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Benlysta

(Belimumab)

Phase 3Monoclonal antibody

GGlaxo Dba Glaxosmithkline

Belimumab is used to treat systemic lupus erythematosus (SLE), an autoimmune disease where the body's immune system attacks its own tissues, causing inflammation and damage to joints, skin, and organs. It works by reducing the activity of certain immune cells that cause the disease.[1] Benlysta is currently being investigated across 30 indications[3], with its most advanced program in Phase 3.[1]

Benlysta is one of 577 monoclonal antibody programs targeting Systemic Lupus Erythematosus. It is currently in Phase 3.

30

Indications

81

Total Trials

20

Active Trials

576

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Systemic Lupus ErythematosusRecruiting

EmphysemaActive, not recruiting

CryoglobulinemiaActive, not recruiting

Rheumatic DiseaseRecruiting

VasculitisActive, not recruiting

Connective Tissue DiseaseActive, not recruiting

MyositisActive, not recruiting

Kidney TransplantActive, not recruiting

Relapsing-Remitting Multiple SclerosisActive, not recruiting

Autoimmune PolyendocrinopathyActive, not recruiting

Systemic Lupus ErythematosusPhase 1

Recruiting

EmphysemaPhase 2

Active, not recruiting

CryoglobulinemiaPhase 2

Active, not recruiting

Rheumatic DiseasePhase 2

Recruiting

VasculitisPhase 3

Active, not recruiting

Connective Tissue DiseasePhase 3

Active, not recruiting

MyositisPhase 2

Active, not recruiting

Kidney TransplantPhase 2

Active, not recruiting

Relapsing-Remitting Multiple SclerosisPhase 2

Active, not recruiting

Autoimmune PolyendocrinopathyPhase 2

Active, not recruiting

Showing 10 of 30 indications

Competition

Competitive Landscape

791 competitors in Rheumatoid Arthritis

#DrugCompanyPhaseTrials

Benlysta

GGlaxo Dba Glaxosmithkline

Orencia

Bristol-Myers Squibb

Actemra

Kevzara

AAzienda U.S.L. 1 di Massa e Carrara

Actos

Celexa

Zelhou

Jiangsu Simcere Pharmaceutical Co., Ltd.

Kineret

SSwedish Orphan Biovitrum

Cataflam

Rituxan

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Lupus

NCT03543839

Post-ApprovalRecruiting

Study completion

NCT06410833

Q2 2027

Phase 2Recruiting

Antibody

NCT06747312

Q3 2027

Phase 2Active, not recruiting

Chronic Lymphocytic Leukemia

NCT05069051

Q4 2027

Phase 1Recruiting

Systemic Lupus Erythematosus

NCT06857214

Clinical

Trials by Indication[1]

Systemic Lupus Erythematosus22 trials

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

Completed· GSK logo

GSK·Phase 3·NCT03312907·292 enrolled

A Study of Belimumab in Subjects With Systemic Lupus Erythematosus

Completed· GSK logo

GSK·Phase 3·NCT00410384·819 enrolled

Effectiveness of Belimumab Treatment in a Subpopulation of Systemic Lupus Erythematosus (SLE) Patients: a Pooled Analysis of BLISS-52 and BLISS-76

Completed· GSK logo

GSK··NCT01914770·1,016 enrolled

Show 19 more trials

BAFF-var as a Biomarker of Response to B-depletive Treatment in Systemic Lupus Erythematosus and Rheumatoid Arthritis

Unknown status·UUniversity of Cagliari··NCT05659407·60 enrolled

Phase 2 Study of Belimumab Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)

Terminated· GSK logo

GSK·Phase 2·NCT00732940·56 enrolled

Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE)

Completed· GSK logo

GSK·Phase 4·NCT01632241·503 enrolled

A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)

Completed· GSK logo

GSK·Phase 3·NCT01484496·839 enrolled

A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)

Completed· GSK logo

GSK·Phase 3·NCT00424476·865 enrolled

Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE)

Completed· GSK logo

GSK·Phase 2·NCT00071487·449 enrolled

A Study to Evaluate the Effect of Belimumab on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE)

Completed· GSK logo

GSK·Phase 4·NCT01597492·79 enrolled

Belimumab Phase I Study in Chinese Subjects With Systemic Lupus Erythematosus

Completed· GSK logo

GSK·Phase 1·NCT02880852·20 enrolled

Efficacy and Immunological Evaluation of Belimumab Plus Low Dose IL-2 in the Treatment of Systemic Lupus Erythematosus

Unknown status·PPeking University People's Hospital·Phase 3·NCT05262686·10 enrolled

Belimumab In Early Systemic Lupus Erythematosus

Completed·PPeking Union Medical College Hospital·Phase 4·NCT04956484·16 enrolled

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

Completed· GSK logo

GSK·Phase 3·NCT01597622·142 enrolled

A Study of Belimumab in Chinese Pediatric Participants With Systemic Lupus Erythematosus

Completed· GSK logo

GSK·Phase 1·NCT05917288·16 enrolled

A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE)

Recruiting· GSK logo

GSK·Phase 4·NCT06411249·350 enrolled

GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia

Completed· GSK logo

GSK·Phase 3·NCT01345253·709 enrolled

A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02

Completed· GSK logo

GSK·Phase 2·NCT00583362·298 enrolled

Phase 1 Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)

Completed· GSK logo

GSK·Phase 1·NCT00657007·70 enrolled

Open-label Study of Belimumab Plus Standard Therapy in Chinese Pediatric Participants With Active Systemic Lupus Erythematosus (SLE)

Completed· GSK logo

GSK·Phase 4·NCT04908865·67 enrolled

A Randomized Controlled Phase I Clinical Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GNC-038 Tetra-specific Antibody Injection in Systemic Lupus Erythematosus

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 1·NCT06857214·84 enrolled

A Phase 1, First-time-in-human, Four-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GSK4527363 in Healthy Participants (Part A), Participants With Active Systemic Lupus Erythematosus (Part B), Healthy Participants of Chinese and Japanese Descent (Part C) and Participants With Interstitial Lung Disease Associated With Connective Tissue Disease (Part D)

Recruiting· GSK logo

GSK·Phase 1·NCT06576271·142 enrolled

Lupus Nephritis5 trials

Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis

Completed· GSK logo

GSK·Phase 3·NCT01639339·448 enrolled

Trial of Belimumab Combined With Multi-target Induction Therapy in Lupus Nephritis

Unknown status·NNanjing University School of Medicine·Phase 3·NCT05863936·15 enrolled

Rituximab and Belimumab for Lupus Nephritis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT02260934·43 enrolled

Show 2 more trials

The Efficacy and Safety of Telitacicept and Belimumab in Active Lupus Nephritis in the Real World: a Prospective Cohort Study

Unknown status·TThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School··NCT05588830·60 enrolled

The Efficacy and Safety of Biologics (Belimumab/ Telitacicept) Induction Therapy in Proliferative Lupus Nephritis Patients for 6 Months Compared With Mycophenolate Mofetil Treatment

Recruiting·NNanjing University School of Medicine·Phase 2·NCT07340463·50 enrolled

Lupus3 trials

A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States

Completed· GSK logo

GSK·Phase 3·NCT00724867·268 enrolled

A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057

Completed· GSK logo

GSK·Phase 3·NCT00712933·738 enrolled

Trial of Belimumab in Early Lupus

Recruiting·NNorthwell Health·Phase 4·NCT03543839·30 enrolled

Kidney Transplant3 trials

Desensitization With Belimumab in Sensitized Patients Awaiting Kidney Transplant

Terminated·UUniversity of Pennsylvania·Phase 2·NCT01025193·8 enrolled

A Study of Belimumab in the Prevention of Kidney Transplant Rejection

Completed· GSK logo

GSK·Phase 2·NCT01536379·30 enrolled

CAMPath and BELimumab for Transplant Tolerance in Sensitized Kidney Transplant Recipients

Terminated·UUniversity of Wisconsin, Madison·Phase 2·NCT03591380·3 enrolled

Vasculitis2 trials

Belimumab in Remission of VASculitis

Completed· GSK logo

GSK·Phase 3·NCT01663623·106 enrolled

Rituximab and Belimumab Combination Therapy in PR3 Vasculitis

Unknown status·RRachel Jones·Phase 2·NCT03967925·31 enrolled

40 more indications

Antibody2 trials

Effect of Belimumab on Antibody Titers in Primary APS Patients

Recruiting·RRuijin Hospital·Phase 2·NCT06747312·20 enrolled

Expanded Access Trial of Belimumab Antibody in RA Patients Who Were Previously Treated Under HGS Protocol LBRA99

No longer available· GSK logo

GSK··NCT00931086

Rheumatoid Arthritis2 trials

A Safety and Efficacy Study of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA)

Completed· GSK logo

GSK·Phase 2·NCT00071812·283 enrolled

A Continuation Trial for Subjects With Rheumatoid Arthritis That Have Completed Protocol LBRA01

Terminated· GSK logo

GSK·Phase 2·NCT00583557·155 enrolled

Connective Tissue Disease2 trials

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)

Recruiting· GSK logo

GSK·Phase 3·NCT06716606·514 enrolled

A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease

Recruiting· GSK logo

GSK·Phase 3·NCT06572384·440 enrolled

Treatment2 trials

Belimumab Treatment Holiday and Treatment Re-start Study in Lupus Patients

Completed· GSK logo

GSK·Phase 3·NCT02119156·80 enrolled

Belimumab for Treatment of cGVHD Following Allo-HCT

Withdrawn·Xxuna·Phase 1/2·NCT05604742

Membranous Nephropathy2 trials

Efficacy and Safety Study of Intravenous Belimumab Versus Placebo in Subjects With Idiopathic Membranous Nephropathy

Withdrawn· GSK logo

GSK·Phase 2·NCT01762852

Belimumab and Rituximab Compared to Rituximab Alone for the Treatment of Primary Membranous Nephropathy (ITN080AI)

Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT03949855·58 enrolled

Systemic Sclerosis2 trials

Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis

Recruiting·HHospital for Special Surgery, New York·Phase 2·NCT03844061·30 enrolled

Belimumab for the Treatment of Diffuse Cutaneous Systemic Sclerosis

Completed·HHospital for Special Surgery, New York·Phase 2·NCT01670565·20 enrolled

Pediatric1 trial

Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy

Completed· GSK logo

GSK·Phase 2·NCT01649765·93 enrolled

Single Dose1 trial

A Study to Estimate the Relative Bioavailability, Tolerability and Safety of a Single Dose of Belimumab Self-Administered Subcutaneously (SC) by Healthy Subjects

Completed· GSK logo

GSK·Phase 1·NCT01894360·81 enrolled

ESS1 trial

Belimumab Assessment of Safety in SLE

Completed· GSK logo

GSK·Phase 4·NCT01705977·4,019 enrolled

Autoimmune Hepatitis1 trial

Belimumab in Autoimmune Hepatitis

Recruiting·UUniversity Health Network, Toronto·Phase 2·NCT06381453·48 enrolled

ISS1 trial

A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies

Completed· GSK logo

GSK··NCT01858792·1 enrolled

Intravenous1 trial

Single Dose Study to Investigate the Pharmacokinetics (PK) and Safety of Belimumab 200 Milligrams (mg) Intravenous and 200 mg Subcutaneous Via Auto-injector in Chinese Healthy Subjects

Completed· GSK logo

GSK·Phase 1·NCT04136145·36 enrolled

Chronic Lymphocytic Leukemia1 trial

Belimumab in Patients with Chronic Lymphocytic Leukemia

Active, not recruiting·UUniversity Hospital Tuebingen·Phase 2·NCT05069051·120 enrolled

Neuromyelitis Optica1 trial

Efficacy and Safety of Belimumab in Neuromyelitis Optica Spectrum Disorders

Completed·TTianjin Medical University General Hospital·Phase 1/2·NCT05154734·14 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Belimumab in SLE Patients

Completed·RRenJi Hospital·Phase 4·NCT04515719·231 enrolled

Immune1 trial

Transcriptional and Immune Parameters of Response to Belimumab

Completed·UUnknown Sponsor··NCT04570306·85 enrolled

Antiphospholipid Syndrome1 trial

The BeLimumab Antiphospholipid Syndrome Trial (BLAST)

Unknown status·UUniversity of Turin, Italy·Phase 2/3·NCT05020782·15 enrolled

Pregnancy1 trial

Belimumab (BENLYSTA®) Pregnancy Registry

Completed· GSK logo

GSK··NCT01532310·77 enrolled

SLE1 trial

A Model About the Response of Belimumab in SLE

Unknown status·FFirst Affiliated Hospital Xi'an Jiaotong University·Phase 4·NCT04893161·72 enrolled

Interstitial Lung Disease1 trial

A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease

Recruiting· GSK logo

GSK·Phase 2/3·NCT05878717·300 enrolled

Relapsing-Remitting Multiple Sclerosis1 trial

Addition of Belimumab to B-cell Depletion in Relapsing-remitting Multiple Sclerosis

Terminated·JJohns Hopkins University·Phase 2·NCT04767698·4 enrolled

ALD1 trial

A Study of Belimumab in Treating Symptomatic Waldenstroms Macroglobulinaemia

Unknown status·CCancer Trials Australia·Phase 2·NCT01142011·15 enrolled

Primary Sjogren's Syndrome1 trial

Safety and Efficacy Study of Subcutaneous Belimumab and Intravenous Rituximab Co-administration in Subjects With Primary Sjogren's Syndrome

Completed· GSK logo

GSK·Phase 2·NCT02631538·86 enrolled

Polyp1 trial

Evaluation of Belimumab Impact on a BLyS Activity Signature Test in the Absence of Confounding Polypharmacy

Unknown status·OOklahoma Medical Research Foundation·Phase 4·NCT02270970·20 enrolled

Immune Thrombocytopenia1 trial

A Study to Investigate Belimumab for the Treatment of Chronic Immune Thrombocytopenia.

Withdrawn· GSK logo

GSK·Phase 2·NCT01440361

TIA1 trial

Sequential Belimumab and T-cell Based Therapy in SLE

Unknown status·NNational University Hospital, Singapore·Phase 4·NCT04447053·80 enrolled

Myasthenia Gravis1 trial

The Evaluation of Belimumab in Myasthenia Gravis (MG)

Completed· GSK logo

GSK·Phase 2·NCT01480596·40 enrolled

Lymphopenia1 trial

Safety of Belimumab in People With Idiopathic CD4 Lymphopenia and Autoantibodies (Phoebe)

Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT04097561·20 enrolled

Prevention1 trial

Belimumab In Prevention of LN

Not yet recruiting·RRenJi Hospital··NCT05585671·48 enrolled

Immunomodulation1 trial

Synergetic B-cell Immunomodulation in SLE - 2nd Study.

Active, not recruiting·LLeiden University Medical Center·Phase 3·NCT03747159·70 enrolled

Myositis1 trial

Belimumab in Idiopathic Inflammatory Myositis

Completed·NNorthwell Health·Phase 2/3·NCT02347891·17 enrolled

Primary Sjögren's Syndrome1 trial

Efficacy and Safety of Belimumab in Subjects With Primary Sjögren's Syndrome

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT01160666·20 enrolled

Cryoglobulinemia1 trial

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)

Recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT04629144·48 enrolled

MPA1 trial

Belimumab Impacting Transplant Eligibility

Completed·EE. Steve Woodle·Phase 1/2·NCT02500251·11 enrolled

Inflammation1 trial

Belimumab in SLE Synovial Inflammation and Lymph Nodes

Recruiting·—··NCT06327724·15 enrolled

Emphysema1 trial

Belimumab Treatment of Emphysema Patients With Anti-GRP78 Autoantibodies

Completed·UUniversity of Alabama at Birmingham·Phase 2·NCT03244059·17 enrolled

Allogeneic Hematopoietic Cell Transplant1 trial

Belimumab for Prevention of Chronic Graft-versus-Host Disease Following Allogeneic Hematopoietic Cell Transplantation

Completed·WWashington University School of Medicine·Phase 1·NCT03207958·10 enrolled

Nephropathy1 trial

A Study of Belimumab in Idiopathic Membranous Glomerulonephropathy

Completed· GSK logo

GSK·Phase 2·NCT01610492·14 enrolled

Rheumatic Disease1 trial

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Recruiting·NNYU Langone Health·Phase 2·NCT07138898·80 enrolled

Unspecified1 trial

Belimumab After Rituximab in Resistant Primary Juvenile SS

Recruiting·PPeking Union Medical College Hospital·Phase 4·NCT06410833·15 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 9, 2011

BENLYSTA

BLA BLA125370

Jul 20, 2017

BENLYSTA

BLA BLA761043

Sources

References

[1]
ClinicalTrials.gov — 81 trial records for Belimumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Belimumab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Belimumab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761043). U.S. Food & Drug Administration.
[5]
PubMed — 1 publication indexed for Belimumab. U.S. National Library of Medicine.
[6]
SEC EDGAR — Glaxo Dba Glaxosmithkline company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Blys Inhibitor[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: GGlaxo Dba Glaxosmithkline

Key Publications[5]

Belimumab Plus Rituximab in Lupus Nephritis: BLISS-BELIEVE

Ann Intern MedSep 6, 2022DOI: 10.7326/M22-0671

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