NDAINJECTIONINJECTABLE
Approved
Aug 1959
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
METHOTREXATE LPF (methotrexate) by Pfizer is reductase. First approved in 1959.
Drug data last refreshed 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Methotrexate LPF is a low-dose parenteral formulation of methotrexate, a folic acid antagonist that inhibits dihydrofolate reductase to disrupt DNA synthesis and cellular replication. It treats rheumatoid arthritis, psoriatic arthritis, psoriasis, Crohn's disease, juvenile idiopathic arthritis, and multiple hematologic malignancies including acute leukemias and lymphomas. The mechanism in autoimmune conditions remains incompletely understood, though in malignancies it directly targets rapidly dividing cells.
LOE Approaching
As a legacy injectable approaching loss of exclusivity, the Methotrexate LPF brand team is likely focused on cost management and defensive positioning rather than growth initiatives.
Mechanism of Action
reductase. Dihydrofolates must be reduced to tetrahydrofolates by this enzyme before they can be utilized as carriers of one-carbon groups in the synthesis of purine nucleotides and thymidylate. Therefore, methotrexate interferes with DNA synthesis, repair, and cellular replication. Actively…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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.