Belimumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2011
- First approval year
- 2011
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Belimumab
- benlysta
- Benlysta
- lymphostat b
- lymphostat b benlysta
- Lymphostat-b
- Lymphostat-b benlysta
- bel 114333
- BEL-114333
- bel114333
- BEL114333
- belimumab
- Belimumab
- Belimumab (Benlysta)
- Belimumab (genetical recombination)
- BELIMUMAB (GENETICAL RECOMBINATION) [JAN]
- Belimumab (GSK1550188)
- BELIMUMAB [EMA EPAR]
- belimumab [INN]
- BELIMUMAB [JAN]
- BELIMUMAB [MART.]
- BELIMUMAB [MI]
- BELIMUMAB [PURPLE BOOK CDER]
- BELIMUMAB [USAN]
- BELIMUMAB [VANDF]
- Belimumab [WHO-DD]
- belimumab 1 mg kg
- belimumab 10 mg
- Belimumab 10 mg
- belimumab 10 mg kg
- Belimumab 10 mg/kg
- belimumab 4 mg kg
And 34 more, listed on the interactive page.
- ATC classification codes
- L04AG04
Sources for recorded values
- CAS registry numbers
- 356547-88-1
- ChEMBL ID
- CHEMBL1789843
- RxNorm IDs (RxCUI)
- 1092437
- FDA ingredient codes (UNII)
- 73B0K5S26A
- Applicant
- HUMAN GENOME SCIENCES INC.
- Approval date
- 9 Mar 2011
- Application number
- BLA125370
- Status
- Authorised
- Status date
- 13 Jul 2011
- Authorisation date
- 13 Jul 2011
- Approved indications
- Benlysta is indicated as add-on therapy in patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti‑dsDNA and low complement) despite standard therapy. Benlysta is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis. Benlysta is indicated as add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti dsDNA and low complement) despite standard therapy.
- Product number
- EMEA/H/C/002015
- Authorisation holder
- GlaxoSmithKline (Ireland) Limited
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Lupus Erythematosus, Systemic
European medicines record
- Patents
- 0
- Designations
- 4
- First in class
- Yes
- Fast track
- Yes
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- United States (FDA)
- Approved
- European Union (EMA)
- Authorised
- Pharmacology name
- belimumab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Binding
- Action type
- Binding
- Target
- BAFF
- Gene symbol
- BAFF
- Median affinity
- 10.62
- Affinity units
- pEC50
- Primary target
- Yes
- Mechanism
- Tumor necrosis factor ligand superfamily member 13B inhibitor
- Action type
- Inhibitor
- Target
- Tumor necrosis factor ligand superfamily member 13B
- Protein identifier
- Q9Y275
Open Targets mechanisms
- Mechanism
- Tumor necrosis factor ligand superfamily member 13B inhibitor
- Action type
- Inhibitor
- Target
- Tumor necrosis factor ligand superfamily member 13B
- Condition
- Leukemia, Lymphocytic, Chronic, B-Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000095
- Subject identifier
- D015451
- Condition
- Emphysema
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000464
- Subject identifier
- D004646
- Condition
- Arthritis, Rheumatoid
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000685
- Subject identifier
- D001172
- Condition
- Sjogren's Syndrome
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000699
- Subject identifier
- D012859
- Condition
- Scleroderma, Systemic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000717
- Subject identifier
- D012595
- Condition
- Myositis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000783
- Subject identifier
- D009220
- Condition
- Kidney Diseases
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003086
- Subject identifier
- D007674
- Condition
- Glomerulonephritis, Membranous
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004254
- Subject identifier
- D015433
- Condition
- Nephrotic Syndrome
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004255
- Subject identifier
- D009404
- Condition
- Neuromyelitis Optica
- Highest recorded phase
- 1
- Condition identifier
- EFO:0004256
- Subject identifier
- D009471
- Condition
- Lupus Nephritis
- Highest recorded phase
- 4
- Condition identifier
- EFO:0005761
- Subject identifier
- D008181
- Condition
- Vasculitis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0006803
- Subject identifier
- D014657
- Condition
- Purpura, Thrombocytopenic, Idiopathic
- Highest recorded phase
- 3
- Condition identifier
- EFO:0007160
- Subject identifier
- D016553
- Condition
- Lymphopenia
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0003783
- Subject identifier
- D008231
- Condition
- Multiple Sclerosis
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0005301
- Subject identifier
- D009103
- Condition
- Lupus Erythematosus, Systemic
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0007915
- Subject identifier
- D008180
- Condition
- Graft vs Host Disease
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0013730
- Subject identifier
- D006086
- Condition
- Polyendocrinopathies, Autoimmune
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0017278
- Subject identifier
- D016884
- Condition identifier
- EFO_0000095
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000685
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000699
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000717
- Condition identifier
- EFO_0000783
- Condition identifier
- EFO_0004244
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004254
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004256
- Condition identifier
- EFO_0005676
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005761
- Condition identifier
- EFO_0006803
- Highest recorded phase
- 3
- Condition identifier
- EFO_0007160
- Highest recorded phase
- 3
- Condition identifier
- EFO_0010134
- Highest recorded phase
- 2
- Condition identifier
- EFO_0803536
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001986
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0000605
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0003783
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0004849
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004948
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005019
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005100
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005240
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005301
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005376
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005556
- Highest recorded phase
- 4
And 22 more, listed on the interactive page.
- Event
- arthralgia
- Reports
- 155
- Reporting signal score
- 54.7648
- Event
- central nervous system lupus
- Reports
- 20
- Reporting signal score
- 111.708
- Event
- headache
- Reports
- 193
- Reporting signal score
- 44.0247
- Event
- hypnotherapy
- Reports
- 6
- Reporting signal score
- 37.6958
- Event
- hypocomplementaemia
- Reports
- 11
- Reporting signal score
- 48.8919
- Event
- leukopenia
- Reports
- 58
- Reporting signal score
- 41.1082
- Event
- lupus endocarditis
- Reports
- 10
- Reporting signal score
- 51.8607
- Event
- lupus nephritis
- Reports
- 99
- Reporting signal score
- 456.039
- Event
- lupus pneumonitis
- Reports
- 25
- Reporting signal score
- 137.52
- Event
- lupus vasculitis
- Reports
- 12
- Reporting signal score
- 58.7929
- Event
- proteinuria
- Reports
- 55
- Reporting signal score
- 84.6531
- Event
- renal vascular thrombosis
- Reports
- 8
- Reporting signal score
- 38.0627
- Event
- rhesus antigen positive
- Reports
- 10
- Reporting signal score
- 64.3736
- Event
- sle arthritis
- Reports
- 62
- Reporting signal score
- 343.304
- Event
- systemic lupus erythematosus
- Reports
- 394
- Reporting signal score
- 1,367.83
- Event
- systemic lupus erythematosus rash
- Reports
- 41
- Reporting signal score
- 177.231
- Event
- therapy interrupted
- Reports
- 67
- Reporting signal score
- 127.466
- Event
- urinary tract infection
- Reports
- 100
- Reporting signal score
- 53.9474
- Event
- vasculitis
- Reports
- 28
- Reporting signal score
- 40.9206
- NCT00071487
- NCT00410384
- NCT00424476
- NCT00583362
- NCT00657007
- NCT00712933
- NCT00724867
- NCT00732940
- NCT01345253
- NCT01381536
- NCT01484496
- NCT01516450
- NCT01597492
- NCT01597622
- NCT01632241
- NCT01649765
- NCT01705977
- NCT01894360
- NCT02119156
- NCT02270970
- NCT02284984
- NCT02880852
- NCT03312907
- NCT03543839
- NCT03747159
And 30 more, listed on the interactive page.
- Dose
- 10 mg/kg
- Route
- Intravenous
- How often
- 10 mg/kg at 2-week intervals for 3 doses, then every 4 weeks
Conditions of use
- Administer as an infusion over 1 hour
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- 49401-088
- 49401-101
- 49401-102
Related records
Trials (89)
- A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057
- A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States
- A Continuation Trial for Subjects With Rheumatoid Arthritis That Have Completed Protocol LBRA01
- A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02
- A Model About the Response of Belimumab in SLE
- A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies
- A Safety and Efficacy Study of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA)
- A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE)
- A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)
- A Study of Belimumab in Chinese Pediatric Participants With Systemic Lupus Erythematosus
- A Study of Belimumab in Idiopathic Membranous Glomerulonephropathy
- A Study of Belimumab in Subjects With Systemic Lupus Erythematosus
- A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)
- A Study of Belimumab in the Prevention of Kidney Transplant Rejection
- A Study of Belimumab in Treating Symptomatic Waldenstroms Macroglobulinaemia
- A Study of GNC-038 Tetra-specific Antibody Injection in Patients With Systemic Lupus Erythematosus
- A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Japanese Participants and CTD-ILD Participants
- A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease
- A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease
- A Study to Estimate the Relative Bioavailability, Tolerability and Safety of a Single Dose of Belimumab Self-Administered Subcutaneously (SC) by Healthy Subjects
Approved for (2)
In development for (31)
- Anti-neutrophil cytoplasmic antibody-associated vasculitis Phase 3
- Autoimmune hepatitis Phase 2
- Autoimmune polyendocrinopathy Phase 2
- Autoimmune thrombocytopenic purpura Phase 3
- B-cell chronic lymphocytic leukemia Phase 2
- Chronic graft versus host disease Phase 1
- Connective tissue disorder Phase 3
- Dermatomyositis Phase 2
- Diffuse scleroderma Phase 2
- Graft versus host disease Phase 1
- Granulomatosis with polyangiitis Phase 3
- Hypersensitivity reaction disease Phase 2
- Idiopathic inflammatory myopathy Phase 2
- Idiopathic membranous glomerulonephritis Phase 2
- Interstitial lung disease Phase 3
- Kidney disorder Phase 2
- Lymphopenia Phase 1
- Membranous glomerulonephritis Phase 2
- Microscopic polyangiitis Phase 3
- Multiple sclerosis Phase 2
Targets (1)
- TNFSF13B Tumor necrosis factor ligand superfamily member 13B inhibitor