LEUPROLIDE ACETATE | N021088 | ORTHO MCNEIL JANSSEN PHARMACEUTICAL INC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 2 | Active | M.D. Anderson Cancer Center | 310 | 2013-02-05 → 2027-02-01 | |
| Phase 3 | Active | Pfizer | 1,068 | 2014-12-17 → 2026-09-19 | |
| Phase 2 | Active | Rana McKay, MD | 32 | 2023-02-01 → 2026-12 | |
| Phase 2/3 | Active | NRG Oncology | 612 | 2017-04-05 → 2030-10-31 | |
| Phase 2 | Active | Jonsson Comprehensive Cancer Center | 28 | 2021-03-17 → 2028-01-01 | |
| Phase 2 | Active | Mark Stein | 26 | 2019-05-16 → 2028-04 | |
| Phase 3 | Active | NRG Oncology | 2,753 | 2021-01-21 → 2038-12-31 | |
| Phase 2/3 | Active | VA Office of Research and Development | 378 | 2021-07-01 → 2029-03-30 | |
| Phase 3 | Active | UNICANCER | 490 | 2020-01-09 → 2033-12-28 | |
| Phase 2 | Active | City of Hope Medical Center | 25 | 2018-08-29 → 2027-01-06 |
Source: ClinicalTrials.gov. Trials matched by ingredient name.
15 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 |
|---|---|---|
| Jan 20, 2011 | SUPPL -25 | View Letter (PDF) |
| Sep 22, 2005 | SUPPL -22 | View Letter (PDF) |
| Sep 14, 2005 | SUPPL -7 | View Letter (PDF) |
| Aug 15, 2003 | SUPPL -15 | View Letter (PDF) |
| Mar 3, 2000 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.