Product Description
Belimumab is the only approved biological agent for the treatment of systemic lupus erythematosus (SLE). It is a fully humanized IgG1γ monoclonal antibody directed against soluble B lymphocyte stimulator (BLyS). It is indicated as an add-on therapy for the treatment of adult patients with active, autoantibody-positive SLE, who are receiving standard therapy. Belimumab is generally well-tolerated, common adverse effects include infections, infusion reactions, hypersensitivity, headache, nausea, and fatigue. (Sourced from: https://pmc.ncbi.nlm.nih.gov/articles/PMC5029243/)
Mechanisms of Action: TNFSF13B Inhibitor
Novel Mechanism: No
Modality: Antibody
Route of Administration: Intravenous, Subcutaneous
FDA Designation: *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Japan | Korea | Latvia | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | Turkey | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela
Approved Indications: None
Company: GSK
Company Location: Europe
Company Founding Year: 2000
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Belgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Korea, Mexico, Netherlands, Panama, South Korea, Spain, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 26
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Lung Diseases, Interstitial|Lupus Erythematosus|Lupus Erythematosus, Systemic|Purpura, Thrombocytopenic, Idiopathic|Scleroderma, Diffuse|Scleroderma, General|Skin Manifestations|Thrombocytopenia
Phase 2: Chronic Lymphoid Leukemia|Glomerulonephritis, Membranous|Hepatitis, Autoimmune|Kidney Diseases|Kidney Transplant|Lupus Erythematosus, Cutaneous|Lymphocytic Chronic B-Cell Leukemia|Membranous Nephropathy|Nephrosis|Nephrotic Syndrome|Scleroderma, Systemic
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT05878717 |
BLISSc-ILD | P3 |
Recruiting |
Lung Diseases, Interstitial|Scleroderma, Diffuse |
2029-05-17 |
50% |
2026-01-13 |
Primary Completion Date|Primary Endpoints |
NCT06572384 |
BEconneCTD-ILD | P3 |
Recruiting |
Lung Diseases, Interstitial |
2028-10-18 |
44% |
2024-08-30 |
Primary Endpoints|Treatments|Trial Status |
jRCT2031230153 |
jRCT2031230153 | P3 |
Not yet recruiting |
Scleroderma, General|Lung Diseases, Interstitial |
2027-03-05 |
|||
NCT05338190 |
RITUX-PLUS 2 | P3 |
Recruiting |
Purpura, Thrombocytopenic, Idiopathic|Thrombocytopenia |
2026-11-14 |
2023-09-12 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
|
2017-003051-35 |
BELI-SKIN | P3 |
Active, not recruiting |
Lupus Erythematosus|Skin Manifestations |
2021-10-09 |
2022-03-13 |
Treatments |
|
NCT07539857 |
BE-MOBILYZED | P2 |
Not yet recruiting |
Kidney Transplant |
2028-01-01 |
12% |
2026-04-23 |
Primary Endpoints|Treatments |
NCT05069051 |
BeliVeR | P2 |
Active, not recruiting |
Chronic Lymphoid Leukemia|Lymphocytic Chronic B-Cell Leukemia |
2026-07-15 |
2024-12-10 |
Primary Endpoints|Treatments|Trial Status |
|
NCT03844061 |
NCT03844061 | P2 |
Recruiting |
Scleroderma, Systemic |
2026-06-30 |
12% |
2026-03-27 |
|
2018-004645-16 |
Ph 2,Benlysta, PLUTO-SC, PK-PD study in pediatric patients with SLE | P2 |
Active, not recruiting |
Lupus Erythematosus, Cutaneous|Lupus Erythematosus, Systemic |
2029-12-27 |
2022-03-13 |
Treatments |
|
NCT03949855 |
REBOOT | P2 |
Recruiting |
Kidney Diseases|Nephrotic Syndrome|Glomerulonephritis, Membranous|Nephrosis|Membranous Nephropathy |
2029-03-01 |
67% |
2024-11-07 |
|
NCT06381453 |
BELief | P2 |
Recruiting |
Hepatitis, Autoimmune |
2028-04-30 |
12% |
2025-08-27 |
Primary Endpoints|Treatments |
JapicCTI-163361 |
JapicCTI-163361 | P2 |
Active |
Lupus Erythematosus, Systemic |
2028-02-16 |
|||
CTR20223328 |
CTR20223328 | P1 |
Completed |
Lupus Erythematosus, Cutaneous|Lupus Erythematosus, Systemic |
2024-10-30 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
NCT03747159 |
SynBioSe-2 | P3 |
Active, not recruiting |
Lupus Erythematosus, Systemic |
2024-06-07 |
2024-10-18 |
Primary Completion Date|Primary Endpoints|Study Completion Date |
|
NCT05917288 |
NCT05917288 | P1 |
Completed |
Lupus Erythematosus, Systemic |
2024-10-30 |
2025-01-17 |
Patient Enrollment|Primary Endpoints|Treatments|Trial Status |
|
2020-002622-87 |
2020-002622-87 | P2 |
Active, not recruiting |
Chronic Lymphoid Leukemia |
2027-04-27 |
2022-03-13 |
Treatments |
|
2024-512730-15-00 |
114055 | P2 |
Active, not recruiting |
Lupus Erythematosus, Systemic |
2025-12-09 |
2025-05-02 |
Treatments |
|
2023-509413-37-00 |
200908 | P2 |
Active, not recruiting |
Lupus Erythematosus, Systemic |
2025-04-30 |
2025-05-02 |
Treatments |
|
JapicCTI-195029 |
JapicCTI-195029 | P2 |
Active |
Lupus Erythematosus, Systemic |
2023-03-08 |
|||
jRCT2011250002 |
jRCT2011250002 | P3 |
Not yet recruiting |
Lung Diseases, Interstitial|Scleroderma, General |
2031-11-30 |
|||
2023-509370-39-00 |
219855 | P3 |
Not yet recruiting |
Scleroderma, General|Lung Diseases, Interstitial |
2029-12-31 |
2025-05-02 |
Treatments |
|
NCT06716606 |
BLISSconneCTD-OLE | P3 |
Recruiting |
Lung Diseases, Interstitial|Scleroderma, Diffuse |
2029-12-27 |
2025-12-11 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
|
2024-513018-36-00 |
221672 | P3 |
Recruiting |
Lung Diseases, Interstitial |
2028-12-13 |
44% |
2025-05-02 |
|
jRCT2011240027 |
jRCT2011240027 | P3 |
Not yet recruiting |
Lung Diseases, Interstitial |
2028-12-13 |
|||
2023-503219-14-01 |
218224 | P3 |
Recruiting |
Lung Diseases, Interstitial|Scleroderma, General |
2027-07-30 |
50% |
2025-05-02 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
04/13/2026 |
News Article |
SLE Market Evolution Accelerates as AstraZeneca's Saphnelo SC Emerges as a Likely Key Challenger to GSK's Benlysta |
|
03/17/2026 |
News Article |
Saphnelo Surpasses Benlysta in CLE as Physicians Expand Use of Biologics Ahead of Key 2027 Catalysts |
|
03/06/2026 |
News Article |
Spherix Global Insights Finds Benlysta Exposure Expanding and Rheumatologists Increasingly Turning to Lupkynis in Lupus Nephritis |
|
01/06/2026 |
News Article |
Lupus Research Alliance Launches New Philanthropic Fund to Advance Treatments and Diagnostics |