Drugs / Nexium
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (5) | US (FDA) | NEXIUM | — | 2004-11-24 – 2011-12-15 | fda.gov ↗ |
| Approved | US (FDA) | NEXIUM | — | 2001-02-20 | fda.gov ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT03558477 | Sep 2017 → Feb 2018 | gastroesophageal reflux disease | Yooyoung Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03211143 | Jun → Aug 2017 | gastroesophageal reflux disease | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 1 | NCT01761513 | Nov 2012 → Feb 2013 | — | Yuhan Corporation | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT02711176 | Sep 2016 → Mar 2017 | Helicobacter pylori infectious disease | Zahra Vahdat Shariatpanahi | Completed | No outcome recorded |
| Phase 4 | NCT02794844 | Jul 2016 → Jan 2017 | gastroesophageal reflux disease | Nemours Children's Clinic | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT03383003 | Mar 2016 → May 2018 | Helicobacter pylori infectious disease | Chang Gung Memorial Hospital | Completed | No outcome recorded |
| — | NCT02596620 | Oct 2013 → Oct 2015 | Helicobacter pylori infectious disease | Chang Gung Memorial Hospital | Completed | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 1 | NCT01921647 Comparator | Jul → Nov 2013 | — | Yuhan Corporation | Completed | No outcome recorded |
| Phase 1 | NCT01153659 Comparator | Jul → Aug 2010 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00444236 Comparator | Apr 2007 → Sep 2009 | exercise-induced bronchoconstriction, gastroesophageal reflux disease | University of Utah | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT01129713 Comparator | May 2010 → May 2015 | dyspepsia, gastroesophageal reflux disease | Effexus Pharmaceutical | Unknown | No outcome recorded |
| Phase 4 | NCT02553083 Comparator | Oct 2015 → Sep 2020 | Helicobacter pylori infectious disease | Rabin Medical Center | Unknown | No outcome recorded |
Press releases naming this drug 31 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Nexium | “adminitration of Nexium tab 40mg, bid for 2weeks” NCT01761513 ↗11“proton pump inhibitors (ppi; Prevacid, Nexium).” NCT02794844 ↗ |
| Known as | esomeprazole | “Nexium (esomeprazole) 40 mg capsule once per day on Days 1-5” NCT01153659 ↗ |
| Route | Oral | “Daily Oral Dose Administration” NCT01153659 ↗ |