Methotrexate: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Methotrexate appears in the FDA drug-label database. Marketed as Methotrexate.
- Drug class
- Folate Analog Metabolic Inhibitor (FDA established pharmacologic class)
- Mechanism of action
- Folic Acid Metabolism Inhibitors (as stated on the FDA label)
- Boxed warning
- The FDA label for Methotrexate carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Methotrexate tablets are a dihydrofolate reductase inhibitor indicated for the: • Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen ( 1.1 ) • Treatment of adults with mycosis fungoides ( 1.1 ) • Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen ( 1.1 ) • Treatment of adults with rheumatoid arthritis ( 1.2 ) • Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) ( 1.3 ) • Treatment of adults with severe psoriasis ( 1.4 ) 1.1 Neoplastic Diseases Methotrexate tablets are indicated for the: • treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen • treatment of adults with mycosis fungoides (cutaneous T-cell lymphoma) as a single agent or as part of a combination chemotherapy regimen. • treatment of adults with relapsed or refractory non-Hodgkin lymphomas as part of a metronomic combination chemotherapy regimen 1.2 Rheumatoid Arthritis Methotrexate tablets are indicated for the treatment of adults with rheumatoid ar…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| CGMP Deviations: Intermittent exposure to temperature excursion during storage. — Cardinal Health Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2021-03-15 |
| The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded pa — Hospira Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2012-06-27 |
| Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring. — West-Ward Columbus Inc | Class III (FDA: unlikely to cause harm) | Ongoing | 2023-09-22 |
Phase breakdown
Conditions being studied
Recruiting trials involving Methotrexate
- BRE-08 Phase II Study of CMC Regimen for Early Stage Breast Cancer
- Card14gene (rs34367357 ) Polymorphism in Egyptian Psoriatic and Psoriatic Arthritis Patient
- Comparison Between Oral Methotrexate and Tofacitinib in Chronic Plaque Psoriasis
- Complementary Herbal Approach to Rheumatoid Management Study (CHARMS)
- Effect of MTX Discontinuation on Shingrix Response in RA
- Efficacy and Safety of Methotrexate Versus Placebo in Adults With Atopic Dermatitis.
- Efficacy and Safety of Resveratrol in Patients With Rheumatoid Arthritis.
- Genetic Variation in TRAF3IP2 (rs13190932)
- Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
- MethMax Trial: MAXimising the METHotrexate Therapy Potential in Patients with Active Rheumatoid Arthritis
- Methotrexate Combined With Tofacitinib in Rheumatoid Arthritis
- Microbiome and Clinical Response to Probiotics and Methotrexate in Early Psoriasis: a Pilot Study
- Mind and Skin - the Neurocutaneous Axis in Atopic Eczema
- Outcomes With Treatment and Withdraw of Ixekizumab in Patients With Plaque Psoriasis
- Pentoxifylline as Anti-Inflammatory in Patients With Rheumatoid Arthritis
- STep-up and Step-down Therapeutic Strategies in Childhood ARthritiS
- Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer
- Swiss Dermatology Network of Targeted Therapies (SDNTT)
- The Clinical Efficacy of Immunomodulators in RA Patients
- To Check Comparison of Apremilast and Methotrexate Efficacy in Patients With Moderate to Severe Plaque Psoriasis Presented to Tertiary Care Hospital
- Treatment of Psoriasis With Depression and/or Anxiety With Methotrexate vs Combined Methotrexate and Antidepressant
- Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response
Common questions
Is Methotrexate FDA-approved?
Yes, marketed as Methotrexate. Its FDA label carries a boxed warning.
How many recruiting trials involve Methotrexate?
22 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.