Fluorouracil
As of the edition of 20 October 2026, Fluorouracil is a small molecule: marketed, first approved in 1971 (CH); acts on TYMS.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2018
- Kind
- Small molecule
- Brand name
- Efudex
- First approved
- 16 July 1971 (CH)
- Approvals on record
- 25 in 6 regions
- Holder of the most recent approval
- Avyxa; 15 holders in all
- Registered trials
- 1,707, 251 stopped early
- Disease areas
- Cancer; Digestive system; Hormones; Skin and connective tissue; Urinary and reproductive; Mouth and teeth
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
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 Fluorouracil.
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 |
|---|---|---|
| TYMS | Thymidylate synthase | P04818 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 79 | 30 | 18 | 7 |
| Phase 1 | 250 | 150 | 56 | 30 |
| Phase 2 | 924 | 424 | 185 | 176 |
| Phase 3 | 425 | 219 | 88 | 37 |
| Phase 4 | 29 | 13 | 9 | 1 |
| All trials | 1,707 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bausch Health | Acquired holder | 1975 to now |
| Almirall | Applicant and Lead sponsor of trials | 1980 to now |
| Pfizer | Later holder and Lead sponsor of trials | 1999 to now |
| Roche | Later holder and Lead sponsor of trials | 2004 to now |
| Elorac | Acquired holder | 2009 to now |
| Cipher Pharmaceuticals | Later holder | 2014 to now |
| AbbVie | Later holder and Lead sponsor of trials | 2014 to now |
| Hill Dermaceuticals | Later holder | 2015 to now |
| Zydus Worldwide DMCC | Acquired holder | 2016 to now |
| Chartwell Rx Sciences | Acquired holder | 2022 to now |
| Extrovis | Acquired holder | 2024 to now |
| Avyxa | Later holder | 2026 to now |
| Kyowa Kirin | Applicant |