Velpatasvir
As of the edition of 20 October 2026, Velpatasvir is a small molecule: marketed, first approved in 2016 (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 2019
- Kind
- Small molecule
- Brand name
- Epclusa
- First approved
- 28 June 2016 (US)
- Approvals on record
- 10 in 3 regions
- Holder of the most recent approval
- Gilead Sciences; 4 holders in all
- Registered trials
- 90, 4 stopped early
- Disease areas
- Digestive system; Infections; Chemically induced; Immune system; Urinary and reproductive; Mental health
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 | 12 | 3 | 1 | 1 |
| Phase 1 | 7 | 5 | 2 | 0 |
| Phase 2 | 25 | 23 | 2 | 0 |
| Phase 3 | 19 | 18 | 0 | 0 |
| Phase 4 | 27 | 11 | 5 | 3 |
| All trials | 90 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Gilead Sciences | Applicant and Lead sponsor of trials | 2012 to now |