Drugs / SOF/VEL
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | chronic hepatitis C virus infection | 2015-10-28 | “Gilead filed the NDA for SOF/VEL on October 28, 2015” gilead.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT02202980 | Aug 2014 → Mar 2016 | chronic hepatitis C virus infection | Gilead Sciences | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2025-04-29 | Gilead Sciences | Results Gilead to Present Latest Advancements Across Primary Biliary Cholangitis and Viral Hepatitis gilead.com ↗
Final results show 98.9% SVR in 7,000 patients treated with SOF/VEL in Asia, Latin America, Middle East, Nordics, and Southern Europe |
| 2016-04-16 | Gilead Sciences | Results Gilead Announces Multiple Scientific Presentations Demonstrating Broad Utility of Sofosbuvir-Based Hepatitis C Therapies gilead.com ↗ |
All press releases naming this drug 3 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SOF/VEL | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02202980 ↗ |
| Action | Inhibit | “the NS5A inhibitor velpatasvir” PMID 27240903 ↗ May 2016 |
| Route | Oral | “400/100 mg FDC tablet administered orally once daily” NCT02202980 ↗ |