belimumab
Trade name: benlysta
mAbapproved
Approved
Mar 9, 2011
Belimumab, sold under the brand name Benlysta, is a human monoclonal antibody that inhibits B-cell activating factor (BAFF), also known as B-lymphocyte stimulator (BLyS). It is approved in the United States and Canada, and the European Union to treat systemic lupus erythematosus and lupus nephritis. — Wikipedia
Clinical trial activity
86 trials · 59 clinical orgs · 2 marketing orgs
Phase 1
16
Phase 2
54
Phase 3
19
Phase 4
13
Earliest trial started Feb 1, 2002 (NCT00657007)
Timeline
2000s
- Jan 1, 2002
Human Genome Sciences — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2003
Human Genome Sciences — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2006
Human Genome Sciences — Earliest Phase 3 Sponsor(trial)
2010s
- Mar 9, 2011
Earliest FDA Approval
- Mar 9, 2011
Human Genome Sciences — Marketing Organization
- Mar 9, 2011
GlaxoSmithKline — NDA Secondary Org
- Mar 10, 2011
Human Genome Sciences — First NDA Organization
- Mar 10, 2011
Human Genome Sciences — NDA Organization
- Jul 20, 2017
GlaxoSmithKline — Marketing Organization
Indications
Approved for
Studied for
- Allergy and Immunology · Phase 2
- Antigens, CD · Phase 1
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis · Phase 2
- Antiphospholipid Syndrome · Phase 2/Phase 3
- Arthritis, Rheumatoid · Phase 2
- Bronchial Diseases · Phase 3
- Carcinoma, Hepatocellular · Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 2
- Cryoglobulinemia · Phase 2
- Drugs, Investigational · Phase 2
- Emphysema · Phase 2
- Esophageal Squamous Cell Carcinoma · Phase 2
- Glomerulonephritis, Membranous · Phase 2
- Graft vs Host Disease · Phase 1/Phase 2
- Granulomatosis with Polyangiitis · Phase 2
- Healthy Volunteers · Phase 1
- Hepatitis, Autoimmune · Phase 2
- Immune Checkpoint Inhibitors · Phase 2
- Immunoglobulin G4-Related Disease · Phase 4
- Kidney Transplantation · Phase 1/Phase 2
- Leukemia, Lymphoid · Phase 4
- Lung Diseases, Interstitial · Phase 3
- Lupus Nephritis · Phase 3
- Multiple Sclerosis · Phase 2
- Myasthenia Gravis · Phase 2
- Myositis · Phase 2/Phase 3
- Neoadjuvant Therapy · Phase 2
- Nephrotic Syndrome · Phase 2
- Neuromyelitis Optica · Phase 1/Phase 2
- Organ Transplantation · Phase 2
- Pancreatic Neoplasms · Phase 2
- Pulmonary Disease, Chronic Obstructive · Phase 2
- Purpura · Phase 2
- Radiation Oncology · Phase 2
- Remission Induction · Phase 3
- Rheumatic Diseases · Phase 2
- Scleroderma, Systemic · Phase 2/Phase 3
- Sjogren's Syndrome · Phase 4
- Thrombocytopenia · Phase 3
- Vasculitis · Phase 3
- Waldenstrom Macroglobulinemia · Phase 2
Mechanism of action
TNFSF13B inhibitor
Approval history
- approvedMar 9, 2011
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
First in class
Sources
- WikipediaBelimumab ↗
- NCATS73B0K5S26A ↗
- ChEMBLCHEMBL1789843 ↗
Also known as
- belimumab
- belimumab
- belimumab
- belimumab
- belimumab
- belimumab
- belimumab
- belimumab
- belimumab
- belimumab
- benlysta
- benlysta
- benlysta
- benlysta
- benlysta
- gsk1550188
- lymphostat b
- lymphostat-b
- lymphostat-b
- lymphostat-b
- lymphostat-b benlysta
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07175220 | Phase 2 | Oct 9, 2025 | Hengrui Therapeutics, Inc. |
| NCT07138898 | Phase 2 | Sep 30, 2025 | New York University |
| NCT06538935 | Phase 2 | Jan 31, 2025 | Fujian Medical University |
| NCT06716606 | Phase 3 | Dec 4, 2024 | GlaxoSmithKline, ICON |
| NCT06576271 | Phase 1 | Sep 2, 2024 | GlaxoSmithKline |
| NCT06572384 | Phase 3 | Aug 26, 2024 | GlaxoSmithKline |
| NCT06576973 | Phase 2 | Aug 8, 2024 | Zhejiang University |
| NCT06411249 | Phase 4 | Jun 4, 2024 | GlaxoSmithKline |
| NCT06381453 | Phase 2 | Apr 30, 2024 | GlaxoSmithKline, University of Toronto |
| NCT06747312 | Phase 2 | Apr 1, 2024 | Jiao Tong University |
| NCT06410833 | Phase 4 | Mar 9, 2024 | Capital Medical University, Central South University, Chinese Academy of Medical Sciences, Chongqing Medical University, Fudan University, Jiao Tong University, Jinlin University, Nanjing Medical University, Qingdao University, Shengjing Hospital, Shenzhen University, Tianjin Medical University |
| NCT06177522 | Phase 2 | Dec 31, 2023 | Hengrui Therapeutics, Inc., Jinlin University |
| NCT05878717 | Phase 2/Phase 3 (Phase 3) | Sep 13, 2023 | GlaxoSmithKline |
| NCT05917288 | Phase 1 | Jun 29, 2023 | GlaxoSmithKline |
| NCT05863936 | Phase 3 | Apr 1, 2023 | Nanjing University |
| NCT05338190 | Phase 3 | Jun 1, 2022 | Assistance Publique - Hôpitaux de Paris, GlaxoSmithKline |
| NCT05262686 | Phase 3 | Apr 1, 2022 | Peking University |
| NCT05020782 | Phase 2/Phase 3 (Phase 3) | Jan 1, 2022 | University of Turin |
| NCT05604742 | Phase 1/Phase 2 (Phase 2) | Jan 1, 2022 | Southern Medical University |
| NCT05154734 | Phase 1/Phase 2 (Phase 2) | Oct 30, 2021 | Tianjin Medical University |
Showing 20 of 86 trials
Page 1 / 5
Organizations
Research & Development (59)
59 organizations
Page 1 / 3
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| GlaxoSmithKline | For profit | MKTG | Jul 20, 2017 |
| GlaxoSmithKline | For profit | NDA2 | Mar 9, 2011 |
| Human Genome Sciences | For profit | MKTG | Mar 9, 2011 |
| Human Genome Sciences | For profit | NDA | Mar 10, 2011 |