IBUPROFEN | N020589 | HALEON US HOLDINGS LLC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 3 | Active | Overseas Pharmaceuticals, Ltd. | 500 | 2021-12-10 → 2026-12-31 | |
| Phase 2 | Active | Menoufia University | 152 | 2023-03-04 → 2027-05 | |
| Phase 4 | Active | St Joseph University, Beirut, Lebanon | 67 | 2018-06-01 → 2026-12-01 | |
| Phase 2 | Active | Seoul National University Bundang Hospital | 90 | 2025-11-21 → 2026-12-25 | |
| Phase 4 | By Invitation | State University of New York at Buffalo | 60 | 2025-09-17 → 2027-01 | |
| Phase 3 | Not Yet Recruiting | University Hospital, Basel, Switzerland | 318 | 2026-10 → 2029-11 | |
| N/A | Not Yet Recruiting | Nanfang Hospital, Southern Medical University | 90 | 2026-09 → 2027-12 | |
| Phase 3 | Not Yet Recruiting | AFT Pharmaceuticals, Ltd. | 180 | 2026-10 → 2027-10 | |
| Phase 4 | Not Yet Recruiting | University of California, Los Angeles | 120 | 2026-11-01 → 2028-07-01 | |
| Phase 4 | Not Yet Recruiting | University of Minnesota | 230 | 2027-04-01 → 2029-07-30 |
Source: ClinicalTrials.gov. Trials matched by ingredient name.
13 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 |
|---|---|---|
| Jun 29, 2026 | SUPPL -44 | View Letter (PDF) |
| May 4, 2026 | SUPPL -43 | View Letter (PDF) |
| Sep 21, 2022 | SUPPL -39 | View Letter (PDF) |
| Jun 22, 2017 | SUPPL -35 | View Letter (PDF) |
| Mar 24, 2017 | SUPPL -34 | View Letter (PDF) |
| Dec 24, 2013 | SUPPL -29 | View Letter (PDF) |
| Sep 7, 2010 | SUPPL -26 | View Letter (PDF) |
| May 26, 2009 | SUPPL -24 | View Letter (PDF) |
| Jun 16, 2008 | SUPPL -23 | View Letter (PDF) |
| Dec 15, 2005 | SUPPL -19 | View Letter (PDF) |
| Mar 23, 2005 | SUPPL -17 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.