elvitegravir
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Stribild | — | 2013-05-24 | europa.eu ↗ |
| Approved | US (FDA) | STRIBILD | — | 2012-08-27 | fda.gov ↗ |
Trials 25 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials | ||||||
| Phase 1 | NCT06274398 | Jan 2024 → Mar 2025 | — | Eastern Virginia Medical School | Completed | No outcome recorded |
| Phase 1 | NCT06087913 | Nov 2023 → Dec 2024 | — | Eastern Virginia Medical School | Completed | No outcome recorded |
| Phase 1 | NCT04047420 | Dec 2019 → Mar 2021 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT03762772 | Dec 2018 → Mar 2019 | HIV infectious disease | CONRAD | Completed | No outcome recorded |
| Phase 1 | NCT02985996 | Feb → Nov 2017 | HIV infectious disease | Emory University | Completed | No outcome recorded |
| Phase 1 | NCT02475135 | Jun → Aug 2015 | — | Janssen Sciences Ireland UC | Completed | No outcome recorded |
| Phase 1 | NCT02219217 | Oct 2014 → Jan 2015 | HIV infectious disease | St Stephens Aids Trust | Completed | No outcome recorded |
| Phase 1 | NCT02203461 | Jul → Oct 2014 | — | Technical University of Munich | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT00445146 | Feb 2007 → Mar 2015 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT00298350 | Feb 2006 → Jun 2007 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT02276612 | Dec 2014 → Nov 2016 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 2/3 | NCT01854775 | May 2013 → May 2020 | AIDS | Gilead Sciences | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT02707601 | Apr 2016 → Sep 2017 | HIV infectious disease, hepatitis C virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT02616029 | Dec 2015 → Oct 2018 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT02071082 | Feb 2014 → Jan 2015 | HIV infectious disease, hepatitis B virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT01533259 | Jan → Nov 2012 | AIDS | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT01495702 | Dec 2011 → Nov 2013 | AIDS | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT00708162 | Jul 2008 → Dec 2010 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT03693508 | Apr 2018 → May 2020 | HIV infectious disease, immunodeficiency disease | Fundacion SEIMC-GESIDA | Completed | No outcome recorded |
| Phase 4 | NCT02198443 | Jun 2015 → Jul 2016 | HIV infectious disease | Fundacion Clinic per a la Recerca Biomédica | Completed | No outcome recorded |
| Phase 4 | NCT02246998 | Dec 2014 → Jan 2016 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 4 | NCT01855867 | May 2013 → Apr 2014 | HIV infectious disease | Kenneth H. Mayer, MD | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT03877536 | Mar 2019 → Sep 2023 | HIV infectious disease | Henry M. Jackson Foundation for the Advancement of Military Medicine | Withdrawn | No outcome recorded |
| — | NCT03405194 | May 2018 → May 2020 | HIV infectious disease | Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic | Withdrawn | No outcome recorded |
| — | NCT01929759 | Jan 2014 → Oct 2015 | HIV infectious disease | Massachusetts General Hospital | Completed | No outcome recorded |
Also used as a comparator or background therapy in 9 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02556268 Background | Feb → Dec 2016 | — | Bayer | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03251144 Background | Apr 2019 → Jul 2021 | AIDS, mitochondrial disease, poisoning | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06338826 Background | Feb 2025 → Sep 2027 expected | HIV infectious disease | ANRS, Emerging Infectious Diseases | Not yet recruiting | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT06630299 Comparator | Oct 2024 → Apr 2026 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03631732 Comparator | Aug 2018 → Aug 2019 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT02397096 Background | Jun 2015 → Feb 2018 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT02302547 Comparator | Dec 2014 → Aug 2017 | HIV infectious disease | University Hospital, Tours | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT04442737 Comparator | Jul 2020 → Aug 2023 | — | Janssen Scientific Affairs, LLC | Completed | No outcome recorded |
| Phase 4 | NCT03447873 Comparator | Jun 2017 → Sep 2020 | HIV infectious disease | Hospitales Universitarios Virgen del Rocío | Completed | No outcome recorded |
Press releases naming this drug 18 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-08-06 | Gilead Sciences | China National Drug Administration Approves Gilead’s Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide), a Single Tablet Regimen for the Treatment of HIV-1 Infection gilead.com ↗ |
| 2018-03-05 | Gilead Sciences | Gilead Presents Data From Phase 3 Study Evaluating Women Who Switched to Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) From a Boosted Protease Inhibitor-Based Regimen or Boosted Elvitegravir-Containing Regimen gilead.com ↗ |
| 2015-11-23 | Gilead Sciences | European Commission Grants Marketing Authorization for Gilead’s Single Tablet Regimen Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) for the Treatment of HIV-1 Infection gilead.com ↗ |
| 2015-11-05 | Gilead Sciences | U.S. Food and Drug Administration Approves Gilead’s Single Tablet Regimen Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) for Treatment of HIV-1 Infection gilead.com ↗ |
| 2015-10-22 | Gilead Sciences | Gilead Announces Phase 3 Results for Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide), an Investigational Once-Daily Single Tablet Regimen for HIV gilead.com ↗ |
| 2015-09-25 | Gilead Sciences | European CHMP Adopts Positive Opinion for Gilead’s Single Tablet Regimen Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) for the Treatment of HIV gilead.com ↗ |
| 2015-07-21 | Gilead Sciences | Gilead Announces Phase 3 Results From the First Study to Evaluate Switching From TDF-Based Regimens to a TAF-Based Regimen Containing Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide (E/C/F/TAF) gilead.com ↗ |
| 2014-04-21 | Gilead Sciences | Gilead Sciences’ New Drug Applications for Cobicistat and Elvitegravir for HIV Therapy Accepted by U.S. FDA gilead.com ↗ |
| 2013-11-18 | Gilead Sciences | European Commission Approves Gilead’s Vitekta™, an Integrase Inhibitor for the Treatment of HIV-1 Infection gilead.com ↗ |
| 2013-04-29 | Gilead Sciences | Gilead Receives Complete Response Letters from U.S. Food and Drug Administration for Elvitegravir and Cobicistat gilead.com ↗ |
| 2012-07-24 | Gilead Sciences | Gilead’s HIV Integrase Inhibitor Elvitegravir Dosed Once Daily as Effective as Twice-Daily Raltegravir Over Two Years of Therapy in Pivotal Phase 3 Study gilead.com ↗ |
| 2012-06-27 | Gilead Sciences | Gilead Submits New Drug Application to U.S. FDA for HIV Integrase Inhibitor Elvitegravir for Treatment-Experienced Patients gilead.com ↗ |
| 2012-06-18 | Gilead Sciences | European Medicines Agency Validates Gilead’s Marketing Application for Elvitegravir for Treatment of HIV Infection gilead.com ↗ |
| 2011-12-09 | Gilead Sciences | Gilead Announces Two-Year Data From Pivotal Phase 3 Study of Elvitegravir, an Integrase Inhibitor for HIV gilead.com ↗ |
| 2011-07-20 | Gilead Sciences | Gilead's Investigational Antiretroviral Elvitegravir Once Daily Non-Inferior to Raltegravir Twice Daily at 48 Weeks gilead.com ↗ |
| 2011-03-23 | Gilead Sciences | Phase III Clinical Trial of Gilead's Investigational Elvitegravir Meets 48-Week Primary Objective gilead.com ↗ |
| 2008-07-22 | Gilead Sciences | Gilead Initiates Phase III Clinical Trial of Elvitegravir, an Investigational Integrase Inhibitor for HIV gilead.com ↗ |
| 2005-04-04 | Gilead Sciences | Gilead Sciences Announces Early Termination of Hart-Scott-Rodino Waiting Period for the Japan Tobacco License for JTK-303 gilead.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 36 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Elvitegravir | “This study will evaluate efficacy of ledipasvir/sofosbuvir (LDV/SOF) and safety and tolerability of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide...” NCT02707601 ↗32“The ability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) to maintain virologic suppression in participants with M184V and/or M184I resistance...” PMID 33315694 ↗ Apr 2021 “The single-tablet, fixed-dose combination of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide is a once-daily, integrase strand transfer inhibitor-based...” PMID 30169223 ↗ Jun 2017 “A Phase I Randomized, Placebo-controlled, Double-blind Study to Assess Safety, Pharmacokinetics, and Modeled Pharmacodynamics of a Vaginal Insert Containing Tenofovir...” NCT06087913 ↗ “Elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen (STR) administered orally once...” NCT01533259 ↗ “The integrase (INI) inhibitors (for example, bictegravir, dolutegravir, elvitegravir/cobicistat, and raltegravir) will be administered in combination with TAF/FTC, as appropriate.” NCT04442737 ↗ “A Phase 3b Open-label Study of the Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1/Hepatitis B Co-infected Adults” NCT02071082 ↗ “Patents treated with elvitegravir (EVG) 150mg / cobicistat (COBI) 150mg / emtricitabine (FTC) 200mg / tenofovir (TAF) 10mg once a day as the first line treatment.” NCT03693508 ↗ “Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food” NCT01495702 ↗ “To Continue with triple therapy with Elvitegravir/cobicistat + tenofovir alafenamide + emtricitabine or Dolutegravir + abacavir + lamivudine once daily.” NCT03447873 ↗ “Genvoya® (Elvitegravir, corbiscistat, Emtricitabine and Tenofovir Alafenamide): once a day antiretroviral pill starting within 1 week of enrollment.” NCT03877536 ↗ “Genvoya is a combination of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamid in one tablet.” NCT02985996 ↗ “Tenofovir+Emtricitabine+Third agent (Including an integrase inhibitor raltegravir or dolutegravir or cobicistat-boosted elvitegravir” NCT02302547 ↗ “150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily” NCT02556268 ↗ “Safety and Pharmacokinetic Study of Tenofovir Alafenamide (TAF)/Elvitegravir (EVG) Administered Rectally” NCT04047420 ↗ “Elvitegravir / Cobicistat / Emtricitabine / Tenofovir Disoproxil Fumarate Single-tablet Regimen” NCT01855867 ↗ “elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/FTC/TAF) 1 tablet once daily” NCT03251144 ↗ “an insert containing tenofovir alafenamide (TAF) and elvitegravir (EVG) in healthy women.” PMID 37153145 ↗ Apr 2023 “elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF)” NCT02276612 ↗ “INSTI = bictegravir, dolutegravir, elvitegravir/cobicistat, raltegravir” NCT06338826 ↗ “Elvitegravir (EVG) tablet administered orally once daily with food” NCT00445146 ↗ “Rectally Administered Tenofovir Alafenamide/Elvitegravir Inserts” NCT06274398 ↗ “elvitegravir (EVG; Vitekta®)/cobicistat (c; Tybost®)/TXF/FTC” NCT06630299 ↗ “Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF” NCT02246998 ↗ “elvitegravir (EVG)” NCT03631732 ↗ |
| Known as | ELV | “Elvitegravir (ELV)/cobicistat CO)/emtricitabine (FTC)/tenofovir (TDF)” NCT03251144 ↗ |
| Known as | Elvitegravir component of genvoya | ChEMBL registry synonym — accepted as the source's own label CHEMBL204656 ↗ |
| Known as | Elvitegravir component of stribild | ChEMBL registry synonym — accepted as the source's own label CHEMBL204656 ↗ |
| Known as | Elvitegravir component of vitekta | ChEMBL registry synonym — accepted as the source's own label CHEMBL204656 ↗ |
| Known as | EVG | “Elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen (STR) administered orally once...” NCT01533259 ↗8“Patents treated with elvitegravir (EVG) 150mg / cobicistat (COBI) 150mg / emtricitabine (FTC) 200mg / tenofovir (TAF) 10mg once a day as the first line treatment.” NCT03693508 ↗ “Participants will be randomized in a 1:1 ratio to receive EVG plus background regimen (Elvitegravir group)” NCT00708162 ↗ “Safety and Pharmacokinetic Study of Tenofovir Alafenamide (TAF)/Elvitegravir (EVG) Administered Rectally” NCT04047420 ↗ “an insert containing tenofovir alafenamide (TAF) and elvitegravir (EVG) in healthy women.” PMID 37153145 ↗ Apr 2023 “Elvitegravir (EVG) tablet administered orally once daily with food” NCT00445146 ↗ “elvitegravir (EVG; Vitekta®)/cobicistat (c; Tybost®)/TXF/FTC” NCT06630299 ↗ “elvitegravir (EVG) boosted with cobicistat (COBI)” NCT01929759 ↗ “elvitegravir (EVG)” NCT03631732 ↗ |
| Known as | GS-9137 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00298350 ↗ |
| Known as | JTK-303 | ChEMBL registry synonym — accepted as the source's own label CHEMBL204656 ↗ |
| Known as | Vitekta | “elvitegravir (EVG; Vitekta®)/cobicistat (c; Tybost®)/TXF/FTC” NCT06630299 ↗ |
| Action | Inhibit | “Elvitegravir is a once daily inhibitor of HIV-1 integrase” PMID 22015077 ↗ Oct 2011 |
| Modality | Small molecule | — CHEMBL204656 ↗ |
| Route | Oral | “Elvitegravir (EVG) tablet administered orally once daily with food” NCT00445146 ↗ |