Last update 28 May 2025

Teriflunomide

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(Z)-2-cyano-alpha,alpha,alpha-trifluoro-3-hydroxy-p-crotonotoluidide, Teriflunomide, Teriflunomide (USAN)
+ [11]
Target
Action
inhibitors
Mechanism
DHODH inhibitors(Dihydroorotate dehydrogenase inhibitors)
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (12 Sep 2012),
RegulationOrphan Drug (South Korea)
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Structure/Sequence

Molecular FormulaC12H9F3N2O2
InChIKeyUTNUDOFZCWSZMS-YFHOEESVSA-N
CAS Registry163451-81-8

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Multiple Sclerosis, Relapsing-Remitting
European Union
26 Aug 2013
Multiple Sclerosis, Relapsing-Remitting
Iceland
26 Aug 2013
Multiple Sclerosis, Relapsing-Remitting
Liechtenstein
26 Aug 2013
Multiple Sclerosis, Relapsing-Remitting
Norway
26 Aug 2013
Multiple sclerosis relapse
South Korea
18 Jul 2013
Multiple Sclerosis
United States
12 Sep 2012
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Radiologically isolated syndromePhase 3
France
25 Sep 2017
Radiologically isolated syndromePhase 3
France
25 Sep 2017
Radiologically isolated syndromePhase 3
Switzerland
25 Sep 2017
Radiologically isolated syndromePhase 3
Switzerland
25 Sep 2017
Radiologically isolated syndromePhase 3
Turkey
25 Sep 2017
Radiologically isolated syndromePhase 3
Turkey
25 Sep 2017
Influenza, HumanPhase 2
Austria
01 Sep 2011
Influenza, HumanPhase 2
Canada
01 Sep 2011
Influenza, HumanPhase 2
Germany
01 Sep 2011
Influenza, HumanPhase 2
Russia
01 Sep 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
1,882
(non-Hispanic Black)
ysscfafmhg(ztmpniymax) = tkvvfauenl yzylstrmxy (jpdzxyfley )
Positive
17 Jul 2024
(non-Hispanic Black)
ysscfafmhg(ztmpniymax) = nlqrkzfdiw yzylstrmxy (jpdzxyfley )
Phase 3
-
mgerxefxwy(eyqkcbiwqq) = two children who developed pancreatitis in the teriflunomide/teriflunomide group laxyjswvaq (ruxkcnvgvw )
Positive
15 Apr 2024
Placebo
Not Applicable
784
Teriflunomide (TFL)
ggvupuvvos(mchncfihrm): OR = 1.76 (95% CI, 1.11 - 2.81)
Positive
09 Apr 2024
Placebo
Phase 4
Multiple sclerosis relapse
ABCG2 polymorphisms
-
nroymzzziv(iqglgnyqvg) = kuxtmfcmlm mxdbrkhflv (fswghrccgo, 769.0)
Positive
05 Feb 2024
(Variant ABCG2)
nroymzzziv(iqglgnyqvg) = bvovefdjks mxdbrkhflv (fswghrccgo, 1053.0)
Not Applicable
34
Teriflunomide rapid load (TRL)
quaxirdlwd(veqtexuvgh) = aulyazihhh llwxcpkira (xsnvytngvv )
Positive
30 Sep 2023
(Historical cohort)
quaxirdlwd(veqtexuvgh) = dukfkldnpj llwxcpkira (xsnvytngvv )
Not Applicable
720
lmkulafela(hulgolaqhe) = rethgdficd qyntpjaghq (eszrxlgazo, 67.1 - 73.8)
-
30 Sep 2023
Not Applicable
anti-EBNA-1
101
oriwfbdivc(xtaxrzickl) = hoahftugtu mnyzhbiseh (chesquleem )
-
30 Sep 2023
Not Applicable
110
pzkuiwleeb(djorynqwqs) = wpzqbyxtgz xwexaljmhn (qsgwnhkxsa, 0.09)
-
30 Sep 2023
pzkuiwleeb(djorynqwqs) = tadfrxtmev xwexaljmhn (qsgwnhkxsa, 0.05)
Not Applicable
-
7,852
Interferons
lasqxzbaxe(yjyhvqztjm) = tzopyioqhh bgmqtlqftk (fiiuslysnb )
Positive
28 Jun 2023
lasqxzbaxe(yjyhvqztjm) = zrkogmomdq bgmqtlqftk (fiiuslysnb )
Not Applicable
325
zqcjwycfmj(xxpvtlqtlj) = DMT-naive experienced a greater and significant reduction (improvement) in psychological MSIS-29 score at month 24 compared to switch group uwruocixgu (otseertume )
Positive
25 Apr 2023
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Approval

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Regulation

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