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EU Simponi
Simponi is a TNF-alpha inhibitor that blocks tumor necrosis factor signaling to reduce inflammation in autoimmune diseases.
Simponi is a TNF-alpha inhibitor that blocks tumor necrosis factor signaling to reduce inflammation in autoimmune diseases. Used for Rheumatoid arthritis, Ankylosing spondylitis, Psoriatic arthritis.
At a glance
| Generic name | EU Simponi |
|---|---|
| Sponsor | Bio-Thera Solutions |
| Drug class | TNF-alpha inhibitor |
| Target | TNF-alpha |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Simponi (golimumab) is a fully human monoclonal antibody that binds to and neutralizes TNF-alpha, a key pro-inflammatory cytokine. By blocking TNF-alpha, it suppresses the inflammatory cascade underlying autoimmune conditions. This mechanism reduces joint inflammation, systemic inflammation, and disease progression in conditions like rheumatoid arthritis and inflammatory bowel disease.
Approved indications
- Rheumatoid arthritis
- Ankylosing spondylitis
- Psoriatic arthritis
- Ulcerative colitis
- Crohn's disease
Common side effects
- Injection site reactions
- Upper respiratory tract infections
- Nasopharyngitis
- Tuberculosis reactivation
- Serious infections
Key clinical trials
- A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi® in Healthy Adult Participants (PHASE1)
- Comparative, Multicenter Study in Subjects with Rheumatoid Arthritis, ALVOFLEX (PHASE3)
- Comparative Study to Evaluate the Pharmacokinetics of BAT2506 vs Simponi® in Healthy Subjects (PHASE1)
- Comparative Study of BAT2506 With Simponi® in Participants With Active Psoriatic Arthritis (PHASE3)
- A Study on Pharmacokinetics and Safety of BAT2506 Injection Versus Simponi® (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 |