Drugs / Golimumab
Golimumab
also known as
Simponi · CNTO 148 · GOL · GLM · Drug: Golimumab (Simponi) · MK-8259 · Ref-GLM · SCH 900259
Monoclonal antibody targets TNF via inhibition
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | SIMPONI | — | 2013-05-15 – 2025-10-07 | fda.gov ↗ |
| Label expansions (4) | US (FDA) | SIMPONI ARIA | — | 2015-08-05 – 2021-02-01 | fda.gov ↗ |
| Approved | EU (EMA) | Simponi | — | 2009-10-01 | europa.eu ↗ |
| Approved | US (FDA) | SIMPONI | — | 2009-04-24 | fda.gov ↗ |
Trials 84 · started per year
today
US approved 2009
EU approved 2009
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03632759 | Aug 2018 → Nov 2021 | type 1 diabetes mellitus | Carla Greenbaum, MD | Completed | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT03298542 | Oct 2017 → Dec 2020 | type 1 diabetes mellitus | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01900574 | Aug 2013 → Feb 2015 | ulcerative colitis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01258777 | Oct 2010 → Apr 2011 | — | Centocor, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01288157 | Sep 2010 → Jan 2011 | — | Centocor, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01362153 | Dec 2007 → Feb 2009 | rheumatoid arthritis | Centocor, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01526174 | Mar 2012 → Dec 2013 | autoimmune inner ear disease | House Research Institute | Terminated | No outcome recorded |
| Phase 218 trials | ||||||
| Phase 2 | NCT07683026 | Aug 2026 → Sep 2032 expected | type 1 diabetes mellitus | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07138898 | Dec 2025 → Jan 2028 expected | rheumatic disorder | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 2 | NCT05960578 | May 2024 → Jul 2025 overdue | prostate adenocarcinoma | University of Washington | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05242484 | Sep 2022 → May 2025 overdue | ulcerative colitis | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05242471 | Jul 2022 → May 2025 overdue | Crohn disease | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05071664 | Oct 2021 → May 2024 | psoriatic arthritis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT04729296 | Jul 2021 → Jul 2027 | type 1 diabetes mellitus | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Withdrawn | No outcome recorded |
| Phase 2 | NCT04218565 | Feb 2020 → Dec 2022 | Behcet disease, uveitis | Wenjie Zheng | Terminated | No outcome recorded |
| Phase 2 | NCT03662542 | Nov 2018 → Dec 2020 | ulcerative colitis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT03182166 | Nov 2017 → Jun 2021 | ulcerative colitis | University Hospital of Saint-Etienne | Completed | No outcome recorded |
| Phase 2 | NCT02846545 | Aug 2016 → May 2019 | type 1 diabetes mellitus | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01988961 | Dec 2013 → Feb 2015 | ulcerative colitis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01715896 | Mar 2013 → Nov 2014 | rheumatoid arthritis | MedImmune LLC | Completed | No outcome recorded |
| Phase 2 | NCT00955279 | Nov 2009 → May 2012 | sarcoidosis | Centocor, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02456363 | Nov 2009 → Oct 2019 | ankylosing spondylitis | Chung Shan Medical University | Unknown | No outcome recorded |
| Phase 2 | NCT00675649 | May 2008 → ? | asthma | Centocor, Inc. | Withdrawn | No outcome recorded |
| Phase 2 | NCT00207740 | Aug 2004 → Jul 2007 | asthma | Centocor, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00207714 | Nov 2003 → Feb 2005 | rheumatoid arthritis | Centocor, Inc. | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT00488774 | Aug 2007 → May 2009 | ulcerative colitis | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| Phase 2/3 | NCT00487539 | Aug 2007 → Oct 2010 | ulcerative colitis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 330 trials | ||||||
| Phase 3 | NCT05379322 | Mar 2023 | rheumatoid arthritis | Abu Dhabi Stem Cells Center | Withdrawn | 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 | NCT03596645 | Oct 2018 → Nov 2023 overdue | ulcerative colitis | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03270501 | Nov 2017 → Dec 2023 | spondyloarthropathy | University Ghent | Completed | No outcome recorded |
| Phase 3 | NCT04108468 | Oct 2015 → Jul 2023 | psoriatic arthritis | The Leeds Teaching Hospitals NHS Trust | Completed | No outcome recorded |
| Phase 3 | NCT02277444 | Dec 2014 → Jul 2018 | polyarticular juvenile idiopathic arthritis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT02181673 | Sep 2014 → May 2016 | psoriatic arthritis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT02186873 | Sep 2014 → Dec 2015 | ankylosing spondylitis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT02065713 | Aug 2014 → Jun 2017 | psoriatic arthritis | Gulbenkian Institute for Molecular Medicine | Completed | No outcome recorded |
| Phase 3 | NCT01962974 | Oct 2013 → Dec 2014 | rheumatoid arthritis | Janssen Biotech, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT01871649 | Aug 2013 → Nov 2018 | psoriatic arthritis | Academic Medical Center - University of Amsterdam | Completed | No outcome recorded |
| Phase 3 | NCT01863771 | Mar 2013 → Jan 2016 | ulcerative colitis | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 3 | NCT01426815 | Mar 2012 → Mar 2019 | spondyloarthropathy | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 3 | NCT01453725 | Feb 2012 → Mar 2014 | ankylosing spondylitis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT01230827 | Dec 2010 → Sep 2013 | juvenile idiopathic arthritis | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| Phase 3 | NCT01248793 | Oct 2010 → May 2011 | ankylosing spondylitis | Centocor, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01248780 | Sep 2010 → Oct 2011 | rheumatoid arthritis | Centocor, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01004432 | Dec 2009 → Jul 2013 | rheumatoid arthritis | Janssen Biotech, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00975130 | Sep 2009 → Aug 2011 | rheumatoid arthritis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00973479 | Sep 2009 → Mar 2011 | rheumatoid arthritis | Centocor, Inc. | 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 | NCT00771251 | May 2008 → Oct 2011 | rheumatoid arthritis | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 3 | NCT00727987 | May 2008 → Dec 2011 | rheumatoid arthritis | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 3 | NCT00488631 | Sep 2007 → Oct 2011 | ulcerative colitis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT00361335 | Sep 2006 → Dec 2007 | rheumatoid arthritis | Centocor, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00299546 | Feb 2006 → Aug 2007 | rheumatoid arthritis | Centocor, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00264537 | Dec 2005 → Apr 2008 | rheumatoid arthritis | Centocor, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00265083 | Dec 2005 → Mar 2007 | ankylosing spondylitis | Centocor, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00264550 | Dec 2005 → Sep 2007 | rheumatoid arthritis | Centocor, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00265096 | Dec 2005 → May 2007 | psoriatic arthritis | Centocor, Inc. | Completed | No outcome recorded |
| Phase 421 trials | ||||||
| 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 | NCT04156984 | Apr 2021 → Jun 2024 | ulcerative colitis | David Drobne | Completed | No outcome recorded |
| Phase 4 | NCT03733925 | Jan 2019 → Nov 2021 | ankylosing spondylitis, psoriatic arthritis | Johnson & Johnson Private Limited | Completed | No outcome recorded |
| Phase 4 | NCT03669029 | Oct 2018 → Dec 2019 | ulcerative colitis | Hospital de Manises | Unknown | No outcome recorded |
| Phase 4 | NCT03253796 | Nov 2017 → Mar 2021 | spondyloarthropathy | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 4 | NCT03124121 | Sep 2017 → Sep 2019 | ulcerative colitis | Guy's and St Thomas' NHS Foundation Trust | Completed | No outcome recorded |
| Phase 4 | NCT02425865 | Dec 2016 → Oct 2021 | ulcerative colitis | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Completed | No outcome recorded |
| Phase 4 | NCT02687724 | Jun 2016 → Feb 2020 | colitis | University College Dublin | Unknown | No outcome recorded |
| Phase 4 | NCT02714634 | Mar 2016 → Mar 2029 expected | rheumatoid arthritis | University Hospital, Strasbourg, France | Recruiting | No outcome recorded |
| Phase 4 | NCT02412085 | Mar 2015 → Dec 2016 | ulcerative colitis | Istituto Clinico Humanitas | Unknown | No outcome recorded |
| Phase 4 | NCT02318667 | Feb 2015 → Jun 2017 | ulcerative colitis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 4 | NCT02186886 | Jun 2014 → Dec 2015 | ulcerative colitis | Kliniken im Naturpark Altmuehltal | Unknown | No outcome recorded |
| Phase 4 | NCT02092285 | May 2014 → May 2016 | ulcerative colitis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 4 | NCT01668004 | Sep 2012 → Apr 2015 | ankylosing spondylitis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 4 | NCT01604629 | Jul 2012 → Apr 2015 | spondyloarthropathy | Spanish Clinical Pharmacology Society | Completed | No outcome recorded |
| Phase 4 | NCT01602302 | Jun 2012 → Nov 2020 | rheumatoid arthritis | Medical University of Graz | Terminated | No outcome recorded |
| 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 not applicable5 trials | ||||||
| — | NCT05305066 | Feb 2023 → Dec 2028 expected | rheumatoid arthritis | Marie Hudson, MD | Recruiting | No outcome recorded |
| — | NCT04531423 | Oct 2020 → Sep 2022 | major depressive disorder | Shanghai Mental Health Center | Unknown | No outcome recorded |
| — | NCT04378621 | Oct 2020 → Sep 2025 | depressive disorder, rheumatoid arthritis, subjective cognitive decline | Vastra Gotaland Region | Unknown | No outcome recorded |
| — | NCT04156425 | Jul 2020 → Dec 2024 | major depressive disorder | Shanghai Mental Health Center | Unknown | No outcome recorded |
| — | NCT02841176 | Jul 2016 → Sep 2017 | psoriatic arthritis | Imperial College Healthcare NHS Trust | Terminated | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03945903 | — | type 1 diabetes mellitus | Janssen Research & Development, LLC | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 23 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05632211 Comparator | Dec 2022 → Oct 2023 | — | Alvotech Swiss AG | Completed | No outcome recorded |
| Phase 1 | NCT05332730 Comparator | Aug 2022 → Jun 2023 | psoriatic arthritis | Bio-Thera Solutions | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT02862574 Background | Dec 2016 → Jun 2017 | rheumatoid arthritis | Gilead Sciences | Terminated | No outcome recorded |
| Phase 2 | NCT01217814 Comparator | Nov 2010 → Sep 2011 | rheumatoid arthritis | Sanofi | Terminated | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT05669833 Comparator | Jul 2023 → Oct 2026 expected | psoriatic arthritis | University of Pennsylvania | Recruiting | No outcome recorded |
| Phase 3 | NCT05842213 Comparator | Mar 2023 → Mar 2024 | rheumatoid arthritis | Alvotech Swiss AG | Completed | No outcome recorded |
| Phase 3 | NCT05046431 Comparator | May 2021 → Oct 2023 | psoriatic arthritis | Bio-Thera Solutions | Completed | No outcome recorded |
| Phase 3 | NCT02437162 Background | Sep 2015 → Mar 2017 | spondyloarthropathy | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| Phase 3 | NCT02438787 Background | Jul 2015 → Aug 2017 | spondyloarthropathy | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| Phase 3 | NCT03414502 Comparator | Dec 2007 → Mar 2028 expected | rheumatoid arthritis | University of Nebraska | Recruiting | No outcome recorded |
| Phase 411 trials | ||||||
| Phase 4 | NCT05313620 Comparator | Apr 2022 → Dec 2025 overdue | ulcerative colitis, venous thromboembolism | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | Recruiting | No outcome recorded |
| Phase 4 | NCT03885713 Comparator | Sep 2019 → Dec 2024 | Crohn disease, ulcerative colitis | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | Completed | No outcome recorded |
| Phase 4 | NCT03445845 Comparator | Dec 2018 → Sep 2024 | spondyloarthropathy | University Hospital of Saint-Etienne | Completed | No outcome recorded |
| Phase 4 | NCT03100253 Comparator | Mar 2018 → Dec 2021 | rheumatoid arthritis | Mario Negri Institute for Pharmacological Research | Terminated | No outcome recorded |
| Phase 4 | NCT02758782 Comparator | Sep 2016 → Jan 2021 | ankylosing spondylitis | Charite University, Berlin, Germany | Completed | No outcome recorded |
| Phase 4 | NCT02242474 Comparator | Jul 2015 → Oct 2019 | rheumatoid arthritis | CHU de Quebec-Universite Laval | Unknown | No outcome recorded |
| Phase 4 | NCT02155335 Background | Jul 2014 → Oct 2015 | ulcerative colitis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 4 | NCT02236481 Comparator | Jul 2013 → Dec 2017 | rheumatoid arthritis, type 2 diabetes mellitus | Prof. Roberto Giacomelli | Terminated | No outcome recorded |
| Phase 4 | NCT01804166 Background | Mar 2013 → Feb 2020 | hepatosplenic T-cell lymphoma | Janssen Scientific Affairs, LLC | Completed | No outcome recorded |
| Phase 4 | NCT01718951 Comparator | Aug 2012 → Mar 2014 | spondyloarthropathy | Tuen Mun Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01212653 Comparator | Oct 2010 → May 2013 | ankylosing spondylitis | Chinese University of Hong Kong | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT06896305 Background | May 2025 → Apr 2027 expected | Crohn disease, ulcerative colitis | IRCCS Ospedale San Raffaele | Recruiting | No outcome recorded |
| — | NCT01610947 Comparator | May 2012 → Oct 2018 | spondyloarthropathy | University Hospital, Montpellier | Completed | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-01-27 | Teva Branded Pharmaceutical Products R&D, Inc. | Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Applications for AVT05, a Proposed Biosimilar to Simponi® and Simponi Aria® (golimumab) tevapharm.com ↗ |
| 2025-01-27 | Teva Branded Pharmaceutical Products R&D, Inc. | Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Applications for AVT05, a Proposed Biosimilar to Simponi® and Simponi Aria® (golimumab) tevapharm.com ↗ |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 113 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | golimumab | “This is a multicenter, prospective study of dose adjustment of golimumab in patients with ulcerative colitis who will initiate golimumab treatment (naïve to anti-TNF) or after...” NCT03669029 ↗102“This study aimed to show equivalent efficacy, pharmacodynamics, pharmacokinetics (PK), safety, and immunogenicity of biosimilar BAT2506 to reference golimumab (Ref-GLM) in...” PMID 42021476 ↗ Apr 2026 “To be given subcutaneously via a prefilled syringe/autoinjector (etanercept, adalimumab, certolizumab pegol, golimumab) or intravenously via infusion (infliximab) at increasing...” NCT05115903 ↗ “TNF-a inhibitors: Etanercept (Enbrel, Benapali), Infliximab (Remicade, Inflectra, Flixabi), Adalimumab (Humira, Imraldi, AMGEVITA), Certolizumabpegol (Cimzia), Golimumab (Simponi)” NCT04378621 ↗ “An approved stable subcutaneous formulation of one of the following TNF inhibitors may include adalimumab, certolizumab, etanercept, or golimumab.” NCT02862574 ↗ “The treatment effect of golimumab, a human monoclonal antibody against tumor necrosis factor (TNF)-alpha, in severe persistent asthma is unknown.” PMID 19136369 ↗ Jan 2009 “golimumab: 50mg every month in subcutaneous injection, in case of overweight (\>100kg) an inadequate response, 100mg every month is allow” NCT03445845 ↗ “Participants were randomised to anakinra or to a TNFi (i.e., adalimumab, certolizumab pegol, etanercept, infliximab, or golimumab)” PMID 31513665 ↗ Sep 2019 “Patients were randomised to golimumab (50 mg SC monthly)+MTX (n=26) (TNFi arm) or matched placebo+MTX (n=25) (MTX arm).” PMID 30808625 ↗ Feb 2019 “Simponi (Golimumab) is a recombinant human IgG1қ mAb developed as a subcutaneous injection” NCT05842213 ↗ “golimumab if initial failure to the receptor fusion protein, etanercept.” NCT03100253 ↗ “golimumab (monoclonal antibody) 50 mg sc every month” NCT05305066 ↗ “Adalimumab, etanercept, certolizumab, or golimumab” NCT05379322 ↗ “Golimumab (Simponi) combine with use of NSAIDs” NCT02456363 ↗ “Methotrexate or leflunomide + golimumab or” NCT02714634 ↗ “Golimumab: 50 mg / 6 weeks” NCT01604629 ↗ “Golimumab (Simponi®)” NCT02779114 ↗ “Golimumab (Simponi)” NCT07149792 ↗ “Golimumab SQ” NCT05080218 ↗ “Golimumab” NCT00727987 ↗ “Golimumab” NCT02242474 ↗ |
| Known as | CNTO 148 | “An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis” NCT00487539 ↗9“An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis” NCT00488631 ↗ “subcutaneous injections of Golimumab (CNTO 148), 50 or 100 mg, at either 2- or 4- week intervals” NCT00207714 ↗ “Golimumab (CNTO 148); placebo SC injections every 4 wks thru wk 20” NCT00265083 ↗ “golimumab (CNTO 148) in subjects with active rheumatoid arthritis” NCT00299546 ↗ “Biological: CNTO 148 / Golimumab” NCT00675649 ↗ “CNTO 148 (Golimumab)” NCT01230827 ↗ |
| Known as | Drug: Golimumab (Simponi) | “Drug: Golimumab (Simponi)” NCT02456363 ↗ |
| Known as | GLM | “golimumab (GLM) Program of Ulcerative Colitis Utilizing an Investigational Treatment (PURSUIT)-maintenance (-M) and long-term extension (-LTE) studies” PMID 37691729 ↗ Aug 20231“were randomized to either intravenous golimumab (IV GLM) + subcutaneous golimumab (SC GLM) or SC GLM alone.” NCT00975130 ↗ |
| Known as | GOL | “Assess 5-year golimumab (GOL) safety in rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS).” PMID 27803138 ↗ Nov 20165“OBJECTIVE: Evaluate effects of intravenous (IV) golimumab (GOL) on radiographic progression in psoriatic arthritis (PsA).” PMID 30770519 ↗ Feb 2019 “To evaluate the safety and efficacy of intravenous golimumab (GOL) in patients with active ankylosing spondylitis (AS).” PMID 29247154 ↗ Dec 2017 “BACKGROUND: Golimumab (GOL) is registered for moderate to severely active ulcerative colitis (UC).” PMID 29920582 ↗ Jan 2019 “Golimumab （GOL）is a fully-humanized anti-TNF-α monoclonal antibody” NCT04218565 ↗ “Golimumab (GOL) 50mg every 4 weeks” NCT05669833 ↗ |
| Known as | MK-8259 | “This two-part study was to evaluate the effect of golimumab (SCH 900259, MK-8259) in participants with active axial spondyloarthritis (axial SpA).” NCT01453725 ↗ |
| Known as | Ref-GLM | “This study aimed to show equivalent efficacy, pharmacodynamics, pharmacokinetics (PK), safety, and immunogenicity of biosimilar BAT2506 to reference golimumab (Ref-GLM) in...” PMID 42021476 ↗ Apr 2026 |
| Known as | SCH 900259 | “This two-part study was to evaluate the effect of golimumab (SCH 900259, MK-8259) in participants with active axial spondyloarthritis (axial SpA).” NCT01453725 ↗ |
| Known as | Simponi | “This is a randomized (study medication assigned by chance), double-blind (both the physician and subject do not know the assigned study medication) study to assess the safety,...” NCT01258777 ↗11“Personalised Medicine: a Break Through Approach for Early Determination of Anti Tumor Necrosis Factor (TNF) Responders and Non Responders Among Patients With Ulcerative Colitis...” NCT02186886 ↗ “The prefilled syringe with golimumab 50mg (Simponi ®) will be administrated subcutaneously every 4 weeks during a study period of 48 weeks.” NCT01426815 ↗ “assess the safety, tolerability, immune response, pharmacokinetics (what the body does to the drug), of golimumab (Simponi).” NCT01288157 ↗ “Prefilled syringe with golimumab 50mg (Simponi®) administrated subcutaneously, once monthly, for 24 weeks.” NCT02065713 ↗ “The possible TNF inhibitors are: Remicade, Humira, Enbrel, Cimzia, Simponi.” NCT01548768 ↗ “Golimumab (Simponi®)” NCT02779114 ↗ “Golimumab (Simponi)” NCT07149792 ↗ |
| Action | Inhibit | “tumor necrosis factor-alpha blockade” PMID 19136369 ↗ Jan 2009 |
| Modality | Monoclonal antibody | “a human monoclonal antibody” PMID 19136369 ↗ Jan 2009 |
| Route | Subcutaneous | “subcutaneous injections of Golimumab” NCT00207714 ↗ |
| Target | TNF | “against tumor necrosis factor (TNF)-alpha” PMID 19136369 ↗ Jan 2009 |