LANSOPRAZOLE | N021281 | TAKEDA PHARMACEUTICALS NORTH AMERICA INC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 3 | Active | Cinclus Pharma Holding AB | 500 | 2025-09-11 → 2026-09 | |
| 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 | |
| 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 3 | Completed | Novartis | 576 | 2006-06 → 2007-01 | |
| Phase 4 | Completed | Children's Mercy Hospital Kansas City | 76 | 2018-07-03 → 2024-12-31 | |
| Phase 4 | Completed | Mackay Memorial Hospital | 100 | 2017-04-28 → 2018-04-30 | |
| Phase 4 | Completed | Takeda | 506 | 2002-06 → 2008-09 | |
| Phase 4 | Completed | King Saud University | 1,920 | 2012-01 → 2015-12 |
Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.
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 |
|---|---|---|
| Nov 12, 2009 | SUPPL -26 | View Letter (PDF) |
| Oct 29, 2008 | SUPPL -24 | View Letter (PDF) |
| Apr 23, 2008 | SUPPL -22 | View Letter (PDF) |
| Jul 5, 2007 | SUPPL -21 | View Letter (PDF) |
| Apr 13, 2006 | SUPPL -17 | View Letter (PDF) |
| Jun 23, 2004 | SUPPL -14 | View Letter (PDF) |
| Aug 15, 2003 | SUPPL -9 | View Letter (PDF) |
| Dec 3, 2002 | SUPPL -4 | View Letter (PDF) |
| Aug 30, 2002 | SUPPL -7 | View Letter (PDF) |
| May 3, 2002 | SUPPL -2 | View Letter (PDF) |
| May 3, 2001 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.