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Methotrexate · Methotrexate Sodium, Rasuvo

Small molecule · Inhibitor of dihydrofolate reductase (DHFR) · developed by Strides Pharma Intl

Approved FDA, Dec 1953

4 Registered trials

What is Methotrexate?

Methotrexate is a folate analog metabolic inhibitor that binds and inhibits dihydrofolate reductase, blocking purine and thymidylate synthesis and thereby DNA synthesis, repair and cellular replication. It is studied in primary vitreoretinal lymphoma, rheumatoid arthritis, proliferative vitreoretinopathy and retinitis pigmentosa.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: Methotrexate Sodium, Rasuvo, Xatmep, MTX, ADX-2191, CL-14377
Drug type: Small molecule
Targets: dihydrofolate reductase (DHFR)
Mechanism: Inhibitor of dihydrofolate reductase (DHFR)
Pathways: purine nucleotide synthesis, thymidylate synthesis, DNA synthesis and repair, cellular replication
Therapy area: Immunology
Developer: Strides Pharma Intl
In trials of: ALDX, CANF
FDA status: Approved as Methotrexate Sodium, Rasuvo, Xatmep (December 7, 1953), NDA008085 · FDA label
UNII: YL5FZ2Y5U1

✅ FDA-approved uses

Acute lymphoblastic leukemia (Methotrexate)
Meningeal leukemia (Methotrexate)
Non-Hodgkin lymphoma (Methotrexate)
Osteosarcoma (Methotrexate)
Breast cancer (Methotrexate)
Squamous cell carcinoma of the head and neck (Methotrexate)
Gestational trophoblastic neoplasia (Methotrexate)
Rheumatoid arthritis (Methotrexate)

From the indications section of the FDA label (version of Aug 22, 2025). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT07402876	Phase 3	Primary Vitreoretinal Lymphoma	Recruiting	ALDX
NCT04136366	Phase 3	Proliferative Vitreoretinopathy	Completed	ALDX
NCT02647762	Phase 3	Rheumatoid Arthritis	Terminated	CANF
NCT05392179	Phase 2	Retinitis Pigmentosa	Completed	ALDX

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Primary Vitreoretinal LymphomaProliferative VitreoretinopathyRetinitis PigmentosaRheumatoid Arthritis

Sources

Updated Oct 11, 2026.

Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z