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Methotrexate-Sulfasalazine-Hydroxychloroquine
This triple-drug combination suppresses immune system activity through multiple pathways to reduce inflammation and autoimmune disease activity.
This triple-drug combination suppresses immune system activity through multiple pathways to reduce inflammation and autoimmune disease activity. Used for Rheumatoid arthritis, Systemic lupus erythematosus.
At a glance
| Generic name | Methotrexate-Sulfasalazine-Hydroxychloroquine |
|---|---|
| Also known as | Trexall, Rheumatrex, Azulfidine®, Plaquenil® |
| Sponsor | University of Nebraska |
| Drug class | Disease-modifying antirheumatic drug (DMARD) combination |
| Modality | Small molecule |
| Therapeutic area | Immunology / Rheumatology |
| Phase | Phase 3 |
Mechanism of action
Methotrexate inhibits dihydrofolate reductase and purine synthesis, reducing T-cell proliferation. Sulfasalazine acts as an immunosuppressant and anti-inflammatory agent. Hydroxychloroquine accumulates in immune cells and reduces antigen presentation and cytokine production. Together, these agents target complementary mechanisms of immune activation in rheumatologic diseases.
Approved indications
- Rheumatoid arthritis
- Systemic lupus erythematosus
Common side effects
- Nausea and gastrointestinal upset
- Bone marrow suppression
- Hepatotoxicity
- Retinal toxicity (hydroxychloroquine)
- Infection risk
Key clinical trials
- Venlafaxine as Adjunct Therapy in Rheumatoid Arthritis (PHASE2)
- 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)
- A Study to Assess Safety and Efficacy of ASP015K in Participants With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to Methotrexate (MTX) (PHASE3)
- The Effect of Nicotinamide on the Clinical Outcome of 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 |
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