Product Description
Methotrexate is one of the most effective and commonly used medications in the treatment of rheumatoid arthritis and other forms of inflammatory arthritis, and also may be used to treat lupus, inflammatory myositis, vasculitis, and some forms of childhood arthritis. It is often used in combination with other medications to treat arthritis. It is known as a disease-modifying anti-rheumatic drug (DMARD), because it not only decreases the pain and swelling of arthritis, but it also can decrease damage to joints and long-term disability. (Sourced from: https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Treatments/Methotrexate-Rheumatrex-Trexall)
Mechanisms of Action: DHFR Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral,Intravenous
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Arthritis, Juvenile | Arthritis, Rheumatoid | Psoriasis | Arthritis | Acute Leukemia | Acute Lymphoid Leukemia | Hodgkin Lymphoma | Leukemia | Lymphoid Leukemia | Lymphoma | Lymphoma, Non-Hodgkin | Osteosarcoma | Sarcoma | Arthritis, Juvenile | Arthritis | Acute Leukemia | Acute Lymphoid Leukemia | Leukemia | Lymphoid Leukemia
Known Adverse Events: Abdominal Pain | Headache | Pain Unspecified | Alopecia | Mouth Abnormalities | Stomatitis | Pancytopenia | Thrombocytopenia | Skin Abnormalities | Bronchitis | Diarrhea | Dyspepsia | Generalized anxiety disorder | Leukopenia | Tumor Lysis Syndrome | Acute Leukemia | Acute Lymphoid Leukemia | Hodgkin Lymphoma | Leukemia | Lymphoid Leukemia | Lymphoma | Lymphoma, Non-Hodgkin | Osteosarcoma | Sarcoma | Oncology Unspecified | Infertility, Female | Contraception | Pregnancy Outcomes | Infertility | Infertility, Male | Oligospermia | Fetal Death | Fetal Diseases | Pregnancy, Abdominal | Fetal Distress | Dizziness | Chills
Company: Hoffmann-La Roche
Company Location: BASEL SWITZERLAND V8
Company CEO: Severin Schwan
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Belarus, Belgium, Bosnia, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, Denmark, Estonia, France, Germany, Greece, Guatemala, Hungary, Ireland, Israel, Italy, Japan, Kazakhstan, Korea, Latvia, Lithuania, Malaysia, Mexico, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, Spain, Switzerland, Taiwan, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 39
Highest Development Phases
Phase 3: Arthritis, Psoriatic|Arthritis, Rheumatoid|Crohn Disease|Dermatitis, Atopic|Diffuse Large B-Cell Lymphoma|Graft vs Host Disease|Lymphoid Leukemia|Lymphoma, Non-Hodgkin|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Precursor T-Cell Lymphoblastic Leukemia-Lymphoma|Primary Central Nervous System Lymphoma|Spondyloarthritis|T-Cell Leukemia|Uveitis, Anterior|Vitreoretinopathy, Proliferative
Phase 2: Gestational Trophoblastic Disease|Retinitis Pigmentosa
Phase 1: COVID-19|Celiac Disease|Gout|Healthy Volunteers|Scleroderma, General|Type 1 Diabetes
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| INCB18424-370 | P3 |
Not yet recruiting |
Graft vs Host Disease |
2030-10-20 |
|
| NCT06730542 | P1 |
Not yet recruiting |
Primary Central Nervous System Lymphoma |
2030-03-31 |
|
| MTR² | P2 |
Not yet recruiting |
Lymphoma, Non-Hodgkin |
2027-02-01 |
|
| METorMET² | P2 |
Recruiting |
Arthritis, Rheumatoid |
2026-12-01 |