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IV golimumab
IV golimumab 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, Psoriatic arthritis, Ankylosing spondylitis. Also known as: SCH 900259, intravenous.
Golimumab is a monoclonal antibody that binds to and neutralizes tumor necrosis factor-alpha (TNF-α), a key inflammatory cytokine.
Golimumab is a monoclonal antibody that binds to and neutralizes tumor necrosis factor-alpha (TNF-α), a key inflammatory cytokine. Used for Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis.
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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 | IV golimumab |
|---|---|
| Also known as | SCH 900259, intravenous |
| 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, golimumab reduces the inflammatory cascade that drives autoimmune and inflammatory diseases. TNF-α is a central mediator of inflammation in conditions like rheumatoid arthritis, psoriasis, and inflammatory bowel disease. The IV formulation allows for systemic delivery and rapid onset of action in moderate to severe inflammatory conditions.
Approved indications
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Ulcerative colitis
- Crohn's disease
Common side effects
- Infections (including serious infections)
- Injection site reactions
- Upper respiratory tract infections
- Headache
- Hypertension
- Tuberculosis reactivation risk
Key clinical trials
- A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (PHASE3)
- A Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Intravenous Golimumab in Pediatric Participants With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy (PHASE3)
- A Study of Golimumab in the Treatment of Indian Participants With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis (PHASE4)
- Rotation or Change of Biotherapy After TNF Blocker Treatment Failure for Axial Spondyloarthritis (PHASE4)
- A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (PHASE2)
- Golimumab (MK-8259 / SCH900259) Treatment Withdrawal in Participants With Non-radiographic Axial Spondyloarthritis (GO-BACK) (MK-8259-038) (PHASE4)
- Comparative and Pragmatic Study of Golimumab Intravenous (IV) (Simponi Aria) Versus Infliximab (Remicade) in Rheumatoid Arthritis
- A Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Golimumab in Patients With Rheumatoid Arthritis (RA) (PHASE1)
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:
- IV golimumab CI brief — competitive landscape report
- IV golimumab updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about IV golimumab
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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 Psoriatic arthritis
- Indication: Drugs for Ankylosing spondylitis
- Also known as: SCH 900259, intravenous
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing