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Leflunomide plus Methotrexate
This combination uses leflunomide to inhibit dihydroorotate dehydrogenase (reducing pyrimidine synthesis) and methotrexate to inhibit dihydrofolate reductase, together suppressing T-cell proliferation and inflammatory cytokine production in autoimmune disease.
This combination uses leflunomide to inhibit dihydroorotate dehydrogenase (reducing pyrimidine synthesis) and methotrexate to inhibit dihydrofolate reductase, together suppressing T-cell proliferation and inflammatory cytokine production in autoimmune disease. Used for Rheumatoid arthritis, Active rheumatoid arthritis inadequately responsive to monotherapy.
At a glance
| Generic name | Leflunomide plus Methotrexate |
|---|---|
| Sponsor | Bangladesh Medical University |
| Drug class | Disease-modifying antirheumatic drug (DMARD) combination |
| Target | Dihydroorotate dehydrogenase (leflunomide); Dihydrofolate reductase (methotrexate) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Rheumatology |
| Phase | FDA-approved |
Mechanism of action
Leflunomide is a disease-modifying antirheumatic drug (DMARD) that blocks pyrimidine synthesis, preferentially affecting activated lymphocytes. Methotrexate is a folate antagonist that inhibits nucleotide synthesis and has immunosuppressive effects. The combination provides synergistic immunosuppression by targeting complementary pathways in cell proliferation and inflammation.
Approved indications
- Rheumatoid arthritis
- Active rheumatoid arthritis inadequately responsive to monotherapy
Common side effects
- Hepatotoxicity
- Bone marrow suppression
- Gastrointestinal disturbance
- Infection risk
- Alopecia
- Elevated liver enzymes
Key clinical trials
- Venlafaxine as Adjunct Therapy in Rheumatoid Arthritis (PHASE2)
- Comparative Study of Leflunomide Plus Methotrexate Versus Methotrexate Monotherapy in Refractory Polyarticular Juvenile Idiopathic Arthritis Patients (PHASE4)
- Effects of Telitacicept vs Cyclophosphamide on Lupus Related Interstitial Lung Disease (PHASE4)
- The Effect of Cilostazol on Rheumatoid Arthritis Patients (PHASE2, PHASE3)
- Severe Psoriatic Arthritis - Early intervEntion to Control Disease: the SPEED Trial (PHASE4)
- Efficacy of a Sequential Treatment Strategy in Rheumatoid Arthritis (PHASE3)
- Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty (PHASE2)
- Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Leflunomide plus Methotrexate CI brief — competitive landscape report
- Leflunomide plus Methotrexate updates RSS · CI watch RSS
- Bangladesh Medical University portfolio CI