Drugs / Belimumab
Belimumab
also known as
Benlysta · HGS1006 · GSK1550188 · BEL · BEL-114333 · Belimumab (genetical recombination) · BENLYSTA (belimumab) · BLM · +2 more
Monoclonal antibody targets TNFSF13B via inhibition
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (8) | US (FDA) | BENLYSTA | — | 2019-04-26 – 2025-06-20 | fda.gov ↗ |
| Approved | EU (EMA) | Benlysta | — | 2011-07-13 | europa.eu ↗ |
| Approved | US (FDA) | BENLYSTA | — | 2011-03-09 | fda.gov ↗ |
Trials 77 · started per year
today
US approved 2011
EU approved 2011
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| Phase 1 | NCT06576271 | Sep 2024 → Jan 2028 expected | systemic lupus erythematosus | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 1 | NCT05917288 | Jul 2023 → Oct 2024 | systemic lupus erythematosus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT04097561 | Jan 2020 → Mar 2027 expected | idiopathic CD4 lymphocytopenia | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 1 | NCT04136145 | Oct 2019 → Jan 2020 | systemic lupus erythematosus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT03207958 | May 2018 → Jun 2022 | graft versus host disease | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 1 | NCT02880852 | Jan → Sep 2017 | systemic lupus erythematosus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01894360 | Oct 2013 → May 2014 | systemic lupus erythematosus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01381536 | Jul → Nov 2010 | systemic lupus erythematosus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00657007 | Feb 2002 → Mar 2003 | systemic lupus erythematosus | Human Genome Sciences Inc. | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT05604742 | Jan 2022 → Dec 2024 | chronic graft versus host disease | xuna | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT05154734 | Dec 2021 → Jun 2023 | neuromyelitis optica | Tianjin Medical University General Hospital | Completed | No outcome recorded |
| Phase 1/2 | NCT02500251 | Jun 2015 → Jun 2018 | transplant rejection | E. Steve Woodle | Completed | No outcome recorded |
| Phase 232 trials | ||||||
| Phase 2 | NCT07539857 | Apr 2026 → Jan 2028 expected | transplant rejection | Leiden University Medical Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07138898 | Dec 2025 → Jan 2028 expected | rheumatic disorder | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 2 | NCT07340463 | Dec 2025 → Jun 2027 expected | lupus nephritis, systemic lupus erythematosus | Nanjing University School of Medicine | Recruiting | No outcome recorded |
| Phase 2 | NCT06381453 | Dec 2024 → Apr 2028 expected | autoimmune hepatitis | University Health Network, Toronto | Recruiting | No outcome recorded |
| Phase 2 | NCT06747312 | Apr 2024 → May 2026 overdue | primary antiphospholipid syndrome | Ruijin Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05069051 | Jan 2022 → Jul 2026 overdue | B-cell chronic lymphocytic leukemia | University Hospital Tuebingen | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04629144 | Oct 2021 → Apr 2025 | cryoglobulinemia, vasculitis | Assistance Publique - Hôpitaux de Paris | Unknown | No outcome recorded |
| Phase 2 | NCT04767698 | Oct 2021 → May 2022 | multiple sclerosis | Johns Hopkins University | Terminated | No outcome recorded |
| Phase 2 | NCT03949855 | Mar 2020 → Mar 2029 expected | membranous glomerulonephritis, nephrotic syndrome | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 2 | NCT04179032 | Nov 2019 → Jan 2023 overdue | systemic lupus erythematosus | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03844061 | Jul 2019 → Jun 2026 overdue | systemic sclerosis | Hospital for Special Surgery, New York | Recruiting | No outcome recorded |
| Phase 2 | NCT03591380 | May 2019 → Dec 2021 | — | University of Wisconsin, Madison | Terminated | No outcome recorded |
| Phase 2 | NCT03244059 | Aug 2018 → Apr 2022 | pulmonary emphysema | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 2 | NCT02631538 | Feb 2016 → Jun 2020 | Sjogren syndrome | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT02260934 | Jul 2015 → Mar 2018 | lupus nephritis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT02284984 | Mar 2014 → Oct 2018 | systemic lupus erythematosus | Leiden University Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT01536379 | Sep 2013 → Feb 2016 | disease related to solid organ transplantation | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01480596 | Apr 2013 → Aug 2015 | generalized myasthenia gravis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01762852 | Apr 2013 → Jan 2014 | membranous glomerulonephritis | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 2 | NCT01440361 | Mar 2013 → Apr 2015 | autoimmune thrombocytopenic purpura | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 2 | NCT01649765 | Sep 2012 → Jan 2018 | systemic lupus erythematosus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01670565 | Aug 2012 → Nov 2015 | systemic sclerosis | Hospital for Special Surgery, New York | Completed | No outcome recorded |
| Phase 2 | NCT01610492 | Jul 2012 → Sep 2014 | idiopathic membranous glomerulonephritis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01160666 | Mar 2010 → Dec 2011 | Sjogren syndrome | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 2 | NCT01025193 | Feb 2010 → Oct 2011 | — | University of Pennsylvania | Terminated | No outcome recorded |
| Phase 2 | NCT01142011 | Nov 2009 → Jun 2012 | Waldenstrom macroglobulinemia | Cancer Trials Australia | Unknown | No outcome recorded |
| Phase 2 | NCT01008982 | Aug 2009 → Aug 2012 | Sjogren syndrome | University of Udine | Completed | No outcome recorded |
| Phase 2 | NCT00732940 | Oct 2008 → Oct 2009 | systemic lupus erythematosus | Human Genome Sciences Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT00583362 | May 2005 → Feb 2016 | systemic lupus erythematosus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00583557 | Jan 2005 → Nov 2009 | rheumatoid arthritis | Human Genome Sciences Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT00071812 | Dec 2003 → Jan 2005 | rheumatoid arthritis | Human Genome Sciences Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00071487 | Oct 2003 → Aug 2005 | systemic lupus erythematosus | Human Genome Sciences Inc. | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT05878717 | Sep 2023 → May 2029 expected | interstitial lung disease, systemic sclerosis | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 2/3 | NCT05020782 | Jun 2022 → Oct 2024 | antiphospholipid syndrome | University of Turin, Italy | Unknown | No outcome recorded |
| Phase 2/3 | NCT02347891 | Jan 2015 → Nov 2020 | myositis disease | Northwell Health | Completed | No outcome recorded |
| Phase 317 trials | ||||||
| Phase 3 | NCT06716606 | Dec 2024 → Dec 2029 expected | connective tissue disorder | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 3 | NCT06572384 | Sep 2024 → Oct 2028 expected | interstitial lung disease | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 3 | NCT05863936 | Apr 2023 → Mar 2024 | lupus nephritis | Nanjing University School of Medicine | Unknown | No outcome recorded |
| Phase 3 | NCT05338190 | Nov 2022 → Nov 2026 expected | autoimmune thrombocytopenia | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 3 | NCT05262686 | Apr 2022 → Jun 2023 | systemic lupus erythematosus | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT03747159 | Oct 2018 → Jun 2024 overdue | systemic lupus erythematosus | Leiden University Medical Center | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03312907 | Mar 2018 → May 2020 | systemic lupus erythematosus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02119156 | May 2014 → Dec 2018 | systemic lupus erythematosus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01663623 | Mar 2013 → Feb 2017 | vasculitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01639339 | Jul 2012 → Jul 2019 | lupus nephritis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01597622 | Jun 2012 → Sep 2018 | systemic lupus erythematosus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01484496 | Nov 2011 → Feb 2015 | systemic lupus erythematosus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01345253 | May 2011 → Sep 2015 | systemic lupus erythematosus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00724867 | Aug 2008 → Mar 2015 | systemic lupus erythematosus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00712933 | May 2008 → Dec 2016 | systemic lupus erythematosus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00424476 | May 2007 → May 2009 | systemic lupus erythematosus | Human Genome Sciences Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00410384 | Dec 2006 → Sep 2009 | systemic lupus erythematosus | Human Genome Sciences Inc. | Completed | No outcome recorded |
| Phase 411 trials | ||||||
| Phase 4 | NCT07611214 | Apr 2026 → Mar 2029 expected | lupus nephritis | Aurinia Pharmaceuticals Inc. | Recruiting | No outcome recorded |
| Phase 4 | NCT06411249 | Jun 2024 → May 2027 expected | systemic lupus erythematosus | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 4 | NCT04893161 | Jun 2024 → Jan 2026 | systemic lupus erythematosus | First Affiliated Hospital Xi'an Jiaotong University | Unknown | No outcome recorded |
| Phase 4 | NCT06410833 | Mar 2024 → Dec 2025 overdue | Sjogren syndrome, childhood acute lymphoblastic leukemia | Peking Union Medical College Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT04447053 | Nov 2021 → May 2025 | systemic lupus erythematosus | National University Hospital, Singapore | Unknown | No outcome recorded |
| Phase 4 | NCT04908865 | Oct 2021 → May 2024 | systemic lupus erythematosus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT04956484 | Sep 2021 → Apr 2022 | systemic lupus erythematosus | Peking Union Medical College Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04515719 | Mar 2021 → Apr 2022 | systemic lupus erythematosus | RenJi Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04660565 | Jan 2021 → Dec 2022 | immunoglobulin G4-related sclerosing disease | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01632241 | Feb 2013 → Jun 2018 | systemic lupus erythematosus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT01705977 | Nov 2012 → Jul 2018 | systemic lupus erythematosus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT03154385 | Mar 2017 → Nov 2019 | thrombocytopenia due to immune destruction | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT00931086 | Apr 2009 → Dec 2011 | rheumatoid arthritis | GlaxoSmithKline | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 9 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT06857214 Comparator | Jun 2025 → Dec 2027 expected | systemic lupus erythematosus | Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT04611971 Comparator | Oct 2020 → May 2021 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01516450 Comparator | Dec 2011 → Apr 2012 | systemic lupus erythematosus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01583530 Comparator | Feb → Sep 2011 | — | Human Genome Sciences Inc. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT03967925 Comparator | Feb 2019 → Apr 2023 | granulomatosis with polyangiitis | Rachel Jones | Unknown | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT03543839 Comparator | Sep 2020 → Sep 2028 expected | systemic lupus erythematosus | Northwell Health | Recruiting | No outcome recorded |
| Phase 4 | NCT02270970 Comparator | Oct 2014 → Dec 2018 | systemic lupus erythematosus | Oklahoma Medical Research Foundation | Unknown | No outcome recorded |
| Phase 4 | NCT01597492 Background | May 2012 → Sep 2015 | systemic lupus erythematosus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03125486 Background | — | systemic lupus erythematosus | GlaxoSmithKline | No longer available | No outcome recorded |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 89 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Belimumab | “This study will examine the effect of the drug Belimumab in patients with SS.” NCT01008982 ↗83“Single IV dose of belimumab 200 mg” NCT01516450 ↗ |
| Known as | BEL | “The efficacy of belimumab (BEL), the first approved biologic treatment for SLE and LN, is generally attributed to depletion of activated naïve B cells and inhibition of B-cell...” PMID 38775637 ↗ Sep 2024 |
| Known as | BEL-114333 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1789843 ↗ |
| Known as | Belimumab (genetical recombination) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1789843 ↗ |
| Known as | Benlysta | “Five belimumab (Benlysta ®) injections will be administered (W0 + 2days, W2 + 2 days, W4, W8, W12) at 10mg/kg doses.” NCT03154385 ↗7“Belimumab (Benlysta ®) is a human immunoglobulin G1λ monoclonal antibody” NCT05154734 ↗ “Belimumab (Benlysta®) is a monoclonal antibody against the B cells” NCT04447053 ↗ “belimumab (Benlysta) to patients with Early Lupus” NCT03543839 ↗ “Belimumab Prefilled Syringe [Benlysta]” NCT07539857 ↗ “Belimumab 200 MG/ML [Benlysta]” NCT05069051 ↗ “Belimumab (Benlysta)” NCT05604742 ↗ |
| Known as | BENLYSTA (belimumab) | “BENLYSTA™ (belimumab)” NCT00931086 ↗ |
| Known as | BLM | “In vitro, immune complexes (ICx) trigger NET formation while NET-derived DNA is a postulated autoantigen for anti-nuclear autoantibodies (ANAs), found in SLE. Based on these...” PMID 29636274 ↗ Apr 2018 |
| Known as | GSK1550188 | “Subcutaneous Belimumab (GSK1550188) and Intravenous Rituximab Co-administration in Subjects With Primary Sjögren's Syndrome” NCT02631538 ↗ |
| Known as | HGS1006 | “A Randomized, Parallel-Group, Open-Label Study to Evaluate the Absolute Bioavailability, Pharmacokinetics, Tolerability and Safety of a High Concentration Formulation of...” NCT01583530 ↗7“A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Wk Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human...” NCT00424476 ↗ “A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black...” NCT01632241 ↗ “belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE)” NCT01484496 ↗ “belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody” NCT00410384 ↗ “belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody” NCT00732940 ↗ “Belimumab (HGS1006, LymphoStat-B), a Fully Human Monoclonal Anti-BLyS Antibody” NCT01008982 ↗ “BENLYSTA™ (Belimumab; HGS1006)” NCT01597492 ↗ |
| Known as | LymphoStat-B | “Belimumab (HGS1006, LymphoStat-B), a Fully Human Monoclonal Anti-BLyS Antibody” NCT01008982 ↗ |
| Known as | Lymphostat-b benlysta | ChEMBL registry synonym — accepted as the source's own label CHEMBL1789843 ↗ |
| Action | Inhibit | “therapeutic mechanism of B-cell-activating factor inhibition by BEL” PMID 38775637 ↗ Sep 20241“Tumor necrosis factor ligand superfamily member 13B inhibitor” CHEMBL1789843 ↗ |
| Modality | Monoclonal antibody | “Monoclonal Anti-BLyS Antibody” NCT00071487 ↗ |
| Route | Intravenous | “Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE” NCT00071487 ↗ |
| Target | TNFSF13B | “Tumor necrosis factor ligand superfamily member 13B inhibitor” CHEMBL1789843 ↗ |