XATMEP (methotrexate sodium)
Xatmep is used for children with acute lymphoblastic leukemia as part of a multi-drug maintenance chemotherapy program. It also helps pediatric patients with active polyarticular juvenile idiopathic arthritis who have not responded well to or cannot tolerate initial treatments like NSAIDs. This medication provides a specialized option for managing these serious conditions in younger populations.
How XATMEP Works
This drug works by inhibiting the enzyme dihydrofolic acid reductase, which prevents the production of tetrahydrofolates necessary for DNA synthesis and cellular replication. This process specifically targets rapidly dividing cells, such as those found in malignancies. While its exact function in treating arthritis is not fully understood, it is thought to influence immune system activity.
Details
- Status
- Prescription
- First Approved
- 2017-04-25
- Patent Cliff
- 2033
- Routes
- ORAL
- Dosage Forms
- SOLUTION
XATMEP Approval History
What XATMEP Treats
2 indicationsXATMEP is approved for 2 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Lymphoblastic Leukemia
- Polyarticular Juvenile Idiopathic Arthritis
XATMEP Boxed Warning
SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-FETAL TOXICITY Methotrexate can cause the following severe or fatal adverse reactions. Monitor closely and modify dose or discontinue methotrexate as appropriate. Bone marrow suppression [see Warnings and Precautions ( 5.1 )] Serious infections [see Warnings and Precautions ( 5.2 )] Renal toxicity and increased toxicity with renal impairment [see Warnings and Precautions ( 5.3 )] Gastrointestinal toxicity [see Warnings and Precautions ( 5.4 )] Hepatic tox...
WARNING: SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-FETAL TOXICITY Methotrexate can cause the following severe or fatal adverse reactions. Monitor closely and modify dose or discontinue methotrexate as appropriate. Bone marrow suppression [see Warnings and Precautions ( 5.1 )] Serious infections [see Warnings and Precautions ( 5.2 )] Renal toxicity and increased toxicity with renal impairment [see Warnings and Precautions ( 5.3 )] Gastrointestinal toxicity [see Warnings and Precautions ( 5.4 )] Hepatic toxicity [see Warnings and Precautions ( 5.5 )] Pulmonary toxicity [see Warnings and Precautions ( 5.6 )] Hypersensitivity and dermatologic reactions [see Warnings and Precautions ( 5.7 )] Methotrexate can cause embryo-fetal toxicity, including fetal death. Use in pJIA is contraindicated in pregnancy. Consider the benefits and risks of XATMEP and risks to the fetus when prescribing XATMEP to a pregnant patient with a neoplastic disease. Advise females and males of reproductive potential to use effective contraception during and after treatment with XATMEP [see Contraindications ( 4 ), Warnings and Precautions ( 5.9 ), Use in Specific Populations ( 8.1 , 8.3 )]. WARNING: SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. Methotrexate can cause severe or fatal toxicities. Monitor closely and modify dose or discontinue for the following toxicities: bone marrow suppression ( 5.1 ), infection ( 5.2 ), renal ( 5.3 ), gastrointestinal ( 5.4 ), hepatic ( 5.5 ), pulmonary ( 5.6 ), hypersensitivity and dermatologic ( 5.7 ). Methotrexate can cause embryo-fetal toxicity and fetal death. Use in polyarticular juvenile idiopathic arthritis is contraindicated in pregnancy ( 4 ). Consider the benefits and risks of XATMEP and risks to the fetus when prescribing XATMEP to a pregnant patient with a neoplastic disease. Advise patients to use effective contraception during and after treatment with XATMEP ( 5.9 , 8.1 , 8.3 ).
XATMEP 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 XATMEP's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications XATMEP treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to XATMEP
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.
XATMEP FDA Label Details
Indications & Usage
FDA Label (PDF)XATMEP is indicated for the treatment of Acute Lymphoblastic Leukemia; Polyarticular Juvenile Idiopathic Arthritis.
WARNING: SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-FETAL TOXICITY Methotrexate can cause the following severe or fatal adverse reactions. Monitor closely and modify dose or discontinue methotrexate as appropriate. Bone marrow suppression [see Warnings and Precautions ( 5.1 )] Serious infections [see ...
XATMEP Patents & Exclusivity
Patents (7 active)
Pro Intelligence Preview
Deep insights for XATMEP
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 9 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.