BLAINJECTIONINJECTABLE1 Generic Approved
Approved
Jul 2017
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
BENLYSTA (belimumab) by GSK is b lymphocyte stimulator-directed antibody interactions [moa]. Approved for b lymphocyte stimulator-specific inhibitor [epc]. First approved in 2017.
Drug data last refreshed 3h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BENLYSTA (belimumab) is a fully human monoclonal antibody that inhibits B lymphocyte stimulator (BLyS), a key driver of B-cell survival and autoantibody production. It is approved for systemic lupus erythematosus (SLE) and lupus nephritis, working by reducing autoreactive B cells and plasma cells. The drug represents a targeted immunologic approach to managing this serious autoimmune disease.
Peak
Product is at peak commercial stage with established market presence; brand teams focused on market penetration and indication expansion rather than launch support.
Mechanism of Action
B Lymphocyte Stimulator-directed Antibody Interactions
Pharmacologic Class:
B Lymphocyte Stimulator-specific Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
PRESERVE: LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab in Patients With Lupus Nephritis
Started Apr 2026
150 enrolled
Lupus Nephritis
Belimumab to Mobilise Memory B-cells From Secondary Lymhoid Organs to Improve Memory B-cell HLA-specificity Profiling to Support Delisting for Transplant Access in Highly-sensitized
Started Apr 2026
25 enrolled
Kidney Transplant Rejection
A Study to Investigate the Long-term Safety and Efficacy of Belimumab in Adults With Interstitial Lung Disease (ILD) Associated With Systemic Sclerosis (SSc) and Other Connective Tissue Diseases (CTD) (BLISSconneCTD-OLE)
Started Dec 2024
514 enrolled
Connective Tissue Diseases
Belimumab in Autoimmune Hepatitis
Started Dec 2024
48 enrolled
Autoimmune Hepatitis
Study to Assess Real-world Effectiveness of Belimumab for Treatment of Adults With LN
Started Oct 2024
300 enrolled
Lupus Nephritis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.