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Methotrexate, Hydroxychloroquine
This combination uses methotrexate to inhibit dihydrofolate reductase and suppress cell proliferation, while hydroxychloroquine accumulates in lysosomes to modulate immune responses and reduce inflammation.
This combination uses methotrexate to inhibit dihydrofolate reductase and suppress cell proliferation, while hydroxychloroquine accumulates in lysosomes to modulate immune responses and reduce inflammation. Used for Rheumatoid arthritis, Systemic lupus erythematosus, Other autoimmune/inflammatory conditions.
At a glance
| Generic name | Methotrexate, Hydroxychloroquine |
|---|---|
| Also known as | Folitrax, HCQS |
| Sponsor | Sanjay Gandhi Postgraduate Institute of Medical Sciences |
| Drug class | Immunosuppressive/Disease-modifying antirheumatic drug (DMARD) combination |
| Target | Dihydrofolate reductase (methotrexate); Toll-like receptors and lysosomal pH (hydroxychloroquine) |
| Modality | Small molecule |
| Therapeutic area | Immunology/Rheumatology |
| Phase | Phase 3 |
Mechanism of action
Methotrexate is a folate antagonist that inhibits dihydrofolate reductase, reducing nucleotide synthesis and suppressing rapidly dividing cells and immune activation. Hydroxychloroquine is an antimalarial that accumulates in acidic compartments and modulates toll-like receptor signaling, reducing inflammatory cytokine production. Together, they provide synergistic immunosuppressive and anti-inflammatory effects.
Approved indications
- Rheumatoid arthritis
- Systemic lupus erythematosus
- Other autoimmune/inflammatory conditions
Common side effects
- Bone marrow suppression (anemia, leukopenia, thrombocytopenia)
- Hepatotoxicity
- Nephrotoxicity
- Gastrointestinal disturbances
- Retinopathy (hydroxychloroquine)
- Infection risk
Key clinical trials
- Venlafaxine as Adjunct Therapy in Rheumatoid Arthritis (PHASE2)
- Early Adalimumab Induction for Immune Checkpoint Inhibitor Associated Inflammatory Arthritis (PHASE2)
- CD40L Antagonism in Rheumatoid Arthritis (RA) (PHASE2)
- Effects of Telitacicept vs Cyclophosphamide on Lupus Related Interstitial Lung Disease (PHASE4)
- Utilization of a Microdevice for Psoriasis and Atopic Dermatitis (PHASE4)
- The Effect of Cilostazol on Rheumatoid Arthritis Patients (PHASE2, PHASE3)
- The Effectiveness of Hydroxychloroquine Versus Methotrexate in the Treatment of Frontal Fibrosing Alopecia in Routine Clinical Care: a Patient Preference Trial (FFA Trial)
- Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty (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 |