed | No outcome recorded |
| Phase 2/3 | NCT03213639 | Mar 2018 → Jul 2020 | preeclampsia | Assiut University | Completed | No outcome recorded |
| Phase 2/3 | NCT01089959 | Mar 2010 → Mar 2012 | gastroesophageal reflux disease | Southern Arizona VA Health Care System | Unknown | No outcome recorded |
| Phase 361 trials · 17 met primary · 7 missed | ||||||
| Phase 3 | NCT06811207 | Feb 2025 | Helicobacter pylori infectious disease | Chang Gung Memorial Hospital | Unknown | Missed primary |
| Phase 3 | NCT06101420 | Jan 2022 → Jun 2023 | — | Ain Shams University | Completed | No outcome recorded |
| Phase 3 | NCT05024721 | Aug 2021 → Mar 2022 | gastritis | Hanmi Pharmaceutical Company Limited | Completed | Met primary |
| Phase 3 | NCT04696783 | Jul → Sep 2021 | gastroesophageal reflux disease | Fifth Affiliated Hospital, Sun Yat-Sen University | Unknown | No outcome recorded |
| Phase 3 | NCT03452865 | Jan 2020 → Aug 2023 | infectious disease with sepsis | Vita-Salute San Raffaele University | Completed | Missed primary |
| Phase 3 | NCT04325620 | Jun 2019 → Aug 2020 | gastroesophageal reflux disease | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 3 | NCT03967886 | Apr → Dec 2019 | gastroesophageal reflux disease | Yooyoung Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03717740 | Dec 2018 → Nov 2021 | preeclampsia | Aswan University Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT04080726 | Oct 2018 → Dec 2019 | gastroesophageal reflux disease | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 3 | NCT03148366 | Feb 2015 → Dec 2019 | Helicobacter pylori infectious disease | National Taiwan University Hospital | Completed | Missed primary |
| Phase 3 | NCT02157376 | Jul 2014 → Feb 2016 | active peptic ulcer disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT02037477 | Jan → Mar 2014 | — | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT01757275 | Feb 2013 → Dec 2014 | active peptic ulcer disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01669811 | Aug 2012 → May 2014 | peptic esophagitis | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT01370525 | Aug → Oct 2011 | dyspepsia | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT01370538 | Aug → Oct 2011 | dyspepsia | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT01544517 | Jan → May 2011 | Helicobacter pylori infectious disease | University of Campania Luigi Vanvitelli | Completed | No outcome recorded |
| Phase 3 | NCT01069939 | Feb 2010 → Nov 2011 | — | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00665431 | Apr → Dec 2008 | osteoarthritis | POZEN | Completed | Met primary |
| Phase 3 | NCT00664560 | Apr → Dec 2008 | osteoarthritis | POZEN | Completed | Met primary |
| Phase 3 | NCT00567658 | Feb 2008 → Jan 2010 | laryngeal disorder | Vanderbilt University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00634114 | Jan 2008 → May 2009 | esophagitis | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00633932 | Dec 2007 → Dec 2008 | peptic esophagitis | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00595517 | Oct 2007 → Sep 2009 | duodenal ulcer, gastric ulcer, lumbar disk disease, osteoarthritis +1 | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00527787 | Sep 2007 → Oct 2008 | gastric ulcer | POZEN | Completed | Met primary |
| Phase 3 | NCT00594854 | Sep 2007 → Sep 2008 | gastric ulcer | POZEN | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01129011 | Sep 2007 → Sep 2008 | gastric ulcer | POZEN | Completed | Met primary |
| Phase 3 | NCT00542789 | Aug 2007 → Feb 2009 | duodenal ulcer, gastric ulcer, lumbar disk disease, osteoarthritis +1 | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00468559 | Apr 2007 → Jun 2008 | gastroesophageal reflux disease | AstraZeneca | Completed | Missed primary |
| Phase 3 | NCT00527904 | Mar 2007 → Mar 2009 | gastric ulcer | POZEN | Completed | No outcome recorded |
| Phase 3 | NCT00455754 | Feb 2007 → Dec 2009 | lymphocytic gastritis | Technical University Dresden | Unknown | No outcome recorded |
| Phase 3 | NCT00441727 | Feb 2007 → Aug 2008 | duodenal ulcer, gastric ulcer | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00455806 | Jan 2007 → Feb 2008 | Helicobacter pylori infectious disease, chronic gastritis | Technical University Dresden | Unknown | No outcome recorded |
| Phase 3 | NCT00427635 | Oct 2006 → Apr 2009 | gastroesophageal reflux disease | AstraZeneca | Completed | Missed primary |
| Phase 3 | NCT00402259 | Aug 2006 → Oct 2007 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00401752 | Mar 2006 → Nov 2008 | gastric ulcer | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00251979 | Oct 2005 → Dec 2007 | — | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00206440 | Aug 2005 → Feb 2009 | — | Baylor Breast Care Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00243724 | Apr 2005 → Jun 2007 | dyspepsia, gastroesophageal reflux disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00357682 | Mar 2005 → May 2017 | esophageal cancer, precancerous condition | University of Oxford | Completed | Mixed |
| Phase 3 | NCT00994708 | Dec 2004 → ? | reactive airway disease | Tampere University Hospital | Completed | Missed primary |
| Phase 3 | NCT00251966 | May 2004 → Sep 2005 | gastroesophageal reflux disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00251901 | May 2004 → Jul 2005 | gastroesophageal reflux disease, intermediate coronary syndrome | AstraZeneca | Completed | Mixed |
| Phase 3 | NCT00241501 | Feb 2004 → Apr 2005 | gastroesophageal reflux disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00079833 | Nov 2003 → Jul 2005 | Zollinger-Ellison syndrome | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00069823 | Sep 2003 → May 2008 | asthma, obstructive lung disease | Johns Hopkins Bloomberg School of Public Health | Completed | Missed primary |
| Phase 3 | NCT00164840 | May 2003 → Nov 2008 | gastroesophageal reflux disease | Chinese University of Hong Kong | Completed | No outcome recorded |
| Phase 3 | NCT00626535 | Mar 2003 → Feb 2004 | gastroesophageal reflux disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00251914 | Dec 2002 → Jan 2005 | dyspepsia | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00251992 | Dec 2002 → Jan 2005 | dyspepsia | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00365313 | Aug 2002 → Jun 2005 | arthritic joint disease, ulcer disease | Chinese University of Hong Kong | Completed | Met primary |
| Phase 3 | NCT00251927 | Oct 2001 → Apr 2009 | gastroesophageal reflux disease | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT02670642 | Aug 2001 → Nov 2002 | gastroesophageal reflux disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00241553 | Apr 2001 → Feb 2003 | dyspepsia | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00629512 | Mar 2001 → Dec 2002 | active peptic ulcer disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00633672 | Feb 2001 → Oct 2003 | active peptic ulcer disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00241514 | Feb 2001 → Feb 2003 | gastroesophageal reflux disease | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00629928 | Feb 2001 → Mar 2003 | active peptic ulcer disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00633412 | Feb 2001 → Mar 2003 | active peptic ulcer disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00241540 | Jan 2001 → Aug 2002 | gastroesophageal reflux disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00241527 | Dec 2000 → Sep 2002 | digestive system disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 491 trials · 6 met primary · 2 missed | ||||||
| Phase 4 | NCT07624422 | Nov 2026 → Dec 2027 expected | Helicobacter pylori infectious disease, gastritis, peptic ulcer disease | Damascus Hospital | 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 | NCT06283381 | Feb 2024 → Jan 2025 | obesity disorder | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Unknown | No outcome recorded |
| Phase 4 | NCT06065267 | Jan 2024 → Dec 2026 expected | Helicobacter pylori infectious disease | Damascus Hospital | 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 | NCT06088316 | Feb 2023 → Feb 2024 | Helicobacter pylori infectious disease | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Unknown | No outcome recorded |
| Phase 4 | NCT05726734 | Feb 2023 → Feb 2025 | Helicobacter pylori infectious disease | Shanghai East Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05664685 | Oct 2022 → Oct 2023 | Helicobacter pylori infectious disease | Pontificia Universidad Catolica de Chile | Completed | Met primary |
| Phase 4 | NCT06687499 | Aug 2022 → Dec 2023 | Helicobacter pylori infectious disease | National Cheng-Kung University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT06687473 | Jan 2022 → Mar 2023 | Helicobacter pylori infectious disease | National Cheng-Kung University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04918017 | Nov 2021 → Dec 2023 | dyspepsia | University of Malaya | Unknown | Missed primary |
| Phase 4 | NCT06359015 | Feb 2021 → May 2025 | severe pre-eclampsia | Christiana Care Health Services | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT04432233 | Jun 2020 → Apr 2021 | Helicobacter pylori infectious disease | Shanghai Jiao Tong University School of Medicine | Unknown | No outcome recorded |
| Phase 4 | NCT03726099 | Mar 2019 → Apr 2020 | Helicobacter pylori infectious disease | Shandong University | Unknown | No outcome recorded |
| Phase 4 | NCT03928470 | Jan → Dec 2019 | gastroesophageal reflux disease | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 4 | NCT03658733 | Dec 2018 → Aug 2019 | Helicobacter pylori infectious disease | Shandong University | Unknown | No outcome recorded |
| Phase 4 | NCT03708848 | Dec 2018 → Sep 2019 | Helicobacter pylori infectious disease | Shanghai Jiao Tong University School of Medicine | Completed | No outcome recorded |
| Phase 4 | NCT03730766 | Aug → Nov 2018 | Helicobacter pylori infectious disease | Shanghai Jiao Tong University School of Medicine | Unknown | No outcome recorded |
| Phase 4 | NCT03413020 | Jan → Jul 2018 | Helicobacter pylori infectious disease | Shanghai Jiao Tong University School of Medicine | Completed | No outcome recorded |
| Phase 4 | NCT03555526 | Dec 2017 → Sep 2021 | Helicobacter pylori infectious disease | National Taiwan University Hospital | Unknown | Met primary |
| Phase 4 | NCT03208426 | Oct 2017 → Dec 2019 | Helicobacter pylori infectious disease | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT03092193 | Mar → Oct 2017 | Amobarbital, deficient N-hydroxylation of | University of Sao Paulo | Completed | No outcome recorded |
| Phase 4 | NCT02935010 | Feb 2017 → Mar 2018 | Helicobacter pylori infectious disease | Shanghai Jiao Tong University School of Medicine | Completed | No outcome recorded |
| Phase 4 | NCT02933229 | Oct 2016 → Oct 2031 expected | Helicobacter pylori infectious disease, gastric intestinal metaplasia | Shandong University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT03333603 | May 2016 → Jan 2017 | schizophrenia | National Taiwan University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02800330 | May 2016 → Feb 2018 | colorectal neoplasm, gastrointestinal stromal tumor | Erasmus Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT02624544 | Jan 2016 | psoriasis | EMS | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT02708355 | Jan → Apr 2016 | dyspepsia | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT02552641 | Sep 2015 → Feb 2016 | Helicobacter pylori infectious disease | EMS | Withdrawn | No outcome recorded |
| Phase 4 | NCT03156855 | Sep 2015 → Dec 2018 | Helicobacter pylori infectious disease | National Taiwan University Hospital | Unknown | Met primary |
| Phase 4 | NCT02456012 | Apr 2015 → Dec 2020 | peptic ulcer disease | Hsiu-Chi Cheng | Completed | Met primary |
| Phase 4 | NCT02296021 | Nov 2014 → Sep 2015 | dyspepsia, gastritis, peptic ulcer disease | Xijing Hospital of Digestive Diseases | Completed | No outcome recorded |
| Phase 4 | NCT02494856 | Oct 2014 → Dec 2015 | impacted teeth, multiple | Giovana Maria Weckwerth | Completed | No outcome recorded |
| Phase 4 | NCT02134405 | Aug 2014 → Jun 2016 | dyspepsia | University of Malaya | Unknown | No outcome recorded |
| Phase 4 | NCT03128736 | Apr 2014 → Feb 2016 | gastroesophageal reflux disease | Kaohsiung Medical University Chung-Ho Memorial Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02635191 | Mar 2014 → Mar 2016 | Helicobacter pylori infectious disease | Beijing Children's Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02045251 | Jun 2013 → Jul 2016 | — | American University of Beirut Medical Center | Withdrawn | No outcome recorded |
| Phase 4 | NCT02197143 | Mar 2013 → Jul 2014 | dyspepsia | Pamukkale University | Completed | No outcome recorded |
| Phase 4 | NCT02047994 | Mar 2013 → Dec 2033 expected | Helicobacter pylori infectious disease, chronic atrophic gastritis, gastric cancer | International Agency for Research on Cancer | Recruiting | No outcome recorded |
| Phase 4 | NCT02703896 | Jan 2012 | lung disorder | King Saud University | Completed | No outcome recorded |
| Phase 4 | NCT01349413 | Aug 2011 → Dec 2017 | dyspepsia, gastroesophageal reflux disease | Chinese University of Hong Kong | Completed | No outcome recorded |
| Phase 4 | NCT01397084 | Aug 2011 → Jan 2012 | gastroesophageal reflux disease, peptic esophagitis | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT01275937 | Aug 2011 → Dec 2013 | active peptic ulcer disease | Taipei Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT01249651 | Nov 2010 → Jun 2011 | dyspepsia | AstraZeneca | Completed | Met primary |
| Phase 4 | NCT01887249 | May 2010 → Jul 2013 | Helicobacter pylori infectious disease | Seoul National University Bundang Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00951431 | Dec 2009 → Dec 2015 | dyspepsia | Chinese University of Hong Kong | 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 | NCT00641004 | Apr 2008 → Mar 2010 | stomach disorder | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT00660660 | Apr → Jul 2008 | gastroesophageal reflux disease | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00361985 | Jan 2008 → Jan 2011 | morbid obesity | Weill Medical College of Cornell University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00734097 | Nov 2007 → Oct 2008 | gastroesophageal reflux disease | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00526006 | Sep 2007 → Mar 2008 | — | Zealand University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT00656968 | May 2007 → Jun 2010 | Helicobacter pylori infectious disease | Kaohsiung Veterans General Hospital. | Completed | No outcome recorded |
| Phase 4 | NCT00444275 | Mar 2007 → Oct 2008 | gastroesophageal reflux disease | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00443963 | Dec 2006 | dyspepsia | Medstar Health Research Institute | Withdrawn | No outcome recorded |
| Phase 4 | NCT00410592 | Oct 2006 → May 2007 | gastroesophageal reflux disease | AstraZeneca | Completed | Met primary |
| Phase 4 | NCT00428701 | Oct → Nov 2006 | gastric ulcer | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00384592 | Sep 2006 → May 2007 | gastroesophageal reflux disease | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00363701 | Aug 2006 → Feb 2008 | dyspepsia, gastroesophageal reflux disease, ulcer disease | Glostrup University Hospital, Copenhagen | Unknown | No outcome recorded |
| Phase 4 | NCT00343161 | Aug 2006 → Aug 2007 | gastroesophageal reflux disease | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00318968 | May 2006 → Nov 2007 | gastroesophageal reflux disease | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00472550 | Jan → Nov 2006 | dyspepsia, gastroesophageal reflux disease | Heidelberg University | Completed | No outcome recorded |
| Phase 4 | NCT00352261 | Jan 2006 → Apr 2007 | Barrett esophagus | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00272701 | Dec 2005 → Feb 2007 | gastroesophageal reflux disease | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00608712 | Nov 2005 → Aug 2006 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00392002 | Oct 2005 → May 2007 | gastroesophageal reflux disease | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00242736 | Oct 2005 → Jan 2006 | gastroesophageal reflux disease | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00230516 | Sep 2005 → Feb 2006 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00471029 | Sep 2005 → Sep 2007 | peptic ulcer disease | Pamela Youde Nethersole Eastern Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT00291746 | Sep 2005 → Nov 2006 | gastroesophageal reflux disease | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00287339 | Sep 2005 → Sep 2008 | gastroesophageal reflux disease | University of North Carolina, Chapel Hill | Completed | Missed primary |
| Phase 4 | NCT00206024 | Nov 2004 → Jul 2005 | dyspepsia | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00228527 | Oct 2004 → Oct 2005 | esophagitis, gastroesophageal reflux disease | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00206050 | Sep → Dec 2004 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00625274 | Jun → Nov 2004 | dyspepsia, gastroesophageal reflux disease | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00206180 | Jun 2004 → Aug 2005 | gastroesophageal reflux disease, peptic esophagitis | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00225238 | Dec 2003 → Oct 2007 | — | Thomas Jefferson University | Completed | No outcome recorded |
| Phase 4 | NCT00574925 | Nov 2003 → Oct 2007 | gastroesophageal reflux disease | University of Zurich | Completed | No outcome recorded |
| Phase 4 | NCT00628342 | Apr → Aug 2003 | gastroesophageal reflux disease | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00318084 | Jan 2003 → ? | gastroesophageal reflux disease | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00644735 | Dec 2002 → Jan 2004 | esophagitis | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00641602 | Dec 2002 → Aug 2003 | esophagitis | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00625495 | Sep → Nov 2002 | gastroesophageal reflux disease | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00635414 | Aug → Oct 2002 | gastroesophageal reflux disease | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00626262 | Jul → Oct 2002 | gastroesophageal reflux disease | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00637845 | Jun 2002 → Feb 2003 | dyspepsia, gastroesophageal reflux disease | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00637988 | Apr 2002 → Jun 2003 | Barrett esophagus | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00637559 | Mar 2002 → Apr 2003 | Barrett esophagus | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00628667 | Feb 2002 → Mar 2003 | chronic laryngitis | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00881413 | — | peptic ulcer disease | Lotung Poh-Ai Hospital | Withdrawn | No outcome recorded Stop: Business |
| Phase not applicable30 trials · 4 missed | ||||||
| — | NCT06943794 | Mar 2026 → May 2030 expected | gastric cancer | Fudan University | Not yet recruiting | No outcome recorded |
| — | NCT06953986 | Dec 2025 → Nov 2026 expected | gastroesophageal reflux disease | Asian Institute of Gastroenterology, India | Recruiting | No outcome recorded |
| — | NCT07563491 | Jan → Sep 2025 | gastroesophageal reflux disease | Muhammad Aamir Latif | Completed | No outcome recorded |
| — | NCT06250634 | Feb → May 2024 | Helicobacter pylori infectious disease | The Third Xiangya Hospital of Central South University | Completed | No outcome recorded |
| — | NCT05549115 | Sep 2022 → Feb 2024 | Helicobacter pylori infectious disease | Liaocheng People's Hospital | Unknown | Missed primary |
| — | NCT04991584 | Aug 2021 → Jun 2022 | Helicobacter pylori infectious disease | Shandong University | Unknown | No outcome recorded |
| — | NCT05097846 | Jun 2021 → Jun 2022 | Helicobacter pylori infectious disease | wang xiaoyan | Unknown | No outcome recorded |
| — | NCT07855497 | Feb 2021 → Sep 2026 overdue | Helicobacter pylori infectious disease | Seoul National University Bundang Hospital | Active not recruiting | No outcome recorded |
| — | NCT05176821 | Jan 2021 → Dec 2022 | Helicobacter pylori infectious disease | Shanghai Zhongshan Hospital | Unknown | No outcome recorded |
| — | NCT03717701 | Dec 2018 → Nov 2020 | preeclampsia | Aswan University Hospital | Unknown | No outcome recorded |
| — | NCT04003350 | Dec 2017 → Nov 2018 | osteoarthritis, knee | Rothman Institute Orthopaedics | Completed | Missed primary |
| — | NCT02730533 | Mar 2016 → Mar 2017 | gastric neoplasm | Xijing Hospital of Digestive Diseases | Completed | No outcome recorded |
| — | NCT02689583 | Mar 2016 → Mar 2017 | gastric ulcer, gastritis | First Affiliated Hospital of Zhejiang University | Unknown | No outcome recorded |
| — | NCT02788591 | Aug 2015 → Jun 2021 | gastroesophageal reflux disease | LCMC Health | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT02359604 | Oct 2014 → Feb 2017 | gastroesophageal reflux disease | Medical University of Graz | Completed | No outcome recorded |
| — | NCT02884713 | Jun 2013 → Apr 2014 | gastritis | King Faisal Specialist Hospital & Research Center | Completed | No outcome recorded |
| — | NCT01854970 | May 2013 → Jul 2015 | gastroesophageal reflux disease | University Hospital, Bordeaux | Completed | Missed primary |
| — | NCT02112812 | Dec 2012 → Mar 2013 | — | National University of Malaysia | Completed | No outcome recorded |
| — | NCT04329000 | Feb 2010 → Feb 2019 | Barrett esophagus, gastroesophageal reflux disease | Kaohsiung Veterans General Hospital. | Completed | No outcome recorded |
| — | NCT01139645 | Oct 2009 → Jul 2010 | calcium metabolic disease | American University of Beirut Medical Center | Completed | No outcome recorded |
| — | NCT01079884 | Jul 2008 → Mar 2011 | gastroesophageal reflux disease | David A. Johnson, MD | Completed | No outcome recorded |
| — | NCT00604942 | Nov 2007 → Oct 2010 | achalasia, gastroesophageal reflux disease | Guy's and St Thomas' NHS Foundation Trust | Terminated | No outcome recorded |
| — | NCT01547559 | Jun 2007 → Nov 2014 | drug allergy | Sun Yat-sen University | Unknown | No outcome recorded |
| — | NCT00520949 | Oct 2006 → Jun 2008 | — | Aga Khan University | Completed | No outcome recorded |
| — | NCT00546065 | Aug 2006 → Sep 2010 | Barrett esophagus | HSK Wiesbaden | Terminated | No outcome recorded |
| — | NCT00786695 | May 2006 → Dec 2009 | gastroesophageal reflux disease | National University Hospital, Singapore | Completed | No outcome recorded |
| — | NCT00745849 | Jun 2005 → Mar 2008 | vasomotor rhinitis | University of Texas Southwestern Medical Center | Completed | Missed primary |
| — | NCT00222079 | Nov 2004 → Oct 2007 | gastroesophageal reflux disease | Douglas Trask | Terminated | No outcome recorded |
| — | NCT00162877 | Jun 2004 → Apr 2005 | active peptic ulcer disease, gastritis | National Taiwan University Hospital | Unknown | No outcome recorded |
| — | NCT00516971 | Jan 2003 → Dec 2008 | gastroesophageal reflux disease | Hospital Authority, Hong Kong | Unknown | No outcome recorded |
| Comparator or background therapy196 trials | ||||||
| Phase 0 | NCT05100446 Comparator | May → Dec 2021 | Helicobacter pylori infectious disease, gastric cancer, gastritis | Unidade Local de Saúde do Alto Ave, EPE | Unknown | No outcome recorded |
| Phase 1 | NCT06561542 Comparator | Aug 2024 → Nov 2025 overdue | — | Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT05586464 Comparator | Nov 2022 → Sep 2024 | Helicobacter pylori infectious disease | Liaocheng People's Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT06181084 Background | Oct 2021 → Apr 2022 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05051566 Background | Sep 2021 → Apr 2022 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Show all 196 trials opens the full record — a long page | ||||||
News releases announcing trial results or a regulatory action · 34
| Date | Issuer | Release |
|---|---|---|
| 2026-03-24 | Hanmi Pharmaceutical Company Limited | Regulatory 한미 NSAIDs+PPI 복합제 ‘낙소졸’ , 국내 최초 요통 적응증 획득 hanmi.co.kr ↗
한미약품의 진통·소염 복합제 낙소졸(Naproxen/Esomeprazole)이 식품의약품안전처(이하, 식약처)로부터 요통 치료에 대한 적응증을 추가 승인받았다. |
| 2024-09-11 | Hanmi Pharmaceutical Company Limited | Results 한미약품 “라본디-낙소졸, 근골격계 질환 치료 임상적 유효성 확인” hanmi.co.kr ↗
낙소졸은 한국인을 대상으로 진행한 2건의 임상시험을 통해 우수한 효과와 안전성을 확인했다. |
| 2024-08-21 | Jeil Pharmaceutical Co., Ltd. | Results 37호 신약 자큐보정 임상 3상 논문 미국소화기학 학술지 게재 jeilpharm.co.kr ↗
8주 투여 후 자스타프라잔은 97.9%의 높은 치료율로 대조군의 94.9% 대비 우수한 효능을 확인하였다. |
| 2024-06-12 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark receives ANDA approval for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg (OTC) glenmarkpharma.com ↗
Glenmark Specialty SA (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg (OTC), determined by the FDA to be bioequivalent1 to Nexium®2 24 HR Delayed-Release Capsules, 20 mg (OTC), of Haleon U.S. Holdings LLC. |
| 2024-05-27 | HK inno.N Corporation | Results HK inno.N presents newest research findings of its new drug “K-CAB” at the DDW 2024 inno-n.com ↗
The results of these two studies were unveiled for the first time through poster presentations in this DDW conference. |
| 2023-06-08 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg and 40 mg zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) for Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg and 40 mg (USRLD: Nexium Delayed-Release for Oral Suspension, 20 mg and 40 mg). |
| 2023-05-17 | HK inno.N Corporation | Results HK inno.N presents latest research results of K-CAB to gastroenterologists worldwide inno-n.com ↗
As a result, K-CAB proved non-interiority in the healing of iatrogenic ulcer compared to esomeprazole, a PPI and showed a higher healing rate (30.3% vs 22.1%)at the 4-week mark. |
| 2019-05-23 | Zydus Lifesciences Limited | Regulatory Zydus receives Final approval from the USFDA for Esomeprazole Magnesium Delayed-Release Capsules USP zyduslife.com ↗
Zydus Cadila has received the final approval from the USFDA to market Esomeprazole Magnesium Delayed-Release Capsules USP (US RLD – NEXIUM), 25 mg and 40 mg. |
| 2019-05-14 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Pharmaceuticals receives ANDA approval for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg and 40 mg glenmarkpharma.com ↗ |
| 2019-01-21 | Zydus Lifesciences Limited | Regulatory Zydus Receives Tentative Approval from the USFDA for Esomeprazole Magnesium Delayed-Release Capsules USP zyduslife.com ↗
Zydus Cadila has received the tentative approval from the USFDA to market Esomeprazole Magnesium Delayed-Release Capsules (US RLD – NEXIUM). |
| 2018-12-17 | Hanmi Pharmaceutical Company Limited | Results <보도자료> 한미약품, 진통소염 복합신약 ‘낙소졸’ 5주년 심포지엄 진행 hanmi.co.kr ↗
특히 한 교수는 낙소졸 발매 후 한국인 대상으로 진행된 관찰연구와 중재연구 결과를 바탕으로 ‘낙소졸 변경 투여 후 관절염 환자들의 삶의 질 향상’과 ‘Celecoxib 대비 동등한 통증효과 및 동등 이상의 위장보호 예방효과’에 대해 각각 소개해 눈길을 끌었다. |
| 2018-01-19 | Daiichi Sankyo | Regulatory Nexium® 10 mg and 20 mg Capsules received additional approval of paediatric dosage and administration, and marketing approval of Nexium® 10 mg and 20 mg Granules for Suspension, Sachet in Japan daiichisankyo.com ↗
Nexium® 10 mg and 20 mg Capsules received additional approval of paediatric dosage and administration, and marketing approval of Nexium® 10 mg and 20 mg Granules for Suspension, Sachet in Japan |
| 2017-09-05 | Lannett Company, Inc. | Regulatory Lannett Receives Approval For Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg And 40 mg investorroom.com ↗
This approval, our seventh thus far in 2017, comes from our wholly owned subsidiary, Kremers Urban Pharmaceuticals. |
| 2017-08-21 | Perrigo Company | Regulatory Perrigo Announces Final FDA Approval And Settlement For The Store Brand OTC Equivalent Of Nexium® 24HR Capsules perrigo.com ↗
Perrigo Company plc (NYSE; TASE: PRGO) today announced that it has received final approval from the U.S. Food & Drug Administration for the store brand OTC equivalent of Nexium ® 24HR (esomeprazole magnesium) capsules. |
| 2017-07-25 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Announces AXS-06 (MoSEIC™ Meloxicam and Esomeprazole) Meets Primary Endpoint in Phase 1 Clinical Trial gcs-web.com ↗
Gastroprotective concentrations of esomeprazole achieved |
| 2015-01-26 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Receives FDA Approval for First Generic Nexium® Delayed-Release Capsules in the United States tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) announces the Food and Drug Administration (FDA) approval of the first generic equivalent to Nexium (esomeprazole magnesium) Delayed-Release Capsules in the United States. |
| 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 |
| 2013-02-21 | Kyowa Kirin, Inc. | Regulatory Pasetocin® and Sawacillin®: Approval for Additional Indication for Helicobacter pylori Eradication by Triple Therapy with Proton Pump Inhibitors and either Clarithromycin or Metronidazole kyowakirin.com ↗
has been approved by Japan's Ministry of Health, Labour and Welfare. |
| 2013-02-21 | Eisai Inc. | Regulatory Helicobacter pylori Gastritis Approved as Additional Indication in Japan for Helicobacter pylori Eradication by Triple Therapy with Proton Pump Inhibitor eisai.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 |
| 2012-08-31 | Eisai Inc. | 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 eisai.com ↗
they have submitted a joint application * to Japan’s Ministry of Health, Labour and Welfare seeking approval of Helicobacter pylori (“ H. pylori ”) gastritis as an additional indication |
| 2012-06-22 | Daiichi Sankyo | Regulatory NEXIUM receives approval in Japan for prevention of recurrence of gastric ulcer and duodenal ulcer in patients treated with aspirin at low doses daiichisankyo.com ↗
NEXIUM receives approval in Japan for prevention of recurrence of gastric ulcer and duodenal ulcer in patients treated with aspirin at low doses |
| 2011-10-24 | Daiichi Sankyo | Regulatory Application Submitted in Japan for Additional Indication for NEXIUM® 10mg and 20mg Capsules daiichisankyo.com ↗
Application Submitted in Japan for Additional Indication for NEXIUM® 10mg and 20mg Capsules |
| 2011-08-02 | AstraZeneca | Regulatory Positive agreement received for approval of AXANUM (low-dose ASA/esomeprazole) in Europe astrazeneca.com ↗
Tuesday, 2 August 2011 AstraZeneca today announced that AXANUM, a fixed dose combination of 81 mg low-dose ASA (acetylsalicylic acid) and 20 mg esomeprazole, has received positive agreement for approval in 23 European Union member countries and in Norway. |
| 2011-07-01 | Daiichi Sankyo | Regulatory NEXIUM receives first regulatory approval in Japan for the treatment of acid-related disease daiichisankyo.com ↗
Daiichi Sankyo Co., Ltd. (hereafter, Daiichi Sankyo) and AstraZeneca KK today announced that AstraZeneca has received approval from the Japanese Ministry of Health, Labour and Welfare for the manufacture and marketing of the proton pump inhibitor, NEXIUM® Capsule (esomeprazole magnesium) 10mg and NEXIUM® Capsule 20mg. |
| 2011-07-01 | AstraZeneca | Regulatory AstraZeneca's NEXIUM receives first regulatory approval in Japan for the treatment of acid-related diseases astrazeneca.com ↗
AstraZeneca today announced that NEXIUM (esomeprazole magnesium) 10 mg and 20 mg capsules have received regulatory approval in Japan for the treatment of acid-related conditions including non-erosive reflux disease (NERD), reflux esophagitis, and peptic ulcer disease (PUD). |
| 2010-10-11 | AstraZeneca | Regulatory Positive agreement received for approval of VIMOVO in Europe astrazeneca.com ↗
Monday, 11 October 2010 AstraZeneca and POZEN Inc. today announced that VIMOVO (naproxen/ esomeprazole magnesium) 500/20 mg modified-release tablets has cleared an important regulatory milestone by receiving positive agreement for approval in 23 countries across the European Union (EU). |
| 2010-06-04 | AstraZeneca | Regulatory AstraZeneca Submits Marketing Authorisation Application To European Union For Cardiovascular Drug Axanum astrazeneca.com ↗ |
| 2010-06-01 | AstraZeneca | Regulatory AstraZeneca Receives FDA Complete Response Letter for AXANUM New Drug Application astrazeneca.com ↗
The company also received a CRL for the supplemental new drug application (sNDA) for NEXIUM (esomeprazole magnesium). |
| 2010-04-30 | AstraZeneca | Regulatory FDA approved VIMOVO for arthritis patients at risk of developing NSAID-associated gastric ulcers astrazeneca.com ↗
AstraZeneca and POZEN Inc. today announced the US Food and Drug Administration (FDA) has approved VIMOVO (naproxen and esomeprazole magnesium) delayed-release tablets for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers. |
| 2009-10-19 | AstraZeneca | Results Patients Taking VIMOVO(TM) Showed Decrease in incidence of NSAID Associated Ulcers astrazeneca.com ↗
Data from study PN400-301 showed a 4.1% incidence of GU in patients taking VIMOVO, compared to 23.1% among patients taking EC naproxen (p<0.001). |
| 2009-10-16 | AstraZeneca | Regulatory AstraZeneca Submits Marketing Authorisation Application to European Union for VIMOVO™ astrazeneca.com ↗
today announced that they have submitted a Marketing Authorisation Application (MAA) in the European Union via the Decentralised Procedure (DCP) for VIMOVO™ |
| 2009-08-31 | AstraZeneca | Regulatory AstraZeneca Announces FDA Acceptance of New Drug Application for VIMOVO astrazeneca.com ↗
the FDA’s notification of acceptance of the NDA filing for VIMOVO prompts a $10 million milestone payment from AstraZeneca to POZEN. |
| 2005-04-29 | Vertex Pharmaceuticals Incorporated | Results New Pharmacokinetic Data On Taking Lexiva Simultaneously With Nexium vrtx.com ↗
When these agents were simultaneously co-administered there was no effect on amprenavir steady-state plasma levels. |
All press releases naming this drug 52 releases
Evidence & citations 24 cited values
Every value below carries the sentence it was read from. 467 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | esomeprazole | “Participants with positive results for infection received a standard 7-day triple therapy (esomeprazole 40 mg once daily, amoxicillin 1 g twice daily, and clarithromycin 500 mg...” PMID 16961802 ↗ Oct 2006454“A is amoxicillin (1000 mg thrice daily), B is colloidal bismuth subcitrate (120 mg thrice daily), M is metronidazole (500 mg thrice daily), P is a proton pump inhibitor, i.e.,...” NCT06687473 ↗ “This is a multicenter, randomized, double blind, double-simulated, parallel control of positive drug phase III clinical study to evaluate the efficacy and safety of Anaprazole...” NCT07606833 ↗ “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 ↗ “Treatment for H. pylori Patients with positive Urea Breath Test (positive for H. pylori infection) will be started on eradication therapy of H. pylori (oral esomeprazole 40mg...” NCT02112812 ↗ “An Open-label, Randomized, Single-center, 2-way Cross-over Interaction Study, Evaluating the Effect of Esomeprazole 20 mg/Acetylsalicylic Acid 81 mg on the Pharmacodynamics and...” NCT01210339 ↗ “Fourteen-day esomeprazole, tripotassium dicitrate bismuthate, metronidazole and tetracycline (EBMT) therapy or esomeprazole, moxifloxacin and amoxicillin (MEA) therapy was...” PMID 26452405 ↗ Oct 2015 “All participants were taking a standard dose QD PPI (dexlansoprazole, esomeprazole, esomeprazole magnesium, lansoprazole, omeprazole, pantoprazole, pantoprazole sodium...” NCT02637557 ↗ “including a proton pump inhibitor (Esomeprazole 20 mg), Bismuth Potassium Citrate 220 mg, and two antibiotics selected based on susceptibility testing (e.g., Amoxicillin,...” NCT06760065 ↗ “A Phase III, Randomized, Open-label, Superiority Study Comparing the Incremental Product Esomeprazole Associated With Sodium Bicarbonate Made by Eurofarma and Nexium® in the...” NCT01471925 ↗ “Study participants will receive fixed dose of esomeprazole administered orally in a pre-specified sequence during the Treatment Period of Part A. This is a non-investigational...” NCT05845645 ↗ |
| Known as | D961H | “This is a phase 3 multicentre, randomised, double-blind, parallel-group, comparative study to evaluate the efficacy of esomeprazole (D961H) 20 mg twice daily and esomeprazole...” NCT01669811 ↗3“The purpose of this study is to assess the efficacy of esomeprazole (D961H) 20 mg versus placebo once daily for up to 24 weeks of treatment” NCT00542789 ↗ “Drug-Drug Interaction Study of Esomeprazole (D961H) Capsule and Loxoprofen Tablet After Repeated Oral Administration in Japanese Males” NCT00676117 ↗ “Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer” NCT00595517 ↗ |
| Known as | Dermaprazole | “prophylactic esomeprazole cream (termed "Dermaprazole")” NCT05269160 ↗ |
| Known as | Emanera | “Esomeprazole ('Emanera') 40 mg bid for 14 days” NCT03572777 ↗ |
| Known as | EPZ | “esomeprazole (EPZ) + bismuth + doxycycline + furazolidone” PMID 37214450 ↗ May 2023 |
| Known as | ESO | “To investigate the effect of esomeprazole (ESO) on the pharmacokinetics of pritelivir (PTV), and to investigate the safety and tolerability of PTV.” NCT05513625 ↗ |
| Known as | ESOM | “Arm B, the same chemotherapy preceded by three days esomeprazole (ESOM) 80 mg p.o. bid, beginning on d1 repeated weekly.” PMID 26297142 ↗ Aug 2015 |
| Known as | esomeprazole magnesium | “All participants were taking a standard dose QD PPI (dexlansoprazole, esomeprazole, esomeprazole magnesium, lansoprazole, omeprazole, pantoprazole, pantoprazole sodium...” NCT02637557 ↗9“The purpose of this study is to decide if controlling stomach acid is related to healing of erosive esophagitis after treatment with esomeprazole magnesium (NEXIUM®) 10 mg and...” NCT00206180 ↗ “esomeprazole magnesium 20 mg bid +colloidal bismuth pectin 200mg bid + amoxicillin 1000 mg bid + furazolidone 100 mg bid, for 14 days.” NCT06823791 ↗ “fixed-dose combination of enteric-coated naproxen 500 mg and immediate-release esomeprazole magnesium 20 mg” PMID 21524238 ↗ Apr 2011 “esomeprazole magnesium enteric-coated tablets” NCT04034641 ↗ “Esomeprazole magnesium (Nexium)” NCT00206024 ↗ “Esomeprazole magnesium (Nexium)” NCT00079833 ↗ “Nexium (esomeprazole magnesium)” NCT01142128 ↗ “Drug: esomeprazole magnesium” NCT00687245 ↗ |
| Known as | Esomeprazole magnesium dihydrate | “Where treatment 1= Esomeprazole magnesium dihydrate 40 mg tablets test product, treatment 2= Esomeprazole magnesium dihydrate 40 mg tablets reference product.” NCT06233097 ↗1“Esomeprazole magnesium dihydrate 40 mg tablets Manufactured by: Cipla Limited, India” NCT06233149 ↗ |
| Known as | esomeprazole magnesium trihydrate | “The medication, esomeprazole magnesium trihydrate (40 mg), should be administered once a day (before breakfast) and the capsules should be taken on an empty stomach (orally)...” NCT01471925 ↗1“Pellets contains esomeprazole 20 mg (esomeprazole magnesium trihydrate 22.3 mg) and excipient granules filled into single-use aluminium sachets” NCT01964131 ↗ |
| Known as | Esomeprazole Mepha | “40 mg Esomeprazole Mepha (Mepha Ltd., Switzerland)” NCT00889850 ↗ |
| Known as | Esomeprazole sodium | “Nexium I.V. (Esomeprazole Sodium) 40mg BID for up to 72 Hours” NCT00428701 ↗1“Esomeprazole sodium for injection” NCT06783257 ↗ |
| Known as | esomprazole | “amoxicillin 1000 mg bid ,esomprazole 20 bid for one week then levofloxacine 500 mg q.d, metraonidazoel 500 500 bid, and esomprazole 20 bid for one week” NCT06065267 ↗ |
| Known as | Esso | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00520949 ↗ |
| Known as | Hanxium | “Esomeprazole(Hanxium®) 40 mg once daily and mosapride (Gasmotin®) 5 mg t.i.d for 4 weeks.” NCT02984930 ↗ |
| Known as | HGP1705 | “This study aimed to compare the efficacy and safety of HIP1601 (dual delayed-release esomeprazole) and HGP1705 (delayed-release esomeprazole) in patients with erosive esophagitis (EE).” PMID 38110901 ↗ Dec 2023 |
| Known as | HIP1601 | “This study aimed to compare the efficacy and safety of HIP1601 (dual delayed-release esomeprazole) and HGP1705 (delayed-release esomeprazole) in patients with erosive esophagitis (EE).” PMID 38110901 ↗ Dec 2023 |
| Known as | HIP2101 | “the dual delayed-release formulation of 10-mg esomeprazole (HIP2101) are currently limited” PMID 39949051 ↗ Feb 2025 |
| Known as | Nexium | “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 ↗31“The purpose of this study is to evaluate whether there is a difference in proportion of patients with resolution of heartburn and other symptoms related to gastroesophageal...” NCT00242736 ↗ “The purpose of this study is to decide if controlling stomach acid is related to healing of erosive esophagitis after treatment with esomeprazole magnesium (NEXIUM®) 10 mg and...” NCT00206180 ↗ “One 40-mg esomeprazole tablet (AstraZeneca, Nexium) together with three 5-mg placebo tablets of ilaprazole in a package being taken orally each morning on an empty stomach for 8 weeks” NCT01107938 ↗ “Subjects to compare the single dose bioavailability of Torrent's Esomeprazole Mg DR Capsule 1×40 mg and Nexium 40 mg DR Capsule containing Esomeprazole 40 mg of AastraZeneca LP, USA.” NCT02680119 ↗ “After omeprazole infusion, oral esomeprazole (Nexium®, AstraZeneca, Sweden) 40 mg per day was given in the normal albumin group and the intervention group until the end of follow-up.” NCT01822600 ↗ “Nexium® (Esomeprazole) gastro-resistant granules for oral suspension 10 or 20 mg taken once daily for 8 weeks, and then 10 or 5 mg taken once daily for 16 weeks.” NCT05267613 ↗ “The purpose of this research study is to measure the effects of the drug, esomeprazole 40 mg (Nexium) or placebo (inactive drug) on vocal cord granulomas.” NCT00567658 ↗ “The purpose of this study is to compare the efficacy of Nexium® with placebo in relief of acid related pain or discomfort in the chest.” NCT00251901 ↗ “Development of an Algorithm for Identification of Responders to Short Term Treatment With Esomeprazole (Nexium) in Primary Care” NCT00318968 ↗ “Study to Assess Management Strategies for the Use of Esomeprazole (Nexium) in Helicobacter Pylori Infected Patients” NCT00574925 ↗ |
| Known as | Nexium (esomeprazole) | “Nexium (esomeprazole)” NCT02037477 ↗ |
| Known as | Nexium MUPS | “A 14-day regimen including proton pump inhibitor (PPI; esomeprazole \[Nexium MUPS\]), bismuth subcitrate (or bismuth subsalicylate), amoxicillin, and metronidazole.” NCT07260006 ↗1“esomeprazole (Nexium mups)” NCT06193811 ↗ |
| Action | Inhibit | “proton-pump inhibitor (PPI) therapy” PMID 25304129 ↗ Oct 2014 |
| Modality | Small molecule | “The proton pump inhibitor esomeprazole has been found to be effective for gastroprotection in NSAID users” PMID 23530709 ↗ Mar 2013 |
| Route | Oral | “Proton pump inhibitor 40 mg orally twice daily” NCT00069823 ↗ |