Methotrexate is a cytotoxic antimetabolite drug used across oncology and immune-mediated diseases in indication-specific dosing regimens, often once weekly in non-oncology uses. Labeling requires careful dose scheduling because medication errors can cause fatal toxicity. Initial U.S. approval dates to 1953.
WHO in January 2024 launched its first list of priority childhood cancer drug formulations, naming six medicines that still lack optimal child-friendly versions. The agency says about 400,000 children and adolescents develop cancer each year and is working to expand access to safe, effective paediatric formulations.
Atopic dermatitis updates in 2026 included long-term upadacitinib safety, phase 3 amlitelimab and rademikibart data, and 5-year interim dupilumab results in children. A market report also listed multiple emerging therapies in late-stage development.
The FDA has accepted a new drug application for tirabrutinib, a BTK inhibitor, for relapsed/refractory primary central nervous system lymphoma under the accelerated approval pathway. The regulatory agency set a PDUFA target action date of December 18, 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07581418 |
Comparison of Methotrexate and Tofacitinib in Chronic Plaque Psoriasis |
NOT_YET_RECRUITING | NA |
| NCT07543640 |
EFFICACY OF ROFLUMILAST IN THE TREATMENT OF FLEXURAL AND/OR GENITAL PSORIASIS: A RANDOMIZED CONTROLLED TRIAL. |
NOT_YET_RECRUITING | PHASE2 |
| NCT07498465 |
A Study to Find the Highest Dose of SNDX-5613 (Revumenib) as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, and Mixed Phenotype Acute Leukemia |
WITHDRAWN | PHASE1 |
| NCT07446400 |
A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together |
RECRUITING | PHASE1 |
| NCT07432815 |
Treatment of Psoriasis With Depression and/or Anxiety With Methotrexate vs Combined Methotrexate and Antidepressant |
RECRUITING | PHASE4 |
| NCT07432386 |
Methotrexate Versus Apremilast for Pruritus in Psoriasis |
NOT_YET_RECRUITING | PHASE4 |
| NCT07388498 |
A Double-blind, Randomized Controlled Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of Pegloticase Administration Via Subcutaneous and Intravenous Routes Both With Methotrexate in Participants With Uncontrolled Gout |
RECRUITING | PHASE3 |
| NCT07176390 |
A Clinical Study of Tulisokibart (MK-7240) to Treat Rheumatoid Arthritis (RA) (MK-7240-014) |
RECRUITING | PHASE2 |
| NCT06997068 |
Methotrexate, Erlotinib, and Celecoxib for the Treatment of Recurrent/Metastatic Head and Neck Cancer in a Rural Midwest United States Population |
RECRUITING | PHASE2 |
| NCT06960577 |
Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2) |
RECRUITING | PHASE3 |
