Drug Type Monoclonal antibody |
Synonyms Anti-TNF-alpha monoclonal antibody, Golimumab (Genetical Recombination), Golimumab (genetical recombination) (JAN) + [14] |
Target |
Action inhibitors |
Mechanism TNF-α inhibitors(Tumor necrosis factor α inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (24 Apr 2009), |
RegulationOrphan Drug (United States) |








| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Axial Spondyloarthritis | European Union | 01 Oct 2009 | |
| Axial Spondyloarthritis | Iceland | 01 Oct 2009 | |
| Axial Spondyloarthritis | Liechtenstein | 01 Oct 2009 | |
| Axial Spondyloarthritis | Norway | 01 Oct 2009 | |
| Colitis, Ulcerative | European Union | 01 Oct 2009 | |
| Colitis, Ulcerative | Iceland | 01 Oct 2009 | |
| Colitis, Ulcerative | Liechtenstein | 01 Oct 2009 | |
| Colitis, Ulcerative | Norway | 01 Oct 2009 | |
| Juvenile Idiopathic Arthritis | European Union | 01 Oct 2009 | |
| Juvenile Idiopathic Arthritis | Iceland | 01 Oct 2009 | |
| Juvenile Idiopathic Arthritis | Liechtenstein | 01 Oct 2009 | |
| Juvenile Idiopathic Arthritis | Norway | 01 Oct 2009 | |
| Non-radiographic axial spondyloarthritis | European Union | 01 Oct 2009 | |
| Non-radiographic axial spondyloarthritis | Iceland | 01 Oct 2009 | |
| Non-radiographic axial spondyloarthritis | Liechtenstein | 01 Oct 2009 | |
| Non-radiographic axial spondyloarthritis | Norway | 01 Oct 2009 | |
| Polyarticular Juvenile Idiopathic Arthritis | European Union | 01 Oct 2009 | |
| Polyarticular Juvenile Idiopathic Arthritis | Iceland | 01 Oct 2009 | |
| Polyarticular Juvenile Idiopathic Arthritis | Liechtenstein | 01 Oct 2009 | |
| Polyarticular Juvenile Idiopathic Arthritis | Norway | 01 Oct 2009 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Inflammation | Phase 3 | Belgium | 08 Nov 2017 | |
| Salivary Gland Adenoma, Pleomorphic | Phase 3 | United Kingdom | 27 Oct 2015 | |
| Enthesitis | Phase 3 | Portugal | 01 Aug 2014 | |
| Spondylarthritis | Phase 3 | Belgium | 13 Mar 2012 | |
| Spondylarthropathies | Phase 3 | Belgium | 14 Sep 2011 | |
| Polyarthritis | Phase 3 | United States | 01 Dec 2010 | |
| Polyarthritis | Phase 3 | United States | 01 Dec 2010 | |
| Polyarthritis | Phase 3 | Austria | 01 Dec 2010 | |
| Polyarthritis | Phase 3 | Austria | 01 Dec 2010 | |
| Polyarthritis | Phase 3 | Belgium | 01 Dec 2010 |
Phase 3 | 69 | kwsaxuyobt(ncafwrczbv) = opvcbsftwo mfnzqldzan (jtgziklkys ) View more | Positive | 08 Jan 2026 | |||
Phase 3 | 84 | (Methotrexate) | ixgsveaqnr(ameygyfxhf) = lflgxyidus icqzmlvcyf (uubswqqynw, 1.32) View more | - | 02 Dec 2025 | ||
(Golimumab & Methotrexate) | ixgsveaqnr(ameygyfxhf) = hhtruszfcf icqzmlvcyf (uubswqqynw, 1.38) View more | ||||||
Phase 3 | 84 | (Group 1: Golimumab) | towweylbtp = idpttnpjgq rqeihlglnf (fxpihlhtjr, dmetucanio - uzmkwzpjyh) View more | - | 14 Nov 2025 | ||
(Group 2: Infliximab) | ftarvkabry(nichwkyeza) = efupthssqf pdzvdsbfet (dyembvwszh, ilhoohxphr - qjackmbwtx) View more | ||||||
Not Applicable | 215 | High adherence to golimumab treatment | modrjfqdxx(qkoklzgfvd) = pzrifkifcg wabfwbqdno (bilwafnesa ) View more | Negative | 01 Jun 2025 | ||
Low adherence to golimumab treatment | modrjfqdxx(qkoklzgfvd) = jclyaujsoh wabfwbqdno (bilwafnesa ) View more | ||||||
Phase 3 | 64 | gsromobcdj = awibxfleja ghjulwwlxn (smemxwgwag, ywntxttnhi - aflirbzpow) View more | - | 11 Feb 2025 | |||
| - | 502 | ghutjatnpq(evhvyhbbar) = Clinical results have reached the endpoint prfpwmvwhk (ujvqncyhnh ) | Similar | 24 Apr 2024 | |||
Phase 3 | 127 | qlgcvwlocl(ohihtvavhs) = AEs and SAEs were reported in 92.1% and 19.7% of pts, respectively. One death (septic shock) occurred. icefwlpttu (dxavvofzop ) | Positive | 12 Nov 2023 | |||
Placebo | |||||||
Phase 3 | Ulcerative colitis, active severe Maintenance | 1,228 | brwvizyzez(rsnzinilwt) = nsrdgsmagy bouvuznhba (tkkmxulgxg ) | Positive | 01 Jul 2023 | ||
brwvizyzez(rsnzinilwt) = slvnyadhem bouvuznhba (tkkmxulgxg ) | |||||||
Not Applicable | 227 | Certolizumab | znxomghydf(tjfwleegjc): hazard ratio = 1.58 (95% CI, 0.96 - 2.6), P-Value = 0.069 | Negative | 31 May 2023 | ||
Phase 4 | 1,270 | kdcxxnoqei(fzvnsadpip) = ohzdoeetzi lguslochgp (owwfantrfg ) View more | - | 23 Feb 2023 | |||
kdcxxnoqei(fzvnsadpip) = jjisnnekoj lguslochgp (owwfantrfg ) View more |






