METHOTREXATE SODIUM
Methotrexate sodium treats a variety of conditions ranging from specific cancers to chronic inflammatory diseases in both adults and children. It helps patients with blood and lymph node cancers, including acute lymphoblastic leukemia and non-Hodgkin lymphoma, as well as mycosis fungoides. This medication is also used for managing severe psoriasis and autoimmune joint conditions like rheumatoid arthritis and polyarticular juvenile idiopathic arthritis.
How METHOTREXATE SODIUM Works
This medication 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, it specifically targets rapidly dividing tissues like malignant cells. While this process explains its effect on cancers, the exact way it helps patients with rheumatoid arthritis and psoriasis remains unknown.
Details
- Status
- Discontinued
- First Approved
- 1953-12-07
- Routes
- INJECTION, ORAL, IRRIGATION, Injection
- Dosage Forms
- INJECTABLE, TABLET, SOLUTION, Injectable
Companies
METHOTREXATE SODIUM Approval History
What METHOTREXATE SODIUM Treats
6 indicationsMETHOTREXATE SODIUM is approved for 6 conditions since its original approval in 1953. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute lymphoblastic leukemia (ALL)
- Mycosis fungoides (cutaneous T-cell lymphoma)
- Relapsed or refractory non-Hodgkin lymphoma
- Rheumatoid arthritis
- Polyarticular juvenile idiopathic arthritis (pJIA)
- Severe psoriasis
METHOTREXATE SODIUM Boxed Warning
EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS AND SEVERE ADVERSE REACTIONS • Methotrexate Tablets can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Methotrexate Tablets are 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 Tablets are contraindicated...
WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS AND SEVERE ADVERSE REACTIONS • Methotrexate Tablets can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Methotrexate Tablets are 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 Tablets are 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 Tablets 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 Tablets can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Methotrexate Tablets are 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 Tablets are 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 Tablets as appropriate. ( 5.3 , 5.4 , 5.5 , 5.6 , 5.7 , 5.8 )
METHOTREXATE SODIUM 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 METHOTREXATE SODIUM's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications METHOTREXATE SODIUM treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to METHOTREXATE SODIUM
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.
METHOTREXATE SODIUM FDA Label Details
Indications & Usage
FDA Label (PDF)METHOTREXATE SODIUM is indicated for the treatment of Acute lymphoblastic leukemia (ALL); Mycosis fungoides (cutaneous T-cell lymphoma); Relapsed or refractory non-Hodgkin lymphoma; Rheumatoid arthritis; Polyarticular juvenile idiopathic arthritis (pJIA); Severe psoriasis.
WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS AND SEVERE ADVERSE REACTIONS • Methotrexate Tablets can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Methotrexate Tablets are contraindicated in pregnancy. For neoplastic diseases, advise females and males...
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Full clinical data, patents, trials, and competitive landscape for methotrexate sodium.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.