LANSOPRAZOLE | N208025 | DEXCEL PHARMA TECHNOLOGIES LTD
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 3 | Not Yet Recruiting | Onconic Therapeutics Inc. | 414 | 2026-11-01 → 2028-10-06 | |
| Phase 3 | Not Yet Recruiting | Daewoong Pharmaceutical Co. LTD. | 384 | 2026-10-15 → 2028-10-15 | |
| Phase 3 | Not Yet Recruiting | Onconic Therapeutics Inc. | 384 | 2026-08-01 → 2028-10-30 | |
| N/A | Recruiting | SUK MIN SEO | 200 | 2024-10-24 → 2028-12-31 | |
| Phase 2 | Recruiting | Indonesia University | 162 | 2026-08-06 → 2027-02-28 | |
| N/A | Completed | Head and Neck Surgery Associates | 20 | 2005-09 → 2008-09 | |
| Phase 2 | Completed | Cinclus Pharma Holding AB | 248 | 2021-08-11 → 2022-09-01 | |
| Phase 3 | Completed | Cinclus Pharma Holding AB | 523 | 2025-09-11 → 2026-09-28 | |
| Phase 3 | Completed | Takeda | 406 | 2011-09 → 2013-12 | |
| Phase 3 | Completed | Takeda | 607 | 2011-10 → 2013-03 |
Source: ClinicalTrials.gov. Trials matched by ingredient name.
22 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 |
|---|---|---|
| Mar 12, 2026 | SUPPL -18 | View Letter (PDF) |
| Nov 2, 2022 | SUPPL -12 | View Letter (PDF) |
| Nov 25, 2020 | SUPPL -10 | View Letter (PDF) |
| Apr 10, 2019 | SUPPL -8 | View Letter (PDF) |
| Dec 4, 2017 | SUPPL -6 | View Letter (PDF) |
| Dec 1, 2017 | SUPPL -7 | View Letter (PDF) |
| Nov 15, 2017 | SUPPL -5 | View Letter (PDF) |
| May 12, 2017 | SUPPL -3 | View Letter (PDF) |
| Jan 30, 2017 | SUPPL -1 | View Letter (PDF) |
| Jun 13, 2016 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.