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Infliximab plus methotrexate
Infliximab plus methotrexate is a TNF-α inhibitor (monoclonal antibody) + DMARD Small molecule drug developed by Helsinki University Central Hospital. It is currently in Phase 3 development for Rheumatoid arthritis, Crohn's disease, Ulcerative colitis. Also known as: IFX: Remicade, MTX: Trexan or Methotrexate.
Infliximab blocks tumor necrosis factor-alpha (TNF-α) to suppress inflammation, while methotrexate inhibits dihydrofolate reductase to reduce immune cell proliferation.
Infliximab, a TNF-alpha inhibitor antibody, is used in combination with methotrexate to treat conditions such as Rheumatoid Arthritis, Arthritis, and Ulcerative Colitis. This combination targets the tumor necrosis factor, a protein involved in inflammation, to help manage these conditions.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Infliximab plus methotrexate |
|---|---|
| Also known as | IFX: Remicade, MTX: Trexan or Methotrexate |
| Sponsor | Helsinki University Central Hospital |
| Drug class | TNF-α inhibitor (monoclonal antibody) + DMARD |
| Target | TNF-α receptor (infliximab); dihydrofolate reductase (methotrexate) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Rheumatology |
| Phase | Phase 3 |
Mechanism of action
Infliximab is a chimeric monoclonal antibody that binds TNF-α, a key pro-inflammatory cytokine, preventing its interaction with TNF receptors and thereby reducing systemic inflammation. Methotrexate acts as a disease-modifying antirheumatic drug (DMARD) by inhibiting dihydrofolate reductase and nucleotide synthesis, suppressing T-cell proliferation and immune activation. The combination provides synergistic anti-inflammatory and immunosuppressive effects.
Approved indications
- Rheumatoid arthritis
- Crohn's disease
- Ulcerative colitis
- Ankylosing spondylitis
- Psoriatic arthritis
Common side effects
- Infections (including serious/opportunistic)
- Injection site reactions
- Headache
- Nausea
- Abdominal pain
- Tuberculosis reactivation
- Hepatotoxicity
- Cytopenias (methotrexate-related)
Key clinical trials
- An Open-Label Study of Effectiveness of Immunomodulatory Medications for Patients With Relapsing Polychondritis (PHASE2)
- Determination of the Optimal Treatment Target in Ulcerative Colitis (PHASE4)
- Infliximab Biosimilar for Intravenous Drip Infusion 100 mg "Pfizer" Drug Use Investigation (Rheumatoid Arthritis)
- Switching From Intravenous to Subcutaneous Infliximab in Adult Patients With Inflammatory Bowel Disease (NA)
- Multicenter Randomized Double Blind Controlled-study to Assess the Potential of Methotrexate Versus Placebo to Improve and Maintain Response to Anti TNF- Alpha Agents in Adult Patients With Moderate to Severe Psoriasis (PHASE4)
- Prospective Cohort Establishment and Clinical Observation of Children With Crohn's Disease
- Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty (PHASE2)
- A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3) (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:
- Infliximab plus methotrexate CI brief — competitive landscape report
- Infliximab plus methotrexate updates RSS · CI watch RSS
- Helsinki University Central Hospital portfolio CI
Frequently asked questions about Infliximab plus methotrexate
What is Infliximab plus methotrexate?
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Is Infliximab plus methotrexate also known as anything else?
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Related
- Drug class: All TNF-α inhibitor (monoclonal antibody) + DMARD drugs
- Target: All drugs targeting TNF-α receptor (infliximab); dihydrofolate reductase (methotrexate)
- Manufacturer: Helsinki University Central Hospital — full pipeline
- Therapeutic area: All drugs in Immunology / Rheumatology
- Indication: Drugs for Rheumatoid arthritis
- Indication: Drugs for Crohn's disease
- Indication: Drugs for Ulcerative colitis
- Also known as: IFX: Remicade, MTX: Trexan or Methotrexate
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing