Drugs / Etanercept
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Etanercept

Protein / enzyme biologic targets TNF via inhibition

Developed for
rheumatoid arthritis · psoriasis · ankylosing spondylitis · psoriatic arthritis · juvenile idiopathic arthritis · spondyloarthropathy · Alzheimer disease · graft versus host disease
+74 more · leukemia · myelodysplastic syndrome · type 1 diabetes mellitus · asthma · HIV infectious disease · acute graft versus host disease · adult acute respiratory distress syndrome · discoid lupus erythematosus · granulomatosis with polyangiitis · hidradenitis suppurativa · metabolic syndrome X · myelodysplastic/myeloproliferative disease · neuroblastoma · osteoarthritis, knee · transplant-related bronchiolitis obliterans · uveitis · acquired aneurysmal subarachnoid hemorrhage · acute lung injury · adenocarcinoma · arthropathy · atopic eczema · Behcet disease · bone cancer · chronic lymphocytic leukemia/small lymphocytic lymphoma · chronic obstructive pulmonary disease · chronic pancreatitis · complex regional pain syndrome · drug allergy · Fanconi anemia · gout · hypoproteinemia, hypercatabolic · idiopathic interstitial pneumonia · idiopathic pulmonary fibrosis · inclusion body myositis · juvenile dermatomyositis · Kawasaki disease · Langerhans cell histiocytosis · lichen planus · lung cancer · lupus nephritis · metastatic neoplasm · myalgic encephalomeyelitis/chronic fatigue syndrome · myocardial infarction · neoplasm · occupational disorder · oligoarticular juvenile idiopathic arthritis · pancreatic neoplasm · pemphigus vulgaris · persian gulf syndrome · pneumonia · polyarticular juvenile idiopathic arthritis · polyarticular juvenile rheumatoid arthritis · polymyalgia rheumatica · primary systemic amyloidosis · prostate cancer · radiculopathy · rheumatoid factor-negative juvenile idiopathic arthritis · SAPHO syndrome · sciatica · Sjogren syndrome · stomatitis · synovitis · temporomandibular joint disorder · tinnitus · uveal disorder · vasculitis · vitiligo · chronic idiopathic urticaria · dermatomyositis · end stage renal failure · juvenile chronic polyarthritis · palmoplantar pustulosis · Stevens-Johnson syndrome · type 2 diabetes mellitus
Investigated by
Amgen · Wyeth is now a wholly owned subsidiary of Pfizer · Pfizer · Immunex Corporation · National Cancer Institute (NCI) · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
+192 more · National Institute of Allergy and Infectious Diseases (NIAID) · University of Michigan Rogel Cancer Center · Fred Hutchinson Cancer Center · Massachusetts General Hospital · Samsung Bioepis Co., Ltd. · Charite University, Berlin, Germany · Chung Shan Medical University · Eli Lilly and Company · Johns Hopkins University · Mycenax Biotech Inc. · National Heart, Lung, and Blood Institute (NHLBI) · National Institute of Dental and Craniofacial Research (NIDCR) · Stanford University · Sun Yat-sen University · University of Leeds · Walter Reed Army Medical Center · Assistance Publique - Hôpitaux de Paris · Baylor College of Medicine · Blood and Marrow Transplant Clinical Trials Network · Chang Gung Memorial Hospital · Children's Hospital Medical Center, Cincinnati · Duke University · Emory University · FDA Office of Orphan Products Development · First Affiliated Hospital of Harbin Medical University · Florida Academic Dermatology Centers · Gema Biotech S.A. · Innovaderm Research Inc. · LG Life Sciences · Lincoln Medical and Mental Health Center · National Eye Institute (NEI) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Ohio State University Comprehensive Cancer Center · QUID Quality in Drugs and Devices Latin American Consulting SRL · Rheumazentrum Ruhrgebiet · Rockefeller University · The Cleveland Clinic · Tobinick, Edward Lewis, M.D. · University of Alabama at Birmingham · University of California, San Francisco · University of Erlangen-Nürnberg Medical School · University of Michigan · University of Pennsylvania · ASIS Corporation · AbbVie · Abu Dhabi Stem Cells Center · Advanced Biotherapy, Inc. · Agenzia Italiana del Farmaco · Alberta Innovates Health Solutions · All India Institute of Medical Sciences · AryoGen Pharmed Co. · Assistance Publique Hopitaux De Marseille · Autoimmunity Centers of Excellence · Azienda Ospedaliera di Padova · Belgium Health Care Knowledge Centre · Benaroya Research Institute · Biogen · Bispebjerg Hospital · Brigham and Women's Hospital · Bristol-Myers Squibb · Center for Cell and Gene Therapy, Baylor College of Medicine · Centocor Ortho Biotech Services, L.L.C. · Chengdu PLA General Hospital · Children's Oncology Group · China Medical University Hospital · Clinical Trials Research Unit, Leeds · Columbia University · Compagnia di San Paolo · Departmet of Rheumatology, J Dietl Hospital, Krakow, Poland · Dermatrials Research · Diamyd Medical AB · EMS · Far Eastern Memorial Hospital · Fen Li · all 198 on the full record

Regulatory milestones approvals, filings & regulatory actions · 19 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (17) 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

Trials 246 · started per year

today
US approved 1998
EU approved 2000
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19971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
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
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 1/210 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 NCT00201682 Oct 2002 → Aug 2006 chronic lymphocytic leukemia/small lymphocytic lymphoma John Byrd 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 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 244 trials
Phase 2 NCT07138898 Dec 2025 → Jan 2028 expected rheumatic disorder NYU Langone Health Recruiting No outcome recorded
Phase 2 NCT04066348 Jul 2022 → Sep 2026 expected tinnitus Wayne State University Recruiting No outcome recorded
Phase 2 NCT03193957 May → Aug 2017 rheumatoid arthritis Samsung Bioepis Co., Ltd. Completed No outcome recorded
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 2/39 trials
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 No outcome recorded
Phase 2/3 NCT00733096 Aug 2008 → Mar 2011 radiculopathy Johns Hopkins University Completed No outcome recorded
Phase 2/3 NCT00111956 Apr 2004 → May 2005 metabolic syndrome X National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Completed No outcome recorded
Phase 2/3 NCT00035958 Aug 2002 juvenile dermatomyositis Children's Hospital Medical Center, Cincinnati Terminated No outcome recorded
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 No outcome recorded
Phase 362 trials
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 → Dec 2026 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 No outcome recorded
Phase 3 NCT02986139 Nov 2016 → Sep 2017 arthropathy Amgen Completed No outcome recorded
Phase 477 trials
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 No outcome recorded
Phase 4 NCT04077957 Oct 2019 → Oct 2021 ankylosing spondylitis Nanfang Hospital, Southern Medical University Unknown No outcome recorded
Phase 4 NCT03813771 Mar 2019 → Feb 2023 rheumatoid arthritis University of Leeds Unknown No outcome recorded
Phase 4 NCT03649061 Jun 2018 → Jul 2022 rheumatoid arthritis P. Verschueren Completed No outcome recorded
Phase not applicable17 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
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
Also used as a comparator or background therapy in 113 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT07519005 Background Jan → Feb 2026 overdue liver failure Xijing Hospital Active not recruiting No outcome recorded
Phase 19 trials
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
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
Phase 1 NCT01431404 Comparator Aug 2011 → Mar 2012 Hanwha Chemical Completed No outcome recorded
Phase 1/26 trials
Phase 1/2 NCT04082910 Background Sep 2019 → Dec 2022 cancer, hematopoietic and lymphoid cell neoplasm Chinese PLA General Hospital Unknown No outcome recorded
Phase 1/2 NCT03160001 Background Aug 2017 → Aug 2018 rheumatoid arthritis Faiq Gorial Completed No outcome recorded
Phase 1/2 NCT02821026 Background May 2016 → Nov 2019 type 1 diabetes mellitus University of Alberta Completed No outcome recorded
Phase 1/2 NCT00784966 Comparator Aug 2011 → Sep 2015 type 1 diabetes mellitus Virginia Commonwealth University Withdrawn No outcome recorded
Phase 1/2 NCT00888628 Background May 2009 → Aug 2014 type 1 diabetes mellitus Massachusetts General Hospital Completed No outcome recorded
Phase 212 trials
Phase 2 NCT06075706 Comparator Nov 2023 → Feb 2026 overdue acute graft versus host disease medac GmbH Active not recruiting No outcome recorded
Phase 2 NCT04118556 Comparator Dec 2021 → Apr 2026 acute graft versus host disease Mats Remberger Terminated No outcome recorded
Phase 2 NCT02464878 Background Jan 2017 → Nov 2022 type 1 diabetes mellitus Massachusetts General Hospital Completed No outcome recorded
Phase 2 NCT02862574 Background Dec 2016 → Jun 2017 rheumatoid arthritis Gilead Sciences Terminated No outcome recorded
Phase 2 NCT02694770 Comparator Jul 2016 → Sep 2017 acute graft versus host disease AbGenomics B.V Taiwan Branch Withdrawn No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT05871086 Background May → Dec 2023 juvenile idiopathic arthritis Nourhan Elsherif Unknown No outcome recorded
Phase 2/3 NCT02809781 Comparator Jun 2016 → Aug 2018 ankylosing spondylitis, ankylosis, disease of bone structure Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Unknown No outcome recorded
Phase 2/3 NCT01030120 Comparator Dec 2010 → Jul 2012 chronic idiopathic urticaria University of Utah Withdrawn No outcome recorded
Phase 333 trials
Phase 3 NCT06596772 Comparator Oct 2024 → Oct 2025 overdue rheumatoid arthritis mAbxience Research S.L. Recruiting No outcome recorded
Phase 3 NCT02987257 Comparator Mar 2023 → Oct 2025 Stevens-Johnson syndrome Vanderbilt University Medical Center Completed No outcome recorded
Phase 3 NCT03451851 Comparator Jul 2018 → Jul 2023 overdue psoriasis Janssen Research & Development, LLC Active not recruiting No outcome recorded
Phase 3 NCT02913261 Comparator Mar 2017 → Jun 2019 acute graft versus host disease Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT02471144 Comparator Sep 2015 → Dec 2018 psoriasis Novartis Pharmaceuticals Completed No outcome recorded
Phase 443 trials
Phase 4 NCT06707194 Background Jun 2025 → Mar 2027 expected ankylosing spondylitis Nanfang Hospital, Southern Medical University Recruiting No outcome recorded
Phase 4 NCT04985435 Comparator May 2021 → Sep 2025 overdue rheumatoid arthritis R.Bos Recruiting No outcome recorded
Phase 4 NCT03976245 Comparator Mar 2020 → Mar 2025 overdue rheumatoid arthritis London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Recruiting No outcome recorded
Phase 4 NCT04086745 Comparator Feb 2020 → May 2025 rheumatoid arthritis Eli Lilly and Company Completed No outcome recorded
Phase 4 NCT04485325 Comparator Nov 2019 → Mar 2024 rheumatoid arthritis Dr. Frank Behrens Completed No outcome recorded
Phase not applicable6 trials
NCT03033095 Background Jul 2016 → Jul 2017 ankylosing spondylitis University Hospital, Grenoble Completed No outcome recorded
NCT01657513 Background Jun 2012 → Jul 2013 psoriasis University Hospital, Gentofte, Copenhagen Unknown No outcome recorded
NCT01610947 Comparator May 2012 → Oct 2018 spondyloarthropathy University Hospital, Montpellier Completed No outcome recorded
NCT00405275 Comparator Jul 2007 → Dec 2011 rheumatoid arthritis US Department of Veterans Affairs Completed No outcome recorded
NCT00413400 Comparator Dec 2006 → Sep 2009 metabolic syndrome X Massachusetts General Hospital Completed No outcome recorded

Press releases naming this drug 21 releases

DateIssuerRelease
2021-05-17 Novartis Pharmaceuticals US Supreme Court denies Sandoz petition to review biosimilar Erelzi® (etanercept-szzs) case novartis.com
2020-07-01 Amgen Appeals Court Affirms Validity Of Enbrel® (etanercept) Patents Injunction Against Sandoz's Infringement Stands amgen.com
2019-11-12 Novartis Pharmaceuticals Sandoz presents real-world data showing effectiveness of Erelzi® (etanercept-szzs) in rheumatic disease treatment novartis.com
2019-08-09 Novartis Pharmaceuticals Sandoz will appeal District Court of New Jersey ruling in biosimilar Erelzi® (etanercept-szzs) US patent case novartis.com
2019-08-09 Amgen Amgen Wins Patent Case On Enbrel® (etanercept) amgen.com
2019-07-26 Takeda Termination of Co-promotion in Japan of Rheumatoid Arthritis Drug Enbrel ® takeda.com
2018-10-24 Amgen 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 Sandoz presents new long-term and switching data for biosimilars Zessly® (infliximab) and Erelzi® (etanercept) in rheumatoid arthritis novartis.com
2017-11-17 Amgen Amgen Launches The ENBREL Mini™ Single-Dose Prefilled Cartridge With AutoTouch™ Reusable Autoinjector That Is Ergonomically Designed For Patients amgen.com
2017-06-27 Novartis Pharmaceuticals Sandoz receives approval in Europe for Erelzi® (biosimilar etanercept) to treat multiple inflammatory diseases novartis.com
2017-04-21 Novartis Pharmaceuticals Sandoz proposed biosimilars rituximab and etanercept recommended for approval in Europe* novartis.com
2016-11-18 Novartis Pharmaceuticals Innovative study with three treatment switches confirms Sandoz biosimilar etanercept has equivalent efficacy to originator novartis.com

Evidence & citations 25 cited values

Every value below carries the sentence it was read from. 377 sources stand behind the page.

FieldValueCited 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

“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

“TNF-a inhibitors: Etanercept (Enbrel, Benapali), Infliximab (Remicade, Inflectra, Flixabi), Adalimumab (Humira, Imraldi, AMGEVITA), Certolizumabpegol (Cimzia), Golimumab (Simponi)” NCT04378621

“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

“We also found that a medicine called ETANercept can slow down neuroblastoma growth, which might enhance the effects of the modified cells.” NCT03294954

“Any of the anti-TNF therapies (Infliximab, Adalimumab, Etanercept, etc.)administered at the approved label dose for at least 3 months” NCT00124982

“Participants were randomised to anakinra or to a TNFi (i.e., adalimumab, certolizumab pegol, etanercept, infliximab, or golimumab)” PMID 31513665 Sep 2019

“OBJECTIVE: To evaluate the safety of etanercept in patients with rheumatoid arthritis (RA) and concomitant comorbidities.” PMID 17470434 Apr 2007

“The drug, called Enbrel (or etanercept), is a protein that is given twice weekly by injection underneath the skin.” NCT00000433

“Participants received a TNF inhibitor (adalimumab or etanercept) administered according to approved local labeling” NCT03915964

“such as Etanercept and infliximab, pentostatin, sirolimus, mycophenolate mofetil and extracorporeal photopheresis” NCT02694770

“extracorporeal photopheresis (ECP), anti-thymocyte globulin (ATG), etanercept, infliximab or ruxolitinib (RUX)” NCT06075706

“We evaluated the safety and efficacy of etanercept, a TNF antagonist, for the treatment of plaque psoriasis.” PMID 14627786 Nov 2003

Etanercept 50 mg iv 1 hour before transplant and 25 mg s.c. on days 3, 7,and 10 post-transplant” NCT00679042

etanercept 50 mg IV before islet transplant, 25 mg subcutaneously post-transplant days 3, 7, 10” NCT00566813

“adalimumab at 40 mg every 2 weeks or etanercept 50 mg per week according to treatments history” NCT04870203

“TNF antagonist as prescribed in clinical practice (such as etanercept or adalimumab)” NCT01400516

“a TNF inhibitor (adalimumab, certolizumab, etanercept, golimumab or infliximab)” NCT01724268

Etanercept (ETN) with methotrexate (MTX) is better than ETN monotherapy in” PMID 20574649 Jun 2010

Etanercept improved clinical outcomes in patients with SJS-TEN.” PMID 29400697 Feb 2018

“namely etanercept (receptor fusion protein) 50 mg sc per week” NCT05305066

Etanercept at 50mg weekly for the duration of the study” NCT01361542

etanercept: 50mg per week in subcutaneous injection” NCT03445845

“Adalimumab, etanercept, certolizumab, or golimumab” NCT05379322

Etanercept subcutaneous injections 50 mg weekly” NCT04985435

“Methotrexate or leflunomide + etanercept or” NCT02714634

Etanercept (anti-TNF-α, 25 mg twice weekly)” NCT07519005

Etanercept (Enbrel) or Golimumab (Simponi)” NCT02456363

“* Etanercept - 0.8 mg/kg/dose once weekly” NCT05871086

Etanercept ≥63 kg (138 lb) 50 mg weekly” NCT06654882

Etanercept 25mg, single dose” NCT01145950

Etanercept: 50 mg / 10 days” NCT01604629

“Enbrel (Etanercept 25mg)” NCT01725620

Etanercept (Enbrel®)” NCT02779114

“Enbrel (etanercept)” NCT00421915

“Enbrel (etanercept)” NCT01895309

“Enbrel (etanercept)” NCT06596772

“Enbrel (etanercept)” NCT00410046

Etanercept (Enbrel)” NCT07149792

“25mg etanerceptNCT02364479

EtanerceptNCT02242474

EtanerceptNCT05080218

NCT00585650

NCT00034060

NCT02509026

NCT00078806

NCT04082910

NCT00936065

NCT00285779

NCT00276029

NCT01000441

NCT03976245

NCT00434811

NCT00112385

NCT00784966

NCT00353119

NCT03193957

NCT00858780

NCT00524381

NCT02840175

NCT00639717

NCT00309907

NCT02471144

NCT00252668

NCT01431404

NCT02132234

NCT03451851

NCT00434850

NCT00195507

NCT00931957

NCT00477191

NCT02799498

NCT02258282

NCT01270997

NCT02109289

NCT00789308

NCT06707194

NCT00006070

NCT00520572

NCT03193203

NCT00110903

NCT01927757

NCT02878161

NCT00888628

NCT00333034

NCT00078819

NCT00001901

NCT02374021

NCT01331837

NCT00581555

NCT01716637

NCT00405275

NCT03997786

NCT00001954

NCT07386587

NCT00444340

NCT01313208

NCT00110981

NCT02373813

NCT01289743

NCT00195494

NCT00502879

NCT02134210

NCT00361634

NCT07138898

NCT00800982

NCT00458185

NCT01602302

NCT00726804

NCT01241591

NCT01865630

NCT00329823

NCT01303874

NCT00447265

NCT07184853

NCT00841789

NCT00141921

NCT00133315

NCT02313922

NCT03273088

NCT01289730

NCT03649061

NCT02346240

NCT01030120

NCT04254627

NCT00967538

NCT02915354

NCT00546533

NCT00111111

NCT01132235

NCT03780959

NCT03414502

NCT00141791

NCT00733096

NCT01597245

NCT01731457

NCT00203320

NCT02821026

NCT03073200

NCT01009879

NCT00833729

NCT00091741

NCT03728478

NCT00118287

NCT01730495

NCT02464878

NCT00249041

NCT02489760

NCT01971346

NCT00141739

NCT00121615

NCT00035958

NCT00640393

NCT00848354

NCT00141726

NCT01298531

NCT00217386

NCT00393471

NCT00802815

NCT00332332

NCT00031551

NCT02999776

NCT03781375

NCT00421980

NCT02809781

NCT01783015

NCT01295151

NCT01578850

NCT02722811

NCT00421174

NCT01287715

NCT00992394

NCT00691964

NCT00201838

NCT00293202

NCT00141713

NCT01901185

NCT00783536

NCT00346294

NCT00796705

NCT02960035

NCT03160001

NCT01372930

NCT01394913

NCT06585384

NCT00203359

NCT00099554

NCT02378506

NCT04345458

NCT01729754

NCT03792841

NCT00418548

NCT01875991

NCT03332719

NCT00247962

NCT02722772

NCT01894412

NCT00048373

NCT04066348

NCT02987257

NCT01068353

NCT01657513

NCT00107991

NCT00063869

NCT02656082

NCT01237262

NCT00205231

NCT00201812

NCT00001955

NCT01421069

NCT00454584

NCT01358578

NCT01543204

NCT03182426

NCT01989689

NCT00111956

NCT00116181

NCT01610947

NCT00134368

NCT00523692

NCT00581165

NCT05135312

NCT00913458

NCT02433184

NCT01258738

NCT01053819

NCT00134394

NCT01170715

NCT02164214

NCT00356356

NCT03403140

NCT00844142

NCT02031211

NCT00730392

NCT00094341

NCT00726375

NCT00443430

NCT01764997

NCT01001208

NCT02144857

NCT04079374

NCT01313221

NCT00962741

NCT00789997

NCT03294954

NCT01072058

NCT01235442

NCT00356590

NCT05281614

NCT00678782

NCT03033095

NCT00797784

NCT00245960

NCT01276847

NCT03504072

NCT00418717

NCT04086745

NCT00654368

NCT03636373

NCT00422227

NCT07352566

NCT04485325

NCT00468117

NCT00713544

NCT00791765

NCT04585711

NCT00259610

NCT00413452

NCT00413400

NCT01690299

NCT02638896

NCT01646177

NCT00837434

NCT00317538

NCT00317499

NCT00663052

NCT02308163

NCT00420303

NCT00127842

NCT03100253

NCT00046904

NCT00409318

NCT01294397

NCT01793519

NCT05950724

NCT00420238

NCT02986139

NCT00111436

NCT02115750

NCT00432406

NCT02464033

NCT01936688

NCT02713997

NCT00965666

NCT04610476

NCT05164198

NCT00825344

NCT04973566

NCT00484237

NCT00445770

NCT00135720

NCT00224874

NCT00581100

NCT00434044

NCT02274792

NCT00768053

NCT00005007

NCT00093366

NCT00364572

NCT02376790

NCT00706797

NCT00710580

NCT00509600

NCT00705042

NCT00029328

NCT06011889

NCT00357903

NCT00161655

NCT00111449

NCT00910273

NCT00115219

NCT00298272

NCT00832364

NCT04077957

NCT02092467

NCT01021735

NCT00565409

NCT02749370

NCT00005853

NCT00873730

NCT00443950

NCT00201682

Known as 50mg entanercept(Yisaipu) 50mg entanercept(Yisaipu)NCT02364479
Known as Benepali ClinicalTrials.gov intervention name — accepted as the source's own label NCT03813771
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
71

“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

“This study will investigate the safety and effectiveness of the drug Enbrel (TNFR:Fc) to treat uveitis (eye inflammation) in patients with juvenile rheumatoid arthritis.” NCT00012506

“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

“An Open-Label Study to Assess the Rate of Failure of an Enbrel® (Etanercept) SureClick™ Auto-injector in Subjects With Rheumatoid Arthritis” NCT00346294

“Evaluation of the efficacy and safety of etanercept (Enbrel) in patients with active, severe and advanced ankylosing spondylitis.” NCT00420238

“Etanercept (Enbrel) will be added to help improve the response to standard treatment for graft-versus-host disease (GVHD).” NCT00141713

“This study will determine if the drug etanercept, also called Enbrel, is effective in producing and maintaining remission” NCT00005007

“This study will examine the use of etanercept (also called Enbrel or TNFR:Fc) in patients with Wegener's granulomatosis” NCT00001901

“Two anti-TNFa agents are currently marketed for the treatment of RA; etanercept (Enbrel®) and infliximab (REMICADE®).” NCT00317538

“The purpose of this study is to assess the antibody formation to Enbrel liquid in subjects with Rheumatoid Arthritis” NCT00249041

“The drug, called Enbrel (or etanercept), is a protein that is given twice weekly by injection underneath the skin.” NCT00000433

Enbrel® 50 mg injectable solution in autoinjector SureClick® contains: 50 mg etanercept and excipients” NCT03332719

“Patients receive Etanercept or Enbrel (depending on the group) in the form of subcutaneous injections” NCT04079374

“Treatment of Resistant Langerhans Cell Histiocytosis With Etanercept (ENBREL, IMMUNEX, SEATTLE)” NCT00048373

“Safety and Efficacy Study of Etanercept (Enbrel) on the Response Rate of HIV-infected Subjects” NCT00091741

“etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week” NCT02464033

“Randomized Controlled 12 Months Trial With Etanercept (Enbrel ®) vs. Sulfasalazine” NCT00844142

“etanercept(Enbrel®) 50mgs subcutaneous (SC) injections twice weekly for 20 weeks” NCT00797784

“Study of the Efficacy and Safety of Etanercept (Enbrel) in Adults With Vitiligo” NCT00134368

“The possible TNF inhibitors are: Remicade, Humira, Enbrel, Cimzia, Simponi.” NCT01548768

“a tumour necrosis factor alpha (TNFalpha) inhibitor (etanercept, Enbrel)” PMID 15115710 Apr 2004

“recommended dose of enbrel is 25mg administered twice weekly.” NCT00581165

“Etanercept (Enbrel) in Undifferentiated Spondyloarthritis” NCT01289730

“Etanercept (Enbrel) for Juvenile Myelomonocytic Leukemia” NCT00509600

“Study of TNFR:Fc (Enbrel) in the Treatment of Asthma” NCT00001893

“Etanercept (Enbrel®; 50 mg once per week, s.c.)” NCT04485325

“Part 2 will evaluate etanercept (Enbrel).” NCT00001955

“Adalimumab (Humira) Etanercept (Enbrel)” NCT04985435

“Drug: Etanercept Injection [Enbrel]” NCT05950724

“Drug: Etanercept (Enbrel)” NCT07184853

“Etanercept (Enbrel®)” NCT02779114

Enbrel® (Etanercept)” NCT00789308

“Etanercept (Enbrel)” NCT00965666

Enbrel (etanercept)” NCT00434044

Enbrel (Etanercept)” NCT00135720

“Etanercept (Enbrel)” NCT01894412

Enbrel (etanercept)” NCT01394913

“Etanercept (Enbrel)” NCT07149792

Enbrel (Etanercept)” NCT00444340

“Etanercept (Enbrel)” NCT01431404

“etanercept (Enbrel)” NCT00006070

Enbrel (etanercept)” NCT00502879

“Etanercept (Enbrel)” NCT00524381

EnbrelNCT00410046

NCT01635686

NCT04559412

NCT02112097

NCT00001862

NCT01895309

NCT01865552

NCT01934933

NCT02353780

NCT02357069

NCT00111124

NCT00410046

NCT06596772

NCT01891864

NCT00244556

NCT01725620

NCT00127387

NCT00224393

NCT00421915

NCT02481180

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
2

NCT01709760

NCT02685904

Known as Etanercept(Enbrel) “Etanercept(Enbrel®)” NCT00679042
Known as Etanercept- ENBREL as brand name Etanercept- ENBREL as brand nameNCT01361542
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 2016
17

“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

“We investigated etanercept (ETN) as a therapeutic option for treating moderate-to-severe persistent asthma.” PMID 21109557 Nov 2010

“Etanercept (ETN) with methotrexate (MTX) is better than ETN monotherapy in” PMID 20574649 Jun 2010

“etanercept (ETN) + MTX vs conventional synthetic DMARDs” PMID 24907147 Jun 2014

“treatment with etanercept (ETN) plus methotrexate (MTX)” PMID 34496979 Sep 2021

“intermittent etanercept (ETN) therapy” PMID 25087839 Aug 2014

“two previous etanercept (ETN) trials” PMID 27175292 Apr 2016

“etanercept (ETN) therapy” PMID 18278836 Feb 2008

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 EU Source Enbrel ClinicalTrials.gov intervention name — accepted as the source's own label NCT06392074
Known as GP2015 ClinicalTrials.gov intervention name — accepted as the source's own label NCT02638259
1

NCT01891864

Known as MB04 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06392074
1

NCT06596772

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
5

“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

“The purpose of this study is to determine if TNFR:Fc (a molecule that attaches to TNF) can lower the amount of IL-6 in HIV-positive patients.” NCT00001116

“This study will examine the use of etanercept (also called Enbrel or TNFR:Fc) in patients with Wegener's granulomatosis” NCT00001901

NCT00001893

NCT00012506

Known as US License Enbrel ClinicalTrials.gov intervention name — accepted as the source's own label NCT06392074
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 subcutaneous injection” NCT00001893
Target TNF TNFR:Fc is a modification of a natural substance that binds to TNF-alpha and neutralizes its activity.” NCT00001116