Certolizumab pegol
As of the edition of 20 October 2026, Certolizumab pegol is an antibody: marketed, first approved in 2008 (US); acts on TNF; US protection ended in 2020.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2012
- Kind
- Antibody
- Brand name
- Cimzia
- First approved
- 22 April 2008 (US)
- Approvals on record
- 7 in 3 regions
- Holder of the most recent approval
- UCB; 3 holders in all
- Registered trials
- 97, 9 stopped early
- Disease areas
- Bones, joints and muscles; Skin and connective tissue; Immune system; Digestive system; Blood and lymph; Inherited and neonatal
US protection
US protection ended in 2020.
US protection ended in 2020, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by UCB. The date is computed, not published.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product1 listing counts towards this date. The exact date and each listing are in the product.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Certolizumab pegol.
Target
| Gene | Protein | UniProt |
|---|---|---|
| TNF | Tumor necrosis factor | P01375 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 13 | 7 | 1 | 1 |
| Phase 1 | 7 | 7 | 0 | 0 |
| Phase 2 | 11 | 10 | 1 | 0 |
| Phase 3 | 55 | 48 | 0 | 6 |
| Phase 4 | 11 | 7 | 0 | 2 |
| All trials | 97 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| UCB | Applicant and Lead sponsor of trials | 2002 to now |