Drugs / Voxilaprevir
Voxilaprevir
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | VOSEVI | — | 2017-07-18 | fda.gov ↗ |
Trials 14
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT02402452 | May → Sep 2015 | hepatitis C virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 1 | NCT02397707 | Mar 2015 → Mar 2016 | hepatitis C virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 1 | NCT02185794 | Jun → Dec 2014 | hepatitis C virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT02745535 | May 2016 → Oct 2018 | chronic hepatitis C virus infection | University of Maryland, Baltimore | Completed | No outcome recorded |
| Phase 2 | NCT02378935 | Feb 2015 → Feb 2016 | chronic hepatitis C virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 35 trials · 2 met primary | ||||||
| Phase 3 | NCT04211909 | Jan → Nov 2020 | chronic hepatitis C virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT03118843 | Apr 2017 → Mar 2018 | hepatitis C virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT02639247 | Dec 2015 → Oct 2016 | chronic hepatitis C virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT02639338 | Dec 2015 → Oct 2016 | chronic hepatitis C virus infection | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT02607735 | Nov 2015 → Oct 2016 | hepatitis C virus infection | Gilead Sciences | Completed | Met primary |
| Phase 44 trials · 1 met primary | ||||||
| Phase 4 | NCT05717400 | Mar 2023 → Aug 2024 | hepatocellular carcinoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 4 | NCT05467826 | Sep 2022 → Nov 2023 | cirrhosis of liver, hepatitis C virus infection | Peking University People's Hospital | Unknown | Met primary |
| Phase 4 | NCT04695769 | Nov 2020 → Oct 2021 | chronic hepatitis C virus infection | Helwan University | Completed | No outcome recorded |
| Phase 4 | NCT02938013 | Jan 2017 → Sep 2019 | HIV infectious disease, hepatitis C virus infection | Johns Hopkins University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2019-12-20 | Gilead Sciences | Regulatory China National Medical Products Administration Approves Vosevi® (Sofosbuvir, Velpatasvir and Voxilaprevir) for People With Chronic Hepatitis C Infection Who Require Re-Treatment gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the China National Medical Products Administration (NMPA) has approved Vosevi ® (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg), a once-daily single-tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection in adults without cirrhosis or with compensated cirrhosis who have failed prior treatment with a direct-acting antiviral (DAA) therapy. |
| 2017-10-20 | Gilead Sciences | Results Gilead Announces Multiple Scientific Presentations Demonstrating High Cure Rates in Difficult-to-Cure HCV Patients and Improved Long-Term Bone and Renal Safety of Vemlidy® in HBV Patients Switched from Viread® gilead.com ↗
Positive results from studies of Harvoni ® (ledipasvir 90mg/sofosbuvir 400mg) in HCV-infected patients with severe renal impairment |
| 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 |
| 2017-07-18 | Gilead Sciences | Regulatory 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 ↗ |
| 2015-04-23 | Gilead Sciences | Results 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 ↗
Data from a three-day monotherapy study also demonstrated that GS-9857 was well-tolerated and achieved median HCV RNA reductions of more than 3 log10 IU/mL for HCV patients with genotypes 1, 2, 3 and 4 at the 100 mg dose (ePoster #P0901). |
All press releases naming this drug 9 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | voxilaprevir | “This primary objectives of the study are to evaluate the safety, tolerability, and efficacy of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination...” NCT02378935 ↗12“treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks” NCT03118843 ↗ “the pangenotypic NS3/4A protease inhibitor voxilaprevir (sofosbuvir-velpatasvir-voxilaprevir).” PMID 28390869 ↗ Apr 2017 “Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection.” PMID 28564569 ↗ Jun 2017 “and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC” NCT04211909 ↗ |
| Known as | GS-9857 | “voxilaprevir (formerly GS-9857, an approved NS3/4A protease inhibitor)” NCT02745535 ↗ |
| Known as | VOX | “This primary objectives of the study are to evaluate the safety, tolerability, and efficacy of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination...” NCT02378935 ↗2“and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC” NCT04211909 ↗ “SOF/VEL/voxilaprevir (VOX)” NCT05467826 ↗ |
| Known as | Voxilaprevir component of vosevi | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707372 ↗ |
| Action | Inhibit | “a pangenotypic HCV NS3/4A protease inhibitor” PMID 29063860 ↗ 2018 |
| Modality | Small molecule | — CHEMBL3707372 ↗ |
| Route | Oral | “Voxilaprevir tablets administered orally once daily” NCT02185794 ↗ |