Drugs / Stribild
Stribild
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 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT00869557 | Apr → Nov 2009 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 34 trials · 3 met primary | ||||||
| Phase 3 | NCT04051970 | Nov 2019 → Jun 2022 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01475838 | Nov 2011 → Nov 2013 | AIDS | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT01106586 | Apr 2010 → Sep 2011 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT01095796 | Mar 2010 → Aug 2011 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
| Phase 45 trials | ||||||
| Phase 4 | NCT02351908 | Mar 2015 → Apr 2016 | HIV infectious disease | St Stephens Aids Trust | Completed | No outcome recorded |
| Phase 4 | NCT02477527 | Feb → Dec 2015 | AIDS, sleep disorder | Midtown Medical Center, Tampa, FL | Completed | No outcome recorded |
| Phase 4 | NCT02199613 | Oct 2014 → Feb 2017 | HIV infectious disease | University of British Columbia | Completed | No outcome recorded |
| Phase 4 | NCT02180438 | Sep 2014 → Jan 2017 | — | University of Washington | Completed | No outcome recorded |
| Phase 4 | NCT02283060 | Sep 2014 → Jul 2016 | HIV infectious disease | University of Hawaii | Unknown | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT02251236 | Jan 2016 → Jan 2017 | HIV infectious disease | University of California, San Diego | Completed | No outcome recorded |
| — | NCT02183909 | May 2013 → Mar 2017 | HIV infectious disease | University of California, San Francisco | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 4 | NCT02220868 Background | Jul 2014 → Aug 2015 | HIV infectious disease, hepatitis C virus infection | Saint Michael's Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT01815580 Comparator | Jul 2013 → Nov 2020 | HIV infectious disease | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2018-12-04 | Gilead Sciences | Regulatory China National Medical Products Administration Approves Descovy® (Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 Infection gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the China National Medical Products Administration (NMPA) has approved Descovy ® (emtricitabine 200 mg/tenofovir alafenamide 10 mg and emtricitabine 200 mg/tenofovir alafenamide 25 mg, F/TAF), a fixed-dose combination for the treatment of HIV. |
| 2018-03-05 | Gilead Sciences | Results 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 ↗ |
| 2017-02-14 | Gilead Sciences | Results Gilead Announces 144-Week Data Evaluating Safety and Efficacy of Genvoya® for Treatment of HIV-1 in Treatment-Naïve Adults gilead.com ↗
Through Week 144, Genvoya demonstrated significantly higher rates of virologic suppression compared to Gilead’s Stribild ® (elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg), based on the percentage of patients with HIV-1 RNA levels less than 50 copies/mL. |
| 2016-04-25 | Gilead Sciences | Regulatory European Commission Grants Marketing Authorization for Gilead’s Fixed-Dose Combination Descovy® (Emtricitabine, Tenofovir Alafenamide) for Treatment of HIV gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for two doses of Descovy ® (emtricitabine and tenofovir alafenamide 200/10 mg and 200/25 mg; F/TAF), a fixed-dose combination for the treatment of HIV-1 infection. |
| 2016-04-16 | Gilead Sciences | Results Gilead Announces Multiple Scientific Presentations Demonstrating Broad Utility of Sofosbuvir-Based Hepatitis C Therapies gilead.com ↗ |
| 2016-04-04 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Descovy® (Emtricitabine, Tenofovir Alafenamide), Gilead’s Third TAF-Based HIV Therapy gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration ( FDA ) has approved Descovy ® (emtricitabine 200 mg/tenofovir alafenamide 25 mg, F/TAF), a fixed-dose combination for the treatment of HIV. |
| 2016-02-26 | Gilead Sciences | Regulatory European CHMP Adopts Positive Opinion for Gilead’s Fixed-Dose Combination Descovy® (Emtricitabine/Tenofovir Alafenamide) for the Treatment of HIV gilead.com ↗
has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for two doses of Descovy ® (emtricitabine and tenofovir alafenamide 200/10 mg and 200/25 mg; F/TAF) |
| 2013-10-16 | Gilead Sciences | Results Gilead’s Single Tablet HIV Regimen Stribild® Demonstrates Durable Viral Suppression Through Three Years of Therapy gilead.com ↗
In these large-scale clinical trials, Stribild demonstrated high and durable viral suppression and a favorable safety profile over three years of therapy. |
| 2013-09-12 | Gilead Sciences | Results Gilead’s Tenofovir Alafenamide (TAF)-Based Single Tablet HIV Regimen Maintains High Viral Suppression Through 48 Weeks in Phase 2 Study gilead.com ↗
In this study, the TAF-based regimen matched Stribild’s high viral suppression and demonstrated a favorable safety profile with respect to renal and bone changes. |
| 2013-05-28 | Gilead Sciences | Regulatory European Commission Approves Stribild®, a New Single Tablet Regimen for the Treatment of HIV-1 Infection gilead.com ↗ |
| 2013-03-22 | Gilead Sciences | Regulatory European CHMP Adopts Positive Opinion for Stribild®, a Once-Daily, Integrase Inhibitor-Based, Single Tablet Regimen for the Treatment of HIV-1 Infection gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorisation Application (MAA) for the once-daily, single tablet regimen Stribild ® for the treatment of HIV-1 infection in adult patients who are antiretroviral-naïve or are infected with HIV-1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild. |
| 2013-03-05 | Gilead Sciences | Results Gilead Announces Full 24-Week Phase 2 Results for Once-Daily Single Tablet HIV Regimen Containing Novel Prodrug Tenofovir Alafenamide (TAF) gilead.com ↗
A regimen of TAF 10 mg/elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg was found to be similar to Stribild ® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) based on the percentage of patients with HIV RNA levels less than 50 copies/mL at 24 weeks of treatment. |
| 2012-11-15 | Gilead Sciences | Results Gilead’s Once-Daily Single Tablet Regimen Stribild™ Maintains High Viral Suppression Through Two Years of Therapy Among Treatment-Naïve HIV Patients gilead.com ↗
These results were presented today in an oral session at the 11th International Congress on Drug Therapy in HIV Infection (HIV11) in Glasgow, United Kingdom . |
All press releases naming this drug 13 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Stribild | “Eligible, consenting subjects will start open-label darunavir 800mg plus the co-formulated tenofovir DF/FTC/cobicistat/elvitegravir (Stribild) tablet once daily with food,...” NCT02199613 ↗13“a once daily integrase inhibitor (Stribild® or Genvoya® or Biktarvy®)” NCT04051970 ↗ |
| Known as | E/C/F/TDF | “Stribild (E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food” NCT01475838 ↗ |
| Known as | elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate | “We report week 96 results from a phase 3 trial of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF, n = 348) vs...” PMID 23392460 ↗ May 2013 |
| Known as | EVG/COBI/FTC/TDF | “We report week 96 results from a phase 3 trial of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF, n = 348) vs...” PMID 23392460 ↗ May 20131“Coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF; Stribild(®))” PMID 26286337 ↗ Oct 2015 |
| Known as | tenofovir DF/emtricitabine/cobicistat/elvitegravir | “tenofovir DF/emtricitabine/cobicistat/elvitegravir (Stribild) tablet” NCT02199613 ↗ |
| Action | Inhibit | “Stribild (elvitegravir/emtricitabine/tenofovir disoproxil fumarate/cobicistat) contains an integrase inhibitor elvitegravir” NCT02283060 ↗ |
| Modality | Other / unclassified | “Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI \[GS-9350\])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)” NCT01106586 ↗ |
| Route | Oral | “Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR administered orally once daily” NCT01095796 ↗ |