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 3d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BENLYSTA (belimumab) is a monoclonal antibody that inhibits B Lymphocyte Stimulator (BLyS), a key driver of B cell survival and autoantibody production in systemic lupus erythematosus (SLE). It is administered by injection and represents the first biologic therapy specifically targeting BLyS in autoimmune disease. The drug reduces disease activity and flares in SLE patients by selectively suppressing pathogenic B cell populations.
Peak
BENLYSTA is at peak commercial maturity with moderate competitive intensity (30% pressure score), indicating stable but not rapidly expanding team dynamics.
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)
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
A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease
Started Sep 2024
440 enrolled
Lung Diseases, Interstitial
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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.