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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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Arava, Leflunomide (discontinued: Leflunomide)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| arava | New Drug Application | 2025-06-04 |
| inflatherm | ANDA | 2022-12-07 |
| lefluniclo | unapproved drug other | 2023-03-29 |
| leflunomide | ANDA | 2025-10-29 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| rheumatoid arthritis | EFO_0000685 | D001172 | M06.9 |
| rheumatic diseases | — | D012216 | M79.0 |
Agency Specific
FDA
EMA
No data
Patent Expiration
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HCPCS
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Clinical
Clinical Trials
134 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Leflunomide |
| INN | leflunomide |
| 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) |  |
| Structure (InChI/SMILES or Protein Sequence) | Cc1oncc1C(=O)Nc1ccc(C(F)(F)F)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 75706-12-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL960 |
| ChEBI ID | 6402 |
| PubChem CID | 3899 |
| DrugBank | DB01097 |
| UNII ID | G162GK9U4W (ChemIDplus, GSRS) |
Target
Agency Approved
DHODH
DHODH
Alternate
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Variants
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Financial
Revenue by drug
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Estimated US medical usage
Leflunomide
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 13,894 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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65,494 adverse events reported
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