Cetuximab
As of the edition of 20 October 2026, Cetuximab is an antibody: marketed, first approved in 2003 (CH); acts on EGFR; US protection ended in 2016.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2008
- Kind
- Antibody
- Brand name
- Erbitux
- First approved
- 1 December 2003 (CH)
- Approvals on record
- 9 in 4 regions
- Holder of the most recent approval
- Merck & Co.; 6 holders in all
- Registered trials
- 867, 155 stopped early
- Disease areas
- Cancer; Digestive system; Lungs and airways; Hormones; Mouth and teeth; Ear, nose and throat
US protection
US protection ended in 2016.
US protection ended in 2016, 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 Eli Lilly. 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 product2 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 2 listings behind itRequest access. Nothing is shown until you do.
Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Cetuximab.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| EGFR | Epidermal growth factor receptor | P00533 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 40 | 19 | 1 | 13 |
| Phase 1 | 174 | 84 | 50 | 31 |
| Phase 2 | 563 | 282 | 110 | 102 |
| Phase 3 | 83 | 39 | 22 | 7 |
| Phase 4 | 7 | 0 | 3 | 2 |
| All trials | 867 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Eli Lilly | Applicant, Earlier holder and Lead sponsor of trials | 2000 to now |
| Merck KGaA | Applicant, Later holder and Lead sponsor of trials | 2004 to now |
| Merck & Co. | Applicant and Lead sponsor of trials | 2007 to now |