Methotrexate

Generic Name: Methotrexate

Brand Names: Metoject, Nordimet, Otrexup, Rasuvo, Reditrex, Trexall, Xatmep, Jylamvo

Drug Type: Small Molecule

Chemical Formula: C_₂₀H_₂₂N_₈O_₅

CAS Number: 59-05-2

Unique Ingredient Identifier: YL5FZ2Y5U1

Background: 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

Associated Therapies: Medically induced abortion

Clinical Trials

Standard of Care vs. Bortezomib in Graft-Versus Host Disease After Hematopoietic Stem Cell Transplant

Phase 2

Completed

Conditions: Graft Versus Host Disease

Interventions: Drug: Tacrolimus
Drug: Methotrexate
Drug: Bortezomib
Drug: Sirolimus

First Posted Date: 2012-12-21

Last Posted Date: 2017-07-18

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 138

Registration Number: NCT01754389

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Insitute, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

and more 1 locations

A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Methotrexate in Patients With Rheumatoid Arthritis

Phase 1

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: peficitinib
Drug: methotrexate

First Posted Date: 2012-12-21

Last Posted Date: 2024-10-21

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 15

Registration Number: NCT01754805

The Effects of mETHotrexate Therapy on ST Segment Elevation MYocardial InfarctionS (TETHYS Trial)

Phase 2

Conditions: Myocardial Infarction

Interventions: Drug: Methotrexate
Drug: Riboflavin

First Posted Date: 2012-12-05

Last Posted Date: 2013-04-09

Lead Sponsor: Instituto de Cardiologia do Rio Grande do Sul

Target Recruit Count: 80

Registration Number: NCT01741558

Locations: 🇧🇷
Instituto de Cardiologia do Rio Grande do Sul / Fundação Universitária de Cardiologia, Porto Alegre, Rio Grande do Sul, Brazil
🇧🇷
Instituto de Cardiologia de Santa Catarina, São José, Santa Catarina, Brazil

Methotrexate Infusion Into the Fourth Ventricle in Children With Malignant Fourth Ventricular Brain Tumors: A Pilot Study

Early Phase 1

Completed

Conditions: Brain Tumor
Malignant Neoplasm of Fourth Ventricle of Brain

Interventions: Procedure: Ommaya Reservoir
Drug: Methotrexate
Drug: Leucovorin

First Posted Date: 2012-11-29

Last Posted Date: 2018-01-19

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 7

Registration Number: NCT01737671

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
Children's Memorial Hermann Hospital, Houston, Texas, United States

A Study in Participants With Moderate to Severe Rheumatoid Arthritis

Phase 3

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Baricitinib
Drug: MTX Placebo
Drug: Baricitinib Placebo
Drug: Methotrexate
Drug: Folic Acid

First Posted Date: 2012-10-22

Last Posted Date: 2019-09-19

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 588

Registration Number: NCT01711359

Locations: 🇬🇧
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., North Shields, Tyneside, United Kingdom

A Study in Moderate to Severe Rheumatoid Arthritis

Phase 3

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Adalimumab
Drug: Methotrexate
Drug: Baricitinib
Drug: Adalimumab Placebo
Drug: Baricitinib Placebo

First Posted Date: 2012-10-19

Last Posted Date: 2019-09-18

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 1307

Registration Number: NCT01710358

Locations: 🇺🇸
Metroplex Clinical Research Center, Dallas, Texas, United States
🇺🇸
The Seattle Arthritis Clinic, Seattle, Washington, United States
🇺🇸
Valley Arthritis Care, LLC, Phoenix, Arizona, United States

and more 45 locations

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

Phase 3

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: placebo
Drug: Sarilumab
Drug: hydroxychloroquine
Drug: methotrexate
Drug: sulfasalazine
Drug: leflunomide

First Posted Date: 2012-10-18

Last Posted Date: 2017-08-08

Lead Sponsor: Sanofi

Target Recruit Count: 546

Registration Number: NCT01709578

Locations: 🇺🇸
Investigational Site Number 840018, Idaho Falls, Idaho, United States
🇺🇸
Investigational Site Number 840058, Columbia, South Carolina, United States
🇺🇸
Investigational Site Number 840124, Clarksburg, West Virginia, United States

and more 193 locations

A Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With Methotrexate Versus Methotrexate Alone in Patients With RA

Phase 3

Conditions: Rheumatoid Arthritis

Interventions: Drug: Methotrexate
Drug: ENIA11
Drug: Placebo

First Posted Date: 2012-10-18

Last Posted Date: 2018-04-17

Lead Sponsor: Mycenax Biotech Inc.

Target Recruit Count: 91

Registration Number: NCT01709760

Locations: 🇨🇳
Taichung Veterans General Hospital, Taichung, Taiwan
🇨🇳
Changhua Christian Hospital, Changhua, Taiwan
🇨🇳
Buddhist Tzu Chi General Hospital, Chiayi City, Taiwan

and more 5 locations

Swiss Dermatology Network of Targeted Therapies (SDNTT)

Recruiting

Conditions: Psoriasis

Interventions: Biological: Adalimumab
Biological: Etanercept
Biological: Infliximab
Biological: Ustekinumab
Drug: Cyclosporine A
Drug: Fumaric acids
Drug: Other anti-psoriatic systemic treatments
Drug: Methotrexate

First Posted Date: 2012-10-15

Last Posted Date: 2024-11-29

Lead Sponsor: Swiss Dermatology Network for Targeted Therapies

Target Recruit Count: 1121

Registration Number: NCT01706692

Locations: 🇨🇭
Aarau Cantonal Hospital, Aarau, Switzerland
🇨🇭
Inselspital - Bern University Hospital, Bern, Switzerland
🇨🇭
Basel University Hospital, Basel, Switzerland

and more 3 locations

Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma

Phase 2

Completed

Conditions: Recurrent B-Cell Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood B-Lymphoblastic Lymphoma

Interventions: Drug: dexamethasone
Drug: vincristine sulfate
Biological: rituximab
Drug: clofarabine
Drug: cyclophosphamide
Drug: etoposide
Biological: aldesleukin
Drug: pegaspargase
Drug: methotrexate
Drug: mercaptopurine
Drug: cytarabine
Drug: mitoxantrone
Drug: teniposide
Drug: vinblastine
Biological: natural killer cell infusion
Other: laboratory biomarker analysis
Procedure: allogeneic hematopoietic stem cell transplantation
Drug: therapeutic hydrocortisone
Device: CliniMACS

First Posted Date: 2012-10-04

Last Posted Date: 2022-09-28

Lead Sponsor: St. Jude Children's Research Hospital

Target Recruit Count: 80

Registration Number: NCT01700946

Locations: 🇺🇸
Rady Children's Hospital and Health Center, San Diego, California, United States
🇺🇸
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
🇺🇸
Cook Children's Medical Center, Fort Worth, Texas, United States

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy