Aubagio(teriflunomide)
Aubagio (teriflunomide) is a small molecule pharmaceutical. Teriflunomide was first approved as Aubagio on 2012-09-12. It is used to treat relapsing-remitting multiple sclerosis in the USA. It has been approved in Europe to treat multiple sclerosis and relapsing-remitting multiple sclerosis. The pharmaceutical is active against dihydroorotate dehydrogenase (quinone), mitochondrial.
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Commercial
Trade Name
FDA
EMA
Aubagio (generic drugs available since 2018-09-04)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Teriflunomide
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
AUBAGIO | Sanofi | N-202992 RX | 2012-09-12 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
aubagio | New Drug Application | 2020-11-19 |
teriflunomide | ANDA | 2023-06-17 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
relapsing-remitting multiple sclerosis | EFO_0003929 | D020529 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
TERIFLUNOMIDE, AUBAGIO, SANOFI AVENTIS US | |||
2024-10-30 | PED | ||
2024-04-30 | M-61 | ||
TERIFLUNOMIDE, TERIFLUNOMIDE, ACCORD HLTHCARE | |||
2023-09-08 | PC | ||
TERIFLUNOMIDE, TERIFLUNOMIDE, AMNEAL PHARMS CO | |||
2023-09-08 | PC | ||
TERIFLUNOMIDE, TERIFLUNOMIDE, APOTEX | |||
2023-09-08 | PC | ||
TERIFLUNOMIDE, TERIFLUNOMIDE, AUROBINDO PHARMA | |||
2023-09-08 | PC | ||
TERIFLUNOMIDE, TERIFLUNOMIDE, GLENMARK PHARMS | |||
2023-09-08 | PC | ||
TERIFLUNOMIDE, TERIFLUNOMIDE, SANDOZ | |||
2023-09-08 | PC | ||
TERIFLUNOMIDE, TERIFLUNOMIDE, TEVA PHARMS USA | |||
2023-09-08 | PC | ||
TERIFLUNOMIDE, TERIFLUNOMIDE, WATSON LABS TEVA | |||
2023-09-08 | PC | ||
TERIFLUNOMIDE, TERIFLUNOMIDE, ZYDUS PHARMS | |||
2023-09-08 | PC |
HCPCS
No data
Clinical
Clinical Trials
48 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Multiple sclerosis | D009103 | EFO_0003885 | G35 | 1 | 7 | 14 | 4 | 2 | 28 |
Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | — | 9 | 1 | 3 | 13 |
Indications Phases 3
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Celiac disease | D002446 | EFO_0001060 | K90.0 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Healthy volunteers/patients | — | 1 | — | — | — | — | 1 | ||
Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Medication adherence | D055118 | EFO_0006344 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | TERIFLUNOMIDE |
INN | teriflunomide |
Description | Teriflunomide is an enamide obtained by formal condensation of the carboxy group of (2Z)-2-cyano-3-hydroxybut-2-enoic acid with the anilino group of 4-(trifluoromethyl)aniline. Used for the treatment of relapsing forms of multiple sclerosis and rheumatoid arthritis. It has a role as an EC 1.3.98.1 [dihydroorotate oxidase (fumarate)] inhibitor, a tyrosine kinase inhibitor, a hepatotoxic agent, a drug metabolite and a non-steroidal anti-inflammatory drug. It is a nitrile, an enol, an aromatic amide, an enamide, a member of (trifluoromethyl)benzenes and a secondary carboxamide. |
Classification | Small molecule |
Drug class | — |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | C/C(O)=C(\C#N)C(=O)Nc1ccc(C(F)(F)F)cc1 |
Target
Agency Approved
DHODH
DHODH
Alternate
No data
Variants
Clinical Variant
No data
Financial
Aubagio - Sanofi
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,232 documents
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Safety
Black-box Warning
Black-box warning for: Aubagio, Teriflunomide
Adverse Events
Top Adverse Reactions
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946 adverse events reported
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