Drugs / Atripla
Atripla
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Atripla | — | 2007-12-13 | europa.eu ↗ |
| Approved | US (FDA) | ATRIPLA | — | 2006-07-12 | fda.gov ↗ |
Trials 5 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 32 trials | ||||||
| Phase 3 | NCT01263015 | Feb 2011 → May 2012 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT01095796 | Mar 2010 → Aug 2011 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT03532425 | Oct 2018 → Aug 2020 | HIV infectious disease | University of Alberta | Terminated | No outcome recorded |
| Phase 4 | NCT01778413 | Jun 2013 → Nov 2014 | HIV infectious disease | Anna Cruceta | Completed | No outcome recorded |
| Phase 4 | NCT00615810 | Mar 2008 → Oct 2009 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
Also used as a comparator or background therapy in 8 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT00869557 Comparator | Apr → Nov 2009 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT02403674 Comparator | Jun 2015 → Mar 2017 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT02057796 Background | Sep 2014 → Apr 2018 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Completed | No outcome recorded |
| Phase 4 | NCT02283060 Comparator | Sep 2014 → Jul 2016 | HIV infectious disease | University of Hawaii | Unknown | No outcome recorded |
| Phase 4 | NCT01815580 Comparator | Jul 2013 → Nov 2020 | HIV infectious disease | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
| Phase 4 | NCT01380080 Background | Oct 2011 → Jan 2015 | HIV infectious disease | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | Completed | No outcome recorded |
| Phase 4 | NCT01343225 Comparator | May 2011 → May 2014 | HIV infectious disease | East Carolina University | Unknown | No outcome recorded |
| Phase 4 | NCT01173510 Comparator | Aug 2010 → Oct 2012 | AIDS | Community Research Initiative of New England | Withdrawn | No outcome recorded |
Press releases naming this drug 12 releases
| Date | Issuer | Release |
|---|---|---|
| 2012-11-15 | Gilead Sciences | Gilead’s Complera® Non-Inferior to Atripla® Among Treatment-Naïve HIV Patients gilead.com ↗ |
| 2012-03-07 | Gilead Sciences | Gilead’s Quad Single Tablet Regimen for HIV Non-Inferior to Atripla® in Pivotal Phase 3 Study gilead.com ↗ |
| 2009-04-06 | Gilead Sciences | Gilead Sciences Announces Notification of ANDA Filing for Atripla(R) gilead.com ↗ |
| 2008-08-01 | Gilead Sciences | Gilead Sciences and Merck & Co., Inc. Enter Into an Agreement to Register and Distribute HIV Medication Atripla(R) (Efavirenz 600 mg/ Emtricitabine 200 mg/ Tenofovir Disoproxil Fumarate 300 mg) in Twelve Countries gilead.com ↗ |
| 2007-12-17 | Gilead Sciences | European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection gilead.com ↗ |
| 2007-12-11 | Gilead Sciences | Bristol-Myers Squibb and Gilead Sciences Expand Their Alliance to Include Commercialization of ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) in Europe gilead.com ↗ |
| 2007-10-18 | Gilead Sciences | European CHMP Issues Positive Opinion for ATRIPLA(R) (efavirenz 600 mg/ emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) gilead.com ↗ |
| 2007-10-17 | Gilead Sciences | Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV gilead.com ↗ |
| 2006-10-09 | Gilead Sciences | Bristol-Myers Squibb, Gilead Sciences and Merck & Co. Submit Marketing Authorisation Application for ATRIPLA(TM) (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) to European Medicines Agency gilead.com ↗ |
| 2006-09-28 | Gilead Sciences | Bristol-Myers Squibb and Gilead Sciences Establish Agreement to Commercialize ATRIPLA(TM) (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) in Canada gilead.com ↗ |
| 2006-08-11 | Gilead Sciences | Gilead Sciences and Merck Establish Agreement for Distribution of ATRIPLA(TM) in Developing Countries gilead.com ↗ |
| 2006-07-12 | Gilead Sciences | U.S. Food and Drug Administration (FDA) Approves ATRIPLA(TM) (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), The First Once-Daily Single Tablet Regimen for Adults with HIV-1 Infection gilead.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ATRIPLA | “Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate (ATRIPLA® a trade mark of Bristol-Myers Squibb and Gilead Sciences LLC)” NCT01263015 ↗13“Atripla (EFV 150 mg/FTC 200mg/TDF 300 mg) STR QHS + placebo to match Stribild QD” NCT00869557 ↗ |
| Known as | efavirenz/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 | EFV/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“Patients are administered one tablet of Efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (EFV/FTC/TDF, Atripla) to taken be taken orally once daily at...” NCT01380080 ↗ |
| Action | Inhibit | “Atripla contains a non-nucleoside reverse transcriptase (NNRTI) drug efavirenz (EFV)” NCT02283060 ↗ |
| Route | Oral | “once daily for oral administration to be taken on an empty stomach” NCT00615810 ↗ |