Drugs / CERTOLIZUMAB PEGOL
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (7) | US (FDA) | CIMZIA | — | 2009-05-13 – 2024-09-13 | fda.gov ↗ |
| Approved | EU (EMA) | Cimzia | — | 2009-10-01 | europa.eu ↗ |
| Refused (EMA) | EU (EMA) | Cimzia | — | 2008-05-21 | europa.eu ↗ |
| Approved | US (FDA) | CIMZIA | — | 2008-04-22 | fda.gov ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT01090154 | Dec 2010 → Dec 2021 | ulcerative colitis | University of Washington | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00552344 | May 2008 → Dec 2014 | Crohn disease | UCB BIOSCIENCES, Inc. | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT01696942 | Feb 2013 → Jun 2016 | Crohn disease | Milton S. Hershey Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01548768 | Oct 2011 → Sep 2019 | rheumatoid arthritis | Columbia University | Completed | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 4 | NCT02353780 Comparator | Mar 2015 → Dec 2017 | rheumatoid arthritis | Dr. Larry W. Moreland | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02466581 Comparator | Feb 2015 → Jul 2023 | rheumatoid arthritis | Karolinska Institutet | Unknown | No outcome recorded |
| Phase 4 | NCT01147341 Comparator | Jul 2010 → Jan 2012 | rheumatoid arthritis | Michael Schiff, MD | Completed | No outcome recorded |
Press releases naming this drug 24 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CERTOLIZUMAB PEGOL | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201831 ↗ |
| Known as | CDP 870 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201831 ↗ |
| Known as | Cimzia | “The possible TNF inhibitors are: Remicade, Humira, Enbrel, Cimzia, Simponi.” NCT01548768 ↗ |
| Known as | CZP | “400 mg of Cimzia (CZP) given as two 200 mg subcutaneous (sc) injections at weeks 0, 2, and 4, followed by 1 sc injection at weeks 6, 8, and 10.” NCT01147341 ↗ |
| Known as | PHA-738144 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201831 ↗ |
| Action | Inhibit | “Cimzia (certolizumab pegol), an inhibitor of tumor necrosis factor-alpha” NCT01090154 ↗ |
| Modality | Monoclonal antibody | “a Pegylated Fab' Fragment of a Humanized Anti-TNF-alpha Monoclonal Antibody” NCT00552344 ↗ |
| Route | Subcutaneous | “Route of Administration: Subcutaneous use” NCT00552344 ↗ |
| Target | TNF | “Humanized Anti-TNF-alpha Monoclonal Antibody” NCT00552344 ↗ |