drugset
Drugs / LDV/SOF
last change Dec 2018 re-read 3 minutes ago

LDV/SOF

also known as ledipasvir/sofosbuvir
Developed for
hepatitis C virus infection
Investigated by
Gilead Sciences

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence 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 has set a target action date” gilead.com ↗

Trials 1

today NCT02350569 · Ph 2
201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT02350569 May 2015 → Mar 2016 hepatitis C virus infection Gilead Sciences Completed No outcome recorded

Press releases naming this drug 12 releases

DateIssuerRelease
2018-12-04 Gilead Sciences China’s National Medical Products Administration Approves Harvoni® (Ledipasvir/Sofosbuvir) for Treatment of Chronic Hepatitis C Virus Genotype 1-6 gilead.com ↗
2018-09-24 Gilead Sciences Gilead Subsidiary to Launch Authorized Generics of Epclusa® (Sofosbuvir/Velpatasvir) and Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C gilead.com ↗
2017-04-21 Gilead Sciences Gilead Announces Scientific Presentations Demonstrating Efficacy of Harvoni® (Ledipasvir/Sofosbuvir) in Special Patient Populations With HCV Infection gilead.com ↗
2014-11-18 Gilead Sciences European Commission Grants Marketing Authorization for Gilead’s Harvoni®▼ (Ledipasvir/Sofosbuvir), the First Single Tablet Regimen to Treat the Majority of Chronic Hepatitis C Patients With Genotype 1 and 4 gilead.com ↗
2014-10-16 Gilead Sciences Health Canada Issues Notice of Compliance for Gilead’s Harvoni™ (Ledipasvir/Sofosbuvir), the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C gilead.com ↗
2014-10-10 Gilead Sciences U.S. Food and Drug Administration Approves Gilead’s Harvoni® (Ledipasvir/Sofosbuvir), the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C gilead.com ↗
2014-09-26 Gilead Sciences European CHMP Adopts Positive Opinion for Gilead’s Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C Infection in Adults gilead.com ↗
2014-09-24 Gilead Sciences 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 ↗
2014-06-15 Gilead Sciences Gilead Announces Phase 3 Data Showing That the Fixed-Dose Combination of Ledipasvir/Sofosbuvir Achieved 100 Percent Sustained Virologic Response (SVR12) Among Patients with Chronic Hepatitis C in Japan gilead.com ↗
2014-04-07 Gilead Sciences Gilead Announces U.S. FDA Priority Review Designation for Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Chronic Hepatitis C Genotype 1 Infection gilead.com ↗
2014-03-27 Gilead Sciences European Medicines Agency Validates Gilead’s Marketing Application for Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Genotype 1 Chronic Hepatitis C Infection gilead.com ↗
2014-02-10 Gilead Sciences Gilead Files for U.S. Approval of Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Genotype 1 Hepatitis C gilead.com ↗

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as LDV/SOF ClinicalTrials.gov intervention name — accepted as the source's own label NCT02350569 ↗
Known as ledipasvir/sofosbuvir “treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) therapy” NCT02350569 ↗
Route Oral “90/400 mg FDC tablet administered orally” NCT02350569 ↗