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Methotrexate sodium, Nordimet(methotrexate)
Jylamvo, Methotrexate, Nordimet, Otrexup, Rasuvo, Reditrex, Xatmep (methotrexate) is a small molecule pharmaceutical. Methotrexate was first approved as Methotrexate sodium on 1982-01-01. It is used to treat breast neoplasms, choriocarcinoma, crohn disease, esophageal neoplasms, and hydatidiform mole amongst others in the USA. It has been approved in Europe to treat arthritis, juvenile arthritis, precursor cell lymphoblastic leukemia-lymphoma, psoriasis, and psoriatic arthritis amongst others. The pharmaceutical is active against dihydrofolate reductase. In addition, it is known to target reduced folate transporter and proton-coupled folate transporter.
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Drugs Approved for Childhood Cancers
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
musculoskeletal diseasesD009140
digestive system diseasesD004066
respiratory tract diseasesD012140
urogenital diseasesD000091642
hemic and lymphatic diseasesD006425
skin and connective tissue diseasesD017437
endocrine system diseasesD004700
immune system diseasesD007154
Trade Name
FDA
EMA
Jylamvo, Otrexup, Rasuvo, Reditrex, Xatmep (generic drugs available since 1986-09-16, discontinued: Abitrexate, Folex, Mexate, Mexate-aq, Mexate-aq preserved)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Calcium chloride
+
Dextrose
+
Glutathione disulfide
+
Magnesium chloride
+
Potassium chloride
+
Sodium bicarbonate
+
Sodium chloride
+
Sodium phosphate
Tradename
Company
Number
Date
Products
METHOTREXATE SODIUMAkornN-020079 DISCN1999-02-26
1 products
Hide discontinued
Methotrexate
Tradename
Company
Number
Date
Products
RASUVOMedexus PharmaceuticalsN-205776 RX2014-07-10
9 products, RLD, RS
REDITREXNordic PharmaN-210737 RX2019-11-27
3 products, RLD, RS
OTREXUPOtter PharmaceuticalsN-204824 RX2013-10-11
7 products, RLD, RS
JYLAMVOTherakindN-212479 RX2022-11-29
1 products, RLD, RS
Show 5 discontinued
Methotrexate sodium
Tradename
Company
Number
Date
Products
XATMEPAzurityN-208400 RX2017-04-25
1 products, RLD, RS
METHOTREXATE SODIUM PRESERVATIVE FREEHospiraN-011719 RX2005-04-13
1 products, RLD, RS
METHOTREXATE SODIUMHospiraN-011719 RX2004-12-15
1 products, RLD, RS
Show 5 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
methotrexateANDA2023-05-24
otrexupNew Drug Application2020-11-23
rasuvoNew Drug Application2020-03-20
reditrexNew Drug Application2019-12-11
trexallANDA2021-04-30
xatmepNew Drug Application2020-09-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
breast neoplasmsEFO_0003869D001943C50
choriocarcinoma—D002822C58
crohn diseaseEFO_0000384D003424K50
esophageal neoplasms—D004938C15
hydatidiform mole—D006828O01
juvenile arthritisEFO_0002609D001171M08
leukemia—D007938C95
lung neoplasms—D008175C34.90
mycosis fungoides—D009182C84.0
osteosarcoma—D012516—
Show 4 more
Agency Specific
FDA
EMA
Expiration
Code
METHOTREXATE SODIUM, XATMEP, AZURITY
2024-04-25ODE-137, ODE-138
Patent Expiration
Patent
Expires
Flag
FDA Information
Methotrexate Sodium, Xatmep, Azurity
92594272033-01-02DP
98552152033-01-02DP
102319272033-01-02U-1349, U-1699
106104852033-01-02DP
111167242033-01-02U-1349, U-1699
Methotrexate, Otrexup, Otter Pharms
88148342031-05-27DP
84806312030-03-19DPU-1442
85798652030-03-19DPU-1442
89450632030-03-19DPU-1442
94213332030-03-19DPU-1442
114977532030-03-19DP
98679492029-03-10DP
107098442029-03-10DP
80213352026-10-04DP
85625642026-01-24DP
95331022026-01-24DP
96299592026-01-24DP
114464412026-01-24DP
Methotrexate, Rasuvo, Medexus
86642312029-06-01U-1442
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01B: Antimetabolites
— L01BA: Folic acid analogs, antimetabolites
— L01BA01: Methotrexate
— L04: Immunosuppressants
— L04A: Immunosuppressants
— L04AX: Other immunosuppressants in atc
— L04AX03: Methotrexate
HCPCS
Code
Description
J8610
Methotrexate; oral, 2.5 mg
J9250
Methotrexate sodium, 5 mg
J9260
Methotrexate sodium, 50 mg
Clinical
Clinical Trials
1289 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Rheumatoid arthritisD001172EFO_0000685M06.924681027118273
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.03796431810185
Graft vs host diseaseD006086D89.81102972444
PsoriasisD011565EFO_0000676L40441117639
Non-hodgkin lymphomaD008228C85.962151335
Large b-cell lymphoma diffuseD016403C83.361652—27
Psoriatic arthritisD015535EFO_0003778L40.52194521
Burkitt lymphomaD002051C83.7312—2—15
Juvenile arthritisD001171EFO_0002609M081—61311
Ectopic pregnancyD011271O00113239
Show 47 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938C952110543—11159
LymphomaD008223C85.9167622—11115
Myelodysplastic syndromesD009190D46185313—781
Breast neoplasmsD001943EFO_0003869C5062428—560
Myeloid leukemia acuteD015470C92.0132916—256
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_00003402175—124
Hodgkin diseaseD006689C812145——21
OsteosarcomaD0125162105—519
Central nervous system neoplasmsD016543492—417
Urinary bladder neoplasmsD001749C67—125——16
Show 63 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Plasma cell neoplasmsD054219417——422
Myeloproliferative disordersD009196D47.1616——320
Myelodysplastic-myeloproliferative diseasesD054437412——113
NeoplasmsD009369C8057——213
Myeloid leukemia chronic-phaseD015466112———12
Hematologic neoplasmsD01933749——112
Follicular lymphomaD008224C8227———8
Primary myelofibrosisD055728D47.425——18
Myeloid leukemia accelerated phaseD01546517———7
B-cell lymphomaD01639324———6
Show 75 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—9————9
Myeloid leukemiaD007951C923————3
Lymphoid leukemiaD007945C912————2
MelanomaD0085452————2
RecurrenceD0120082————2
Male breast neoplasmsD0185671————1
Plasma cell leukemiaD007952C90.11————1
HypersensitivityD006967EFO_0003785T78.401————1
SyndromeD0135771————1
Psychotic disordersD011618F20.811————1
Show 8 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Inflammatory bowel diseasesD015212EFO_0003767————22
Chediak-higashi syndromeD002609Orphanet_167D72.0————22
Alzheimer diseaseD000544EFO_0000249F03————11
DementiaD003704F03————11
Behcet syndromeD001528EFO_0003780M35.2————11
Uveal diseasesD014603————11
Ataxia telangiectasiaD001260Orphanet_100G11.3————11
Liver cirrhosisD008103EFO_0001422K74.0————11
Lung neoplasmsD008175C34.90————11
Malignant pleural effusionD016066J91.0————11
Show 18 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMETHOTREXATE
INNmethotrexate
Description
Methotrexate is a member of pteridines, a monocarboxylic acid amide and a dicarboxylic acid. It has a role as an antineoplastic agent, an antirheumatic drug, an EC 1.5.1.3 (dihydrofolate reductase) inhibitor, a DNA synthesis inhibitor, an abortifacient, a dermatologic drug, an antimetabolite and an immunosuppressive agent. It is functionally related to a L-glutamic acid. It is a conjugate acid of a methotrexate(1-).
Classification
Small molecule
Drug classantimetabolites (folic acid derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1
Identifiers
PDB1AXW
CAS-ID59-05-2
RxCUI6851
ChEMBL IDCHEMBL34259
ChEBI ID44185
PubChem CID126941
DrugBankDB00563
UNII IDYL5FZ2Y5U1 (ChemIDplus, GSRS)
Target
Agency Approved
DHFR
DHFR
Organism
Homo sapiens
Gene name
DHFR
Gene synonyms
NCBI Gene ID
1719
Protein name
dihydrofolate reductase
Protein synonyms
Uniprot ID
Q6IRW8
Mouse ortholog
Dhfr (13361)
dihydrofolate reductase (Q61579)
Alternate
SLC19A1
SLC19A1
SLC46A1
SLC46A1
Organism
Homo sapiens
Gene name
SLC19A1
Gene synonyms
FLOT1, RFC1
NCBI Gene ID
6573
Protein name
reduced folate transporter
Protein synonyms
Cyclic dinucleotide:anion antiporter SLC19A1, folate transporter 1, Folate:anion antiporter SLC19A1, hRFC, hSLC19A1, IFC-1, Intestinal folate carrier 1, Placental folate transporter, reduced folate carrier 1, Reduced folate carrier protein, Reduced folate transporter 1, RFC, RFT-1, solute carrier family 19 (folate transporter), member 1, Solute carrier family 19 member 1
Uniprot ID
P41440
Mouse ortholog
Slc19a1 (20509)
reduced folate transporter (Q62451)
Variants
Clinical Variant
Identifier
Target mutation
Effect
Evaluation
Status
VCV000157588SLC19A1, 80A>G, His27Argdrug response2021-03-242A
VCV000003520MTHFR, 665C>T, Ala222Valdrug response2021-10-212A
VCV000225999ATIC, 1503+675T>Cdrug response2021-03-242B
Financial
Otrexup - Assertio Therapeutics
$
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£
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Reditrex - Cumberland Pharmaceuticals
$
€
£
₣
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Methotrexate - Pfizer
$
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 107,406 documents
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Safety
Black-box Warning
Black-box warning for: Methotrexate, Otrexup, Rasuvo, Reditrex, Trexall, Xatmep
Adverse Events
Top Adverse Reactions
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119,211 adverse events reported
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