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
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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 | 2025-09-19 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| rheumatoid arthritis | EFO_0000685 | D001172 | M06.9 |
| rheumatic diseases | — | D012216 | M79.0 |
Agency Specific
FDA
EMA
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Clinical
Clinical Trials
134 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 | 8 | 22 | 18 | 14 | 62 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | 2 | 6 | 17 | 11 | 15 | 48 |
| Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | 1 | 3 | — | 1 | 3 | 8 |
| Psoriatic arthritis | D015535 | EFO_0003778 | L40.5 | 1 | — | 1 | 2 | 3 | 7 |
| Juvenile arthritis | D001171 | EFO_1002007 | M08 | — | 2 | 1 | 1 | 1 | 4 |
| Immunoglobulin g4-related disease | D000077733 | — | D89.84 | — | — | — | 1 | 1 | 2 |
| Renal insufficiency | D051437 | — | N19 | — | — | — | 1 | 1 | 2 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | 1 | 1 | — | 1 | — | 2 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | — | 1 | — | 1 |
| Glomerulonephritis | D005921 | — | N05 | — | — | — | 1 | — | 1 |
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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 | — | 1 | 3 |
| Nephritis | D009393 | — | N05 | — | 1 | 2 | — | 1 | 3 |
| Central nervous system neoplasms | D016543 | — | — | — | 1 | 1 | — | — | 2 |
| Nervous system neoplasms | D009423 | — | — | — | 1 | 1 | — | — | 2 |
| Inflammation | D007249 | MP_0001845 | — | — | 1 | 1 | — | 1 | 2 |
| Giant cell arteritis | D013700 | EFO_1001209 | M31.6 | — | — | 1 | — | — | 1 |
| Polymyalgia rheumatica | D011111 | EFO_0008518 | M35.3 | — | — | 1 | — | — | 1 |
| Myasthenia gravis | D009157 | EFO_0004991 | G70.0 | — | — | 1 | — | — | 1 |
| Muscle weakness | D018908 | — | — | — | — | 1 | — | — | 1 |
Show 4 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | — | C90.0 | 2 | 4 | — | — | — | 5 |
| Plasma cell neoplasms | D054219 | — | — | 2 | 3 | — | — | — | 4 |
| Neoplasms | D009369 | — | C80 | 2 | 2 | — | — | — | 3 |
| Smoldering multiple myeloma | D000075122 | — | — | 1 | 2 | — | — | — | 3 |
| Hematologic neoplasms | D019337 | — | — | 2 | 1 | — | — | — | 2 |
| Bronchiolitis obliterans syndrome | D000092122 | — | D89.811 | 1 | 1 | — | — | — | 2 |
| Iga vasculitis | D011695 | EFO_1000965 | D69.0 | — | 1 | — | — | 1 | 2 |
| Viremia | D014766 | — | B34.9 | — | 1 | — | — | 1 | 2 |
| Melanoma | D008545 | — | — | 1 | 1 | — | — | — | 2 |
| Syndrome | D013577 | — | — | 1 | 2 | — | — | — | 2 |
Show 25 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | 1 | — | — | — | 4 | 5 |
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | — | 3 |
| Graft vs host disease | D006086 | — | D89.81 | 2 | — | — | — | — | 2 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | — | — | — | — | 1 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 1 | — | — | — | — | 1 |
| Disease | D004194 | EFO_0000408 | R69 | 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 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Herpesviridae infections | D006566 | EFO_0007309 | B00.4 | — | — | — | — | 2 | 2 |
| Takayasu arteritis | D013625 | EFO_1001857 | M31.4 | — | — | — | — | 2 | 2 |
| Osteomyelitis | D010019 | EFO_0003102 | M86 | — | — | — | — | 1 | 1 |
| Kidney transplantation | D016030 | — | — | — | — | — | — | 1 | 1 |
| Vasculitis | D014657 | EFO_0006803 | M31 | — | — | — | — | 1 | 1 |
| Maintenance chemotherapy | D060046 | — | — | — | — | — | — | 1 | 1 |
| Anti-neutrophil cytoplasmic antibody-associated vasculitis | D056648 | — | I77.82 | — | — | — | — | 1 | 1 |
| Arteritis | D001167 | EFO_0009011 | I77.6 | — | — | — | — | 1 | 1 |
| Pregnancy rate | D018873 | — | — | — | — | — | — | 1 | 1 |
| Defense mechanisms | D003674 | — | — | — | — | — | — | 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
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Estimated US medical usage
Leflunomide
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Trends
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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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