Drugs / Epclusa

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Epclusa — 2016-07-06 europa.eu ↗
Approved US (FDA) EPCLUSA — 2016-06-28 fda.gov ↗

Trials 9

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT03377478 Jul 2019 → Sep 2021 hepatitis C virus infection Pablo Sanchez Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT03724149 Dec 2018 → Dec 2021 lung disorder University of Pennsylvania Completed No outcome recorded
Phase 22 trials
Phase 2 NCT04075916 Jun 2021 → Jul 2025 end stage renal failure University of Pennsylvania Completed No outcome recorded
Phase 2 NCT03383419 Mar 2018 → Dec 2026 expected heart failure Baylor Research Institute Recruiting No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT02825212 Feb 2016 → Jul 2019 chronic hepatitis C virus infection, cryoglobulinemia Icahn School of Medicine at Mount Sinai Completed No outcome recorded
Phase 44 trials
Phase 4 NCT07098481 Sep 2025 → Dec 2027 expected hepatitis C virus infection ANRS, Emerging Infectious Diseases Not yet recruiting No outcome recorded
Phase 4 NCT03625687 Feb 2019 → Apr 2022 hepatitis C virus infection, respiratory failure Massachusetts General Hospital Terminated No outcome recorded Stop: Business
Phase 4 NCT03549312 Feb 2018 → Jul 2020 HIV infectious disease, chronic hepatitis C virus infection, coinfection, metabolic bone disorder +1 Saskatchewan Health Authority - Regina Area Unknown No outcome recorded
Phase 4 NCT03207399 Sep 2017 → Mar 2019 chronic hepatitis C virus infection Duke University Terminated No outcome recorded Stop: Enrollment

Press releases naming this drug 9 releases

DateIssuerRelease
2021-06-10 Gilead Sciences U.S. Food and Drug Administration Approves New Formulation of Epclusa®, Expanding Pediatric Indication to Treat Children Ages 3 and Older With Chronic Hepatitis C gilead.com ↗
2020-03-19 Gilead Sciences U.S. Food And Drug Administration Approves Epclusa® (Sofosbuvir/Velpatasvir) for Children Ages 6 and Older or Weighing at Least 17 kg with Chronic Hepatitis C Infection gilead.com ↗
2019-01-08 Gilead Sciences Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) 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 ↗
2018-05-30 Gilead Sciences China Drug Administration Approves Epclusa® (Sofosbuvir/Velpatasvir), Gilead’s Pan-Genotypic Treatment for Chronic Hepatitis C Virus Infection gilead.com ↗
2017-08-01 Gilead Sciences U.S. FDA Approves Expanded Labeling for Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of Chronic Hepatitis C in Patients Co-Infected with HIV gilead.com ↗
2016-07-08 Gilead Sciences European Commission Grants Marketing Authorization for Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C gilead.com ↗
2016-06-28 Gilead Sciences U.S. Food and Drug Administration Approves Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C gilead.com ↗
2016-05-27 Gilead Sciences European CHMP Adopts Positive Opinion for Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C gilead.com ↗

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 9 sources stand behind the page.

FieldValueCited text
Known as Epclusa ClinicalTrials.gov intervention name — accepted as the source's own label NCT04075916 ↗
8

NCT03207399 ↗

NCT02825212 ↗

NCT03625687 ↗

NCT07098481 ↗

NCT03549312 ↗

NCT03724149 ↗

NCT03383419 ↗

NCT03377478 ↗

Route Oral “Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food.” NCT03207399 ↗