Arava(leflunomide)
Arava (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
Trade Name
FDA
EMA
Arava (generic drugs available since 2005-09-13)
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 |
|---|---|---|---|---|
| ARAVA | Sanofi | N-020905 RX | 1998-09-10 | 3 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| arava | New Drug Application | 2018-10-30 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| rheumatic diseases | — | D012216 | M79.0 |
| rheumatoid arthritis | EFO_0000685 | D001172 | M06.9 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
82 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 | 1 | 1 | 11 | 14 | 4 | 31 |
| Psoriatic arthritis | D015535 | EFO_0003778 | L40.5 | 1 | — | 1 | 2 | — | 4 |
| Chronic renal insufficiency | D051436 | N18 | — | — | — | 1 | — | 1 | |
| Iga glomerulonephritis | D005922 | EFO_0004194 | — | — | — | 1 | — | 1 | |
| Immunoglobulin g4-related disease | D000077733 | — | — | — | 1 | — | 1 | ||
| Juvenile arthritis | D001171 | EFO_0002609 | M08 | — | — | — | 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 | — | — | 3 | |
| 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 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | C90.0 | 1 | 2 | — | — | — | 2 | |
| Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | — | 2 | — | — | — | 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 | |
| Bullous pemphigoid | D010391 | EFO_0007187 | L12 | — | 1 | — | — | — | 1 |
| Uveitis | D014605 | EFO_1001231 | H20.9 | — | 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 | ||
| Melanoma | D008545 | 1 | — | — | — | — | 1 | ||
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| 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 | ||
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | — | — | — | — | 1 | 1 |
| Nephritis | D009393 | N05 | — | — | — | — | 1 | 1 | |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | — | — | 1 | 1 |
| Herpesviridae infections | D006566 | EFO_0007309 | B00.4 | — | — | — | — | 1 | 1 |
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 | 27169 |
| 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
Clinical Variant
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Arava
Adverse Events
Top Adverse Reactions
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15 adverse events reported
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