Drugs / Etanercept
Etanercept
also known as
Enbrel · ETN · ENIA11 · TNFR:Fc · GP2015 · MB04 · 50mg entanercept(Yisaipu) · Drug: Etanercept (Enbrel) · +9 more
Protein / enzyme biologic targets TNF via inhibition
Regulatory milestones approvals, filings & regulatory actions · 19 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed pustular psoriasis 2 milestones | |||||
| Filed | EU (EMA) | — | pustular psoriasis | 2015-12-08 | “Der Zulassungsantrag von Sandoz für das Biosimilar Enbrel® (Etanercept), einen TNF-alpha-Inhibitor, wurde von der Europäischen Arzneimittelagentur (EMA) angenommen.” novartis.com ↗ “the European Medicines Agency (EMA) has accepted their Marketing Authorization Application (MAA) for a biosimilar to Pfizer's EU-licensed Enbrel ® (etanercept)” novartis.com ↗ “L'Agence européenne des médicaments (EMA) a accepté la demande d'homologation déposée par Sandoz pour le biosimilaire d'Enbrel® (etanercept)” novartis.com ↗ “It is currently under regulatory review by the EMA after the submission was accepted in the second half of 2015.” novartis.com ↗ “Sandoz' biosimilar etanercept was accepted by the FDA and EMA for regulatory review in the last quarter of 2015.” novartis.com ↗ “An application for Sandoz biosimilar etanercept has been accepted by the European Medicines Agency (Q4 2015)” novartis.com ↗ “The EMA accepted Sandoz's regulatory submission for biosimilar Enbrel® (etanercept), a TNF-alpha inhibitor.” novartis.com ↗ |
| Filed | US (FDA) | — | pustular psoriasis | 2015-10-02 | “has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen's US-licensed Enbrel ®* (etanercept)” novartis.com ↗ “Sandoz' biosimilar etanercept was accepted by the FDA and EMA for regulatory review in the last quarter of 2015.” novartis.com ↗ |
| Filed spondyloarthropathy 1 milestone | |||||
| Filed | EU (EMA) | — | spondyloarthropathy | 2018-05-25 | “today that its Marketing Authorization Application (MAA) for a biosimilar of Etanercept has been accepted for review by the European Medicines Agency (EMA).” lupin.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (14) | US (FDA) | ENBREL | — | 1999-05-27 – 2023-10-18 | fda.gov ↗ |
| Approved | EU (EMA) | Enbrel | — | 2000-02-02 | europa.eu ↗ |
| Approved | US (FDA) | ENBREL | — | 1998-11-02 | fda.gov ↗ |
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 04 trials | ||||||
| Phase 0 | NCT05950724 | Sep 2023 → Dec 2026 expected | — | Northwestern University | Enrolling by invitation | No outcome recorded |
| Phase 0 | NCT05281614 | Sep 2022 → Jan 2024 | type 1 diabetes mellitus | Benaroya Research Institute | Completed | No outcome recorded |
| Phase 0 | NCT00965666 | Oct 2005 → Oct 2010 | Fanconi anemia | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| Phase 0 | NCT00802815 | Apr 2005 → May 2014 | inclusion body myositis | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 123 trials | ||||||
| Phase 1 | NCT04585711 | Jul 2026 → Feb 2027 | juvenile idiopathic arthritis, obesity disorder, rheumatoid arthritis | Duke University | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT06585384 | Apr 2025 → Jun 2028 expected | Alzheimer disease | Fondation Ophtalmologique Adolphe de Rothschild | Recruiting | No outcome recorded |
| Phase 1 | NCT06392074 | Mar 2024 → May 2025 | — | mAbxience Research S.L. | Completed | No outcome recorded |
| Phase 1 | NCT04973566 | Aug 2021 → May 2022 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04559412 | Mar 2021 → Jan 2024 | rheumatoid arthritis | Sorrento Therapeutics, Inc. | Unknown | No outcome recorded |
| Phase 1 | NCT01865630 | Jan 2021 → Jan 2022 | acquired aneurysmal subarachnoid hemorrhage | Unity Health Toronto | Withdrawn | No outcome recorded |
| Phase 1 | NCT03294954 | Jan 2018 → Dec 2027 expected | neuroblastoma | Baylor College of Medicine | Recruiting | No outcome recorded |
| Phase 1 | NCT04255498 | Oct 2017 → Aug 2019 | occupational disorder, persian gulf syndrome | South Florida Veterans Affairs Foundation for Research and Education | Unknown | No outcome recorded |
| Phase 1 | NCT03193203 | Mar → Aug 2017 | — | Samsung Bioepis Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03273088 | Dec 2016 → Mar 2017 | — | AryoGen Pharmed Co. | Completed | No outcome recorded |
| Phase 1 | NCT02999776 | Nov 2016 → Dec 2017 | psoriasis | Pantec Biosolutions AG | Unknown | No outcome recorded |
| Phase 1 | NCT01894412 | Jul 2013 → Dec 2015 | — | Hanwha Chemical | Completed | No outcome recorded |
| Phase 1 | NCT01865552 | May → Aug 2013 | — | Samsung Bioepis Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01725620 | Nov 2012 → Apr 2013 | — | LG Life Sciences | Completed | No outcome recorded |
| Phase 1 | NCT01294397 | Mar 2011 → Jan 2016 | postmenopausal osteoporosis, rheumatoid arthritis | Amgen | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT01145950 | Jun → Nov 2010 | — | LG Life Sciences | Completed | No outcome recorded |
| Phase 1 | NCT00705042 | Jul → Sep 2008 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00502879 | Jul → Aug 2007 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00361634 | Sep 2006 → Aug 2009 | rheumatoid arthritis | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT00203320 | Apr 2005 → Jan 2006 | Alzheimer disease | Tobinick, Edward Lewis, M.D. | Completed | No outcome recorded |
| Phase 1 | NCT00203359 | Sep 2004 → Apr 2006 | Alzheimer disease | Tobinick, Edward Lewis, M.D. | Completed | No outcome recorded |
| Phase 1 | NCT00201812 | Nov 2000 → Jan 2004 | neoplasm | Ohio State University Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00091741 | ? → Oct 2004 | HIV infectious disease | Georgetown University | Completed | No outcome recorded |
| Phase 1/210 trials | ||||||
| Phase 1/2 | NCT03182426 | Aug 2017 → Jul 2024 | type 1 diabetes mellitus | University of Alberta | Completed | No outcome recorded |
| Phase 1/2 | NCT02112097 | Jan → Jun 2016 | psoriasis | ASIS Corporation | Unknown | No outcome recorded |
| Phase 1/2 | NCT00585650 | May 2007 → May 2008 | psoriasis | University of California, Irvine | Completed | No outcome recorded |
| Phase 1/2 | NCT00364572 | May 2006 → Dec 2007 | sciatica | Johns Hopkins University | Completed | No outcome recorded |
| Phase 1/2 | NCT00118287 | Apr 2005 → Oct 2008 | myelodysplastic syndrome | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT00093366 | Jun 2004 → Jul 2006 | leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative disease | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT00730392 | Oct 2002 → Oct 2007 | type 1 diabetes mellitus | State University of New York at Buffalo | Completed | No outcome recorded |
| Phase 1/2 | NCT00201682 | Oct 2002 → Aug 2006 | chronic lymphocytic leukemia/small lymphocytic lymphoma | John Byrd | Completed | No outcome recorded |
| Phase 1/2 | NCT00029328 | Sep 2001 → Sep 2003 | adult acute respiratory distress syndrome, pneumonia, transplant-related bronchiolitis obliterans | FDA Office of Orphan Products Development | Completed | No outcome recorded |
| Phase 1/2 | NCT00201838 | Jul 2001 → Oct 2006 | adenocarcinoma, pancreatic neoplasm | Ohio State University Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 243 trials · 1 met primary · 4 missed | ||||||
| Phase 2 | NCT07138898 | Dec 2025 → Jan 2028 expected | rheumatic disorder | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 2 | NCT04066348 | Jul 2022 → Sep 2026 overdue | tinnitus | Wayne State University | Recruiting | No outcome recorded |
| Phase 2 | NCT03193957 | May → Aug 2017 | rheumatoid arthritis | Samsung Bioepis Co., Ltd. | Completed | Met primary |
| Phase 2 | NCT02656082 | Feb 2016 → Dec 2017 | discoid lupus erythematosus | University of Leeds | Completed | No outcome recorded |
| Phase 2 | NCT02464033 | May 2015 → Feb 2019 | type 1 diabetes mellitus | Johnny Ludvigsson | Completed | No outcome recorded |
| Phase 2 | NCT01730495 | Oct 2012 → Aug 2014 | myalgic encephalomeyelitis/chronic fatigue syndrome | Haukeland University Hospital | Terminated | No outcome recorded |
| Phase 2 | NCT01731457 | Apr 2011 → Feb 2014 | — | Medical University of Warsaw | Completed | No outcome recorded |
| Phase 2 | NCT01068353 | Jan 2011 → Dec 2013 | Alzheimer disease | University of Southampton | Completed | No outcome recorded |
| Phase 2 | NCT01989689 | Aug 2010 → Sep 2013 | psoriasis | Emory University | Completed | No outcome recorded |
| Phase 2 | NCT02456363 | Nov 2009 → Oct 2019 | ankylosing spondylitis | Chung Shan Medical University | Unknown | No outcome recorded |
| Phase 2 | NCT00639717 | Mar 2009 → Jan 2012 | graft versus host disease | University of Michigan Rogel Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00841789 | Mar 2009 → Jan 2018 | Kawasaki disease | Michael Portman | Completed | Missed primary |
| Phase 2 | NCT00797784 | Oct 2008 → Apr 2011 | discoid lupus erythematosus | Florida Academic Dermatology Centers | Unknown | No outcome recorded |
| Phase 2 | NCT00447265 | Feb 2008 → Mar 2009 | lupus nephritis | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| Phase 2 | NCT00285779 | Aug 2006 → Nov 2009 | lichen planus | Stanford University | Terminated | Missed primary Stop: Enrollment |
| Phase 2 | NCT00309907 | Apr 2006 → Sep 2011 | Burkitt lymphoma, Hodgkins lymphoma, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, childhood acute lymphoblastic leukemia +7 | Children's Oncology Group | Completed | No outcome recorded |
| Phase 2 | NCT00844142 | Nov 2005 → Jul 2013 | ankylosing spondylitis | Charite University, Berlin, Germany | Unknown | No outcome recorded |
| Phase 2 | NCT00329823 | Sep 2005 → May 2006 | hidradenitis suppurativa | University of Athens | Completed | No outcome recorded |
| Phase 2 | NCT00224874 | Sep 2005 → Jan 2009 | graft versus host disease | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 2 | NCT00141791 | May 2005 → Jul 2006 | asthma | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | Missed primary |
| Phase 2 | NCT00107991 | Apr 2005 → Aug 2008 | hidradenitis suppurativa | University of Pennsylvania | Completed | No outcome recorded |
| Phase 2 | NCT00678782 | Apr 2005 → Dec 2007 | synovitis | University of Padova | Completed | No outcome recorded |
| Phase 2 | NCT00509600 | Sep 2004 → Apr 2009 | leukemia | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00141739 | Aug 2004 → Aug 2011 | graft versus host disease | University of Michigan Rogel Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00135720 | Jun 2004 → Nov 2007 | pemphigus vulgaris | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00217386 | Mar 2004 → Dec 2007 | leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative disease | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00134368 | Nov 2003 → Dec 2007 | vitiligo | University of Medicine and Dentistry of New Jersey | Completed | No outcome recorded |
| Phase 2 | NCT00141713 | Oct 2003 → Nov 2006 | acute graft versus host disease | University of Michigan Rogel Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00141726 | Oct 2003 → Jul 2008 | acute lung injury, adult acute respiratory distress syndrome, transplant-related bronchiolitis obliterans | University of Michigan Rogel Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00034060 | Apr 2002 → Dec 2005 | rheumatoid arthritis | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Completed | No outcome recorded |
| Phase 2 | NCT00031551 | Mar 2002 → Aug 2010 | stomatitis | National Institute of Nursing Research (NINR) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01289730 | Feb 2002 → Sep 2003 | spondyloarthropathy | Charite University, Berlin, Germany | Unknown | No outcome recorded |
| Phase 2 | NCT01289743 | Feb 2002 → Sep 2003 | ankylosing spondylitis | Charite University, Berlin, Germany | Unknown | No outcome recorded |
| Phase 2 | NCT00048373 | Oct 2001 → Apr 2004 | Langerhans cell histiocytosis | Baylor College of Medicine | Completed | No outcome recorded |
| Phase 2 | NCT00224393 | Feb 2001 → Aug 2005 | primary systemic amyloidosis | The Cleveland Clinic | Completed | No outcome recorded |
| Phase 2 | NCT00006070 | Jul 2000 → May 2004 | — | National Institute of Dental and Craniofacial Research (NIDCR) | Completed | No outcome recorded |
| Phase 2 | NCT00001954 | Dec 1999 → Nov 2003 | Sjogren syndrome | National Institute of Dental and Craniofacial Research (NIDCR) | Completed | No outcome recorded |
| Phase 2 | NCT00001955 | Dec 1999 → Feb 2004 | temporomandibular joint disorder | National Institute of Dental and Craniofacial Research (NIDCR) | Completed | No outcome recorded |
| Phase 2 | NCT00005853 | Dec 1999 → Aug 2005 | leukemia, myelodysplastic syndrome | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00000433 | Oct 1999 → Mar 2002 | ankylosing spondylitis | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Completed | No outcome recorded |
| Phase 2 | NCT00001862 | Feb 1999 → Mar 2003 | juvenile idiopathic arthritis, uveitis | National Eye Institute (NEI) | Completed | No outcome recorded |
| Phase 2 | NCT00001901 | Feb 1999 → Mar 2005 | granulomatosis with polyangiitis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT00063869 | ? → Mar 2005 | idiopathic pulmonary fibrosis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | Missed primary |
| Phase 2/39 trials · 2 met primary · 2 missed | ||||||
| Phase 2/3 | NCT06011889 | Sep 2024 → Oct 2028 expected | SAPHO syndrome | National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland | Recruiting | No outcome recorded |
| Phase 2/3 | NCT03997786 | Jan 2020 → Apr 2025 overdue | psoriasis | Sun Pharmaceutical Industries, Inc. | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT00789997 | Nov 2008 → Aug 2011 | chronic obstructive pulmonary disease | Ottawa Hospital Research Institute | Completed | Missed primary |
| Phase 2/3 | NCT00733096 | Aug 2008 → Mar 2011 | radiculopathy | Johns Hopkins University | Completed | Missed primary |
| Phase 2/3 | NCT00111956 | Apr 2004 → May 2005 | metabolic syndrome X | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | Met primary |
| Phase 2/3 | NCT00035958 | Aug 2002 | juvenile dermatomyositis | Children's Hospital Medical Center, Cincinnati | Terminated | No outcome recorded Stop: Business |
| Phase 2/3 | NCT00127387 | May 2001 → Sep 2005 | bone cancer, lung cancer, metastatic neoplasm, prostate cancer | The University of Texas Health Science Center at San Antonio | Terminated | No outcome recorded |
| Phase 2/3 | NCT00005007 | Jun 2000 → Mar 2003 | granulomatosis with polyangiitis | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Completed | No outcome recorded |
| Phase 2/3 | NCT03780959 | May 1997 → Jul 1998 | juvenile idiopathic arthritis | Amgen | Completed | Met primary |
| Phase 361 trials · 12 met primary · 4 missed | ||||||
| Phase 3 | NCT07386587 | Jan → Jul 2026 overdue | juvenile idiopathic arthritis | University of Child Health Sciences and Children's Hospital, Lahore | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT06654882 | Jan 2026 → May 2029 expected | polyarticular juvenile idiopathic arthritis | Duke University | Recruiting | No outcome recorded |
| Phase 3 | NCT05379322 | Mar 2023 | rheumatoid arthritis | Abu Dhabi Stem Cells Center | Withdrawn | No outcome recorded |
| Phase 3 | NCT04870203 | Jul 2021 → Mar 2027 expected | rheumatoid arthritis | University Hospital, Bordeaux | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04610476 | Oct 2020 → Oct 2024 | psoriatic arthritis, substance withdrawal syndrome | University of Erlangen-Nürnberg Medical School | Unknown | No outcome recorded |
| Phase 3 | NCT03728478 | May 2019 → Feb 2025 overdue | oligoarticular juvenile idiopathic arthritis, rheumatoid factor-negative juvenile idiopathic arthritis | Gaslini Institute | Recruiting | No outcome recorded |
| Phase 3 | NCT04079374 | Sep 2018 → Dec 2021 | rheumatoid arthritis | Joint Stock Company "Farmak" | Unknown | No outcome recorded |
| Phase 3 | NCT02840175 | May 2017 → Oct 2019 | juvenile idiopathic arthritis | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 3 | NCT03073200 | Mar 2017 → Feb 2019 | psoriasis | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT02986139 | Nov 2016 → Sep 2017 | arthropathy | Amgen | Completed | Met primary |
| Phase 3 | NCT03403140 | Oct 2016 → Sep 2018 | rheumatoid arthritis | Gema Biotech S.A. | Unknown | No outcome recorded |
| Phase 3 | NCT02685904 | Sep 2016 → Jan 2018 | ankylosing spondylitis | Mycenax Biotech Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT03332719 | Feb 2016 → Mar 2017 | rheumatoid arthritis | Gema Biotech S.A. | Completed | Met primary |
| Phase 3 | NCT02378506 | Apr 2015 → May 2016 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT02376790 | Mar 2015 → Jan 2018 | psoriatic arthritis | Amgen | Completed | Met primary |
| Phase 3 | NCT02638259 | Feb 2015 → Dec 2016 | rheumatoid arthritis | Sandoz | Completed | No outcome recorded |
| Phase 3 | NCT02373813 | Feb 2015 → Dec 2019 | rheumatoid arthritis | Amgen | Completed | Met primary |
| Phase 3 | NCT02701205 | Jan 2015 → Jan 2017 | psoriasis | Shanghai Celgen Bio-Pharmaceutical Co.,Ltd | Unknown | No outcome recorded |
| Phase 3 | NCT01900782 | Oct 2013 → Jun 2015 | psoriasis | Novartis Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 3 | NCT01787149 | Sep 2013 → Dec 2017 | — | Mycenax Biotech Inc. | Unknown | No outcome recorded |
| Phase 3 | NCT01394913 | Aug 2013 → Mar 2014 | rheumatoid arthritis | EMS | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT01709760 | Nov 2012 → Dec 2017 | rheumatoid arthritis | Mycenax Biotech Inc. | Unknown | No outcome recorded |
| Phase 3 | NCT01690299 | Oct 2012 → Jul 2014 | psoriasis, psoriatic arthritis | Amgen | Completed | Met primary |
| Phase 3 | NCT01421069 | Oct 2011 → Feb 2021 | juvenile idiopathic arthritis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT02164214 | Sep 2011 → Mar 2015 | psoriatic arthritis | Assistance Publique Hopitaux De Marseille | Completed | No outcome recorded |
| Phase 3 | NCT01313221 | Apr 2011 → Dec 2012 | psoriasis | Amgen | Completed | Missed primary |
| Phase 3 | NCT01235442 | Sep 2010 → Oct 2011 | psoriasis | Amgen | Completed | Met primary |
| Phase 3 | NCT01001208 | Nov 2009 → Dec 2010 | psoriasis | Amgen | Completed | Met primary |
| Phase 3 | NCT00962741 | Sep 2009 → Jun 2011 | juvenile idiopathic arthritis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT02779114 | Jan 2009 → Dec 2017 | rheumatoid arthritis | University of Erlangen-Nürnberg Medical School | Unknown | No outcome recorded |
| Phase 3 | NCT00726375 | May 2008 → Jul 2013 | acute graft versus host disease | University of Michigan Rogel Cancer Center | Completed | No outcome recorded |
| Phase 3 | NCT00524381 | Aug 2007 → Jul 2009 | polymyalgia rheumatica | Bispebjerg Hospital | Completed | No outcome recorded |
| Phase 3 | NCT00421174 | Aug 2007 → Jun 2010 | idiopathic interstitial pneumonia | National Heart, Lung, and Blood Institute (NHLBI) | Completed | Missed primary |
| Phase 3 | NCT00484237 | Apr → Dec 2007 | rheumatoid arthritis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00418717 | Feb → Dec 2007 | rheumatoid arthritis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | Missed primary |
| Phase 3 | NCT00434044 | Feb → Jun 2007 | ankylosing spondylitis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00413452 | Dec 2006 → Aug 2007 | rheumatoid arthritis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00445770 | Jul 2006 → Jul 2010 | rheumatoid arthritis | Pfizer | Completed | Met primary |
| Phase 3 | NCT00443950 | Jun 2006 → Jul 2007 | rheumatoid arthritis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00333034 | Jun 2006 → May 2007 | psoriasis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00249041 | Oct 2005 → Dec 2006 | rheumatoid arthritis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00141921 | Aug 2005 → Dec 2011 | psoriasis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00121615 | Oct 2004 → ? | psoriasis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00116181 | Oct 2004 → Jan 2007 | psoriasis | Rockefeller University | Completed | No outcome recorded |
| Phase 3 | NCT00078819 | Sep 2004 → Feb 2006 | psoriasis | Amgen | Completed | Met primary |
| Phase 3 | NCT00418548 | Jun 2004 → Feb 2005 | ankylosing spondylitis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00317538 | Jun 2003 → Nov 2004 | rheumatoid arthritis | Centocor Ortho Biotech Services, L.L.C. | Completed | No outcome recorded |
| Phase 3 | NCT00111449 | Jun 2003 → ? | psoriasis | Amgen | Completed | Met primary |
| Phase 3 | NCT00046904 | May 2003 → Sep 2007 | hypoproteinemia, hypercatabolic | Mayo Clinic | Completed | Missed primary |
| Phase 3 | NCT00111436 | Apr 2003 → Jul 2005 | psoriasis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00421980 | Jun 2002 → Jul 2004 | ankylosing spondylitis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00356356 | Apr 2002 → Aug 2006 | ankylosing spondylitis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00421915 | Mar → Aug 2002 | ankylosing spondylitis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00078806 | Jun 2001 → May 2004 | juvenile idiopathic arthritis | Amgen | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00393471 | Oct 2000 → Oct 2001 | rheumatoid arthritis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT03781375 | Aug 2000 → Jun 2002 | polyarticular juvenile rheumatoid arthritis | Amgen | Terminated | No outcome recorded |
| Phase 3 | NCT00317499 | Apr 2000 → Jun 2002 | psoriasis, psoriatic arthritis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00356590 | Dec 1998 → Dec 2008 | rheumatoid arthritis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00357903 | Apr 1997 → Dec 2008 | rheumatoid arthritis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00110903 | — | rheumatoid arthritis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00111111 | — | psoriasis | Amgen | Completed | Met primary |
| Phase 476 trials · 11 met primary · 10 missed | ||||||
| Phase 4 | NCT07352566 | Aug 2026 → Jun 2030 expected | atopic eczema, psoriasis | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07149792 | Jul 2025 → Dec 2026 expected | psoriasis, psoriatic arthritis | Taichung Veterans General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT05164198 | Jan 2022 → Oct 2024 | ankylosing spondylitis | Hanyang University Seoul Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05115903 | Dec 2021 → Jul 2024 | spondyloarthropathy | University Health Network, Toronto | Unknown | No outcome recorded |
| Phase 4 | NCT05080218 | Nov 2021 → Apr 2024 | psoriatic arthritis, spondyloarthropathy | Jeffrey Curtis | Completed | No outcome recorded |
| Phase 4 | NCT05135312 | Aug 2021 → Aug 2022 | psoriasis, psoriatic arthritis | OptiSkin Medical | Unknown | No outcome recorded |
| Phase 4 | NCT03636373 | Oct 2019 → Aug 2021 | gout | Rutgers, The State University of New Jersey | Terminated | Missed primary Stop: Enrollment |
| Phase 4 | NCT04077957 | Oct 2019 → Oct 2021 | ankylosing spondylitis | Nanfang Hospital, Southern Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT03649061 | Jun 2018 → Jul 2022 | rheumatoid arthritis | P. Verschueren | Completed | Missed primary |
| Phase 4 | NCT02713997 | Dec 2016 → Jul 2023 | chronic pancreatitis | University of Minnesota | Completed | No outcome recorded |
| Phase 4 | NCT02749370 | May 2016 → Aug 2017 | psoriasis | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT02714634 | Mar 2016 → Mar 2029 expected | rheumatoid arthritis | University Hospital, Strasbourg, France | Recruiting | No outcome recorded |
| Phase 4 | NCT02878161 | Jan 2016 → Dec 2019 | rheumatoid arthritis | Fen Li | Unknown | No outcome recorded |
| Phase 4 | NCT02638896 | Jan 2016 → Feb 2017 | ankylosing spondylitis | Zhixiang Huang | Unknown | No outcome recorded |
| Phase 4 | NCT02509026 | Sep 2015 → May 2019 | ankylosing spondylitis | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT02274792 | Jan → Nov 2015 | psoriasis | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT02109289 | Apr 2014 → Nov 2016 | rheumatoid arthritis, vasculitis | Innovaderm Research Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02960035 | Apr 2014 → Sep 2016 | spondyloarthropathy | Sun Yat-sen University | Completed | No outcome recorded |
| Phase 4 | NCT01971346 | Mar 2014 → Nov 2017 | psoriasis | University of Michigan | Completed | Missed primary |
| Phase 4 | NCT02364479 | Feb 2014 → Jul 2016 | spondyloarthropathy | Sun Yat-sen University | Completed | No outcome recorded |
| Phase 4 | NCT01783015 | Sep 2013 → Aug 2014 | rheumatoid arthritis | Pfizer | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02132234 | Jun 2013 → Jul 2014 | ankylosing spondylitis, hypertensive disorder, psoriatic arthritis | Jagiellonian University | Unknown | No outcome recorded |
| Phase 4 | NCT01927757 | May 2013 → Jun 2015 | rheumatoid arthritis | Amgen | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01578850 | Jul 2012 → Mar 2015 | rheumatoid arthritis | Pfizer | Completed | Met primary |
| Phase 4 | NCT01604629 | Jul 2012 → Apr 2015 | spondyloarthropathy | Spanish Clinical Pharmacology Society | Completed | Met primary |
| Phase 4 | NCT01602302 | Jun 2012 → Nov 2020 | rheumatoid arthritis | Medical University of Graz | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01543204 | Feb 2012 → May 2015 | psoriasis | Amgen | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01548768 | Oct 2011 → Sep 2019 | rheumatoid arthritis | Columbia University | Completed | No outcome recorded |
| Phase 4 | NCT01295151 | Aug 2011 → Nov 2015 | rheumatoid arthritis | Julia Brown | Completed | No outcome recorded |
| Phase 4 | NCT01313208 | Mar 2011 → Feb 2013 | rheumatoid arthritis | Amgen | Completed | Missed primary |
| Phase 4 | NCT01372930 | Apr 2010 → Jul 2014 | myocardial infarction | Xijing Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01132235 | Apr → Dec 2010 | psoriasis | Florida Academic Dermatology Centers | Unknown | No outcome recorded |
| Phase 4 | NCT00992394 | Jan 2010 → Apr 2013 | psoriasis | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00913458 | Sep 2009 → Jun 2012 | rheumatoid arthritis | Pfizer | Completed | Met primary |
| Phase 4 | NCT00967538 | Sep 2009 → Jul 2014 | psoriasis | Innovaderm Research Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00910273 | Jul 2009 → Oct 2011 | ankylosing spondylitis | Pfizer | Terminated | Missed primary |
| Phase 4 | NCT00848354 | Jun 2009 → Apr 2013 | rheumatoid arthritis | Pfizer | Completed | Met primary |
| Phase 4 | NCT00837434 | Mar 2009 → Nov 2013 | rheumatoid arthritis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Phase 4 | NCT00833729 | Feb 2009 → Feb 2010 | psoriasis | Dermatrials Research | Completed | No outcome recorded |
| Phase 4 | NCT00796705 | Nov 2008 → Oct 2010 | rheumatoid arthritis | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00783536 | Nov 2008 → Jun 2010 | rheumatoid arthritis | Wyeth is now a wholly owned subsidiary of Pfizer | Withdrawn | No outcome recorded |
| Phase 4 | NCT00791765 | Oct 2008 → Jan 2010 | psoriasis | Amgen | Completed | Met primary |
| Phase 4 | NCT00768053 | Oct 2008 → Mar 2010 | rheumatoid arthritis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | Met primary |
| Phase 4 | NCT00780793 | Sep 2008 → Sep 2011 | rheumatoid arthritis | Assistance Publique - Hôpitaux de Paris | Completed | Missed primary |
| Phase 4 | NCT02489760 | Jul 2008 → Dec 2015 | ankylosing spondylitis | Chung Shan Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT00663052 | Jun 2008 → Jan 2010 | psoriasis | Pfizer | Completed | Met primary |
| Phase 4 | NCT00654368 | Jun 2008 → Dec 2012 | rheumatoid arthritis | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT00726804 | Mar 2008 → May 2012 | spondyloarthropathy | Glostrup University Hospital, Copenhagen | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01072058 | Feb 2008 → Feb 2011 | ankylosing spondylitis | University of Sao Paulo | Unknown | No outcome recorded |
| Phase 4 | NCT00581555 | Oct 2007 → Nov 2009 | psoriasis | Pfizer | Completed | Met primary |
| Phase 4 | NCT00523692 | Sep 2007 → ? | rheumatoid arthritis | University Hospital Birmingham | Unknown | No outcome recorded |
| Phase 4 | NCT01053819 | Sep 2007 → Apr 2012 | melanoma, psoriasis, skin cancer | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 4 | NCT02915354 | Jul 2007 → Sep 2010 | ankylosing spondylitis | Sun Yat-sen University | Completed | Missed primary |
| Phase 4 | NCT00420238 | Jan 2007 → Feb 2009 | ankylosing spondylitis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | Met primary |
| Phase 4 | NCT00420303 | Jan 2007 → Sep 2008 | spondyloarthropathy | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | Met primary |
| Phase 4 | NCT00410046 | Dec 2006 → Oct 2008 | ankylosing spondylitis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | Mixed |
| Phase 4 | NCT00873730 | Dec 2006 → Jun 2008 | ankylosing spondylitis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | Missed primary |
| Phase 4 | NCT01303874 | Sep 2006 → Nov 2010 | rheumatoid arthritis | University of Leeds | Completed | No outcome recorded |
| Phase 4 | NCT00458185 | Aug 2006 → Apr 2007 | ankylosing spondylitis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00332332 | Mar 2006 → Jul 2009 | psoriasis | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT00581165 | Feb 2006 → Aug 2007 | psoriasis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00247962 | Dec 2005 → Feb 2008 | ankylosing spondylitis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | Met primary |
| Phase 4 | NCT00127842 | Aug 2005 | psoriatic arthritis | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT00115219 | May 2005 → ? | rheumatoid arthritis | Amgen | Completed | Missed primary |
| Phase 4 | NCT00161655 | Apr 2005 → Aug 2006 | psoriasis, psoriatic arthritis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00110981 | Mar 2005 → Feb 2006 | psoriasis | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT00195507 | Dec 2004 → Feb 2007 | psoriasis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00094341 | Oct 2004 → ? | rheumatoid arthritis | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT00133315 | Sep 2004 → Apr 2007 | ankylosing spondylitis, psoriatic arthritis | Hvidovre University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00252668 | Jun 2004 → Sep 2005 | rheumatoid arthritis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00099554 | May 2004 → ? | rheumatoid arthritis | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT00444340 | Apr 2004 → Jul 2007 | ankylosing spondylitis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00244556 | Mar 2003 → May 2004 | rheumatoid arthritis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00546533 | Jan 2003 → Feb 2005 | rheumatoid arthritis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00132418 | Apr 2000 → Feb 2004 | rheumatoid arthritis | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT00111124 | — | psoriasis | Amgen | Completed | No outcome recorded |
| Phase not applicable16 trials | ||||||
| — | NCT07184853 | Sep 2025 → Sep 2027 expected | graft versus host disease | First Affiliated Hospital of Zhejiang University | Recruiting | No outcome recorded |
| — | NCT05305066 | Feb 2023 → Dec 2028 expected | rheumatoid arthritis | Marie Hudson, MD | Recruiting | No outcome recorded |
| — | NCT04378621 | Oct 2020 → Sep 2025 | depressive disorder, rheumatoid arthritis, subjective cognitive decline | Vastra Gotaland Region | Unknown | No outcome recorded |
| — | NCT02722772 | Feb 2016 → Jul 2017 | osteoarthritis, knee | First Affiliated Hospital of Harbin Medical University | Unknown | No outcome recorded |
| — | NCT02722811 | Feb 2016 → Jul 2017 | osteoarthritis, knee | First Affiliated Hospital of Harbin Medical University | Unknown | No outcome recorded |
| — | NCT02031211 | Jun 2014 → Oct 2016 | complex regional pain syndrome | Stanford University | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT02258282 | May 2014 → Dec 2022 | psoriasis | Chengdu PLA General Hospital | Unknown | No outcome recorded |
| — | NCT01361542 | Feb → Dec 2011 | ankylosing spondylitis | All India Institute of Medical Sciences | Completed | No outcome recorded |
| — | NCT00931957 | Oct 2010 → Oct 2012 | Behcet disease, uveal disorder | Tehran University of Medical Sciences | Unknown | No outcome recorded |
| — | NCT01170715 | Jul 2010 → Sep 2013 | psoriasis | Rockefeller University | Completed | No outcome recorded |
| — | NCT00825344 | Jan 2009 → Nov 2011 | — | Johns Hopkins University | Completed | No outcome recorded |
| — | NCT01276314 | Jan 2009 → May 2015 | drug allergy | Chang Gung Memorial Hospital | Completed | Mixed |
| — | NCT00800982 | Oct 2008 → Jan 2012 | psoriasis | University of California, San Francisco | Completed | No outcome recorded |
| — | NCT00477191 | May 2007 → Dec 2013 | hyperlipidemia, hypertensive disorder, metabolic syndrome X, obesity disorder +1 | Massachusetts General Hospital | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT00276029 | Dec 2003 → Sep 2004 | asthma | University Hospitals, Leicester | Completed | No outcome recorded |
| — | NCT00205231 | May 2002 → May 2004 | HIV infectious disease | University of Wisconsin, Madison | Completed | No outcome recorded |
| Comparator or background therapy113 trials | ||||||
| Phase 0 | NCT07519005 Background | Jan → Feb 2026 overdue | liver failure | Xijing Hospital | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04254627 Background | Sep 2021 → Sep 2025 | persian gulf syndrome | Nova Southeastern University | Completed | No outcome recorded |
| Phase 1 | NCT03792841 Background | Feb 2019 → Jun 2023 | castration-resistant prostate carcinoma | Amgen | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT02481180 Comparator | Jul 2015 → Nov 2017 | rheumatoid arthritis | Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. | Terminated | No outcome recorded |
| Phase 1 | NCT01635686 Comparator | Sep 2012 → Jun 2013 | rheumatoid arthritis | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Show all 113 trials opens the full record — a long page | ||||||
News releases announcing trial results or a regulatory action · 47
| Date | Issuer | Release |
|---|---|---|
| 2022-09-13 | Lupin Limited | Regulatory Lupin Receives Health Canada Approval for Rymti® (biosimilar Etanercept) lupin.com ↗
Global pharma major Lupin Limited (Lupin) announced today that Health Canada has approved Rymti®, its biosimilar to Enbrel® (etanercept), for use in Canada. |
| 2021-04-23 | Eli Lilly and Company | Results Taltz® Delivers More Cumulative Days with Completely Clear Skin for Adults with Psoriasis Compared to Seven Other Biologics in Novel Network Meta-Analysis lilly.com ↗
Taltz offered patients with psoriasis the greatest number of cumulative days of completely clear skin compared to adalimumab, brodalumab, etanercept, guselkumab, risankizumab, secukinumab and ustekinumab. |
| 2020-06-12 | Eli Lilly and Company | Results Lilly Highlights the Evolution of Its Dermatology Portfolio at Annual American Academy of Dermatology Meeting (AAD) lilly.com ↗
Achieving a PASI 50 at 2 weeks was associated with better long term clinical outcomes and low discontinuation: a subgroup analysis of a phase 3 trial of ixekizumab and etanercept in moderate to severe psoriasis |
| 2020-06-04 | Lupin Limited | Regulatory Lupin and Mylan Receive European Marketing Authorization for Nepexto®, Biosimilar Etanercept lupin.com ↗
The centralized marketing authorization applies to all member countries of the European Union. |
| 2020-03-27 | Lupin Limited | Regulatory Lupin and Mylan announce Positive European Medicines Agency opinion recommending Approval of Nepexto®, Biosimilar Etanercept lupin.com ↗
The CHMP positive opinion will now be considered by the European Commission (EC). |
| 2019-11-12 | Novartis Pharmaceuticals | Results Sandoz presents real-world data showing effectiveness of Erelzi® (etanercept-szzs) in rheumatic disease treatment novartis.com ↗
For RA patients, improvements in effectiveness and functional disability were shown. |
| 2019-10-22 | Samsung Bioepis Co., Ltd. | Results 삼성바이오에피스, 유럽 학회에서 환자 처방 데이터 발표 samsungbioepis.com ↗
PASI가 10이상인 환자 28명은 6개월 후 PASI가 감소하여 (평균 15.7 → 5.0), 베네팔리를 처방받은 환자들에게서 긍정적 치료 효과를 확인했다.7) |
| 2019-06-13 | Samsung Bioepis Co., Ltd. | Results 삼성바이오에피스, 유럽 학회에서 바이오시밀러 입지 강화 samsungbioepis.com ↗
연구 결과에 따르면, SB4와 에타너셉트 성분 오리지널 의약품 간 류마티스 관절염 및 축성 척추 관절염 환자 533명의 바이오시밀러 스위칭 결과 6개월 경과 시점까지 임상적으로 유의미한 차이가 없었다.3) |
| 2019-06-11 | Biogen | Results Biogen to Present New Safety and Efficacy Data on Biosimilars and Estimates 1.8 Billion Euros in Savings for the European Healthcare System in 2019 biogen.com ↗
biosimilar etanercept - no evidence for a relevant nocebo effect – a retrospective analysis of real-life data. |
| 2019-04-26 | Samsung Bioepis Co., Ltd. | Regulatory 삼성바이오에피스, 에티코보 미국 판매허가 samsungbioepis.com ↗
삼성바이오에피스는 지난 25일(현지시간) 미국 식품의약국(FDA, Food and Drug Administration)으로부터 엔브렐 바이오시밀러‘에티코보′(Eticovo, 성분名 에타너셉트, 프로젝트名 SB4)의 판매 허가를 최종 통보 받았다고 밝혔다. |
| 2019-03-26 | Lupin Limited | Regulatory Lupin and YL Biologics receives PMDA approval for Etanercept biosimilar in Japan lupin.com ↗
The approval to treat moderate to severe Rheumatoid Arthritis (RA) and Juvenile Idiopathic Arthritis was received today. |
| 2018-10-24 | Amgen | Results First Head-to-Head Trial of a TNF Inhibitor Versus Methotrexate Monotherapy in Psoriatic Arthritis Shows ENBREL® (Etanercept) Monotherapy and Combination Therapy Both Superior to Methotrexate amgen.com ↗ |
| 2018-06-15 | Novartis Pharmaceuticals | Results Sandoz presents new long-term and switching data for biosimilars Zessly® (infliximab) and Erelzi® (etanercept) in rheumatoid arthritis novartis.com ↗
This new research demonstrated that switching rheumatoid arthritis patients from reference etanercept to Sandoz etanercept does not affect the overall therapy outcome in terms of efficacy, safety and immunogenicity. |
| 2018-05-25 | Lupin Limited | Regulatory Lupin submits Marketing Authorization Application for Etanercept Biosimilar in Europe lupin.com ↗
Lupin announced today that its Marketing Authorization Application (MAA) for a biosimilar of Etanercept has been accepted for review by the European Medicines Agency (EMA). |
| 2018-05-08 | Lupin Limited | Regulatory Lupin submits New Drug Application for Etanercept biosimilar in Japan lupin.com ↗
With the application now filed, we are preparing to launch an affordable and high-quality biosimilar for consumers in Japan. |
| 2018-02-07 | Lupin Limited | Results Lupin and Yoshindo’s JV – YL Biologics announces successful outcome of global Phase III study for Etanercept biosimilar in Rheumatoid Arthritis lupin.com ↗
In their board meeting held at Pune last week, YL Biologics (YLB) announced that a global Phase III clinical trial of its investigational Etanercept biosimilar (YLB113) has met with successful outcome. |
| 2017-12-22 | Clover Biopharmaceuticals AUS Pty | Regulatory Clover Receives CFDA Approval to Initiate Clinical Trials in China with Etanercept Biosimilar Candidate SCB-808 cloverbiopharma.com ↗
SCB-808, a Prefilled Syringe Formulation Etanercept Biosimilar Candidate, Received CTA Approval from the CFDA |
| 2017-06-27 | Novartis Pharmaceuticals | Regulatory Sandoz receives approval in Europe for Erelzi® (biosimilar etanercept) to treat multiple inflammatory diseases novartis.com ↗
Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, announced today that the European Commission (EC) has approved Erelzi ® (biosimilar etanercept) for use in Europe*. |
| 2017-06-14 | Biogen | Results Real World Data Being Presented at EULAR 2017 Demonstrate Acceptance and Confirm Sustainability of Effectiveness, Safety and Adherence among Patients Switching To BENEPALI® (Etanercept Biosimilar of Biogen) from Reference Etanercept biogen.com ↗
Furthermore, in a separate cohort of 92 patients with RA, PsA or ankylosing spondylitis (AS) in the UK, a low rate of treatment discontinuations due to inefficacy or adverse events was demonstrated at 6 months post-switch. |
| 2017-04-21 | Novartis Pharmaceuticals | Regulatory Sandoz proposed biosimilars rituximab and etanercept recommended for approval in Europe* novartis.com ↗
Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions, separately recommending the approval of both Sandoz' biosimilar rituximab and biosimilar etanercept in Europe, to treat the same indications as their respective reference medicines. |
| 2016-11-18 | Novartis Pharmaceuticals | Results Innovative study with three treatment switches confirms Sandoz biosimilar etanercept has equivalent efficacy to originator novartis.com ↗
The confirmatory clinical safety and efficacy study shows Sandoz biosimilar etanercept is equivalent to the originator product, Enbrel ® ***, in more than 500 adult patients over 52 weeks[1]. |
| 2016-11-04 | Amgen | Regulatory FDA Approves Expanded Use Of ENBREL® (etanercept) To Treat Children With Chronic Moderate-To-Severe Plaque Psoriasis amgen.com ↗ |
| 2016-10-06 | Coherus Oncology, Inc. | Results Coherus BioSciences Completes two Pharmacokinetic Bioequivalence Studies of CHS-0214 coherus.com ↗
The ‘06 Study achieved the primary PK BE endpoint, as the 90% confidence intervals for the geometric mean ratio for the two groups was within 80% to 125% for all PK parameters. |
| 2016-08-30 | Novartis Pharmaceuticals | Regulatory FDA approves Sandoz Erelzi(TM) to treat multiple inflammatory diseases novartis.com ↗ |
| 2016-07-13 | Novartis Pharmaceuticals | Regulatory Sandoz biosimilar etanercept recommended by FDA advisory committee for approval to treat multiple inflammatory diseases novartis.com ↗
Sandoz, a Novartis division and leader in biosimilars, announced today that the US Food and Drug Administration (FDA) Arthritis Advisory Committee recommended approval of its proposed biosimilar etanercept. |
| 2016-07-07 | Novartis Pharmaceuticals | Results New data shows Sandoz biosimilar etanercept candidate has equivalent efficacy to originator product novartis.com ↗
today announced results from the EGALITY trial in which the primary endpoint of achieving equivalence in Psoriasis Area and Severity Index (PASI) 75 response rates at week 12 was met. |
| 2016-06-10 | Coherus Oncology, Inc. | Results Coherus Presents Study Results Demonstrating Equivalence of its CHS-0214 Biosimilar to Etanercept coherus.com ↗
Results of the study demonstrated the equivalence of CHS-0214 to etanercept with respect to efficacy as measured by a primary endpoint. |
| 2016-06-09 | Novartis Pharmaceuticals | Results New data demonstrates Sandoz' etanercept and rituximab biosimilar candidates bioequivalent to originator products novartis.com ↗
Sandoz' biosimilar etanercept candidate shows pharmacokinetic (PK) bioequivalence with no clinically meaningful differences in safety, tolerability and immunogenicity to the originator. |
| 2016-06-09 | Biogen | Results New Data Presented at the Annual European Congress of Rheumatology (EULAR 2016) Demonstrate Safety and Efficacy of Biogen’s Anti-TNF Biosimilars Portfolio biogen.com ↗
Results showed that in patients who were switched from the reference product Enbrel i to BENEPALI, there were no treatment-emergent safety or immunogenicity issues, and efficacy was sustained for up to two years. |
| 2016-06-07 | Samsung Bioepis Co., Ltd. | Results 삼성바이오에피스, ANTI-TNF-α 바이오시밀러 3개 제품의 스위칭 임상 결과를 유럽 류마티스 학회에서 발표 samsungbioepis.com ↗
삼성바이오에피스는 8일(현지시간)부터 11일까지 영국 런던에서 개최되는 2016 유럽 류마티스 학회(EULAR: The Annual European League Against Rheumatism)에서 바이오시밀러 3개제품(브렌시스®, 렌플렉시스®, SB5)의 임상결과를 발표했다. |
| 2016-03-10 | Amgen | Regulatory FDA Accepts Amgen's Supplemental Biologics License Application For The Expanded Use Of Enbrel® (Etanercept) To Treat Pediatric Patients With Chronic Severe Plaque Psoriasis amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration ( FDA ) has accepted for review Amgen's supplemental Biologics License Application (sBLA) for the expanded use of Enbrel ® (etanercept) to treat pediatric patients with chronic severe plaque psoriasis. |
| 2016-03-07 | Eli Lilly and Company | Results Studies Show Ixekizumab Improved Work Productivity for Patients with Moderate-to-Severe Plaque Psoriasis: Results Published in JAMA Dermatology lilly.com ↗
Patients treated with ixekizumab also showed significantly greater improvement in the following WPAI scores compared to those treated with etanercept: presenteeism, work productivity loss and activity impairment (p < 0.001 for all comparison scores). |
| 2016-01-16 | Biogen | Regulatory BENEPALI®, the First Etanercept Biosimilar Referencing Enbrel®, Approved in the European Union biogen.com ↗
BENEPALI has been granted marketing authorization in the European Union (EU) for the treatment of adults with moderate to severe rheumatoid arthritis (RA), psoriatic arthritis, non-radiographic axial spondyloarthritis and plaque psoriasis. |
| 2016-01-12 | Daiichi Sankyo | Results Daiichi Sankyo Announces Results of Phase 3 International Joint Trial (RApsody) of Investigational Etanercept Biosimilar daiichisankyo.com ↗
The primary endpoint (ACR20*2), evaluating the disease activity of rheumatoid arthritis at 24 weeks after the administration of CHS-0214, met the criteria of equivalence as defined in advance in CHS-0214 and reference product groups, achieving the intended purpose. |
| 2015-12-08 | Novartis Pharmaceuticals | Regulatory Sandoz advances its biosimilars program with European Medicines Agency (EMA) acceptance of regulatory submission for biosimilar etanercept novartis.com ↗
The acceptance by the EMA of our biosimilar etanercept regulatory submission is a move towards enabling more patients with chronic inflammatory conditions such psoriasis and rheumatoid arthritis to be treated with biologics |
| 2015-11-20 | Biogen | Regulatory Biogen Announces Benepali™ (Etanercept) is the First Biosimilar of Enbrel® to Receive a Positive Opinion from CHMP biogen.com ↗
Samsung Bioepis, the joint venture between Samsung Biologics and Biogen, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the marketing authorization of Benepali ™ (etanercept). |
| 2015-11-13 | Clover Biopharmaceuticals AUS Pty | Regulatory Clover filed IND with CFDA for SCB-808, a ready-for-injection biosimilar of blockbuster anti-TNF biologic, Enbrel (etanercept) cloverbiopharma.com ↗
Clover has completed IND filing with the CFDA for SCB-808, a biosimilar of blockbuster anti-TNF biologic, Enbrel (etanercept). |
| 2015-11-09 | Coherus Oncology, Inc. | Results Coherus BioSciences Reports Third Quarter 2015 Financial and Operating Results and Corporate Events coherus.com ↗
Coherus and Baxalta announced today that CHS-0214 met its primary efficacy endpoints in its phase 3 psoriasis clinical study. |
| 2015-11-09 | Coherus Oncology, Inc. | Results Coherus and Baxalta Announce CHS-0214 (Investigational Etanercept Biosimilar) Met Primary Efficacy Endpoints in Phase 3 Psoriasis Clinical Study (RaPsODY) coherus.com ↗
At Week 12, the primary endpoints, the mean percent change in PASI from baseline and the proportion of subjects achieving 75% improvement in PASI from baseline, were within the pre-specified margins for demonstrating equivalence of CHS-0214 compared to Enbrel®. |
| 2015-10-02 | Novartis Pharmaceuticals | Regulatory FDA accepts Sandoz regulatory submission for a proposed biosimilar etanercept novartis.com ↗
we believe we are the first company to receive FDA file acceptance of a biosimilar version of etanercept. |
| 2015-09-08 | Merck Sharp & Dohme LLC | Regulatory Merck and Samsung Bioepis Announce Approval of BRENZYS™ (Etanercept), a Biosimilar of Enbrel, in Korea merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Samsung Bioepis Co., Ltd. today announced the approval of BRENZYS™ (etanercept), a biosimilar of the immunology medicine Enbrel, by the Ministry of Food and Drug Safety (MFDS) in Korea. |
| 2015-09-07 | Samsung Bioepis Co., Ltd. | Regulatory 삼성바이오에피스, 『브렌시스™』 국내 품목 허가 획득 samsungbioepis.com ↗
삼성바이오에피스와 한국MSD는 7일, 삼성바이오에피스의 첫 번째 바이오시밀러인 브렌시스™가 식품의약품안전처(MFDS)로부터 품목 허가를 받았다고 밝혔다. |
| 2015-06-10 | Merck Sharp & Dohme LLC | Results Merck and Samsung Bioepis Announce Pivotal Phase 3 Studies for Investigational Biosimilars SB4, Enbrel (Etanercept), and SB2, Remicade (Infliximab), Met Primary Endpoints merck.com ↗
In these studies, SB4 and SB2 demonstrated a safety profile equivalent to the originator medicines. |
| 2015-06-10 | Biogen | Results Biogen and Samsung Bioepis Announce New Data for Three Anti-TNF Biosimilar Development Candidates at EULAR 2015 Congress biogen.com ↗ |
| 2014-10-09 | Janssen Research & Development, LLC | Results New Findings From The Psoriasis Longitudinal Assessment And Registry (PSOLAR) jnj.com ↗
This particular analysis of the PSOLAR registry showed higher treatment longevity and lower rates of discontinuation with ustekinumab compared with anti-TNF-alpha agents. |
| 2014-08-21 | Eli Lilly and Company | Results Lilly's Ixekizumab Superior to Etanercept and Placebo in Phase 3 Psoriasis Studies lilly.com ↗ |
| 2009-09-22 | Protalix | Results Protalix Reports Preclinical Data on Anti-TNF Follow-on Biologic Arthritis Drug protalix.com ↗
In a proof-of-concept in vivo study using an established arthritis animal model, pr-antiTNF administered intraperitoneally significantly improved the clinical arthritis parameters associated with this accepted arthritis mouse model including joint inflammation, swelling and tissue degradation. |
All press releases naming this drug 67 releases
Evidence & citations 22 cited values
Every value below carries the sentence it was read from. 373 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | etanercept | “The BAT in this study was identified by the investigator prior to patient randomization among the following treatments currently used in this setting: anti-thymocyte globulin...” NCT02913261 ↗338“The BAT in this study will freely be identified by the Investigator prior to patient randomization and may include treatments such as: anti-thymocyte globulin (ATG),...” NCT04118556 ↗ “The investigator proposes to perform a Phase I study assessing safety, efficacy, and biomarker response to the therapeutic interventions of Etanercept followed by mifepristone...” NCT04255498 ↗ “To be given subcutaneously via a prefilled syringe/autoinjector (etanercept, adalimumab, certolizumab pegol, golimumab) or intravenously via infusion (infliximab) at increasing...” NCT05115903 ↗ “This withdrawn study was to assess the safety and efficacy of secukinumab compared to etanercept and placebo in patients who have moderate to severe, chronic, plaque-type psoriasis.” NCT01900782 ↗ “TNF-a inhibitors: Etanercept (Enbrel, Benapali), Infliximab (Remicade, Inflectra, Flixabi), Adalimumab (Humira, Imraldi, AMGEVITA), Certolizumabpegol (Cimzia), Golimumab (Simponi)” NCT04378621 ↗ “RA treated with subcutaneous TNF-blockers (etanercept or adalimumab) at stable and standard dosage for 1 year or more, as monotherapy or associated with stable conventional DMARD;” NCT00780793 ↗ “Sandoz etanercept (SDZ ETN; GP2015) is an etanercept biosimilar with equivalent efficacy and comparable safety and immunogenicity to reference etanercept (ETN)” PMID 31138316 ↗ May 2019 “An approved stable subcutaneous formulation of one of the following TNF inhibitors may include adalimumab, certolizumab, etanercept, or golimumab.” NCT02862574 ↗ “Enbrel®, also known as etanercept, has already been approved by the Federal Food Drug Administration for the treatment of psoriatic arthritis.” NCT00111124 ↗ “Study Comparing Enbrel (Etanercept) Plus Methotrexate Versus Enbrel Alone in Active Rheumatoid Arthritis Despite Current Methotrexate Therapy” NCT00244556 ↗ |
| Known as | 50mg entanercept(Yisaipu) | “50mg entanercept(Yisaipu)” NCT02364479 ↗ |
| Known as | Drug: Etanercept (Enbrel) | “Drug: Etanercept (Enbrel)” NCT02456363 ↗ |
| Known as | Enbrel | “The purpose of this pilot study is to investigate the safety and efficacy of etanercept (Enbrel™; Amgen) for the treatment of an acute gout attack will be non-inferior to...” NCT03636373 ↗69“This trial is a phase III study to help understand the action of the drug etanercept, trade name Enbrel, for the adult patient with moderate to severe plaque psoriasis and who...” NCT00116181 ↗ “The purpose of this research study is to see how well (compared to placebo) Enbrel® (etanercept) 50 mg twice a week for 12 weeks affects plaque psoriasis of the hands and/or...” NCT00585650 ↗ “Discontinuation of infusion infliximab (Remicade) 3-5mg/kg every 6-8 week, injection of etanercept (Enbrel) 25 mg x 2/week or injection of adalimumab (Humira) 40 mg eow.” NCT00726804 ↗ “OptiSkin is now enrolling a new study to monitor nail changes in patients with nail psoriasis treated with Enbrel® (etanercept) with optical coherence tomography (OCT).” NCT05135312 ↗ “The purpose of this study is to determine the preference of RA patients for the new Enbrel® (etanercept) pre-filled syringe in patients who are already taking Enbrel®.” NCT00094341 ↗ “Single dose of etanercept (ENBREL®) in a pre-filled syringe administered with an auto-injector device manufactured by Scandinavian Health Limited (SHL)” NCT02799498 ↗ “This study will test the effectiveness of etanercept (Enbrel) for treating Sjogren's syndrome-an autoimmune disease that affects the secreting glands.” NCT00001954 ↗ “Double-blind, Randomized, Placebo-controlled Study of Enbrel (Etanercept) in the Treatment of Rheumatoid Arthritis Subjects With Comorbid Disorders” NCT00132418 ↗ “A Study to Assess the Effect of Ustekinumab (Stelara®) and Etanercept (Enbrel®) in Participants With Moderate to Severe Psoriasis (MK-0000-206)” NCT01276847 ↗ “* group 1) - 50 kidneys - examined group - "cured" with etanercept (ENBREL) in the first hour of perfusion by adding drug to perfusion fluid,” NCT01731457 ↗ |
| Known as | Enbrel (etanercept) | “Enbrel (etanercept)” NCT02112097 ↗ |
| Known as | EnbrelTM | “etanercept (EnbrelTM)” NCT00706797 ↗ |
| Known as | ENIA11 | “A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With...” NCT01787149 ↗ |
| Known as | Etanercept(Enbrel) | “Etanercept(Enbrel®)” NCT00679042 ↗ |
| Known as | Etanercept- ENBREL as brand name | “Etanercept- ENBREL as brand name” NCT01361542 ↗ |
| Known as | ETN | “The main aim of the VEDERA study (Very Early versus Delayed Etanercept in Rheumatoid Arthritis) is to assess the depth of remission, sustainability of remission and...” PMID 26847108 ↗ Feb 201617“The aim of the Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Patients Who Have Achieved a Stable Low Disease Activity-State study...” PMID 25873634 ↗ Apr 2015 “A Multicenter, Open-label, Randomized, Pilot-study to Evaluate the Efficacy and Safety of the Combination of Etanercept (ETN) and Methotrexate and of Etanercept (ETN) Alone in...” NCT00161655 ↗ “BACKGROUND: To describe the 6-year safety and efficacy of etanercept (ETN) in children with extended oligoarticular juvenile idiopathic arthritis (eoJIA), enthesitis-related...” PMID 31122296 ↗ May 2019 “The present paper aims to investigate the effect of psoriatic arthritis (PsA) disease duration on the outcome of treatment with etanercept (ETN) in patients with PsA who also...” PMID 25535650 ↗ Dec 2014 “OBJECTIVE: To evaluate the immunogenicity, safety, and efficacy of etanercept (ETN) manufactured using the serum-free, high-capacity manufacturing (SFHCM) process in patients...” PMID 30451655 ↗ Jan 2019 “To evaluate the efficacy and safety of etanercept (ETN) after 48 weeks in patients with early active non-radiographic axial spondyloarthritis (nr-axSpA).” PMID 26269397 ↗ Aug 2015 “The tumor necrosis factor inhibitors(TNFi) like etanercept(ETN) has been always recommended as the primary treatment option for active AS.” NCT04077957 ↗ “RCT patients were treated with IXE or etanercept (ETN; UNCOVER-2/3), guselkumab (GUS; IXORA-R), or ustekinumab (UST; IXORA-S).” PMID 38521874 ↗ Mar 2024 “Etanercept (ETN) is a dimeric fusion protein consisting of the p75 TNFR linked to the Fc portion of human IgG1” NCT01303874 ↗ “Data from a multicenter, open-label study investigating the immunogenicity of etanercept (ETN) were analyzed.” PMID 20156946 ↗ Feb 2010 |
| Known as | ETN50 | “we compared efficacy maintenance with etanercept 50 mg once weekly (ETN50) versus placebo (PBO), on a background of methotrexate (MTX) ± other non-biologic, disease-modifying...” PMID 30200078 ↗ Sep 2018 |
| Known as | GP2015 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02638259 ↗ |
| Known as | MB04 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06392074 ↗ |
| Known as | Reumatocept | “Reumatocept (etanercept)” NCT01394913 ↗ |
| Known as | SB4 | “SB4 (etanercept) 50 mg/mL PFS and AI” NCT03193203 ↗ |
| Known as | SDZ ETN | “Sandoz etanercept (SDZ ETN; GP2015) is an etanercept biosimilar with equivalent efficacy and comparable safety and immunogenicity to reference etanercept (ETN)” PMID 31138316 ↗ May 2019 |
| Known as | TNFR:Fc | “Adult Rheumatoid Arthritis (RA) patients on etanercept (TNFR:Fc) with well controlled arthritic symptoms will continue on the etanercept (TNFR:Fc) dose administered in their...” NCT00357903 ↗2“In this Phase II clinical trial we will use tumor necrosis factor receptor p75 fusion protein (TNFR:Fc, or etanercept) to treat patients with ankylosing spondylitis (AS).” NCT00000433 ↗ “This study will examine the use of etanercept (also called Enbrel or TNFR:Fc) in patients with Wegener's granulomatosis” NCT00001901 ↗ |
| Known as | Yisaipu | “prefilled liquid etanercept(Yisaipu)” NCT04345458 ↗ |
| Action | Inhibit | “It blocks the action of tumor necrosis factor-alpha (TNF-alpha)” NCT00000433 ↗ |
| Modality | Protein / enzyme biologic | “The drug, called Enbrel (or etanercept), is a protein that is given twice weekly by injection underneath the skin.” NCT00000433 ↗ |
| Route | Subcutaneous | “TNFR:Fc (25mg subcutaneously twice weekly)” NCT00001901 ↗ |
| Target | TNF | “The drug works by blocking the activity of TNF-a protein made by white blood cells” NCT00001901 ↗ |