golimumab
Trade name: simponi
Approved
Apr 24, 2009
Golimumab, sold under the brand name Simponi, is a human monoclonal antibody which is used as an immunosuppressive medication. Golimumab targets tumor necrosis factor alpha (TNF-alpha), a pro-inflammatory molecule and hence is a TNF inhibitor. Profound reduction in C-reactive protein (CRP) levels, interleukin (IL)-6, intercellular adhesion molecules (ICAM)-1, matrix metalloproteinase (MMP)-3, and vascular endothelial growth factor (VEGF) demonstrates golimumab as an effective modulator of inflammatory markers and bone metabolism. Golimumab is given via subcutaneous injection. — Wikipedia
Clinical trial activity
99 trials · 67 clinical orgs · 1 marketing orgs
Earliest trial started Nov 1, 2003 (NCT00207714)
Timeline
2000s
- Jan 1, 2003
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2005
Earliest Phase 3 Sponsor(trial)
- Jan 1, 2007
Earliest Phase 1 Sponsor(trial)
- Apr 24, 2009
Johnson and Johnson — Earliest FDA Approval
- Apr 24, 2009
Johnson and Johnson — Marketing Organization
- Apr 24, 2009
Johnson and Johnson — NDA Organization
Indications
Approved for
Studied for
- Arthritis · Phase 3
- Arthritis, Juvenile · Phase 3
- Asthma · Phase 2
- Autoimmune Diseases · Phase 3
- Axial Spondyloarthritis · Phase 4
- Behcet Syndrome · Phase 2
- Colitis · Phase 4
- Crohn Disease · Phase 4
- Diabetes Mellitus, Type 1 · Phase 2
- Drug Combinations · Phase 4
- Fibrosis · Phase 3
- Healthy Volunteers · Phase 1
- Inflammatory Bowel Diseases · Phase 4
- Lymphoma, T-Cell · Phase 4
- Methotrexate · Phase 4
- Prostatic Neoplasms · Phase 2
- Prostatic Neoplasms, Castration-Resistant · Phase 2
- Rheumatic Diseases · Phase 2
- Sarcoidosis · Phase 2
- Spondylarthropathies · Phase 4
- Substance Withdrawal Syndrome · Phase 3
- Thromboembolism · Phase 4
- Uveitis · Phase 2
Mechanism of action
- TNF-alphaINHIBITOR
TNF inhibitor
Approval history
- approvedApr 24, 2009
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaGolimumab ↗
- NCATS91X1KLU43E ↗
- ChEMBLCHEMBL1201833 ↗
Also known as
- cnto148
- cnto 148
- cnto 148
- cnto-148
- cnto-148
- golimumab
- golimumab
- golimumab
- golimumab
- golimumab
- golimumab
- golimumab
- golimumab
- golimumab
- golimumab
- simponi
- simponi
- simponi
- simponi
- simponi
- symponi
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07138898 | Phase 2 | Sep 30, 2025 | New York University |
| NCT05960578 | Phase 2 | Jan 7, 2024 | Janssen Pharmaceutica NV, University of Washington |
| NCT05669833 | Phase 3 | Jul 14, 2023 | Janssen Pharmaceutica NV, University of Pennsylvania |
| NCT05842213 | Phase 3 | Mar 30, 2023 | Alvotech |
| NCT05632211 | Phase 1 | Nov 21, 2022 | Alvotech, IQVIA, New Zealand Clinical Research |
| NCT05242484 | Phase 2 | Sep 19, 2022 | — |
| NCT05242471 | Phase 2 | Jul 22, 2022 | — |
| NCT05332730 | Phase 1 | May 22, 2022 | Biothera, Jinlin University |
| NCT05313620 | Phase 4 | Apr 1, 2022 | Universidad Autonoma de Madrid |
| NCT05164198 | Phase 4 | Jan 15, 2022 | Hanyang University, Linical Co., Ltd. |
| NCT05115903 | Phase 4 | Nov 1, 2021 | University of Toronto |
| NCT05071664 | Phase 2 | Oct 25, 2021 | Janssen Pharmaceutica NV |
| NCT04729296 | Phase 2 | Jul 1, 2021 | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Type 1 Diabetes TrialNet, University of South Florida |
| NCT05046431 | Phase 3 | May 6, 2021 | Biothera |
| NCT04610476 | Phase 3 | Oct 31, 2020 | University of Erlangen-Nuremberg |
| NCT04531423 | N/A | Oct 1, 2020 | Jiao Tong University |
| NCT04435288 | Phase 3 | Jul 1, 2020 | Ghent University, Merck, Universitair Ziekenhuis Gent |
| NCT04218565 | Phase 2 | Jan 15, 2020 | Chinese Academy of Medical Sciences |
| NCT04156984 | Phase 4 | Nov 30, 2019 | University of Ljubljana |
| NCT04152759 | Phase 1 | Sep 9, 2019 | Biothera |
Organizations
Research & Development (67)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Johnson and Johnson | For profit | 23 | 22 | 5 | 2007 |
| Merck | For profit | 18 | 7 | 4 | 2007 |
| Centocor | For profit | 16 | 16 | 3 | 2003 |
| Janssen Pharmaceutica NV | For profit | 11 | 2 | 3 | 2008 |
| Schering-Plough | For profit | 9 | 0 | 1 | 2005 |
| Biothera | For profit | 3 | 3 | 2 | 2019 |
| Ghent University | Academic/Hospital | 3 | 3 | 1 | 2012 |
| Alvotech | For profit | 2 | 2 | 2 | 2022 |
| Mitsubishi Tanabe | For profit | 2 | 0 | 1 | 2008 |
| Universidad Autonoma de Madrid | Academic/Hospital | 2 | 2 | 1 | 2019 |
| University of Erlangen-Nuremberg | Academic/Hospital | 2 | 2 | 1 | 2009 |
| University of Leeds | Academic/Hospital | 2 | 2 | 2 | 2011 |
| University of London | Academic/Hospital | 2 | 2 | 2 | 2016 |
| University of Lyon | Academic/Hospital | 2 | 2 | 2 | 2017 |
| Assistance Publique - Hôpitaux de Paris | Academic/Hospital | 1 | 1 | 1 | 2007 |
| Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte | Academic/Hospital | 1 | 0 | 1 | 2017 |
| Bristol-Myers Squibb | For profit | 1 | 0 | 1 | 2015 |
| Chinese Academy of Medical Sciences | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Chinese University of Hong Kong | Academic/Hospital | 1 | 1 | 1 | 2010 |
| Genentech | For profit | 1 | 0 | 1 | 2015 |
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Johnson and Johnson | For profit | MKTG | Apr 24, 2009 |
| Johnson and Johnson | For profit | SYN | Jul 18, 2013 |
| Johnson and Johnson | For profit | NDA | Apr 24, 2009 |