ARIPIPRAZOLE | N021866 | OTSUKA PHARMACEUTICAL CO LTD
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 2 | Not Yet Recruiting | Christiana Franke | 138 | 2026-10-01 → 2028-12-31 | |
| Phase 2 | Not Yet Recruiting | Vigonvita Life Sciences | 500 | 2026-07-31 → 2027-12-31 | |
| Phase 1 | Recruiting | University of California, San Francisco | 25 | 2025-09-30 → 2027-08-30 | |
| Phase 4 | Recruiting | Northwell Health | 180 | 2024-09-04 → 2030-07-30 | |
| Phase 3 | Recruiting | Minerva Neurosciences | 380 | 2026-04-23 → 2028-12 | |
| Phase 4 | Completed | Federal University of Rio Grande do Sul | 20 | 2005-08 → 2008-03 | |
| Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 1,151 | 2004-09-01 → 2006-12-01 | |
| Phase 2 | Completed | Ajay Wasan, MD, Msc | 308 | 2021-03-31 → 2024-12-20 | |
| Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 135 | 2011-07-27 → 2013-11-06 | |
| Phase 1 | Completed | CMG Pharmaceutical Co. Ltd | 36 | 2015-10 → 2016-03 |
Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.
39 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 |
|---|---|---|
| Feb 6, 2020 | SUPPL -30 | View Letter (PDF) |
| Feb 6, 2020 | SUPPL -29 | View Letter (PDF) |
| Aug 8, 2019 | SUPPL -28 | View Letter (PDF) |
| Mar 2, 2017 | SUPPL -27 | View Letter (PDF) |
| Aug 18, 2016 | SUPPL -26 | View Letter (PDF) |
| Jan 20, 2016 | SUPPL -25 | View Letter (PDF) |
| Dec 15, 2014 | SUPPL -23 | View Letter (PDF) |
| Jul 11, 2014 | SUPPL -21 | View Letter (PDF) |
| Aug 5, 2013 | SUPPL -22 | View Letter (PDF) |
| Feb 27, 2012 | SUPPL -20 | View Letter (PDF) |
| Mar 8, 2011 | SUPPL -19 | View Letter (PDF) |
| Feb 18, 2011 | SUPPL -16 | View Letter (PDF) |
| Dec 7, 2010 | SUPPL -18 | View Letter (PDF) |
| Dec 3, 2010 | SUPPL -17 | View Letter (PDF) |
| Feb 17, 2010 | SUPPL -15 | View Letter (PDF) |
| Feb 14, 2010 | SUPPL -3 | View Letter (PDF) |
| Jul 24, 2009 | SUPPL -14 | View Letter (PDF) |
| Aug 19, 2008 | SUPPL -13 | View Letter (PDF) |
| May 14, 2008 | SUPPL -7 | View Letter (PDF) |
| May 14, 2008 | SUPPL -6 | View Letter (PDF) |
| May 14, 2008 | SUPPL -9 | View Letter (PDF) |
| Mar 7, 2008 | SUPPL -10 | View Letter (PDF) |
| Feb 29, 2008 | SUPPL -8 | View Letter (PDF) |
| Nov 19, 2007 | SUPPL -5 | View Letter (PDF) |
| Nov 8, 2007 | SUPPL -4 | View Letter (PDF) |
| Oct 4, 2007 | SUPPL -2 | View Letter (PDF) |
| Sep 25, 2006 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.