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AboutPricing
Drug ReportsTeriflunomide
Aubagio(teriflunomide)
Aubagio, Teriflunomide (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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FDA approval date
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Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
immune system diseasesD007154
Trade Name
FDA
EMA
Aubagio, Teriflunomide (discontinued: Teriflunomide)
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
AUBAGIOSanofiN-202992 RX2012-09-12
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
aubagioNew Drug Application2024-06-24
teriflunomideANDA2024-10-21
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
relapsing-remitting multiple sclerosisEFO_0003929D020529—
Agency Specific
FDA
EMA
Expiration
Code
TERIFLUNOMIDE, AUBAGIO, SANOFI AVENTIS US
2024-10-30PED
2024-04-30M-61
TERIFLUNOMIDE, TERIFLUNOMIDE, ACCORD HLTHCARE
2023-09-08PC
TERIFLUNOMIDE, TERIFLUNOMIDE, AMNEAL PHARMS CO
2023-09-08PC
TERIFLUNOMIDE, TERIFLUNOMIDE, APOTEX
2023-09-08PC
TERIFLUNOMIDE, TERIFLUNOMIDE, AUROBINDO PHARMA
2023-09-08PC
TERIFLUNOMIDE, TERIFLUNOMIDE, GLENMARK PHARMS
2023-09-08PC
TERIFLUNOMIDE, TERIFLUNOMIDE, SANDOZ
2023-09-08PC
TERIFLUNOMIDE, TERIFLUNOMIDE, TEVA PHARMS USA
2023-09-08PC
TERIFLUNOMIDE, TERIFLUNOMIDE, WATSON LABS TEVA
2023-09-08PC
TERIFLUNOMIDE, TERIFLUNOMIDE, ZYDUS PHARMS
2023-09-08PC
Patent Expiration
Patent
Expires
Flag
FDA Information
Teriflunomide, Aubagio, Sanofi Aventis Us
91863462034-02-04U-1786
88027352030-09-14DP
67944102026-09-12U-1285
ATC Codes
L: Antineoplastic and immunomodulating agents
— L04: Immunosuppressants
— L04A: Immunosuppressants
— L04AA: Selective immunosuppressants
— L04AA31: Teriflunomide
HCPCS
No data
Clinical
Clinical Trials
85 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 sclerosisD009103EFO_0003885G35182862770
SclerosisD012598———82752161
Relapsing-remitting multiple sclerosisD020529EFO_0003929———122923
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic progressive multiple sclerosisD020528EFO_0003840———1—12
Neoplasm metastasisD009362EFO_0009708———1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Thrombocytopenic purpura idiopathicD016553EFO_0007160D69.3—3———3
ThrombocytopeniaD013921HP_0001873D69.6—3———3
Breast neoplasmsD001943EFO_0003869C5011———1
Triple negative breast neoplasmsD064726——11———1
Breast diseasesD001941—N60-N6511———1
Celiac diseaseD002446EFO_0001060K90.011———1
Spinal cord diseasesD013118HP_0002196G95.911———1
Tropical spastic paraparesisD015493EFO_0007527G04.111———1
ParaparesisD020335HP_0002385G82.211———1
Spastic paraparesisD020336HP_0002313—11———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———2———13
Renal insufficiencyD051437HP_0000083N191———12
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Medication adherenceD055118EFO_0006344—————11
LeukoencephalopathiesD056784HP_0002352—————11
Progressive multifocal leukoencephalopathyD007968EFO_0007455A81.2————11
Herpesviridae infectionsD006566EFO_0007309B00.4————11
ViremiaD014766—B34.9————11
Demyelinating diseasesD003711——————11
Covid-19D000086382——————11
Acne vulgarisD000152EFO_0003894L70————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTeriflunomide
INNteriflunomide
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)Loading
Structure (InChI/SMILES or Protein Sequence)
C/C(O)=C(\C#N)C(=O)Nc1ccc(C(F)(F)F)cc1
Identifiers
PDB—
CAS-ID163451-81-8
RxCUI—
ChEMBL IDCHEMBL973
ChEBI ID68540
PubChem CID54684141
DrugBankDB08880
UNII ID1C058IKG3B (ChemIDplus, GSRS)
Target
Agency Approved
DHODH
DHODH
Organism
Homo sapiens
Gene name
DHODH
Gene synonyms
NCBI Gene ID
1723
Protein name
dihydroorotate dehydrogenase (quinone), mitochondrial
Protein synonyms
Dihydroorotate oxidase, human complement of yeast URA1
Uniprot ID
Q6P176
Mouse ortholog
Dhodh (56749)
dihydroorotate dehydrogenase (quinone), mitochondrial (O35435)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Aubagio – Sanofi
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,442 documents
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Safety
Black-box Warning
Black-box warning for: Aubagio, Teriflunomide
Adverse Events
Top Adverse Reactions
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40,532 adverse events reported
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