Trifluridine
As of the edition of 20 October 2026, Trifluridine is a small molecule: marketed, first approved in 1982 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2016
- Kind
- Small molecule
- Brand name
- Viroptic
- First approved
- 1 January 1982 (US)
- Approvals on record
- 9 in 5 regions
- Holder of the most recent approval
- Servier; 6 holders in all
- Registered trials
- 100, 10 stopped early
- Disease areas
- Cancer; Digestive system; Hormones; Skin and connective tissue; Urinary and reproductive; Blood and lymph
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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 11 | 9 | 2 | 0 |
| Phase 1 | 18 | 10 | 5 | 3 |
| Phase 2 | 60 | 12 | 34 | 6 |
| Phase 3 | 11 | 3 | 7 | 1 |
| All trials | 100 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bausch Health | Applicant | 1987 to now |
| Taiho | Applicant and Lead sponsor of trials | 2013 to now |
| Servier | Applicant and Lead sponsor of trials | 2016 to now |
| Pfizer | Acquired holder | 2017 to now |
| GSK | Earlier holder |