NDAINTRAVENOUSSOLUTION
Approved
Aug 2020
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Drug Shortage Active
METHOTREXATE is currently in shortage. Reason: Manufacturing discontinuation. This may impact manufacturing, supply chain, and quality hiring at the manufacturer.
METHOTREXATE (methotrexate) by Accord Biopharma is reductase. First approved in 2020.
Drug data last refreshed 14h ago · AI intelligence enriched 3mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Methotrexate is a small-molecule antimetabolite that inhibits dihydrofolate reductase, disrupting DNA synthesis and cellular replication in rapidly dividing cells. It is used to treat malignancies, rheumatoid arthritis, psoriasis, and other autoimmune conditions. The IV solution formulation targets patients requiring parenteral administration for optimal bioavailability and disease control.
Peak
Peak lifecycle positioning indicates mature market presence with established sales infrastructure; competitive pressure of 30% suggests stable but contested market dynamics favoring efficient operations teams.
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, Prospective Clinical Trial With a Concurrent Control Evaluating Methotrexate Combined With Rituximab,Sintilimab and Pirtobrutinib vs. Investigator-Selected Standard of Care in Treatment-Naive PCNSL
Started Dec 2025
77 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.