Product Description
The drug, belimumab, which was approved on March 9, 2011, by FDA, is the first ever targeted biological for the treatment of SLE patients with active, autoantibody-positive disease, who are already on standard therapy. (Sourced from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3198539/)
Mechanisms of Action: BLyS Inhibitor
Novel Mechanism: No
Modality: Antibody
Route of Administration: Intravenous,Subcutaneous
FDA Designation: None *
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: Erythema | Lupus Erythematosus | Lupus Erythematosus, Systemic | Lupus Nephritis | Nephritis
Known Adverse Events: Migraine Disorders | Pain Unspecified | Insomnia | Nasopharyngitis | Pharyngitis | Bronchitis | Diarrhea
Company: GlaxoSmithKline
Company Location: BRENTFORD MIDDLESEX X0 TW8 9GS
Company CEO: Emma Walmsley
Additonal 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, Spain, United Kingdom, United States
Active Clinical Trial Count: 28
Highest Development Phases
Phase 3: Lung Diseases, Interstitial|Lupus Erythematosus|Lupus Erythematosus, Systemic|Purpura, Thrombocytopenic, Idiopathic|Scleroderma, Diffuse|Scleroderma, General|Scleroderma, Systemic|Skin Manifestations|Thrombocytopenia
Phase 2: Antiphospholipid Syndrome|Chronic Lymphoid Leukemia|Chronic Obstructive Pulmonary Disease|Cryoglobulinemia|Emphysema|Glomerulonephritis, Membranous|Hepatitis A|Hepatitis, Autoimmune|Kidney Diseases|Lupus Erythematosus, Cutaneous|Lymphocytic Chronic B-Cell Leukemia|Membranous Nephropathy|Nephrosis|Nephrotic Syndrome|Vasculitis
Phase 1: Bronchiolitis Obliterans|Graft vs Host Disease
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| 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 |
|
| REBOOT | P2 |
Recruiting |
Membranous Nephropathy|Glomerulonephritis, Membranous|Nephrotic Syndrome|Kidney Diseases|Nephrosis |
2029-03-01 |
|
| 221672 | P3 |
Unknown Status |
Lung Diseases, Interstitial |
2028-12-13 |
|
| jRCT2011240027 | P3 |
Not yet recruiting |
Lung Diseases, Interstitial |
2028-12-13 |