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Drug

Methotrexate

Approved · EMA
ClassDihydrofolate reductase inhibitorEmerging researchLate-stage developmentSteady momentum
Also known as 4-amino-10-methylfolic acid, 4-amino-N(10)-methylpteroylglutamic acid, Amethopterin, Jylamvo+13 more

4-amino-10-methylfolic acid, 4-amino-N(10)-methylpteroylglutamic acid, Amethopterin, Jylamvo, MTX, MTX - methotrexate, Otrexup, Rasuvo, RediTrex, Trexall, Xatmep, methylaminopterin, Methotrexat, Metotrexato, Méthotrexate, Methotrexate Sodium, Methotrexatum.

13
Research papers
32
Active clinical trials
Dihydrofolate reductase
Primary target
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents

Clinical trial2026-07-16Results expected Q4 2026 · ClinicalTrials.gov

Phase II Study of Hyper-CVAD Plus Nelarabine in Previously Untreated T-ALL and Lymphoblastic Lymphoma

Clinical trial2026-07-15Results expected Q4 2026 · ClinicalTrials.gov

Adalimumab plus Methotrexate for Uveitis in Juvenile Idiopathic Arthritis.

Research2017-04-01The New England journal of medicine

Approval: Jylamvo (EMA)

Regulatory2017-03-29EMA

Approval: Nordimet (EMA)

Regulatory2016-08-18EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Methotrexate
Aliases & brands
4-amino-10-methylfolic acid4-amino-N(10)-methylpteroylglutamic acidAmethopterinJylamvoMTXMTX - methotrexateOtrexupRasuvoRediTrexTrexallXatmepmethylaminopterinMethotrexatMetotrexatoMéthotrexateMethotrexate SodiumMethotrexatum
RxNorm CUI
6851
ChEMBL ID
CHEMBL34259
ATC codes
L04AX03L01BA01
UNII
YL5FZ2Y5U1
Primary mechanism
Dihydrofolate reductase inhibitor
Regulatory jurisdictions
emamhra

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

INHIBITORDihydrofolate reductase inhibitor

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2016-08-18
Latest approval
2017-03-29
Authorities
EMA · MHRA
Total events
3
emaEuropean Medicines Agency· 2 events
2017-03-29Approval
Approval: Jylamvo (EMA)
Indication: In rheumatological and dermatological diseases Active rheumatoid arthritis in adult patients. Polyarthritic forms of active, severe juvenile idiopathic arthritis (JIA) inShow full indication

In rheumatological and dermatological diseases Active rheumatoid arthritis in adult patients. Polyarthritic forms of active, severe juvenile idiopathic arthritis (JIA) in adolescents and children aged 3 years and over when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequate. Severe, treatment-refractory, disabling psoriasis which does not respond sufficiently to other forms of treatment such as phototherapy, psoralen and ultraviolet A radiation (PUVA) therapy and retinoids, and severe psoriatic arthritis in adult patients. In oncology Maintenance treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children aged 3 years and over.

Evidence ↗
2016-08-18Approval
Approval: Nordimet (EMA)
Indication: Nordimet is indicated for the treatment of: active rheumatoid arthritis in adult patients, polyarthritic forms of severe, active juvenile idiopathic arthritis (JIA), when theShow full indication

Nordimet is indicated for the treatment of: active rheumatoid arthritis in adult patients, polyarthritic forms of severe, active juvenile idiopathic arthritis (JIA), when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate, moderate to severe plaque psoriasis in adults who are candidates for systemic therapy, and severe psoriatic arthritis in adult patients,  induction of remission in moderate steroid-dependent Crohn's disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2023-08-30Safety communicationSafety
Drug Safety Update: Methotrexate: advise patients to take precautions in the sun to avoid photosensitivity reactions
Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

196 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
196
registered trials across all phases
LATEST COMPLETION 2025
32
Active studies
19
Recruiting
96
Late-stage (III+)
124
Completed
40
Discontinued
PHASE DISTRIBUTIONn = 196
Early Phase 14Phase 116Phase 1 / 28Phase 272Phase 2 / 33Phase 350Phase 432Phase N / A11

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

13 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20032020
Most influential
Recent papers
Major research themes4
Autoimmune Diseases1Cystectomy1Immunomodulation1Inflammation1
Journals, researchers & institutions
Top journals
  • Annals of the rheumatic diseases2
  • The British journal of dermatology2
  • The New England journal of medicine2
  • American heart journal1
  • Annals of internal medicine1
  • Cell research1
Leading researchers
  • Amital H2
  • Bernasconi C2
  • Conaghan PG2
  • Dougados M2
  • Huizinga TW2
  • Kissel K2
  • Mola EM2
  • Ortonne JP2
Leading institutions
free-text, unnormalised
  • Brigham and Women's Hospital1
  • Catholic Children's Hospital1
  • Center for Rheumatology1
  • Charité University Medicine1
  • Cochin Hospital1
  • Comprehensive Center for Inflammation Medicine1

Related drugs

7 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Studied across 3 of the same disease areas as Methotrexate in the shared literature.

3 shared diseases1 shared paper

Studied across 3 of the same disease areas as Methotrexate in the shared literature.

3 shared diseases1 shared paper

Studied across 3 of the same disease areas as Methotrexate in the shared literature.

3 shared diseases1 shared paper

Studied across 3 of the same disease areas as Methotrexate in the shared literature.

3 shared diseases1 shared paper

Studied across 2 of the same disease areas as Methotrexate in the shared literature.

2 shared diseases1 shared paper

Studied across 2 of the same disease areas as Methotrexate in the shared literature.

2 shared diseases1 shared paper

Studied across 2 of the same disease areas as Methotrexate in the shared literature.

2 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.