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Leflunomide-Sulfasalazine-Hydroxychloroquine
Leflunomide-Sulfasalazine-Hydroxychloroquine is a Disease-modifying antirheumatic drug (DMARD) combination Small molecule drug developed by University of Nebraska. It is currently in Phase 3 development for Rheumatoid arthritis, Other autoimmune inflammatory conditions. Also known as: Arava®, Azulfidine®, Plaquenil®.
This triple-drug combination suppresses immune system activity through multiple pathways to reduce inflammation and autoimmune disease progression.
This triple-drug combination suppresses immune system activity through multiple pathways to reduce inflammation and autoimmune disease progression. Used for Rheumatoid arthritis, Other autoimmune inflammatory conditions.
At a glance
| Generic name | Leflunomide-Sulfasalazine-Hydroxychloroquine |
|---|---|
| Also known as | Arava®, Azulfidine®, Plaquenil® |
| Sponsor | University of Nebraska |
| Drug class | Disease-modifying antirheumatic drug (DMARD) combination |
| Target | Multiple targets: dihydroorotate dehydrogenase (leflunomide), NF-κB pathway (sulfasalazine), lysosomal function and TLR signaling (hydroxychloroquine) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Rheumatology |
| Phase | Phase 3 |
Mechanism of action
Leflunomide inhibits dihydroorotate dehydrogenase to reduce pyrimidine synthesis in T and B cells. Sulfasalazine acts as an anti-inflammatory and immunosuppressant through multiple mechanisms including NF-κB inhibition. Hydroxychloroquine accumulates in lysosomes to modulate immune responses and reduce inflammatory cytokine production. Together, these agents provide complementary immunosuppressive effects.
Approved indications
- Rheumatoid arthritis
- Other autoimmune inflammatory conditions
Common side effects
- Hepatotoxicity
- Gastrointestinal disturbance
- Bone marrow suppression
- Rash
- Retinal toxicity (hydroxychloroquine)
Key clinical trials
- Venlafaxine as Adjunct Therapy in Rheumatoid Arthritis (PHASE2)
- "Effect of Vitamin E (α-Tocopherol) on Clinical Activity and Inflammation in Rheumatoid Arthritis" (PHASE2, PHASE3)
- Analysis of T and B Cell Repertoire Changes in Response to Orencia® (Abatacept) in Rheumatoid Arthritis
- The Effect of Cilostazol on Rheumatoid Arthritis Patients (PHASE2, PHASE3)
- Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty (PHASE2)
- Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response (PHASE3)
- Clinical Trial Evaluating Methotrexate or Leflunomide + Targeted Therapy Versus Methotrexate or Leflunomide + Sulfasalazine + Hydroxychloroquine in Patients With Rheumatoid Arthritis and Insufficient Response to Methotrexate or Leflunomide (PHASE4)
- L-carnitine Supplementation in Rheumatoid Arthritis Patients (PHASE2)
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-Sulfasalazine-Hydroxychloroquine CI brief — competitive landscape report
- Leflunomide-Sulfasalazine-Hydroxychloroquine updates RSS · CI watch RSS
- University of Nebraska portfolio CI
Frequently asked questions about Leflunomide-Sulfasalazine-Hydroxychloroquine
What is Leflunomide-Sulfasalazine-Hydroxychloroquine?
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Is Leflunomide-Sulfasalazine-Hydroxychloroquine also known as anything else?
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Related
- Drug class: All Disease-modifying antirheumatic drug (DMARD) combination drugs
- Target: All drugs targeting Multiple targets: dihydroorotate dehydrogenase (leflunomide), NF-κB pathway (sulfasalazine), lysosomal function and TLR signaling (hydroxychloroquine)
- Manufacturer: University of Nebraska — full pipeline
- Therapeutic area: All drugs in Immunology / Rheumatology
- Indication: Drugs for Rheumatoid arthritis
- Indication: Drugs for Other autoimmune inflammatory conditions
- Also known as: Arava®, Azulfidine®, Plaquenil®
- Compare: Leflunomide-Sulfasalazine-Hydroxychloroquine vs similar drugs
- Pricing: Leflunomide-Sulfasalazine-Hydroxychloroquine cost, discount & access