elvitegravir
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed HIV infectious disease 4 milestones | |||||
| Filed | US (FDA) | — | HIV infectious disease | 2014-11-06 | “submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) for an investigational, once-daily single tablet regimen containing elvitegravir” gilead.com ↗ |
| Filed | US (FDA) | — | HIV infectious disease | 2012-06-27 | “Gilead submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) for elvitegravir as a standalone agent on June 27, 2012” gilead.com ↗ “Gilead submitted a New Drug Application (NDA) to U.S. Food and Drug Administration ( FDA ) for elvitegravir as a standalone agent on June 27, 2012” gilead.com ↗ “submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) for marketing approval of elvitegravir” gilead.com ↗ “Gilead submitted a New Drug Application (NDA) to FDA for elvitegravir as a standalone agent on June 27, 2012” gilead.com ↗ “On June 27, 2012 , Gilead submitted a marketing application to FDA for elvitegravir.” gilead.com ↗ “Gilead submitted NDAs for cobicistat and elvitegravir in June 2012 .” gilead.com ↗ |
| Filed | EU (EMA) | — | HIV infectious disease | 2012-06-18 | “An MAA for elvitegravir in the EU was validated for review by EMA on June 18, 2012 .” gilead.com ↗ |
| Rejected (CRL) | US (FDA) | — | HIV infectious disease | — | “In its communications, the agency stated that it could not approve the cobicistat and elvitegravir applications in their current forms” gilead.com ↗ |
| Rejected HIV-associated cancer 1 milestone | |||||
| Rejected (CRL) | US (FDA) | — | HIV-associated cancer | 2013-04-29 | “received Complete Response Letters from the U.S. Food and Drug Administration ( FDA ) for its New Drug Applications (NDAs) for elvitegravir and cobicistat” gilead.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Stribild | — | 2013-05-24 | europa.eu ↗ |
| Approved | US (FDA) | STRIBILD | — | 2012-08-27 | fda.gov ↗ |
Trials 25
| 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 · 1 met primary | ||||||
| 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 | Met primary |
| 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 · 2 met primary | ||||||
| Phase 3 | NCT02707601 | Apr 2016 → Sep 2017 | HIV infectious disease, hepatitis C virus infection | Gilead Sciences | Completed | Met primary |
| 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 | Met primary |
| 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 Stop: Enrollment |
| — | NCT01929759 | Jan 2014 → Oct 2015 | HIV infectious disease | Massachusetts General Hospital | Completed | No outcome recorded |
| Comparator or background therapy9 trials | ||||||
| Phase 1 | NCT02556268 Background | Feb → Dec 2016 | — | Bayer | Completed | No outcome recorded |
| Phase 1/2 | NCT03251144 Background | Apr 2019 → Jul 2021 | AIDS, mitochondrial disease, poisoning | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 2 | NCT06338826 Background | Feb 2025 → Sep 2027 expected | HIV infectious disease | ANRS, Emerging Infectious Diseases | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06630299 Comparator | Oct 2024 → Apr 2026 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | Met primary |
| Phase 3 | NCT03631732 Comparator | Aug 2018 → Aug 2019 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT02397096 Background | Jun 2015 → Feb 2018 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT02302547 Comparator | Dec 2014 → Aug 2017 | HIV infectious disease | University Hospital, Tours | Completed | No outcome recorded |
| Phase 4 | NCT04442737 Comparator | Jul 2020 → Aug 2023 | — | Janssen Scientific Affairs, LLC | Completed | Missed primary |
| Phase 4 | NCT03447873 Comparator | Jun 2017 → Sep 2020 | HIV infectious disease | Hospitales Universitarios Virgen del Rocío | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 23
| Date | Issuer | Release |
|---|---|---|
| 2023-07-23 | Gilead Sciences | Results New Biktarvy® Data Presented at IAS 2023 Further Demonstrate Safety and Efficacy Profile in a Broad Range of People and Communities Affected by the Global HIV Epidemic gilead.com ↗
At Week 48, the proportion of participants who were underweight decreased from 20.4% to 14.3%, while the proportion of normal weight participants increased from 67.3% to 73.5%, respectively. |
| 2015-07-21 | Gilead Sciences | Results 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 ↗
The study met its primary endpoint by demonstrating non-inferiority of E/C/F/TAF to the TDF-based regimens at Week 48. |
| 2014-04-21 | Gilead Sciences | Regulatory Gilead Sciences’ New Drug Applications for Cobicistat and Elvitegravir for HIV Therapy Accepted by U.S. FDA gilead.com ↗ |
| 2013-11-18 | Gilead Sciences | Regulatory European Commission Approves Gilead’s Vitekta™, an Integrase Inhibitor for the Treatment of HIV-1 Infection gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for Vitekta™ (elvitegravir 85 mg and 150 mg) tablets, an integrase inhibitor for the treatment of HIV-1 infection in adults without known mutations associated with resistance to elvitegravir. |
| 2013-04-29 | Gilead Sciences | Regulatory Gilead Receives Complete Response Letters from U.S. Food and Drug Administration for Elvitegravir and Cobicistat gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company has received Complete Response Letters from the U.S. Food and Drug Administration ( FDA ) for its New Drug Applications (NDAs) for elvitegravir and cobicistat for use as part of HIV treatment regimens. |
| 2012-07-24 | Gilead Sciences | Results 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 ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced two-year Phase 3 clinical trial results showing that the integrase inhibitor elvitegravir dosed once daily is non-inferior to raltegravir dosed twice daily among treatment-experienced HIV patients. |
| 2012-06-27 | Gilead Sciences | Regulatory Gilead Submits New Drug Application to U.S. FDA for HIV Integrase Inhibitor Elvitegravir for Treatment-Experienced Patients gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) announced today it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) for marketing approval of elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced adults. |
| 2012-06-18 | Gilead Sciences | Regulatory European Medicines Agency Validates Gilead’s Marketing Application for Elvitegravir for Treatment of HIV Infection gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) announced today that its Marketing Authorisation Application (MAA) for elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced patients, has been validated by the European Medicines Agency (EMA). |
| 2012-05-11 | Gilead Sciences | Regulatory FDA Advisory Committee Supports Approval of Gilead’s Once-Daily Quad Single Tablet Regimen for HIV gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration ( FDA ) has voted 13 to 1 in support of approval of the Quad, a complete single tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, for the treatment of HIV-1 infection in treatment-naïve adults. |
| 2012-03-08 | Gilead Sciences | Results Data Show Gilead’s Quad Regimen for HIV Non-Inferior to Protease-Based Regimen at 48 Weeks in Second Pivotal Phase 3 Study gilead.com ↗
The study found that the Quad was non-inferior to a protease-based regimen of ritonavir-boosted atazanavir (ATV/r) plus Truvada ® (emtricitabine/tenofovir disoproxil fumarate) at 48 weeks of therapy among HIV-1 infected treatment-naïve adults. |
| 2012-03-07 | Gilead Sciences | Results Gilead’s Quad Single Tablet Regimen for HIV Non-Inferior to Atripla® in Pivotal Phase 3 Study gilead.com ↗
These data show that the Quad is as effective as a current standard of care in HIV therapy. |
| 2011-12-23 | Gilead Sciences | Regulatory U.S. FDA Accepts New Drug Application for Gilead’s Once-Daily, Single-Tablet Quad HIV Regimen gilead.com ↗ |
| 2011-12-20 | Gilead Sciences | Regulatory Gilead Files European Marketing Application for the Quad, a Once-Daily Single-Tablet Regimen for the Treatment of HIV Infection gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) announced today that the Marketing Authorisation Application (MAA) for the Quad single-tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate for the treatment of HIV-1 infection in adults, submitted on November 24, 2011 , has been validated by the European Medicines Agency (EMA). |
| 2011-12-09 | Gilead Sciences | Results Gilead Announces Two-Year Data From Pivotal Phase 3 Study of Elvitegravir, an Integrase Inhibitor for HIV gilead.com ↗
today announced topline Phase 3 clinical trial results showing that elvitegravir, an integrase inhibitor being evaluated for the treatment of HIV-1 infection, was non-inferior to the integrase inhibitor raltegravir after two years (96 weeks) of therapy in treatment-experienced patients. |
| 2011-10-27 | Gilead Sciences | Regulatory Gilead Submits New Drug Application to U.S. FDA for Once-Daily, Single-Tablet "Quad" HIV Regimen gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) |
| 2011-08-15 | Gilead Sciences | Results Gilead's Investigational Antiretroviral Quad Regimen Meets 48-Week Primary Objective in Pivotal Phase 3 Clinical Study 102 gilead.com ↗
The mean 48-week increase in CD4 cell count from baseline was 239 cells/mm 3 in the Quad arm compared to 206 cells/mm 3 in the Atripla arm (p=0.009). |
| 2011-07-20 | Gilead Sciences | Results Gilead's Investigational Antiretroviral Elvitegravir Once Daily Non-Inferior to Raltegravir Twice Daily at 48 Weeks gilead.com ↗
Discontinuation rates due to adverse events, and safety and resistance profiles were comparable in both arms of the study. |
| 2011-03-23 | Gilead Sciences | Results Phase III Clinical Trial of Gilead's Investigational Elvitegravir Meets 48-Week Primary Objective gilead.com ↗
The primary endpoint analysis indicated that 59.0 percent of patients in the elvitegravir arm compared to 57.8 percent in the raltegravir arm (95% CI for the difference: -6.0% to +8.2%) achieved and maintained a viral load of less than 50 copies/mL through week 48. |
| 2010-09-13 | Gilead Sciences | Results Gilead's Single-Tablet "Quad" HIV Regimen Maintains High Viral Suppression Through 48 Weeks in Phase II Study gilead.com ↗
At week 48, the proportion of patients who achieved HIV RNA (viral load) less than 50 copies/mL was 90 percent in the Quad arm and 83 percent in the Atripla arm (using an analysis where missing equals failure). |
| 2010-02-17 | Gilead Sciences | Results Gilead's Single-Tablet "Quad" Regimen for HIV Achieves a High Rate of Virologic Suppression in Phase II Study gilead.com ↗
These positive efficacy and safety results indicate that the Quad has the potential to become an important new treatment option in HIV therapy. |
| 2010-01-06 | Gilead Sciences | Results Phase II Clinical Trial of Gilead's Investigational Integrase-Based, Once-Daily, Fixed-Dose "Quad" Regimen Meets 24-Week Primary Objective gilead.com ↗
The study met its primary objective of achieving HIV RNA levels (viral load) of less than 50 copies/mL at 24 weeks of treatment. |
| 2009-02-09 | Gilead Sciences | Results Gilead Announces Data Demonstrating Pharmacokinetic Boosting Activity of GS 9350 gilead.com ↗
Study results also show that GS 9350 effectively boosts elvitegravir, when both drugs are dosed as part of a single tablet complete fixed-dose regimen with Truvada ® (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg). |
| 2007-03-01 | Gilead Sciences | Results Gilead Announces 24-Week Results from Phase II Study of Investigational HIV Integrase Inhibitor GS 9137 gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) today announced 24-week data from a Phase II clinical trial evaluating three doses of GS 9137 (elvitegravir), a novel oral HIV integrase inhibitor. |
All press releases naming this drug 31 releases
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 ↗ |
| 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 ↗ |