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Belimumab (GSK1550188)
Belimumab is a monoclonal antibody that inhibits B-lymphocyte stimulator (BLyS), reducing B cell proliferation and autoantibody production in systemic lupus erythematosus.
Belimumab is a monoclonal antibody that inhibits B-lymphocyte stimulator (BLyS), reducing B cell proliferation and autoantibody production in systemic lupus erythematosus. Used for Systemic lupus erythematosus (SLE) with active disease, Lupus nephritis.
At a glance
| Generic name | Belimumab (GSK1550188) |
|---|---|
| Also known as | BEL (BENLYSTA) |
| Sponsor | GlaxoSmithKline |
| Drug class | BLyS inhibitor monoclonal antibody |
| Target | BLyS (B-lymphocyte stimulator / BAFF) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
Belimumab binds to soluble BLyS (also known as BAFF), a cytokine essential for B cell survival and differentiation. By neutralizing BLyS, the drug reduces the survival of autoreactive B cells and plasma cells, thereby decreasing pathogenic autoantibody levels and immune complex formation. This mechanism addresses a key driver of lupus pathogenesis.
Approved indications
- Systemic lupus erythematosus (SLE) with active disease
- Lupus nephritis
Common side effects
- Infection (including serious infections)
- Nasopharyngitis
- Bronchitis
- Diarrhea
- Nausea
- Pyrexia
- Infusion reactions
Key clinical trials
- A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease (PHASE3)
- A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease (PHASE2, PHASE3)
- A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE) (PHASE4)
- Safety and Efficacy Study of Subcutaneous Belimumab and Intravenous Rituximab Co-administration in Subjects With Primary Sjogren's Syndrome (PHASE2)
- Belimumab Phase I Study in Chinese Subjects With Systemic Lupus Erythematosus (PHASE1)
- GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia (PHASE3)
- Compassionate Use for Subcutaneous (SC) Belimumab
- A Study of Belimumab in Idiopathic Membranous Glomerulonephropathy (PHASE2)
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:
- Belimumab (GSK1550188) CI brief — competitive landscape report
- Belimumab (GSK1550188) updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI