METHOTREXATE | N214121 | ACCORD HEALTHCARE INC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 3 | Active | Takeda | 245 | 2018-10-04 → 2027-07-31 | |
| Phase 2 | Active | UNICANCER | 1,460 | 2014-04-07 → 2025-12 | |
| Phase 2/3 | Active | North American Consortium for Histiocytosis | 1,400 | 2016-11-02 → 2026-07 | |
| Phase 1 | Active | St. Jude Children's Research Hospital | 37 | 2021-11-15 → 2027-09 | |
| Phase 2 | Active | M.D. Anderson Cancer Center | 88 | 2011-10-05 → 2027-10-31 | |
| Phase 1 | Active | Ono Pharmaceutical Co., Ltd. | 20 | 2024-05-17 → 2028-08-31 | |
| Phase 1 | Active | National Cancer Institute (NCI) | 47 | 2021-05-24 → 2027-08-01 | |
| Phase 1/2 | Active | University of Michigan Rogel Cancer Center | 43 | 2020-02-04 → 2026-04-01 | |
| Phase 3 | Active | Children's Cancer Group, China | 150 | 2016-01 → 2031-12 | |
| Phase 3 | Active | National Cancer Institute (NCI) | 488 | 2014-05-19 → 2027-02-25 |
Source: ClinicalTrials.gov. Trials matched by ingredient name.
Total Spending
$57.2M
Total Claims
2,414,242
Beneficiaries
551,528
Avg Cost/Unit
$0.63
Spending Trend
Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.
8 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 |
|---|---|---|
| Oct 19, 2026 | SUPPL -6 | View Letter (PDF) |
| Mar 16, 2026 | SUPPL -5 | View Letter (PDF) |
| Jun 2, 2025 | SUPPL -3 | View Letter (PDF) |
| Jun 2, 2025 | SUPPL -4 | View Letter (PDF) |
| Mar 11, 2022 | SUPPL -1 | View Letter (PDF) |
| Aug 25, 2020 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.