LEUPROLIDE ACETATE | N021088 | ORTHO MCNEIL JANSSEN PHARMACEUTICAL INC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 1/2 | Active | University of Michigan Rogel Cancer Center | 102 | 2020-11-06 → 2029-05 | |
| Phase 2 | Active | City of Hope Medical Center | 25 | 2018-08-29 → 2027-01-06 | |
| Phase 3 | Active | Pfizer | 1,068 | 2014-12-17 → 2026-09-19 | |
| Phase 1 | Active | Roswell Park Cancer Institute | 3 | 2024-12-19 → 2028-03-09 | |
| Phase 2 | Active | Spanish Breast Cancer Research Group | 200 | 2020-10-02 → 2033-02-28 | |
| Phase 2 | Active | Jonsson Comprehensive Cancer Center | 28 | 2021-03-17 → 2028-01-01 | |
| Phase 2 | Active | M.D. Anderson Cancer Center | 310 | 2013-02-05 → 2027-02-01 | |
| Phase 2 | Active | Astellas Pharma Global Development, Inc. | 900 | 2016-12-22 → 2029-07-31 | |
| Phase 2 | Active | Xiao X. Wei, MD | 47 | 2020-05-11 → 2026-10-30 | |
| Phase 3 | Active | Alliance for Clinical Trials in Oncology | 788 | 2007-05-08 → 2030-10 |
Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.
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.