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 (generic drugs available since 2005-09-13)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| inflatherm | ANDA | 2022-12-07 |
| lefluniclo | unapproved drug other | 2023-03-29 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| rheumatic diseases | — | D012216 | M79.0 |
| rheumatoid arthritis | EFO_0000685 | D001172 | M06.9 |
Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
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Clinical
Clinical Trials
125 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 arthritis | D001172 | EFO_0000685 | M06.9 | 2 | 5 | 21 | 18 | 13 | 58 |
| Psoriatic arthritis | D015535 | EFO_0003778 | L40.5 | 1 | — | 1 | 2 | 2 | 6 |
| Juvenile arthritis | D001171 | EFO_1002007 | M08 | — | — | — | 1 | 1 | 2 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | — | 1 | — | 1 |
| Iga glomerulonephritis | D005922 | EFO_0004194 | — | — | — | — | 1 | — | 1 |
| Immunoglobulin g4-related disease | D000077733 | — | D89.84 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | — | U07.1 | 2 | 1 | 1 | — | 1 | 4 |
| Lupus nephritis | D008181 | EFO_0005761 | — | — | 1 | 2 | — | — | 2 |
| Central nervous system neoplasms | D016543 | — | — | — | 1 | 1 | — | — | 2 |
| Polymyalgia rheumatica | D011111 | EFO_0008518 | M35.3 | — | — | 1 | — | — | 1 |
| Myasthenia gravis | D009157 | EFO_0004991 | G70.0 | — | — | 1 | — | — | 1 |
| Aortic valve stenosis | D001024 | HP_0001650 | — | — | — | 1 | — | — | 1 |
| Prostatic neoplasms | D011471 | — | C61 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Systemic lupus erythematosus | D008180 | HP_0002725 | M32 | 1 | 3 | — | — | 1 | 5 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | 2 | — | — | — | 2 |
| Melanoma | D008545 | — | — | 1 | 1 | — | — | — | 2 |
| Lymphoproliferative disorders | D008232 | Orphanet_2442 | D47.9 | — | 1 | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 1 | — | — | — | 1 |
| Triple negative breast neoplasms | D064726 | — | — | 1 | 1 | — | — | — | 1 |
| Breast diseases | D001941 | — | N60-N65 | 1 | 1 | — | — | — | 1 |
| Iga vasculitis | D011695 | EFO_1000965 | D69.0 | — | 1 | — | — | — | 1 |
| Viremia | D014766 | — | B34.9 | — | 1 | — | — | — | 1 |
| Adult-onset still's disease | D016706 | EFO_0007135 | M06.1 | — | 1 | — | — | — | 1 |
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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 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | — | — | — | — | 1 |
| Sarcoma | D012509 | — | — | 1 | — | — | — | — | 1 |
| Glioma | D005910 | EFO_0000520 | — | 1 | — | — | — | — | 1 |
| Neoplasms | D009369 | — | C80 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Autoimmune diseases | D001327 | HP_0002960 | M30-M36 | — | — | — | — | 4 | 4 |
| Herpesviridae infections | D006566 | EFO_0007309 | B00.4 | — | — | — | — | 2 | 2 |
| Takayasu arteritis | D013625 | EFO_1001857 | M31.4 | — | — | — | — | 2 | 2 |
| Anti-neutrophil cytoplasmic antibody-associated vasculitis | D056648 | — | I77.82 | — | — | — | — | 1 | 1 |
| Pregnancy rate | D018873 | — | — | — | — | — | — | 1 | 1 |
| Defense mechanisms | D003674 | — | — | — | — | — | — | 1 | 1 |
| Treatment refusal | D016312 | — | — | — | — | — | — | 1 | 1 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | — | — | — | — | 1 | 1 |
| Arthritis | D001168 | HP_0001369 | M05-M14 | — | — | — | — | 1 | 1 |
| Nephritis | D009393 | — | N05 | — | — | — | — | 1 | 1 |
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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
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 11,602 documents
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Safety
Black-box Warning
Black-box warning for: Inflatherm, Lefluniclo
Adverse Events
Top Adverse Reactions
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46,155 adverse events reported
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