BENLYSTA (belimumab)
BENLYSTA is indicated for the treatment of Systemic Lupus Erythematosus; Lupus Nephritis.
How BENLYSTA Works
BENLYSTA functions by blocking the binding of soluble BLyS, a B-cell survival factor, to its receptors on B cells. While the drug does not bind to B cells directly, its inhibition of BLyS prevents the survival of B cells, including autoreactive B cells. This process reduces the differentiation of B cells into plasma cells that produce immunoglobulins.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2011-03-09
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
BENLYSTA Approval History
What BENLYSTA Treats
2 indicationsBENLYSTA is approved for 2 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Systemic Lupus Erythematosus
- Lupus Nephritis
BENLYSTA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in BENLYSTA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications BENLYSTA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to BENLYSTA
3 of 6FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
39 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04908865 results posted | 213560 | Ph 4 | completed | Open-label Study of Belimumab Plus Standard Therapy in Chinese Pediatric Participants With Active Systemic Lupus Erythematosus (SLE) |
| NCT06576271 | 221458 2024-514186-18-00 | Ph 1 | recruiting | A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Japanese Participants and CTD-ILD Participants |
| NCT04097561 | 190140 19-I-0140 | Ph 1 | recruiting | Safety of Belimumab in People With Idiopathic CD4 Lymphopenia and Autoantibodies (Phoebe) |
| NCT03207958 results posted | 201709068 | Ph 1 | completed | Belimumab for Prevention of Chronic Graft-versus-Host Disease Following Allogeneic Hematopoietic Cell Transplantation |
| NCT03844061 | 2018-2011 | Ph 2 | recruiting | Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis |
| NCT07340463 | 2024LCYXXH009 | Ph 2 | recruiting | The Efficacy and Safety of Biologics (Belimumab/ Telitacicept) Induction Therapy in Proliferative Lupus Nephritis Patients for 6 Months Compared With Mycophenolate Mofetil Treatment |
| NCT06572384 BEconneCTD-ILD | 221672 2024-513018-36-00 | Ph 3 | recruiting | A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease |
| NCT03949855 REBOOT | DAIT ITN080AI NIAID CRMS ID#:38478 | Ph 2 | recruiting | Belimumab With Rituximab for Primary Membranous Nephropathy |
| NCT05878717 BLISSc-ILD | 218224 2023-503219-14-01 | Ph 2, Ph 3 | recruiting | A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease |
| NCT06716606 | 219855 2023-509370-39 | Ph 3 | recruiting | 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) |
| NCT05917288 results posted | 217091 | Ph 1 | completed | A Study of Belimumab in Chinese Pediatric Participants With Systemic Lupus Erythematosus |
| NCT07138898 | 25-00380 | Ph 2 | not yet recruiting | Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty |
| NCT04515719 | Btrial | Ph 4 | completed | Efficacy and Safety of Belimumab in SLE Patients |
| NCT03312907 results posted | 205646 2016-003050-32 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) - BLISS-BELIEVE |
| NCT04611971 | CR108910 2020-002481-14, NOPRODPANAP1002 | Ph 1 | completed | A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 2 |
| NCT05154734 | IRB2021-YX-187-01 | Ph 1, Ph 2 | completed | Efficacy and Safety of Belimumab in Neuromyelitis Optica Spectrum Disorders |
| NCT04629144 TRIBECA | APHP180351 | Ph 2 | recruiting | Efficacy and Safety of Belimumab in the Treatment of Non-infectious Active Cryoglobulinemia Vasculitis Compared to Placebo. TRIBECA STUDY (Treatment nd BElimumab in Cryoglobulinemia Associated Vasculitis) |
| NCT06410833 BRRPJS | K3926 | Ph 4 | recruiting | Belimumab After Rituximab in Resistant Primary Juvenile SS |
| NCT03543839 | 17-0861 | Ph 4 | recruiting | Trial of Belimumab in Early Lupus |
| NCT02347891 BIM results posted | 14-621 | Ph 2, Ph 3 | completed | Belimumab in Idiopathic Inflammatory Myositis |
| NCT03244059 BOTEGA results posted | IRB-300000119 | Ph 2 | completed | Belimumab Treatment of Emphysema Patients With Anti-GRP78 Autoantibodies |
| NCT04767698 results posted | IRB00246563 | Ph 2 | terminated | Addition of Belimumab to B-cell Depletion in Relapsing-remitting Multiple Sclerosis |
| NCT03591380 CAMPBEL results posted | 2017-1385 Protocol Version 8/17/2020, A539742 | Ph 2 | terminated | CAMPath and BELimumab for Transplant Tolerance in Sensitized Kidney Transplant Recipients |
| NCT04956484 | LXM-210622 | Ph 4 | completed | Belimumab In Early Systemic Lupus Erythematosus |
| NCT01670565 results posted | 2014-279 | Ph 2 | completed | Belimumab for the Treatment of Diffuse Cutaneous Systemic Sclerosis |
| NCT02631538 results posted | 201842 2015-000400-26 | Ph 2 | completed | Safety and Efficacy Study of Subcutaneous Belimumab and Intravenous Rituximab Co-administration in Subjects With Primary Sjogren's Syndrome |
| NCT02260934 CALIBRATE results posted | DAIT ITN055AI CALIBRATE | Ph 2 | completed | Rituximab and Belimumab for Lupus Nephritis |
| NCT02880852 results posted | 200909 | Ph 1 | completed | Belimumab Phase I Study in Chinese Subjects With Systemic Lupus Erythematosus |
| NCT01597622 results posted | 114333 | Ph 3 | completed | BEL114333, a Continuation Study of BEL113750 in Subjects With Systemic Lupus Erythematosus (SLE) in Northeast Asia, and in Japan Subjects Completing the Open-label Extension of HGS1006-C1115 |
| NCT02119156 results posted | 116027 | Ph 3 | completed | Belimumab Treatment Holiday and Treatment Re-start Study in Lupus Patients |
| NCT00712933 results posted | 112234 2007-007648-85 | Ph 3 | completed | A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057 |
| NCT01345253 results posted | 113750 | Ph 3 | completed | GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia |
| NCT02500251 | Belimumab | Ph 1, Ph 2 | completed | Belimumab Impacting Transplant Eligibility |
| NCT01610492 results posted | 116472 | Ph 2 | completed | A Study of Belimumab in Idiopathic Membranous Glomerulonephropathy |
| NCT01025193 results posted | IND 106342 | Ph 2 | terminated | Desensitization With Belimumab in Sensitized Patients Awaiting Kidney Transplant |
| NCT01536379 results posted | 114424 | Ph 2 | completed | A Study of Belimumab in the Prevention of Kidney Transplant Rejection |
| NCT01480596 results posted | 115123 | Ph 2 | completed | The Evaluation of Belimumab in Myasthenia Gravis (MG) |
| NCT01440361 | 114870 | Ph 2 | withdrawn | A Study to Investigate Belimumab for the Treatment of Chronic Immune Thrombocytopenia. |
| NCT01160666 BELISS | P090208 | Ph 2 | completed | Efficacy and Safety of Belimumab in Subjects With Primary Sjögren's Syndrome |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BENLYSTA FDA Label Details
Indications & Usage
FDA Label (PDF)BENLYSTA is indicated for the treatment of Systemic Lupus Erythematosus; Lupus Nephritis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment