velpatasvir
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Epclusa | — | 2016-07-06 | europa.eu ↗ |
| Approved | US (FDA) | EPCLUSA | — | 2016-06-28 | fda.gov ↗ |
Trials 52 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 8 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03513393 Comparator | Aug → Dec 2018 | hepatitis C virus infection | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT07037277 Comparator | Jun 2025 → Dec 2026 expected | chronic hepatitis C virus infection | Atea Pharmaceuticals, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06868264 Comparator | Apr 2025 → Sep 2026 expected | chronic hepatitis C virus infection | Atea Pharmaceuticals, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02639247 Background | Dec 2015 → Oct 2016 | chronic hepatitis C virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT05467826 Background | Sep 2022 → Nov 2023 | cirrhosis of liver, hepatitis C virus infection | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT06306300 Comparator | Jul 2022 → Dec 2025 | hepatitis C virus infection | Oswaldo Cruz Foundation | Unknown | No outcome recorded |
| Phase 4 | NCT02938013 Background | Jan 2017 → Sep 2019 | HIV infectious disease, hepatitis C virus infection | Johns Hopkins University | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT05248919 Comparator | Jun 2023 → Sep 2027 expected | hepatitis C virus infection | Queen Mary University of London | Enrolling by invitation | No outcome recorded |
Press releases naming this drug 21 releases
| Date | Issuer | Release |
|---|---|---|
| 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 ↗ |
| 2019-12-20 | Gilead Sciences | China National Medical Products Administration Approves Vosevi® (Sofosbuvir, Velpatasvir and Voxilaprevir) for People With Chronic Hepatitis C Infection Who Require Re-Treatment 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 ↗ |
| 2017-07-28 | Gilead Sciences | European Commission Grants Marketing Authorization for Gilead’s Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir) for the Treatment of All Genotypes of Chronic Hepatitis C gilead.com ↗ |
| 2017-07-18 | Gilead Sciences | U.S. Food and Drug Administration Approves Gilead’s Vosevi™ (Sofosbuvir/Velpatasvir/Voxilaprevir) for Re-Treatment of Adults with Chronic Hepatitis C Virus gilead.com ↗ |
| 2017-06-23 | Gilead Sciences | European CHMP Adopts Positive Opinion for Gilead’s Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir) for the Treatment of All Chronic Hepatitis C Genotypes gilead.com ↗ |
| 2017-01-20 | Gilead Sciences | European Medicines Agency Validates Gilead’s Marketing Authorization Application for Investigational Chronic Hepatitis C Therapy Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) gilead.com ↗ |
| 2016-12-08 | Gilead Sciences | Gilead Submits New Drug Application to U.S. Food and Drug Administration for the Investigational Single Tablet Regimen Sofosbuvir/Velpatasvir/Voxilaprevir gilead.com ↗ |
| 2016-10-20 | Gilead Sciences | Gilead Announces SVR12 Rates From Four Phase 3 Studies of a Once-Daily, Fixed-Dose Combination of Sofosbuvir, Velpatasvir and Voxilaprevir in Treatment-Naïve and Treatment-Experienced Genotype 1-6 Chronic HCV-Infected Patients 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 ↗ |
| 2016-01-04 | Gilead Sciences | Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir/Velpatasvir for Treatment of All Genotypes of Chronic Hepatitis C Infection gilead.com ↗ |
| 2015-12-04 | Gilead Sciences | European Medicines Agency Validates Gilead’s Marketing Application for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for the Treatment of Hepatitis C gilead.com ↗ |
| 2015-10-28 | Gilead Sciences | Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for Treatment of All Six Genotypes of Hepatitis C gilead.com ↗ |
| 2015-09-21 | Gilead Sciences | Gilead Announces SVR12 Rates from Four Phase 3 Studies Evaluating a Once-Daily, Fixed-Dose Combination of Sofosbuvir (SOF) and Velpatasvir (VEL) (GS-5816) for the Treatment of All Six Hepatitis C Genotypes gilead.com ↗ |
| 2015-04-23 | Gilead Sciences | Gilead Announces Data for Investigational, All-Oral, Pan-Genotypic Three-Drug Regimen of Sofosbuvir, GS-5816 and GS-9857 for Chronic Hepatitis C gilead.com ↗ |
| 2014-11-11 | Gilead Sciences | Gilead Announces Phase 2 Data for Investigational All-Oral Regimen of Sofosbuvir Plus GS-5816 for the Treatment of Chronic Hepatitis C gilead.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 68 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | velpatasvir | “The primary objective of this study is to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for...” NCT02300103 ↗55“Participants will be treated with the pan-genotypic therapeutic regimen "single-pill daily," at a fixed dose and duration: sofosbuvir/velpatasvir 400/100 mg (Epclusa, Gilead...” NCT06306300 ↗ “Fixed dose combination of sofosbuvir 400 mg plus velpatasvir 100 mg once daily plus ribavirin 1000 mg (body weight \<75 kg) or 1200 mg (body weight =\>75 kg) daily in two divided doses” NCT03483987 ↗ “Patients in each cohort were randomly assigned to 25 mg of velpatasvir once daily with or without ribavirin or 100 mg of velpatasvir once daily with or without ribavirin.” PMID 26551263 ↗ Nov 2015 “At 20 sites, 37 individuals with chronic HCV infection of any genotype and compensated cirrhosis received sofosbuvir-velpatasvir (400 mg/100 mg) daily for 12 weeks.” PMID 35802063 ↗ Aug 2022 “voxilaprevir 100 mg plus sofosbuvir (SOF)/velpatasvir (VEL) (400/100 mg) fixed-dose combination (FDC)on Days 2 and 3 after either a light or moderate-fat meal” NCT02185794 ↗ “We assessed the efficacy and safety of the NS5B polymerase inhibitor sofosbuvir and the NS5A inhibitor velpatasvir for HCV in patients coinfected with HIV-1.” PMID 28369210 ↗ Jul 2017 “Relapse occurred post treatment in a single case of a non-cirrhotic male with genotype 3, who was treated with sofosbuvir/velpatasvir for 6 weeks.” PMID 33082372 ↗ Oct 2020 “a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).” NCT03222531 ↗ “Sofosbuvir With Velpatasvir in Treatment-Naive Noncirrhotic Patients With Genotype 1 to 6 Hepatitis C Virus Infection: A Randomized Trial.” PMID 26551051 ↗ Nov 2015 “Epclusa (Sofosbuvir/Velpatasvir 400mg/100mg) course initiated at same day of visit following a +ve HCV RNA result from the POC test.” NCT05264558 ↗ “In this study, we evaluated the efficacy and safety of sofosbuvir/velpatasvir for 12 weeks in patients from Russia and Sweden.” PMID 30499360 ↗ Nov 2018 “the nucleotide polymerase inhibitor sofosbuvir, the NS5A inhibitor velpatasvir, and the NS3/4A protease inhibitor GS-9857” PMID 27486034 ↗ Jul 2016 “Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection” NCT03074331 ↗ “Patients self-administered a combined sofosbuvir (400 mg) and velpatasvir (100 mg) tablet once daily for 12 weeks.” PMID 30555048 ↗ Dec 2018 “Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC)” NCT04211909 ↗ “treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks” NCT03118843 ↗ “Participants received oral sofosbuvir (400 mg) and velpatasvir (100 mg) once daily for 12 weeks” PMID 29310928 ↗ Jan 2018 “the nucleotide polymerase inhibitor sofosbuvir combined with the NS5A inhibitor velpatasvir.” PMID 28390869 ↗ Apr 2017 “the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor velpatasvir once daily” PMID 26569658 ↗ Nov 2015 “Treatment is: 1 tablet SOF/VEL (400 mg sofosbuvir/100 mg velpatasvir) daily x 12 weeks.” NCT03987503 ↗ “the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor velpatasvir” PMID 26571066 ↗ Nov 2015 “Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection.” PMID 28564569 ↗ Jun 2017 “Sofosbuvir (400mg/day) and Velpatasvir(100mg/day) for 12 weeks or 24 weeks” NCT05248919 ↗ “patients received once daily for 12 weeks either sofosbuvir-velpatasvir” PMID 38644678 ↗ Apr 2024 “Epclusa (sofosbuvir/velpatasvir) + Ribavirin - Genotypes 1-6; GFR\>30” NCT03702218 ↗ “Velpatasvir (VEL) tablet(s) administered orally once daily” NCT01826981 ↗ “sofosbuvir /velpatasvir (SOF/VEL) fixed-dose combination” NCT02781571 ↗ “SOFOSBUVIR/VELPATASVIR (Epclusa, Gilead)” NCT03249194 ↗ “the NS5A inhibitor velpatasvir” PMID 27486033 ↗ Jul 2016 |
| Known as | GS-5816 | “sofosbuvir (SOF)/velpatasvir (VEL; GS-5816) fixed-dose combination (FDC) for 12 weeks” NCT02671500 ↗3“velpatasvir (formerly GS-5816, a second generation NS5A inhibitor)” NCT02745535 ↗ |
| Known as | SOF/VEL | “Sofosbubir/velpatasvir (SOF/VEL) will be administered once daily for 12 weeks to eligible HCV treatment-naïve participants.” NCT03888729 ↗ |
| Known as | sofosbubir/velpatasvir | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03888729 ↗ |
| Known as | sofosbuvir-velpatasvir | “Safety and efficacy of sofosbuvir-velpatasvir to treat chronic hepatitis C virus infection in treatment-naive patients in Rwanda (SHARED-3): a single-arm trial.” PMID 35248213 ↗ Mar 2022 |
| Known as | VEL | “sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1, 2, 3, 4, 5, or 6 hepatitis C virus (HCV) infection.” NCT01858766 ↗12“The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV)” NCT01909804 ↗ “voxilaprevir 100 mg plus sofosbuvir (SOF)/velpatasvir (VEL) (400/100 mg) fixed-dose combination (FDC)on Days 2 and 3 after either a light or moderate-fat meal” NCT02185794 ↗ “Velpatasvir (VEL) is an HCV non-structural protein 5A (NS5A) inhibitor and sofosbuvir (SOF) is an HCV NS5B nucleotide polymerase inhibitor.” NCT03250910 ↗ “In India, four DAAs are available (sofosbuvir [SOF], daclatasvir [DCV], ledipasvir [LDV] and velpatasvir [VEL]).” NCT03483987 ↗ “sofosbuvir (SOF)/velpatasvir (VEL) ± ribavirin (RBV), glecaprevir/pibrentasvir and SOF/VEL/voxilaprevir (VOX)” NCT05467826 ↗ “Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC)” NCT04211909 ↗ “voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC)” NCT02378935 ↗ “sofosbuvir (SOF)/velpatasvir (VEL; GS-5816) fixed-dose combination (FDC) for 12 weeks” NCT02671500 ↗ “Velpatasvir (VEL) tablet(s) administered orally once daily” NCT01826981 ↗ “sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination” NCT02201901 ↗ “the NS5A inhibitor velpatasvir (VEL) 100 mg” NCT03513393 ↗ “sofosbuvir/velpatasvir (SOF/VEL)” NCT06159504 ↗ |
| Known as | Velpatasvir component of epclusa | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545062 ↗ |
| Known as | Velpatasvir component of vosevi | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545062 ↗ |
| Action | Inhibit | “Velpatasvir (VEL, GS-5816) is a novel pan-genotypic hepatitis C virus (HCV) nonstructural protein 5A (NS5A) inhibitor with activity against genotype 1 (GT1) to GT6 HCV replicons.” PMID 27353271 ↗ Aug 2016 |
| Modality | Other / unclassified | “Sofosbuvir-velpatasvir, a pangenotypic direct-acting antiviral regimen” PMID 30946553 ↗ Apr 2019 |
| Route | Oral | “administered orally once daily” NCT01826981 ↗ |