Drugs / Belimumab
Belimumab
also known as
Benlysta · HGS1006 · GSK1550188 · BEL · BEL-114333 · Belimumab (genetical recombination) · BENLYSTA (belimumab) · BLM · +3 more
Monoclonal antibody targets TNFSF13B via inhibition
Regulatory milestones approvals, filings & regulatory actions · 12 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed systemic lupus erythematosus 2 milestones | |||||
| Filed | US (FDA) | Benlysta | systemic lupus erythematosus | 2010-06-09 | “has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA), for Benlysta (belimumab)” gsk.com ↗ |
| Filed | EU (EMA) | Benlysta | systemic lupus erythematosus | 2010-06-04 | “GSK submitted a Marketing Authorisation Application for belimumab to the European Medicines Agency (EMA) on 4 June 2010.” gsk.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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 · 1 met primary · 4 missed | ||||||
| Phase 2 | NCT07539857 | Apr 2026 → Jan 2028 expected | transplant rejection | Leiden University Medical Center | 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 Stop: Business |
| 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 Stop: Enrollment |
| 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 | Missed primary |
| Phase 2 | NCT01762852 | Apr 2013 → Jan 2014 | membranous glomerulonephritis | GlaxoSmithKline | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01480596 | Apr 2013 → Aug 2015 | generalized myasthenia gravis | GlaxoSmithKline | Completed | Missed primary |
| 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 | Missed primary |
| 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 Stop: Business |
| 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 Stop: Business |
| Phase 2 | NCT00071812 | Dec 2003 → Jan 2005 | rheumatoid arthritis | Human Genome Sciences Inc. | Completed | Met primary |
| Phase 2 | NCT00071487 | Oct 2003 → Aug 2005 | systemic lupus erythematosus | Human Genome Sciences Inc. | Completed | Missed primary |
| Phase 2/33 trials · 1 missed | ||||||
| Phase 2/3 | NCT05878717 | Sep 2023 → Aug 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 | Missed primary |
| Phase 317 trials · 5 met primary · 2 missed | ||||||
| Phase 3 | NCT06716606 | Dec 2024 → Sep 2030 expected | connective tissue disorder | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 3 | NCT06572384 | Sep 2024 → Aug 2029 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 2026 | systemic lupus erythematosus | Leiden University Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT03312907 | Mar 2018 → May 2020 | systemic lupus erythematosus | GlaxoSmithKline | Completed | Missed primary |
| 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 | Missed primary |
| Phase 3 | NCT01639339 | Jul 2012 → Jul 2019 | lupus nephritis | GlaxoSmithKline | Completed | Met primary |
| 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 | Met primary |
| Phase 3 | NCT01345253 | May 2011 → Sep 2015 | systemic lupus erythematosus | GlaxoSmithKline | Completed | Met primary |
| 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 | Met primary |
| Phase 3 | NCT00410384 | Dec 2006 → Sep 2009 | systemic lupus erythematosus | Human Genome Sciences Inc. | Completed | Met primary |
| Phase 411 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT07611214 | Apr 2026 → Mar 2029 expected | lupus nephritis | Aurinia Pharmaceuticals Inc. | Recruiting | No outcome recorded |
| Phase 4 | NCT06411249 | Jun 2024 → Jun 2027 expected | systemic lupus erythematosus | GlaxoSmithKline | Active not 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 | Met primary |
| 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 | Missed primary |
| 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 |
| Comparator or background therapy9 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 2 | NCT03967925 Comparator | Feb 2019 → Apr 2023 | granulomatosis with polyangiitis | Rachel Jones | Unknown | No outcome recorded |
| 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 |
| — | NCT03125486 Background | — | systemic lupus erythematosus | GlaxoSmithKline | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 36
| Date | Issuer | Release |
|---|---|---|
| 2023-02-01 | GlaxoSmithKline | Regulatory Benlysta granted Orphan Drug Designation by US FDA for the potential treatment of systemic sclerosis gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Benlysta (belimumab), a B-cell inhibiting monoclonal antibody, for the potential treatment of systemic sclerosis. |
| 2022-02-10 | GlaxoSmithKline | Regulatory China’s National Medical Products Administration approves Benlysta (belimumab) for adult patients with active lupus nephritis gsk.com ↗
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that China’s National Medical Products Administration (NMPA) has approved Benlysta (belimumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard of care. |
| 2021-05-05 | GlaxoSmithKline | Regulatory European Commission approves Benlysta for adult patients with active lupus nephritis gsk.com ↗
The EU marketing authorisation follows the recent approval for the similar expanded LN indication in the U.S. |
| 2021-03-26 | GlaxoSmithKline | Regulatory GSK receives CHMP positive opinion recommending approval of Benlysta for adult patients with active lupus nephritis gsk.com ↗
The CHMP’s positive opinion brings us one step closer to providing physicians and patients in Europe with the first treatment option specifically designed to work in lupus and lupus nephritis. |
| 2020-12-17 | GlaxoSmithKline | Regulatory FDA approves GSK’s BENLYSTA as the first medicine for adult patients with active lupus nephritis in the US gsk.com ↗
GlaxoSmithKline plc (LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA) has approved BENLYSTA (belimumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy. |
| 2019-12-18 | GlaxoSmithKline | Results GSK announces positive headline results in phase 3 study of Benlysta in patients with lupus nephritis gsk.com ↗
The results of the BLISS-LN study show that Benlysta could make a clinically meaningful improvement to the lives of these patients who currently have limited treatment options. |
| 2019-10-29 | GlaxoSmithKline | Regulatory Intravenous Benlysta is the first biologic treatment to be approved for children with lupus in Europe gsk.com ↗ |
| 2019-09-20 | GlaxoSmithKline | Regulatory GSK receives positive CHMP opinion for intravenous Benlysta in children with lupus aged five years and above gsk.com ↗
A CHMP positive opinion is one of the final steps before a marketing authorisation decision is made by the European Commission. |
| 2019-04-26 | GlaxoSmithKline | Regulatory GSK receives US approval of Benlysta for intravenous use in children with lupus aged five years and above gsk.com ↗
The go-ahead from the FDA for belimumab to be used to treat children with lupus is terrific news for a community desperate for more treatment options. |
| 2018-06-13 | GlaxoSmithKline | Results GSK presents new results showing low rates of organ damage with long term use of Benlysta gsk.com ↗
Both analyses, which used data from the long-term extension studies from the pivotal BLISS studies, showed low rates of organ damage with Benlysta treatment. |
| 2017-11-13 | GlaxoSmithKline | Regulatory GSK receives European marketing authorisation for self-injectable formulation of Benlysta for the treatment of systemic lupus erythematosus gsk.com ↗
We are delighted to receive today’s European approval. |
| 2017-11-08 | GlaxoSmithKline | Results First long-term efficacy analysis on the effect of GSK’s Benlysta on rate of organ damage progression in SLE versus standard therapy alone gsk.com ↗
Results demonstrated that patients treated with belimumab plus SoC had significantly less SLE-related organ damage progression (0.44 smaller unit increase in SDI score), compared to patients in the TLC receiving SoC (p=0.001). |
| 2017-09-27 | GlaxoSmithKline | Regulatory GSK receives approval for Benlysta in Japan for the treatment of systemic lupus erythematosus gsk.com ↗
GSK announced today that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Benlysta (belimumab) for the treatment of adult patients with systemic lupus erythematosus (SLE) who are inadequate responders to existing therapies. |
| 2017-09-15 | GlaxoSmithKline | Regulatory GSK receives CHMP positive opinion for self-injectable formulation of Benlysta for systemic lupus erythematosus gsk.com ↗ |
| 2017-07-21 | GlaxoSmithKline | Regulatory GSK receives FDA approval for a new self-injectable formulation of Benlysta (belimumab) for systemic lupus erythematosus gsk.com ↗
GSK announced today that the US Food and Drug Administration (FDA) has approved a new subcutaneous formulation of Benlysta (belimumab) for the treatment of adult patients with active, autoantibody‑positive SLE who are receiving standard therapy. |
| 2017-06-16 | GlaxoSmithKline | Results GSK announces results from 10-year continuation study showing sustained disease control with Benlysta (belimumab) in SLE gsk.com ↗
GSK today announced results from a 10-year continuation study, which showed that Benlysta (belimumab) plus standard of care prolonged control of disease activity in patients with active systemic lupus erythematosus (SLE). |
| 2016-12-13 | GlaxoSmithKline | Regulatory GSK submits regulatory application in Japan for belimumab in systemic lupus erythematosus gsk.com ↗
GSK today announced the submission of a regulatory application to the Japanese Ministry of Health, Labour and Welfare (MHLW) for belimumab, in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who have an inadequate response to standard therapy. |
| 2016-11-16 | GlaxoSmithKline | Results GSK’s Benlysta® (belimumab) shows sustained benefits in patients with SLE gsk.com ↗
GSK today announced results from a 7-year safety and efficacy continuation study for Benlysta® (belimumab) in patients with active, autoantibody-positive systemic lupus erythematosus (SLE). |
| 2016-11-13 | GlaxoSmithKline | Results GSK announces positive results in fourth consecutive pivotal trial of Benlysta® (belimumab) in SLE gsk.com ↗
GSK today announced positive efficacy and safety data from a pivotal study of patients with systemic lupus erythematosus (SLE) in Northeast Asia (Japan, China and South Korea). |
| 2016-09-23 | GlaxoSmithKline | Regulatory GSK announces regulatory submissions for subcutaneous formulation of Benlysta® (belimumab) for patients with systemic lupus disease gsk.com ↗
GSK today announced that it has filed regulatory submissions in the US and Europe for Benlysta® (belimumab) for approval as a subcutaneous formulation in patients with active, autoantibody-positive systemic lupus erythematosus (SLE). |
| 2016-06-08 | GlaxoSmithKline | Results New Phase III data shows greater treatment response with GSK’s Benlysta® (belimumab) vs placebo in patients with highly active SLE gsk.com ↗
For the pre-specified secondary endpoints, patients in the belimumab group showed a 62% reduction in their risk of experiencing a severe flare compared to those in the placebo group (Hazard Ratio = 0.38, p<0.0001). |
| 2016-03-03 | GlaxoSmithKline | Results New long-term organ damage analysis published for GSK’s Benlysta® (belimumab) gsk.com ↗
GSK today announced publication of a new long-term analysis showing that patients with moderate-to-severe systemic lupus erythematosus (SLE) treated with Benlysta (belimumab) plus standard of care (SoC) over five years experienced low rates of organ damage progression, regardless of their baseline level of damage. |
| 2015-11-07 | GlaxoSmithKline | Results GSK announces positive results from phase III BLISS-SC study of Benlysta® (belimumab) administered subcutaneously in patients with systemic lupus erythematosus gsk.com ↗
For the primary efficacy endpoint (Systemic Lupus Erythematosus Responder Index (SRI) at Week 52), significantly more patients treated with belimumab administered subcutaneously plus SoC (60.8%) showed reduced disease activity compared to placebo plus SoC (48.47%, p=0.0011). |
| 2015-11-03 | GlaxoSmithKline | Results GSK profiles innovative R&D portfolio to investors gsk.com ↗
New data presented today from a 3rd consecutive successful pivotal study show efficacy in a subcutaneous formulation of belimumab, which has potential to help patients manage their disease. |
| 2011-07-14 | GlaxoSmithKline | Regulatory GlaxoSmithKline and Human Genome Sciences receive European authorisation for Benlysta® (belimumab) gsk.com ↗ |
| 2011-05-20 | GlaxoSmithKline | Regulatory GlaxoSmithKline and Human Genome Sciences receive positive opinion in Europe from the CHMP for Benlysta® belimumab gsk.com ↗ |
| 2011-03-09 | GlaxoSmithKline | Regulatory GlaxoSmithKline and Human Genome Sciences announce FDA approval of Benlysta® (belimumab) for the treatment of systemic lupus erythematosus gsk.com ↗
GlaxoSmithKline plc (GSK) and Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that the U.S. Food and Drug Administration (FDA) has approved Benlysta® (belimumab) for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy. |
| 2011-02-07 | GlaxoSmithKline | Results GlaxoSmithKline and Human Genome Sciences announce publication of BLISS-52 phase lll study results for Benlysta® in The Lancet gsk.com ↗ |
| 2010-12-02 | GlaxoSmithKline | Regulatory GlaxoSmithKline and Human Genome Sciences announce FDA extension of Benlysta® PDUFA target date to 10th March 2011 gsk.com ↗
After the FDA Arthritis Advisory Committee met on 16 November 2010 to consider the Benlysta BLA , the FDA requested some additional information from HGS, which has been submitted. |
| 2010-11-15 | GlaxoSmithKline | Regulatory Human Genome Sciences and GlaxoSmithKline announce vote of FDA advisory committee to recommend approval of Benlysta® for systemic lupus erythematosus gsk.com ↗
Human Genome Sciences, Inc. (Nasdaq: HGSI) and GlaxoSmithKline PLC (GSK) today announced that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted 13 to 2 to recommend that the FDA approve BENLYSTA® (belimumab) for the treatment of autoantibody-positive patients with active systemic lupus erythematosus (SLE). |
| 2010-08-18 | GlaxoSmithKline | Regulatory GlaxoSmithKline and Human Genome Sciences announce FDA priority review designation for Benlysta® (belimumab) as a potential treatment for systemic lupus erythematosus gsk.com ↗
GlaxoSmithKline PLC (GSK) and Human Genome Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted a priority review designation to Benlysta® (belimumab) as a potential treatment for systemic lupus erythematosus (SLE). |
| 2010-06-09 | GlaxoSmithKline | Regulatory Regulatory update – BLA filed for Benlysta® (belimumab) gsk.com ↗ |
| 2010-06-06 | GlaxoSmithKline | Regulatory Regulatory update - Benlysta® (belimumab) gsk.com ↗
GlaxoSmithKline PLC (GSK) announced today that it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA), for Benlysta (belimumab) for reducing disease activity in adult patients with autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standardtherapy. |
| 2010-04-19 | GlaxoSmithKline | Results GlaxoSmithKline and Human Genome Sciences announce topline 76-week results of phase 3 trial of Benlysta™ in systemic lupus erythematosus gsk.com ↗
At Week 76 in the BLISS-76 study, belimumab plus standard of care showed higher response rates compared with placebo plus standard of care as measured by the SLE Responder Index; however, this secondary endpoint did not reach statistical significance. |
| 2009-10-19 | GlaxoSmithKline | Results GlaxoSmithKline and Human Genome Sciences announce full presentation at ACR of positive phase 3 study results for Benlysta in systemic lupus erythematosus gsk.com ↗ |
| 2009-07-20 | GlaxoSmithKline | Results Human Genome Sciences and GlaxoSmithKline announce positive Phase 3 study results for Benlysta™ in systemic lupus erythematosus gsk.com ↗
In the placebo-controlled BLISS-52 study, the results showed that belimumab plus standard of care achieved a clinically and statistically significant improvement in patient response rate at Week 52, compared with standard of care alone. |
All press releases naming this drug 41 releases
Evidence & citations 16 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 | BML | “with 200mg belimumab (BML) for the duration of the entire study period of two years.” NCT03747159 ↗ |
| 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” NCT00732940 ↗ “belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody” NCT00410384 ↗ “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 ↗ |