DECITABINE | N205582 | SUN PHARMACEUTICAL INDUSTRIES LTD
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 2 | Active | Franziska Wachter | 29 | 2023-04-19 → 2029-09-01 | |
| Phase 2 | Active | Novartis Pharmaceuticals | 33 | 2023-02-28 → 2028-02-14 | |
| Phase 1/2 | Active | M.D. Anderson Cancer Center | 64 | 2022-03-04 → 2027-01-29 | |
| Phase 1 | Active | National Cancer Institute (NCI) | 54 | 2017-09-05 → 2026-08-19 | |
| Phase 2 | Active | Northwell Health | 41 | 2024-10-07 → 2028-10 | |
| Phase 2 | Active | St. Jude Children's Research Hospital | 206 | 2017-06-15 → 2027-06 | |
| Phase 2 | Active | Stichting Hemato-Oncologie voor Volwassenen Nederland | 140 | 2019-12-05 → 2026-11 | |
| Phase 1 | Active | University of Virginia | 37 | 2022-02-02 → 2026-05-25 | |
| Phase 1 | Active | M.D. Anderson Cancer Center | 9 | 2021-09-27 → 2027-02-02 | |
| Phase 2 | Active | National Cancer Institute (NCI) | 178 | 2011-09-16 → 2027-02-01 |
Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.
17 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 |
|---|---|---|
| Sep 17, 2020 | SUPPL -15 | View Letter (PDF) |
| May 28, 2020 | SUPPL -14 | View Letter (PDF) |
| Feb 5, 2020 | SUPPL -12 | View Letter (PDF) |
| May 23, 2019 | SUPPL -9 | View Letter (PDF) |
| Jan 24, 2014 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.