Drugs / Ledipasvir/Sofosbuvir
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | chronic hepatitis C virus infection | 2014-09-15 | “The FDA and the European Medicines Agency are currently reviewing the company’s applications for a single tablet regimen of ledipasvir/sofosbuvir” gilead.com ↗ |
| Filed | US (FDA) | — | chronic hepatitis C virus infection | 2014-09-15 | “The FDA and the European Medicines Agency are currently reviewing the company’s applications for a single tablet regimen of ledipasvir/sofosbuvir” gilead.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT02868242 | Aug 2016 → Nov 2018 | hepatitis C virus infection | Gilead Sciences | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2014-09-24 | Gilead Sciences | Regulatory Gilead Submits New Drug Application to Japan’s Pharmaceutical and Medical Devices Agency for Fixed-Dose Combination of Ledipasvir/Sofosbuvir for Chronic Hepatitis C Genotype 1 Infection gilead.com ↗ |
| 2014-04-10 | Gilead Sciences | Results Gilead Announces Phase 2 Results for Two Investigational All-Oral Sofosbuvir-Based Regimens for the Treatment of Chronic Hepatitis C gilead.com ↗
Among genotype 1-infected patients who had failed prior treatment with SOF plus RBV, 100 percent (19/19) achieved SVR12 following 12 weeks of LDV/SOF plus RBV. |
All press releases naming this drug 13 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ledipasvir-sofosbuvir | “A Phase 2, Open-label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in...” NCT02868242 ↗1“We evaluated the safety and efficacy of ledipasvir-sofosbuvir for 12weeks in these patients.” PMID 35149641 ↗ Feb 2022 |
| Route | Oral | “Tablet(s) administered orally once daily” NCT02868242 ↗ |