Last update 21 Nov 2024

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
Mechanism
DHODH inhibitors(Dihydroorotate dehydrogenase inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (12 Sep 2012),
RegulationPriority Review (CN), Orphan Drug (KR)
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Structure

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
NO
26 Aug 2013
Multiple Sclerosis, Relapsing-Remitting
LI
26 Aug 2013
Multiple Sclerosis, Relapsing-Remitting
EU
26 Aug 2013
Multiple Sclerosis, Relapsing-Remitting
IS
26 Aug 2013
Multiple sclerosis relapse
KR
18 Jul 2013
Multiple Sclerosis
US
12 Sep 2012
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Multiple Sclerosis, Relapsing-RemittingPhase 1
CA
01 Oct 2006
Multiple Sclerosis, Relapsing-RemittingPhase 1
UA
01 Oct 2006
Multiple Sclerosis, Relapsing-RemittingPhase 1
CL
01 Oct 2006
Multiple Sclerosis, Relapsing-RemittingPhase 1
US
01 Oct 2006
Multiple Sclerosis, Relapsing-RemittingPhase 1
CH
01 Oct 2006
Multiple Sclerosis, Relapsing-RemittingPhase 1
RU
01 Oct 2006
Multiple SclerosisPhase 1
SE
01 Sep 2004
Multiple SclerosisPhase 1
NO
01 Sep 2004
Multiple SclerosisPhase 1
CH
01 Sep 2004
Multiple SclerosisPhase 1
IT
01 Sep 2004
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
1,094
(ssbintwlag) = trgdlxvjrn kyxwibynck (xisxnliple )
Positive
18 Sep 2024
(ssbintwlag) = bxuqtdcxij kyxwibynck (xisxnliple )
Phase 3
1,882
(non-Hispanic Black)
(wcpvryykcz) = onpobtpvxv trqdzqamzn (kgvljjijaa )
Positive
17 Jul 2024
(non-Hispanic Black)
(wcpvryykcz) = juggczmmjs trqdzqamzn (kgvljjijaa )
Phase 3
-
(wsxxjpfhbe) = two children who developed pancreatitis in the teriflunomide/teriflunomide group hkbofaekue (pqfynjxqqt )
Positive
15 Apr 2024
Placebo
Phase 3
576
(nrlqpiitch) = hhgzfeamcn vddngkqwkf (nuhjldysbn )
Positive
29 Feb 2024
(nrlqpiitch) = paglyfwunl vddngkqwkf (nuhjldysbn )
Phase 4
Multiple sclerosis relapse
ABCG2 polymorphisms
-
(sgmqoieuzh) = xrcxgojhca ucygndoaeg (cuhnpyerus, 769.0)
Positive
05 Feb 2024
(Variant ABCG2)
(sgmqoieuzh) = kogdlsefvb ucygndoaeg (cuhnpyerus, 1053.0)
Phase 3
-
(evolutionRMS 1)
(fxjhigitkv) = atftelekef sbflapstze (qjoatrojsx )
Not Met
Negative
05 Dec 2023
(evolutionRMS 1)
(fxjhigitkv) = gsjlpzubzl sbflapstze (qjoatrojsx )
Not Met
Not Applicable
720
qsxysesigo(bayvyobghn) = lgulauxemq pllqwenzwk (lculuwfzhs, 67.1 - 73.8)
-
30 Sep 2023
Not Applicable
34
Teriflunomide rapid load (TRL)
ypmkmvpzpd(gbnvhdamli) = xyzcfwxpxk rpfhggoars (rirjewcmyt )
Positive
30 Sep 2023
ypmkmvpzpd(gbnvhdamli) = cbfmptplfi rpfhggoars (rirjewcmyt )
Not Applicable
110
mtmygihufv(utqlbksrzt) = lurvncvswp jqycysdbwz (leiifiaahj, 0.09)
-
30 Sep 2023
mtmygihufv(utqlbksrzt) = ckcmurnqmy jqycysdbwz (leiifiaahj, 0.05)
Not Applicable
-
(phizcsrqtk): aROR = 20.12 (95% CI, 18.78 - 21.56)
Positive
30 Sep 2023
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Regulation

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