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Methotrexate

Generic Name
Methotrexate
Brand Names
Metoject, Nordimet, Otrexup, Rasuvo, Reditrex, Trexall, Xatmep, Jylamvo
Drug Type
Small Molecule
Chemical Formula
C20H22N8O5
CAS Number
59-05-2
Unique Ingredient Identifier
YL5FZ2Y5U1

Overview

Methotrexate is a folate derivative that inhibits several enzymes responsible for nucleotide synthesis. This inhibition leads to suppression of inflammation as well as prevention of cell division. Because of these effects, methotrexate is often used to treat inflammation caused by arthritis or to control cell division in neoplastic diseases such as breast cancer and non-Hodgkin's lymphoma. Due to the toxic effects of methotrexate, it is indicated for treatment of some forms of arthritis and severe psoriasis only if first line treatment has failed or patients are intolerant of those treatments. Methotrexate was granted FDA approval on 7 December 1953.

Indication

Methotrexate oral solution is indicated for pediatric acute lymphoblastic leukemia and pediatric polyarticular juvenile idiopathic arthritis. Methotrexate injections for subcutaneous use are indicated for severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and severe, recalcitrant, disabling psoriasis. Other formulations are indicated to treat gestational choriocarcinoma, chorioadenoma destruens, hydatiform mole, breast cancer, epidermoid cancer of the head and neck, advanced mycosis fungoides, lung cancer, and advanced non-Hodgkin's lymphoma. It is also used in the maintenance of acute lymphocytic leukemia. Methotrexate is also given before treatment with leucovorin to prolong relapse-free survival following surgical removal of a tumour in non-metastatic osteosarcoma.

Associated Conditions

  • Acute Lymphoblastic Leukemia (ALL)
  • Acute Promyelocytic Leukemia
  • Bladder Cancer
  • Breast Cancer
  • Central Nervous System Lymphoma
  • Crohn's Disease (CD)
  • Dermatomyositis (DM)
  • Extrauterine Pregnancy
  • Gestational Trophoblastic Neoplasia
  • Graft-versus-host Disease (GVHD)
  • Meningeal leukemia
  • Multiple Sclerosis
  • Mycosis Fungoides (MF)
  • Non-Hodgkin's Lymphoma (NHL)
  • Non-Hodgkin's Lymphoma, Relapsed
  • Osteosarcoma
  • Polyarticular Juvenile Idiopathic Arthritis
  • Polymyositis
  • Rheumatoid Arthritis
  • Soft Tissue Sarcoma
  • Squamous Cell Carcinoma of the Head and Neck (SCCHN)
  • Systemic Lupus Erythematosus
  • Uveitis
  • Nonleukemic meningeal cancer
  • Refractory Non-Hodgkin's lymphoma
  • Refractory Takayasu arteritis
  • Severe Psoriasis

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/08/24
Not Applicable
Not yet recruiting
2025/07/28
Not Applicable
Recruiting
2025/07/25
Not Applicable
Recruiting
2025/07/18
Not Applicable
Not yet recruiting
2025/06/11
Phase 2
Not yet recruiting
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
2025/05/31
Phase 2
Recruiting
2025/05/30
Phase 2
Recruiting
2025/05/15
Phase 2
Not yet recruiting
2025/05/11
Phase 3
Not yet recruiting
2025/05/07
Phase 3
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Accord Healthcare, Inc.
16729-277
INTRA-ARTERIAL, INTRAMUSCULAR, INTRATHECAL, INTRAVENOUS
25 mg in 1 mL
6/4/2021
Hospira, Inc.
61703-408
INTRAMUSCULAR, INTRAVENOUS, INTRATHECAL, SUBCUTANEOUS
25 mg in 1 mL
6/18/2021
Teva Women's Health, Inc.
51285-368
ORAL
10 mg in 1 1
4/30/2021
Antares Pharma, Inc.
54436-010
SUBCUTANEOUS
10 mg in 0.4 mL
11/21/2017
REMEDYREPACK INC.
70518-3672
ORAL
2.5 mg in 1 1
3/27/2024
Amneal Pharmaceuticals NY LLC
69238-1423
ORAL
2.5 mg in 1 1
12/30/2023
Medexus Pharma Inc.
59137-505
SUBCUTANEOUS
7.5 mg in 0.15 mL
3/20/2020
Antares Pharma, Inc.
54436-017
SUBCUTANEOUS
17.5 mg in 0.4 mL
11/21/2017
Fresenius Kabi USA, LLC
63323-123
INTRAMUSCULAR, INTRAVENOUS, INTRA-ARTERIAL
25 mg in 1 mL
5/5/2020
Antares Pharma, Inc.
54436-025
SUBCUTANEOUS
25 mg in 0.4 mL
11/21/2017

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
METHOTREXATE
02170671
Solution - Intramuscular ,  Intravenous ,  Intra-Arterial
25 MG / ML
1/24/1997
RHEUMATREX TAB 2.5MG
lederle cyanamid canada inc.
00874132
Tablet - Oral
2.5 MG / TAB
12/31/1990
METHOTREXATE SODIUM INJ 25MG/ML
lederle cyanamid canada inc.
00519286
Liquid - Intrathecal ,  Intravenous ,  Intramuscular
50 MG / VIAL
12/31/1981
METHOTREXATE TAB 2.5MG
lederle cyanamid canada inc.
00014915
Tablet - Oral
2.5 MG
12/31/1955
EUGIA-METHOTREXATE TABLETS
eugia pharma inc.
02448165
Tablet - Oral
10 MG
N/A
METHOTREXATE TABLETS, USP
02182750
Tablet - Oral
10 MG
4/12/2004
METHOTREXATE TAB 2.5MG USP
david bull laboratories (pty) ltd.
00632619
Tablet - Oral
2.5 MG
12/31/1991
JAMP METHOTREXATE TABLETS
02553740
Tablet - Oral
10 MG
6/10/2025

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
METOJECT PEN 22.5 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA
Medac Gesellschaft Für Klinische Spezialpräparate Gmbh
78635
SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA
Medicamento Sujeto A Prescripción Médica
Commercialized
METOJECT 25 mg/ 0,50 ml SOLUCION INYECTABLE EN JERINGA PRECARGADA
Medac Gesellschaft Für Klinische Spezialpräparate Gmbh
71111
SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA
Medicamento Sujeto A Prescripción Médica
Commercialized
QUINUX 20 MG/0,8 ML SOLUCION INYECTABLE EN JERINGA PRECARGADA
Especialidades Farmaceuticas Centrum S.A.
79128
SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA
Medicamento Sujeto A Prescripción Médica
Commercialized
NORDIMET 10 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA
1161124002
SOLUCIÓN INYECTABLE
Medicamento Sujeto A Prescripción Médica
Commercialized
NORDIMET 15 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA
1161124004
SOLUCIÓN INYECTABLE
Medicamento Sujeto A Prescripción Médica
Commercialized
IMETH 15 MG/0,6 ML SOLUCION INYECTABLE EN JERINGA PRECARGADA
79562
SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA
Medicamento Sujeto A Prescripción Médica
Commercialized
METHOFILL 20 MG/ 0,40 ML SOLUCION INYECTABLE EN JERINGA PRECARGADA EFG
80869
SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA
Medicamento Sujeto A Prescripción Médica
Commercialized
METHOFILL PEN 12,5 MG/0,25 ML SOLUCION INYECTABLE EN PLUMA PRECARGADA EFG
85486
SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA
Medicamento Sujeto A Prescripción Médica
Commercialized
METOJECT PEN 27.5 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA
Medac Gesellschaft Für Klinische Spezialpräparate Gmbh
78637
SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA
Medicamento Sujeto A Prescripción Médica
Commercialized
IMETH 10 MG/0,4 ML SOLUCION INYECTABLE EN JERINGA PRECARGADA
79580
SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA
Medicamento Sujeto A Prescripción Médica
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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