ESOMEPRAZOLE MAGNESIUM | N214278 | DEXCEL PHARMA TECHNOLOGIES LTD
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| N/A | Not Yet Recruiting | University of Medicine and Pharmacy at Ho Chi Minh City | 600 | 2026-07-27 → 2027-12-27 | |
| N/A | Not Yet Recruiting | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | 45 | 2026-11-01 → 2028-12-01 | |
| N/A | Recruiting | Seoul National University Bundang Hospital | 600 | 2014-08 → 2027-12 | |
| Phase 2 | Recruiting | Stanford University | 25 | 2019-05-29 → 2028-12 | |
| Phase 1 | Recruiting | Basilea Pharmaceutica | 96 | 2025-01-07 → 2026-12-30 | |
| Phase 3 | Completed | AstraZeneca | 343 | 2014-07 → 2016-02 | |
| Phase 1 | Completed | Nurix Therapeutics, Inc. | 223 | 2024-11-30 → 2026-05-01 | |
| Phase 4 | Completed | Elpen Pharmaceutical Co. Inc. | 364 | 2017-01-30 → 2017-12-30 | |
| Phase 4 | Completed | King Saud University | 1,920 | 2012-01 → 2015-12 | |
| Phase 4 | Completed | Seoul National University Bundang Hospital | 648 | 2003-01 → 2010-12 |
Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.
30 active API suppliers hold Drug Master Files for this ingredient.
Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.
| Date | Submission | Document |
|---|---|---|
| May 12, 2022 | SUPPL -2 | View Letter (PDF) |
| Sep 9, 2021 | SUPPL -1 | View Letter (PDF) |
| Oct 21, 2020 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.