Last reviewed 2026-04-20 · How we verify

Benlysta

At a glance

Approved indications

• Systemic lupus erythematosus

Common side effects

• Nausea
• Diarrhea
• Pyrexia
• Nasopharyngitis
• Bronchitis
• Insomnia
• Pain in extremity
• Depression
• Migraine
• Pharyngitis
• Cystitis
• Leukopenia

Serious adverse events

• Serious infections
• Infusion reactions
• Lupus nephritis

Key clinical trials

• Safety of Belimumab in People With Idiopathic CD4 Lymphopenia and Autoantibodies (Phoebe) (PHASE1)
• Study to Assess Real-world Effectiveness of Belimumab for Treatment of Adults With LN
• Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis (PHASE2)
• Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) Registry
• A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Japanese Participants and CTD-ILD Participants (PHASE1)
• The Efficacy and Safety of Biologics (Belimumab/ Telitacicept) Induction Therapy in Proliferative Lupus Nephritis Patients for 6 Months Compared With Mycophenolate Mofetil Treatment (PHASE2)
• A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease (PHASE3)
• Belimumab in Autoimmune Hepatitis (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Benlysta CI brief — competitive landscape report
• Benlysta updates RSS · CI watch RSS
• GlaxoSmithKline portfolio CI