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Belimumab Injection
Belimumab is a monoclonal antibody that inhibits B-lymphocyte stimulator (BLyS), reducing B cell proliferation and autoantibody production in autoimmune diseases.
Belimumab is a monoclonal antibody that inhibits B-lymphocyte stimulator (BLyS), reducing B cell proliferation and autoantibody production in autoimmune diseases. Used for Systemic lupus erythematosus (SLE), Lupus nephritis.
At a glance
| Generic name | Belimumab Injection |
|---|---|
| Also known as | Beliumab induction therapy, Benlysta subcutaneous injection of 200mg |
| Sponsor | Nanjing University School of Medicine |
| Drug class | BLyS inhibitor monoclonal antibody |
| Target | BLyS (B-lymphocyte stimulator / BAFF) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Belimumab binds to soluble BLyS (also known as BAFF), a cytokine essential for B cell survival and maturation. By neutralizing BLyS, the drug decreases B cell activation, proliferation, and differentiation into plasma cells, thereby reducing pathogenic autoantibodies and immune-mediated inflammation characteristic of systemic lupus erythematosus and other B cell-driven autoimmune conditions.
Approved indications
- Systemic lupus erythematosus (SLE)
- Lupus nephritis
Common side effects
- Infection (including serious infections)
- Nasopharyngitis
- Bronchitis
- Diarrhea
- Nausea
- Pyrexia
Key clinical trials
- Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis (PHASE2)
- The Efficacy and Safety of Biologics (Belimumab/ Telitacicept) Induction Therapy in Proliferative Lupus Nephritis Patients for 6 Months Compared With Mycophenolate Mofetil Treatment (PHASE2)
- Belimumab in Autoimmune Hepatitis (PHASE2)
- Belimumab With Rituximab for Primary Membranous Nephropathy (PHASE2)
- Effects of Telitacicept vs Cyclophosphamide on Lupus Related Interstitial Lung Disease (PHASE4)
- BENLYSTA® Special Drug Use Investigation
- A Study of Belimumab in Chinese Pediatric Participants With Systemic Lupus Erythematosus (PHASE1)
- Study of Subcutaneous (SC) Belimumab in Pediatric Participants With Systemic Lupus Erythematosus (SLE) (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 Injection CI brief — competitive landscape report
- Belimumab Injection updates RSS · CI watch RSS
- Nanjing University School of Medicine portfolio CI