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 |
|---|---|---|---|---|---|
2025/07/28 | 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 | |||
2025/04/30 | Phase 1 | Completed |
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 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 3/29/2017 | ||
Authorised | 8/18/2016 | ||
Authorised | 8/18/2016 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| MEREX 2.5-METHOTREXATE TABLETS USP 2.5 mg | SIN16737P | TABLET | 2.5 mg | 3/13/2023 | |
| TREXAN TABLET 2.5MG | SIN00241P | TABLET | 2.5 mg | 4/5/1988 | |
| DBL METHOTREXATE INJECTION BP 50 mg/2 ml (WITHOUT PRESERVATIVE) | SIN00758P | INJECTION | 50 mg/2 ml | 5/4/1988 | |
| EMTHEXATE 2.5 TABLET 2.5 mg | SIN12414P | TABLET | 2.5 mg | 8/30/2003 | |
| Methotrexate Injection BP 50mg in 2ml | SIN14155P | INJECTION | 50mg/2ml | 6/11/2012 | |
| METHOTREXATE ORION TABLETS 2.5 MG | SIN16395P | TABLET | 2.5mg | 12/9/2021 | |
| METHOTREXATE INJECTION BP 1000mg in 10ml | SIN04993P | INJECTION | 100mg/ml | 8/3/1990 | |
| METHOTREXATE TABLET 2.5 mg | SIN00260P | TABLET | 2.500 mg | 4/6/1988 | |
| DBL METHOTREXATE INJECTION BP 1 g/10 ml | SIN00242P | INJECTION | 1 g/10 ml | 4/25/1988 | |
| METHOTREXATE REMEDICA FILM-COATED TABLET 2.5MG | SIN17136P | TABLET, FILM COATED | 2.50mg | 11/12/2024 |
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. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Pfizer (Australia) METHOTREXATE 50mg/2mL injection BP | 10777 | Medicine | A | 7/9/1991 | |
| METHOTREXATE INTAS methotrexate 1000mg/10mL injection vial | 213735 | Medicine | A | 10/10/2014 | |
| TREXJECT methotrexate (as sodium) 22.5mg/0.45mL solution for injection pre-filled syringe | 233720 | Link Medical Products Pty Ltd T/A Link Pharmaceuticals | Medicine | A | 8/25/2015 |
| METHOTREXATE CIPLA 10 methotrexate10 mg tablet blister pack | 365594 | Medicine | A | 5/15/2023 | |
| DBL METHOTREXATE 500mg/20mL Injection | 47252 | Medicine | A | 1/31/1994 | |
| DBL METHOTREXATE 1g/10mL Injection | 16312 | Medicine | A | 10/8/1991 | |
| Methotrexate Injection 500 mg/20 mL (1) | 401082 | Medicine | A | 12/14/2022 | |
| CHEXATE methotrexate (as sodium) 10 mg tablet blister pack | 380990 | Medicine | A | 11/14/2022 | |
| Hospira Methotrexate 25mg/mL Injection 50mg/2mL vial | 124492 | Medicine | A | 12/21/2005 | |
| ARX-METHOTREXATE methotrexate 10 mg/0.4 mL solution for injection pre-filled syringe | 408398 | Medicine | A | 2/8/2024 |
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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