Belimumab

Summary

Belimumab (CHEMBL1789843) is an approved antibody (ATC L04AG04); indicated across 18 conditions including lupus nephritis and systemic lupus erythematosus.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Antibody
• ATC class: L04AG04
• Indications: 18 conditions
• Clinical trials: 81

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL1789843
Name	Belimumab
Type	Antibody
Max phase	4
ATC	L04AG04

Also known as: BEL-114333, BEL114333, Belimumab, Belimumab (genetical recombination), Benlysta, GSK-1550188, GSK1550188, HGS-1006, HGS1006, Lymphostat-b, Lymphostat-b benlysta, BELIMUMAB

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

18 indications (2 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
lupus nephritis	4	MONDO:0005556	EFO:0005761
systemic lupus erythematosus	4	MONDO:0007915	MONDO:0007915
autoimmune thrombocytopenic purpura	3	MONDO:0008558	EFO:0007160
vasculitis	3	MONDO:0018882	EFO:0006803
rheumatoid arthritis	2	MONDO:0008383	EFO:0000685
systemic sclerosis	2	MONDO:0005100	EFO:0000717
membranous glomerulonephritis	2	MONDO:0005376	EFO:0004254
Sjogren syndrome	2	MONDO:0010030	EFO:0000699
myositis disease	2	MONDO:0021167	EFO:0000783
pulmonary emphysema	2	MONDO:0004849	EFO:0000464
B-cell chronic lymphocytic leukemia	2	MONDO:0004948	EFO:0000095
nephrotic syndrome	2	MONDO:0005377	EFO:0004255
multiple sclerosis	2	MONDO:0005301	MONDO:0005301
kidney disorder	2	MONDO:0005240	EFO:0003086
graft versus host disease	1	MONDO:0013730	MONDO:0013730
neuromyelitis optica	1	MONDO:0019100	EFO:0004256
lymphopenia	1	MONDO:0003783	MONDO:0003783

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 81.

Phase distribution

Phase	Trials
PHASE2	29
PHASE3	15
PHASE4	12
Not specified	10
PHASE1	9
PHASE2/PHASE3	3
PHASE1/PHASE2	3

Top trials by phase / activity

NCT	Phase	Status	Title
NCT03543839	PHASE4	RECRUITING	Trial of Belimumab in Early Lupus
NCT06410833	PHASE4	RECRUITING	Belimumab After Rituximab in Resistant Primary Juvenile SS
NCT06411249	PHASE4	RECRUITING	A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE)
NCT07611214	PHASE4	RECRUITING	PRESERVE: LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab in Patients With Lupus Nephritis
NCT01632241	PHASE4	COMPLETED	Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE)
NCT01705977	PHASE4	COMPLETED	Belimumab Assessment of Safety in SLE
NCT02270970	PHASE4	UNKNOWN	Evaluation of Belimumab Impact on a BLyS Activity Signature Test in the Absence of Confounding Polypharmacy
NCT04515719	PHASE4	COMPLETED	Efficacy and Safety of Belimumab in SLE Patients
NCT04660565	PHASE4	UNKNOWN	Belimumab Treatment for IgG4-related Disease
NCT04893161	PHASE4	UNKNOWN	A Model About the Response of Belimumab in SLE
NCT04908865	PHASE4	COMPLETED	Open-label Study of Belimumab Plus Standard Therapy in Chinese Pediatric Participants With Active Systemic Lupus Erythematosus (SLE)
NCT04956484	PHASE4	COMPLETED	Belimumab In Early Systemic Lupus Erythematosus
NCT03747159	PHASE3	ACTIVE_NOT_RECRUITING	Synergetic B-cell Immunomodulation in SLE - 2nd Study.
NCT05878717	PHASE2/PHASE3	RECRUITING	A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease
NCT06572384	PHASE3	RECRUITING	A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease
NCT06716606	PHASE3	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)
NCT00410384	PHASE3	COMPLETED	A Study of Belimumab in Subjects With Systemic Lupus Erythematosus
NCT00424476	PHASE3	COMPLETED	A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)
NCT00712933	PHASE3	COMPLETED	A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057
NCT00724867	PHASE3	COMPLETED	A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States
NCT01345253	PHASE3	COMPLETED	GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia
NCT01597622	PHASE3	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
NCT01639339	PHASE3	COMPLETED	Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis
NCT01663623	PHASE3	COMPLETED	Belimumab in Remission of VASculitis
NCT02119156	PHASE3	COMPLETED	Belimumab Treatment Holiday and Treatment Re-start Study in Lupus Patients
NCT02347891	PHASE2/PHASE3	COMPLETED	Belimumab in Idiopathic Inflammatory Myositis
NCT03312907	PHASE3	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
NCT05020782	PHASE2/PHASE3	UNKNOWN	The BeLimumab Antiphospholipid Syndrome Trial (BLAST)
NCT05262686	PHASE3	UNKNOWN	Efficacy and Immunological Evaluation of Belimumab Plus Low Dose IL-2 in the Treatment of Systemic Lupus Erythematosus
NCT05863936	PHASE3	UNKNOWN	Trial of Belimumab Combined With Multi-target Induction Therapy in Lupus Nephritis
NCT03844061	PHASE2	RECRUITING	Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis
NCT03949855	PHASE2	RECRUITING	Belimumab With Rituximab for Primary Membranous Nephropathy
NCT04179032	PHASE2	ACTIVE_NOT_RECRUITING	Study of Subcutaneous (SC) Belimumab in Pediatric Participants With Systemic Lupus Erythematosus (SLE)
NCT04629144	PHASE2	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)
NCT05069051	PHASE2	ACTIVE_NOT_RECRUITING	Belimumab in Patients with Chronic Lymphocytic Leukemia
NCT06747312	PHASE2	RECRUITING	Effect of Belimumab on Antibody Titers in Primary APS Patients
NCT07138898	PHASE2	NOT_YET_RECRUITING	Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
NCT07340463	PHASE2	RECRUITING	The Efficacy and Safety of Biologics (Belimumab/ Telitacicept) Induction Therapy in Proliferative Lupus Nephritis Patients for 6 Months Compared With Mycophenolate Mofetil Treatment
NCT00071487	PHASE2	COMPLETED	Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE)
NCT00071812	PHASE2	COMPLETED	A Safety and Efficacy Study of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA)

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).