TREXALL (methotrexate sodium)
Trexall is a versatile medication used to manage various cancers and autoimmune conditions in both adult and pediatric populations. It helps patients with acute lymphoblastic leukemia during maintenance therapy and treats adults with mycosis fungoides or specific forms of non-Hodgkin lymphoma. The drug is also used for adults with rheumatoid arthritis or severe psoriasis, as well as children living with polyarticular juvenile idiopathic arthritis.
How TREXALL Works
Trexall works by blocking the enzyme dihydrofolic acid reductase, which prevents the body from creating the tetrahydrofolates needed for DNA synthesis and repair. By interfering with cellular replication, the drug specifically impacts rapidly proliferating tissues like malignant cells. While this process explains its effect on cancer, the specific way it works to improve rheumatoid arthritis and psoriasis is not yet fully understood.
Details
- Status
- Prescription
- First Approved
- 2001-03-21
- Routes
- ORAL
- Dosage Forms
- TABLET
TREXALL Approval History
What TREXALL Treats
6 indicationsTREXALL is approved for 6 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Lymphoblastic Leukemia
- Mycosis Fungoides
- Non-Hodgkin Lymphoma
- Rheumatoid Arthritis
- Juvenile Idiopathic Arthritis
- Psoriasis
TREXALL Boxed Warning
EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, and SEVERE ADVERSE REACTIONS WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS AND SEVERE ADVERSE REACTIONS Methotrexate can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, methotrexate is contraindicated in pregnancy. For neoplastic diseases, advise females and males of reproductive potential to use effective contraception [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), Use in Specific P...
WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, and SEVERE ADVERSE REACTIONS WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS AND SEVERE ADVERSE REACTIONS Methotrexate can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, methotrexate is contraindicated in pregnancy. For neoplastic diseases, advise females and males of reproductive potential to use effective contraception [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.1 , 8.3 )] . Methotrexate is contraindicated in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis [Contraindications ( 4 ), Warnings and Precautions ( 5.2 )] . Serious adverse reactions, including death, have been reported with methotrexate. Closely monitor for adverse reactions of the bone marrow, gastrointestinal tract, liver, lungs, skin, and kidneys. Withhold or discontinue methotrexate as appropriate [Warnings and Precautions ( 5.3 , 5.4 , 5.5 , 5.6 , 5.7 , 5.8 )] . WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, and SEVERE ADVERSE REACTIONS See full prescribing information for complete boxed warning. Methotrexate can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, methotrexate is contraindicated in pregnancy. For neoplastic diseases, advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception ( 4 , 5.1 , 8.1 , 8.3 ). Methotrexate is contraindicated in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis ( 4 , 5.2 ). Serious adverse reactions, including death, have been reported with methotrexate. Closely monitor for adverse reactions of the bone marrow, gastrointestinal tract, liver, lungs, skin, and kidneys. Withhold or discontinue methotrexate as appropriate ( 5.3 , 5.4 , 5.5 , 5.6 , 5.7 , 5.8 ).
TREXALL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in TREXALL's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TREXALL treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to TREXALL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02143414 results posted | NCI-2014-01047 NCI-2014-01047, SWOG-S1318 | Ph 2 | active not recruiting | Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia |
| NCT06354439 EcZOL | 77015224.6.1001.5327 | Ph 4 | recruiting | Use of Letrozole for Ectopic Pregnancy |
| NCT05575297 | MRFI | Ph 1 | completed | A Drug-drug Interaction Study to Evaluate the Effect of Rifampicin and Febuxostat on the Pharmacokinetics of Methotrexate in Healthy Subjects |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TREXALL FDA Label Details
Indications & Usage
TREXALL is indicated for the treatment of Acute Lymphoblastic Leukemia; Mycosis Fungoides; Non-Hodgkin Lymphoma; Rheumatoid Arthritis; Juvenile Idiopathic Arthritis; Psoriasis.
WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, and SEVERE ADVERSE REACTIONS WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS AND SEVERE ADVERSE REACTIONS Methotrexate can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, methotrexate is contraind...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.