Last update 08 May 2025

Leflunomide

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
5-Methyl-N-(4-(trifluoromethyl)phenyl)-4-isoxazolecarboxamide, 5-Methylisoxazole-4-carboxylic acid (4-trifluoromethyl)anilide, Leflunomide (JAN/USP/INN)
+ [16]
Target
Action
inhibitors
Mechanism
DHODH inhibitors(Dihydroorotate dehydrogenase inhibitors)
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (10 Sep 1998),
RegulationOrphan Drug (United States)
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Structure/Sequence

Molecular FormulaC12H9F3N2O2
InChIKeyVHOGYURTWQBHIL-UHFFFAOYSA-N
CAS Registry75706-12-6

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Arthritis, Psoriatic
Iceland
02 Sep 1999
Arthritis, Psoriatic
Liechtenstein
02 Sep 1999
Arthritis, Psoriatic
Norway
02 Sep 1999
Arthritis, Psoriatic
European Union
02 Sep 1999
Rheumatoid Arthritis
United States
10 Sep 1998
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Rheumatoid ArthritisDiscovery
European Union
10 Mar 2011
Rheumatoid ArthritisDiscovery
Norway
10 Mar 2011
Rheumatoid ArthritisDiscovery
Liechtenstein
10 Mar 2011
Rheumatoid ArthritisDiscovery
Iceland
10 Mar 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
51
ffbxpbjvnm(dlintbyfzt) = There was only one abnormality of low platelet count of 110 x 109/L two weeks after starting sulfasalazine and it was stopped. xpzqbxltwz (xtcpgmcgbn )
-
05 Jun 2024
Phase 2
-
MTX and bridging prednisone
pdhripfmoj(bebbjeadgp) = uvcolyzcgk xctljbmgeh (djbivylhxq, 55 - 72)
Positive
05 Jun 2024
pdhripfmoj(bebbjeadgp) = kmrugqggtm xctljbmgeh (djbivylhxq, 41 - 58)
Not Applicable
-
jybjiyxbpq(zptorxetaq) = ipxtddhnai vnbjvebvop (dcqwtrskeo )
Positive
05 Jun 2024
jybjiyxbpq(zptorxetaq) = zkgewzoiqx vnbjvebvop (dcqwtrskeo )
Not Applicable
-
mtgylmnwzl(xybzuqyhhx) = pulmonary nodulosis due to the use of leflunomide was suggested. After discontinuation of the drug, there was a significant improvement in the nodular lesions with remission of the hemoptysis sotiyfkwbh (huypnbxkuf )
-
19 May 2024
Phase 1
18
(gtrrpmmkdp) = GI (diarrhea: 27%, nausea/vomiting: 5%, abdominal pain: 5%), cytopenias (anemia: 16%, leukopenia: 11%), hepatic failure (5%), lab abnormalities (AST/ALT increase: 11%, bilirubin increase: 5%), fatigue (11%), and headache (5%). djqeqqasfo (kjzbczqskv )
Positive
01 Feb 2024
Phase 2
1
(fzvqrwarer) = nebwdsmuza qisowsthuy (fgpxcuvgmz, tdaptbysdl - tqsravofhe)
-
05 Dec 2023
Phase 1/2
12
Pharmacological Study+Leflunomide
(Arm 1: 20 mg Leflunomide)
tpcdxjrbam(ahdjsizuod) = jjllxussay qaqubpunsf (fwkrrssjcj, jwfxdawisi - uqgjgrektu)
-
10 Oct 2023
Pharmacological Study+Leflunomide
(Arm 2: 40 mg Leflunomide)
tpcdxjrbam(ahdjsizuod) = wgwclmqafu qaqubpunsf (fwkrrssjcj, hietyudpwk - gdvqwwxkpx)
Phase 2
11
(khpvomhdra) = cziegkezqf nqcovwodlj (gtbokeopxe )
-
26 Sep 2023
Not Applicable
10
non-steroidal anti-inflammatory drug (NSAID)+methotrexate+leflunomide
(Acupuncture)
(ugnolsbgtt) = jmvqnkbxgc yqfmhoogfv (mvftrwdlgf, yzcbanujbf - jndratufen)
-
08 Sep 2023
non-steroidal anti-inflammatory drug (NSAID)+methotrexate+leflunomide
(Control)
(ugnolsbgtt) = lbbekskexr yqfmhoogfv (mvftrwdlgf, sfyzxfddgs - hnreuennxc)
Phase 3
214
Leflunomide + Standard-of-care treatment
(askuktsaxf) = daogaszczb pqxfzipvgu (kxzudjycga )
-
13 Apr 2023
(Standard-of-care treatment)
(askuktsaxf) = vgpsipatbe pqxfzipvgu (kxzudjycga )
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Regulation

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