drugset
Drugs / Ledipasvir/Sofosbuvir
last change Feb 2020 re-read 3 minutes ago

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 Japan (PMDA) — chronic hepatitis C virus infection 2014-09-24

“Gilead filed a New Drug Application (NDA) in Japan for a single-tablet regimen of sofosbuvir and the NS5A inhibitor ledipasvir” gilead.com ↗

Trials 1

today NCT01924949 · Ph 2
20142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT01924949 Jul 2013 → May 2014 hepatitis C virus infection Gilead Sciences Completed No outcome recorded

News releases announcing trial results or a regulatory action · 6

DateIssuerRelease
2020-02-04 Gilead Sciences Regulatory Gilead Sciences Announces Fourth Quarter and Full Year 2019 Financial Results gilead.com ↗
Approval of Vosevi ® (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) by the China National Medical Products Administration
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 ↗
Sofosbuvir/velpatasvir for 12 weeks is safe and effective in patients undergoing dialysis (late-breaking poster #LB-15)
2018-05-15 Gilead Sciences Regulatory U.S. Food and Drug Administration Approves Expanded Indication for Truvada® (Emtricitabine and Tenofovir Disoproxil Fumarate) for Reducing the Risk of Acquiring HIV-1 in Adolescents gilead.com ↗
Truvada for PrEP is now indicated in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing at least 35 kg.
2017-07-28 Gilead Sciences Regulatory European Commission Grants Marketing Authorization for Gilead’s Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir) for the Treatment of All Genotypes of Chronic Hepatitis C gilead.com ↗
European Commission Also Extends Marketing Authorization for Harvoni ® (sofosbuvir/ledipasvir), Enabling First Direct-Acting Antiviral Regimen for Adolescent Hepatitis C Patients
2015-11-12 Gilead Sciences Regulatory U.S. FDA Approves New Indications for Harvoni®, Gilead’s Once-Daily Single Tablet Regimen for Chronic Hepatitis C gilead.com ↗
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 ↗

All press releases naming this drug 17 releases

DateIssuerRelease

Evidence & citations 2 cited values

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

FieldValueCited text
Known as Ledipasvir/Sofosbuvir “Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Nosocomial Genotype 1 HCV Infection” NCT01924949 ↗
Route Oral “administered orally” NCT01924949 ↗