Methotrexate clinical trials
Methotrexate is named as an intervention in 119 current clinical trials in our China, Canada, Australia, Israel, France, Mexico, Egypt, USA, Germany, Italy, Spain, Japan, Netherlands, Switzerland, Austria, Czechia, Norway, Brazil, Singapore, Sweden, Poland, South Korea, Taiwan, Belgium, Denmark, Ireland, UK, Portugal and Turkey registers. 72 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is National Cancer Institute (NCI) (9). The most-studied condition is Acute Lymphoblastic Leukemia. The EU clinical trials register (CTIS) separately lists 6 authorised or ongoing trials.
Where Methotrexate is approved
All regulators →Of the three regulators tracked here, the first to approve Methotrexate was the US, on 7 Dec 1953. It is approved in 3 of the 3 regulators tracked here.
- 5 EU orphan designations, most recently for treatment of primary large B-cell lymphoma of immune-privileged sites (22 Aug 2025, positive)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Methotrexate patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Methotrexate, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 11 listed patents; the last listed expires 28 Oct 2035 (US 11129833).
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Methotrexate
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Methotrexate works
All drug targets →- Dihydrofolate reductase inhibitor InhibitorTarget: DHFR dihydrofolate reductase✓ In ChEMBL and the Guide to Pharmacology
- B-cell acute lymphoblastic leukemiaPhase 3
- Crohn diseasePhase 3
- Hodgkins lymphomaPhase 3
- IgG4-related retroperitoneal fibrosisPhase 3
- Langerhans cell histiocytosisPhase 3
- T-cell acute lymphoblastic leukemiaPhase 3
- T-cell non-Hodgkin lymphomaPhase 3
- T-lymphoblastic lymphomaPhase 3
- Takayasu arteritisPhase 3
- Acute graft versus host diseasePhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL34259, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 4674, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Methotrexate
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 48 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EU
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Methotrexate
- ChEMBL
- CHEMBL34259
- DrugBank
- DB00563
- PubChem CID
- 126941
- CAS number
- 59-05-2
- FDA UNII
- YL5FZ2Y5U1
- Wikidata
- Q422232
- Wikipedia
- Methotrexate
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Methotrexate
119 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Methotrexate in the EU trials register (CTIS)
6 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Methotrexate. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
Methotrexate across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
48 single-substance products containing Methotrexate on the HPRA medicines list.
- Methofill 10 mg solution for injection in pre-filled injectorAccord Healthcare Ireland Ltd. · PA2315/060/003 · Marketed
- Methofill 12.5 mg solution for injection in pre-filled injectorAccord Healthcare Ireland Ltd. · PA2315/060/004 · Marketed
- Methofill 15 mg solution for injection in pre-filled injectorAccord Healthcare Ireland Ltd. · PA2315/060/005 · Marketed
- Methofill 17.5 mg solution for injection in pre-filled injectorAccord Healthcare Ireland Ltd. · PA2315/060/006 · Marketed
- Methofill 20 mg solution for injection in pre-filled injectorAccord Healthcare Ireland Ltd. · PA2315/060/007 · Marketed
Supply shortages
- MethotrexateEU (EMA) · Shortage resolved · first published 9 Aug 2023
- Methotrexate Sodium InjectionUS (FDA) · Current · updated 3 Nov 2026
- Methofill 20 mg Injektionslösung im FertiginjektorGermany (BfArM) · Production problem · 30 Jun 2026 to 31 Dec 2027
- Methofill 20 mg Injektionslösung im FertiginjektorGermany (BfArM) · Production problem · 30 Jun 2026 to 31 Dec 2027
- Methofill 25 mg Injektionslösung im FertiginjektorGermany (BfArM) · Production problem · 31 Jul 2026 to 31 Dec 2027
- Methofill 25 mg Injektionslösung im FertiginjektorGermany (BfArM) · Production problem · 31 Jul 2026 to 31 Dec 2027
- Methofill 10 mg Injektionslösung im FertiginjektorGermany (BfArM) · Production problem · 18 Oct 2026 to 31 Dec 2026
- Methofill 30 mg Injektionslösung im FertiginjektorGermany (BfArM) · Production problem · 31 May 2026 to 31 Dec 2027
+ 8 more German shortage notices.
Conditions studied with Methotrexate
132 conditionsAll 132 conditions
| Condition (as registered) | Trials |
|---|---|
| Acute Lymphoblastic Leukemia | 10 |
| B Acute Lymphoblastic Leukemia | 7 |
| Rheumatoid Arthritis | 6 |
| Childhood Leukemia, Acute Lymphoblastic | 4 |
| Primary Central Nervous System Lymphoma | 4 |
| Rheumatoid Arthritis (RA) | 4 |
| Mixed Phenotype Acute Leukemia | 3 |
| Recurrent B Acute Lymphoblastic Leukemia | 3 |
| Down Syndrome | 3 |
| B Lymphoblastic Lymphoma | 3 |
| Ectopic Pregnancy | 3 |
| Lymphoblastic Lymphoma, Childhood | 2 |
| Arthritis, Rheumatoid | 2 |
| Gout | 2 |
| Precursor Cell Lymphoblastic Leukemia-Lymphoma | 2 |
| Acute Lymphoblastic Leukemia ALL | 2 |
| B Cell Acute Lymphoblastic Leukemia (B-ALL) | 2 |
| Gestational Trophoblastic Neoplasia | 2 |
| Graft Versus Host Disease | 2 |
| Medulloblastoma | 2 |
| Acute Lymphoblastic Leukemia, Pediatric | 2 |
| Hematologic Malignancy | 2 |
| Psoriasis | 2 |
| Hand Osteoarthritis | 2 |
| Erosive Osteoarthritis | 2 |
| Acute Myeloid Leukemia | 2 |
| Recurrent Acute Lymphoblastic Leukemia | 2 |
| B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 | 2 |
| Plaque Psoriasis | 2 |
| Psoriatic Arthritis | 2 |
| Childhood Ependymoma | 1 |
| Multiple Myeloma | 1 |
| Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL) | 1 |
| Lymphoma | 1 |
| Phenylketonuria | 1 |
| Graft-versus-host Disease (GVHD) | 1 |
| Carcinoma, Non-Small-Cell Lung | 1 |
| Uncontrolled Gout | 1 |
| Solid Tumors | 1 |
| Graft-versus-host Disease | 1 |
| Extranodal NK/T-cell Lymphoma | 1 |
| Precursor B-Cell Lymphoblastic Leukemia | 1 |
| DLBCL - Diffuse Large B Cell Lymphoma | 1 |
| PCNSL | 1 |
| Primary Intraocular Lymphoma | 1 |
| Acute Leukemia of Ambiguous Lineage | 1 |
| Neuroblastoma | 1 |
| Squamous Cell Carcinoma of the Head and Neck | 1 |
| Diffuse Large B-Cell Lymphoma | 1 |
| Primary Central Nervous System Lymphoma (PCNSL) | 1 |
| Secondary Central Nervous System Lymphoma (SCNSL) | 1 |
| Hematologic Neoplasms | 1 |
| Central Nervous System Lymphoma | 1 |
| Gestational Trophoblastic Tumor | 1 |
| Stage I Gestational Trophoblastic Tumor | 1 |
| Stage II Gestational Trophoblastic Tumor | 1 |
| T Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma | 1 |
| Lymphomas | 1 |
| Takayasu Arteritis | 1 |
| Rheumatoid Arthritis Associated Interstitial Lung Disease | 1 |
| Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+) | 1 |
| Non-Hodgkin Lymphoma | 1 |
| Mature B-cell Non-Hodgkin Lymphoma | 1 |
| T Acute Lymphoblastic Leukemia | 1 |
| Urinary Bladder Neoplasms | 1 |
| Immune Checkpoint Inhibitors | 1 |
| Methotrexate | 1 |
| Vinblastine | 1 |
| Acute Myeloid Leukemia (AML) | 1 |
| Metastatic Breast Cancer | 1 |
| Sarcoma | 1 |
| Insufficient Response to Methotrexate or Leflunomide | 1 |
| Erosive Hand Osteoarthritis | 1 |
| Moderate to Severe Atopic Dermatitis | 1 |
| Dermatitis, Atopic | 1 |
| Juvenile Chronic Arthritis | 1 |
| Frontal Fibrosing Alopecia | 1 |
| Cicatricial Alopecia | 1 |
| Acute Myeloid Leukemia in Children | 1 |
| Alopecia Areata(AA) | 1 |
| Alopecia Areata (AA) | 1 |
| Alopecia Totalis/Universalis | 1 |
| Alopecia Universalis (AU) | 1 |
| Metastatic Colorectal Cancer | 1 |
| Juvenile Idiopathic Arthritis | 1 |
| Non-hodgkin Lymphoma | 1 |
| B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative | 1 |
| Sickle Cell Disease | 1 |
| Central Nervous System Leukemia | 1 |
| Lymphoblastic Leukemia | 1 |
| Central Nervous System Embryonal Tumors | 1 |
| Adult T Acute Lymphoblastic Leukemia | 1 |
| Ann Arbor Stage II Adult Lymphoblastic Lymphoma | 1 |
| Ann Arbor Stage II Childhood Lymphoblastic Lymphoma | 1 |
| Ann Arbor Stage III Adult Lymphoblastic Lymphoma | 1 |
| Recurrent Acute Leukemia of Ambiguous Lineage | 1 |
| Recurrent Acute Myeloid Leukemia Due to Lineage Switch From Acute Leukemia of Ambiguous Lineage | 1 |
| Recurrent Acute Myeloid Leukemia Due to Lineage Switch From B Acute Lymphoblastic Leukemia, KMT2A-Rearranged | 1 |
| Cardiac Sarcoidosis | 1 |
| Sarcoidosis | 1 |
| Myelodysplastic Syndrome | 1 |
| Vulvar Lichen Sclerosus | 1 |
| Acute Lymphoblastic Leukemia, in Relapse | 1 |
| Acute Lymphoblastic Leukemia With Failed Remission | 1 |
| Acute Lymphoid Leukemia | 1 |
| Minimal Residual Disease | 1 |
| Gene Abnormality | 1 |
| Chemotherapeutic Toxicity | 1 |
| Renal Pelvis and Ureter Urothelial Carcinoma | 1 |
| Childhood Cancer | 1 |
| Leukemia, Lymphoblastic, Acute, Philadelphia-Positive | 1 |
| Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia | 1 |
| Drug Drug Interaction (DDI) | 1 |
| Idiopathic Granulomatous Mastitis | 1 |
| B Lymphoblastic Leukemia | 1 |
| AML | 1 |
| ALL | 1 |
| BPDCN | 1 |
| Acute Lymphoblastic Lymphoma | 1 |
| Healthy Volunteers | 1 |
| ALL, Childhood | 1 |
| Lymphoblastic Leukemia, Acute, Childhood | 1 |
| Recurrent B Lymphoblastic Lymphoma | 1 |
| Refractory B Acute Lymphoblastic Leukemia | 1 |
| Refractory B Lymphoblastic Lymphoma | 1 |
| Rheumatic Arthritis | 1 |
| Rheumatoid Arthritis (RA) Prevention | 1 |
| Inflamation | 1 |
| Antioxidant | 1 |
| Squamous Cell Carcinoma | 1 |
| Advanced Head and Neck Cancer | 1 |
| Psoriasis (PsO) | 1 |
Sponsors
lead sponsor per trial+ 68 more sponsors in the trial list above.
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Methotrexate trials
How many clinical trials are testing Methotrexate?
119 current trials in our China, Canada, Australia, Israel, France, Mexico, Egypt, USA, Germany, Italy, Spain, Japan, Netherlands, Switzerland, Austria, Czechia, Norway, Brazil, Singapore, Sweden, Poland, South Korea, Taiwan, Belgium, Denmark, Ireland, UK, Portugal and Turkey registers name Methotrexate (also registered as CL 14377) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Methotrexate trials recruiting patients?
Yes. 72 of the 119 trials are recruiting: 25 with sites in China, 9 with sites in Canada, 9 with sites in Australia, 8 with sites in Israel, 9 with sites in France, 5 with sites in Mexico, 6 with sites in Egypt, 5 with sites in USA, 5 with sites in Germany, 5 with sites in Italy, 4 with sites in Spain, 2 with sites in Japan, 5 with sites in Netherlands, 4 with sites in Switzerland, 4 with sites in Austria, 4 with sites in Czechia, 4 with sites in Norway, 5 with sites in Brazil, 3 with sites in Singapore, 2 with sites in Sweden, 2 with sites in Poland, 1 with sites in South Korea, 1 with sites in Taiwan, 2 with sites in Belgium, 2 with sites in Denmark, 2 with sites in Ireland and 1 with sites in Portugal. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Methotrexate clinical trials?
National Cancer Institute (NCI) (9), Institute of Hematology & Blood Diseases Hospital, China (7), Children's Oncology Group (6) and Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (3), among 83 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Methotrexate clinical trials in Ireland?
Yes. 2 trials in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Methotrexate licensed in Ireland?
Yes. The HPRA medicines list includes 48 single-substance products containing Methotrexate, for example Methofill 10 mg solution for injection in pre-filled injector (Accord Healthcare Ireland Ltd.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Methotrexate shortage?
The registers we track list 16 entries for Methotrexate: Methotrexate (EU: shortage resolved); US FDA: current; 14 German notices. Shortages are product- and country-specific; check with a pharmacist.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Methotrexate works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Methotrexate works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Methotrexate (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.