Drugs / Ledipasvir/Sofosbuvir
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | acute hepatitis C virus infection | 2014-02-10 | “Gilead filed the NDA for LDV/SOF on February 10, 2014 , and the FDA has set a target action date” gilead.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT02413593 | Apr → Dec 2015 | hepatitis C virus infection | Gilead Sciences | Completed | Met primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2018-10-11 | Gilead Sciences | Results Gilead to Present Wide-Ranging New Data on Treatment and Diagnosis of Liver Diseases at The Liver Meeting® 2018 gilead.com ↗
Ledipasvir/sofosbuvir for 12 weeks is safe and effective in children 3 to |
All press releases naming this drug 13 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ledipasvir/Sofosbuvir | “Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naive Adults With Chronic HCV Genotype 3 Infection” NCT02413593 ↗ |
| Known as | LDV/SOF | “Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naive Adults With Chronic HCV Genotype 3 Infection” NCT02413593 ↗ |
| Route | Oral | “90/400 mg FDC tablet administered orally once daily” NCT02413593 ↗ |