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Adalimumab+Methotrexate
Adalimumab+Methotrexate is a TNF-alpha inhibitor + DMARD combination Small molecule drug developed by Hospital San Carlos, Madrid. It is currently in Phase 3 development for Rheumatoid arthritis, Other inflammatory arthropathies.
Adalimumab blocks TNF-alpha to reduce inflammation, while methotrexate inhibits dihydrofolate reductase and suppresses immune cell proliferation, together providing synergistic anti-inflammatory and immunosuppressive effects.
Adalimumab, a TNF-alpha inhibitor, is used in combination with methotrexate to treat conditions such as Psoriatic Arthritis and Ulcerative Colitis. This combination therapy involves the administration of adalimumab, an antibody that inhibits tumor necrosis factor, alongside methotrexate, a medication used to treat various inflammatory diseases.
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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 | Adalimumab+Methotrexate |
|---|---|
| Sponsor | Hospital San Carlos, Madrid |
| Drug class | TNF-alpha inhibitor + DMARD combination |
| Target | TNF-alpha receptor; dihydrofolate reductase |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Adalimumab is a TNF-alpha inhibitor that binds and neutralizes tumor necrosis factor-alpha, a key pro-inflammatory cytokine. Methotrexate is a disease-modifying antirheumatic drug (DMARD) that inhibits folate metabolism and reduces proliferation of activated lymphocytes. The combination enhances efficacy in suppressing inflammatory pathways and immune responses.
Approved indications
- Rheumatoid arthritis
- Other inflammatory arthropathies
Common side effects
- Infection (including serious infections)
- Injection site reactions
- Nausea
- Hepatotoxicity
- Bone marrow suppression
- Headache
Key clinical trials
- Preventing Structural Damage in Early Psoriatic Arthritis (PHASE4)
- Early Adalimumab Induction for Immune Checkpoint Inhibitor Associated Inflammatory Arthritis (PHASE2)
- Apremilast and Adalimumab in Psoriatic Arthritis Patients (NA)
- 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)
- Utilization of a Microdevice for Psoriasis and Atopic Dermatitis (PHASE4)
- Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants With Moderate to Severe Rheumatoid Arthritis (PHASE3)
- Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study (PHASE4)
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:
- Adalimumab+Methotrexate CI brief — competitive landscape report
- Adalimumab+Methotrexate updates RSS · CI watch RSS
- Hospital San Carlos, Madrid portfolio CI
Frequently asked questions about Adalimumab+Methotrexate
What is Adalimumab+Methotrexate?
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What does Adalimumab+Methotrexate target?
Related
- Drug class: All TNF-alpha inhibitor + DMARD combination drugs
- Target: All drugs targeting TNF-alpha receptor; dihydrofolate reductase
- Manufacturer: Hospital San Carlos, Madrid — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Rheumatoid arthritis
- Indication: Drugs for Other inflammatory arthropathies
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing