Drugs / LDV/SOF
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 | 2014-02-10 | “Gilead filed the NDA for LDV/SOF on February 10, 2014 , and the FDA” gilead.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT01726517 | Oct 2012 → Jul 2013 | chronic hepatitis C virus infection | Gilead Sciences | Completed | No outcome recorded |
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 | LDV/SOF | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01726517 ↗ |
| Action | Inhibit | “the nucleotide polymerase inhibitor sofosbuvir (400 mg) and the HCV NS5A inhibitor ledipasvir (90 mg)” PMID 24209977 ↗ Nov 2013 |
| Route | Oral | “LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily” NCT01726517 ↗ |