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AboutPricing
Drug ReportsLeflunomide
Arava(leflunomide)
Arava, Leflunomide (leflunomide) is a small molecule pharmaceutical. Leflunomide was first approved as Arava on 1998-09-10. It is used to treat rheumatic diseases and rheumatoid arthritis in the USA. It has been approved in Europe to treat psoriatic arthritis and rheumatoid arthritis. The pharmaceutical is active against dihydroorotate dehydrogenase (quinone), mitochondrial.
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Clinical
Drug
Target
Variants
Financial
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Safety
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FDA approval date
EMA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
skin and connective tissue diseasesD017437
immune system diseasesD007154
Trade Name
FDA
EMA
Arava, Leflunomide (discontinued: Leflunomide)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Leflunomide
Tradename
Company
Number
Date
Products
ARAVASanofiN-020905 RX1998-09-10
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
aravaNew Drug Application2025-06-04
inflathermANDA2022-12-07
lefluniclounapproved drug other2023-03-29
leflunomideANDA2025-06-27
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
L04: Immunosuppressants
L04A: Immunosuppressants
L04AA: Selective immunosuppressants
L04AA13: Leflunomide
HCPCS
No data
Clinical
Clinical Trials
133 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ArthritisD001168EFO_0005856M05-M142924211770
Rheumatoid arthritisD001172EFO_0000685M06.92822181462
Systemic lupus erythematosusD008180EFO_0002690M3213138
Psoriatic arthritisD015535EFO_0003778L40.511237
Juvenile arthritisD001171EFO_1002007M0821114
Immunoglobulin g4-related diseaseD000077733D89.84112
Renal insufficiencyD051437N19112
Lung diseasesD008171EFO_0003818J98.41112
Chronic renal insufficiencyD051436N1811
GlomerulonephritisD005921N0511
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Indications Phases 3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple myelomaD009101C90.0245
Plasma cell neoplasmsD054219245
NeoplasmsD009369C80223
Smoldering multiple myelomaD000075122123
Hematologic neoplasmsD019337212
Iga vasculitisD011695EFO_1000965D69.0112
PurpuraD011693HP_0000979D69.2112
ViremiaD014766B34.9112
MelanomaD008545112
SyndromeD013577122
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients33
Graft vs host diseaseD006086D89.8122
Bronchiolitis obliterans syndromeD000092122D89.81111
MalnutritionD044342EFO_0008572E40-E4611
DiseaseD004194EFO_0000408R6911
Therapeutic equivalencyD01381011
Hiv infectionsD015658EFO_0000764B2011
SarcomaD01250911
GliomaD005910EFO_000052011
Pancreatic ductal carcinomaD02144111
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Autoimmune diseasesD001327EFO_0000540M30-M3644
Herpesviridae infectionsD006566EFO_0007309B00.422
ArteritisD001167EFO_0009011I77.622
Takayasu arteritisD013625EFO_1001857M31.422
Aortic arch syndromesD00101522
OsteomyelitisD010019EFO_0003102M8611
InfectionsD007239EFO_000054411
Kidney transplantationD01603011
Communicable diseasesD00314111
VasculitisD014657EFO_0006803M3111
Show 13 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLeflunomide
INNleflunomide
Description
Leflunomide is a monocarboxylic acid amide obtained by formal condensation of the carboxy group of 5-methyl-1,2-oxazole-4-carboxylic acid with the anilino group of 4-(trifluoromethyl)aniline. The prodrug of teriflunomide. It has a role as a non-steroidal anti-inflammatory drug, an antineoplastic agent, an antiparasitic agent, an EC 1.3.98.1 [dihydroorotate oxidase (fumarate)] inhibitor, a hepatotoxic agent, a prodrug, a pyrimidine synthesis inhibitor, an immunosuppressive agent, an EC 3.1.3.16 (phosphoprotein phosphatase) inhibitor and a tyrosine kinase inhibitor. It is a monocarboxylic acid amide, a member of isoxazoles and a member of (trifluoromethyl)benzenes.
Classification
Small molecule
Drug class
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Cc1oncc1C(=O)Nc1ccc(C(F)(F)F)cc1
Identifiers
PDB
CAS-ID75706-12-6
RxCUI
ChEMBL IDCHEMBL960
ChEBI ID6402
PubChem CID3899
DrugBankDB01097
UNII IDG162GK9U4W (ChemIDplus, GSRS)
Target
Agency Approved
DHODH
DHODH
Organism
Homo sapiens
Gene name
DHODH
Gene synonyms
NCBI Gene ID
Protein name
dihydroorotate dehydrogenase (quinone), mitochondrial
Protein synonyms
Dihydroorotate oxidase, human complement of yeast URA1
Uniprot ID
Mouse ortholog
Dhodh (56749)
dihydroorotate dehydrogenase (quinone), mitochondrial (O35435)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
£
No data
Estimated US medical usage
Leflunomide
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 13,358 documents
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Safety
Black-box Warning
Black-box warning for: Arava, Inflatherm, Lefluniclo, Leflunomide
Adverse Events
Top Adverse Reactions
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61,375 adverse events reported
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