Drugs / Genvoya
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed HIV infectious disease 1 milestone | |||||
| Filed | US (FDA) | Genvoya | HIV infectious disease | 2014-11-05 | “Gilead filed a New Drug Application for Genvoya with the U.S. Food and Drug Administration ( FDA ) on November 5, 2014 .” gilead.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Genvoya | — | 2015-11-19 | europa.eu ↗ |
| Approved | US (FDA) | GENVOYA | — | 2015-11-05 | fda.gov ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT03976752 | Mar → Sep 2019 | HIV infectious disease | Emory University | Completed | No outcome recorded |
| Phase 1 | NCT03472963 | Apr 2018 → Mar 2019 | HIV infectious disease | Emory University | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT04051970 | Nov 2019 → Jun 2022 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT02998320 | Mar 2017 → Jun 2018 | — | Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux | Completed | No outcome recorded |
| Phase 3 | NCT03493568 | Feb 2017 → Mar 2018 | HIV infectious disease | IRCCS San Raffaele | Terminated | No outcome recorded |
| Phase 41 trial | ||||||
| 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 not applicable1 trial | ||||||
| — | NCT02251236 | Jan 2016 → Jan 2017 | HIV infectious disease | University of California, San Diego | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT03717129 Comparator | Apr 2019 → Nov 2021 | — | Johns Hopkins University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
All press releases naming this drug 7 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Genvoya | “a once daily integrase inhibitor (Stribild® or Genvoya® or Biktarvy®)” NCT04051970 ↗ |
| Route | Oral | “To be administered orally, once daily with food.” NCT02251236 ↗ |