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Remicade (infliximab)
Remicade (infliximab) is a TNF-α inhibitor (monoclonal antibody) Biologic drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 3 development for Rheumatoid arthritis, Crohn's disease, Ulcerative colitis. Also known as: Remicade, SCH 215596.
Infliximab is a monoclonal antibody that binds to and neutralizes tumor necrosis factor-alpha (TNF-α), a key inflammatory cytokine.
Remicade (infliximab) is a chimeric monoclonal antibody that inhibits tumor necrosis factor, a protein involved in inflammation. It is used to treat conditions such as Crohn's disease, rheumatoid arthritis, ulcerative colitis, inflammatory bowel diseases, and psoriasis vulgaris.
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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. -
Big-pharma sponsor
+3.0pp
Merck Sharp & Dohme LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | Remicade (infliximab) |
|---|---|
| Also known as | Remicade, SCH 215596 |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | TNF-α inhibitor (monoclonal antibody) |
| Target | TNF-α (tumor necrosis factor-alpha) |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
By blocking TNF-α, infliximab reduces the inflammatory cascade that drives autoimmune and inflammatory diseases. TNF-α is a central mediator of inflammation in conditions like rheumatoid arthritis, Crohn's disease, and psoriasis, so its neutralization suppresses disease activity and symptoms. This mechanism allows immune tolerance to be restored in these conditions.
Approved indications
- Rheumatoid arthritis
- Crohn's disease
- Ulcerative colitis
- Ankylosing spondylitis
- Psoriatic arthritis
- Plaque psoriasis
- Behçet's disease
Common side effects
- Infections (including serious infections)
- Infusion reactions
- Headache
- Abdominal pain
- Nausea
- Tuberculosis reactivation
- Malignancy risk
Key clinical trials
- Efficacy of Different Biological Treatments in Patients With Inflammatory Bowel Disease After One Year of Treatment in Upper Egypt
- Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained Remission (NA)
- A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (PHASE3)
- Combined Immunosuppression for Pediatric Crohn's Disease (PHASE4)
- Zymfentra (Infliximab-dyyb) REal World Cohort STudy
- Effectiveness and Safety of Upadacitinib for Acute Severe Ulcerative Colitis
- MICI-BIO: Study on Patient With Chronic Inflammatory Bowel Disease (NA)
- A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease
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:
- Remicade (infliximab) CI brief — competitive landscape report
- Remicade (infliximab) updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about Remicade (infliximab)
What is Remicade (infliximab)?
How does Remicade (infliximab) work?
What is Remicade (infliximab) used for?
Who makes Remicade (infliximab)?
Is Remicade (infliximab) also known as anything else?
What drug class is Remicade (infliximab) in?
What development phase is Remicade (infliximab) in?
What are the side effects of Remicade (infliximab)?
What does Remicade (infliximab) target?
Related
- Drug class: All TNF-α inhibitor (monoclonal antibody) drugs
- Target: All drugs targeting TNF-α (tumor necrosis factor-alpha)
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Rheumatoid arthritis
- Indication: Drugs for Crohn's disease
- Indication: Drugs for Ulcerative colitis
- Also known as: Remicade, SCH 215596
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing