Capecitabine
As of the edition of 20 October 2026, Capecitabine is a small molecule: marketed, first approved in 1998 (US); acts on TYMS; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Small molecule
- Brand name
- Xeloda
- First approved
- 30 April 1998 (US)
- Approvals on record
- 10 in 5 regions
- Holder of the most recent approval
- BIOPAS BRASIL PRODUTOS FARMACEUTICOS LTDA; 4 holders in all
- Withdrawn from market
- 21 June 2021 (in some regions)
- Registered trials
- 1,652, 257 stopped early
- Disease areas
- Cancer; Digestive system; Skin and connective tissue; Hormones; Mouth and teeth; Urinary and reproductive
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
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 Capecitabine.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| TYMS | Thymidylate synthase | P04818 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 85 | 29 | 18 | 9 |
| Phase 1 | 212 | 140 | 26 | 30 |
| Phase 2 | 1,003 | 375 | 256 | 184 |
| Phase 3 | 326 | 109 | 103 | 31 |
| Phase 4 | 26 | 13 | 5 | 3 |
| All trials | 1,652 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Roche | Originator, Applicant and Lead sponsor of trials | 1998 to now |
| Cheplapharm Arzneimittel | Acquired holder | 2023 to now |