Leflunomide
Established medicineAlso known as 4-ISOXAZOLECARBOXAMIDE, 5-METHYL-N-(4-(TRIFLUOROMETHYL)PHENYL)-, 5-Methyl-N-(4-(trifluoromethyl)phenyl)-4-isoxazolecarboxamide, 5-Methylisoxazole-4-carboxylic acid (4-trifluoromethyl)anilide, Arava+4 more
4-ISOXAZOLECARBOXAMIDE, 5-METHYL-N-(4-(TRIFLUOROMETHYL)PHENYL)-, 5-Methyl-N-(4-(trifluoromethyl)phenyl)-4-isoxazolecarboxamide, 5-Methylisoxazole-4-carboxylic acid (4-trifluoromethyl)anilide, Arava, N-(4-(TRIFLUOROMETHYL)PHENYL) 5 METHYLISOXAZOLE-4-CARBOXAMIDE, Leflunomida, Leflunomidum, alpha,alpha,alpha-Trifluoro-5-methyl-4-isoxazolecarboxy-p-toluidide.
Recent clinical, regulatory, research and industry developments relating to this drug.
Approval: Leflunomide ratiopharm (EMA)
Approval: Leflunomide medac (EMA)
Approval: Leflunomide Zentiva (previously Leflunomide Winthrop) (EMA)
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Pharmacology & targets
Known molecular targets and mechanisms supported by curated pharmacology databases.
Regulatory timeline
The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.
Indication: Leflunomide is indicated for the treatment of adult patients with: active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD); active psoriatic arthritis.… Show full indicationShow less
Leflunomide is indicated for the treatment of adult patients with: active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD); active psoriatic arthritis. Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects. Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.
Indication: Leflunomide is indicated for the treatment of adult patients with: active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD). Recent or concurrent… Show full indicationShow less
Leflunomide is indicated for the treatment of adult patients with: active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD). Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions, therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects. Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.
Indication: Leflunomide is indicated for the treatment of adult patients with: active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD); active psoriatic arthritis.… Show full indicationShow less
Leflunomide is indicated for the treatment of adult patients with: active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD); active psoriatic arthritis. Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects. Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.
Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
Clinical trials
The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.
Late-stage studies
Phase III+ trials still open or recently active — where late-stage evidence is being generated.
Recent completions
Trials that read out recently, adding to the completed evidence base.
- RxNorm (U.S. National Library of Medicine) — drug identity
- ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
- ClinicalTrials.gov — clinical trials
- Regulatory event sources are credited in the Regulatory Timeline above.