NDAORALSOLUTION
Approved
Apr 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
XATMEP (methotrexate) by R-Pharm US is folic acid metabolism inhibitors [moa]. Approved for rheumatoid arthritis. First approved in 2017.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XATMEP is an oral solution formulation of methotrexate, a folic acid metabolism inhibitor approved in 2017. It treats 24+ indications spanning oncology (leukemias, lymphomas, breast cancer), rheumatology (rheumatoid arthritis, psoriatic arthritis), and autoimmune diseases (Crohn's disease, multiple sclerosis, giant cell arteritis). The drug works by inhibiting dihydrofolate reductase, disrupting nucleotide synthesis and triggering apoptosis in rapidly dividing cells.
$0.248MPart D
Peak6.7 years to LOEXATMEP is in peak lifecycle with minimal Part D penetration ($248K spend, 240 claims in 2023), suggesting a niche oral solution play with modest commercial scale relative to blockbuster competitors.
Mechanism of Action
Folic Acid Metabolism Inhibitors
Pharmacologic Class:
Folate Analog Metabolic Inhibitor
Indications (1)
Clinical Trials (20)
Natrunix in Combination With Methotrexate for Rheumatoid Arthritis Treatment
Started Jul 2026
108 enrolled
Rheumatoid Arthritis
A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together
Started Mar 2026
48 enrolled
Healthy Volunteers
A Study to Assess the Safety and Efficacy of Different Doses of ELV001 to Treat Active Rheumatoid Arthritis in Patients With an Inadequate Response to Methotrexate and Tumor Necrosis Factor Inhibition (START SYNERGY)
Started Feb 2026
180 enrolled
Active Rheumatoid Arthritis
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
Started Feb 2026
270 enrolled
Uncontrolled Gout
A Multicenter Two-Cohort Study of Methotrexate, Rituximab, Sintilimab and Pirtobrutinib for Treatment-Naive PCNSL vs. Real-World Investigator-Selected Treatment (Observational Cohort)
Started Dec 2025
110 enrolled
PCNSLPrimary Central Nervous System Lymphoma
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.