Efavirenz
Other / unclassified targets CARD8, CYP2B6, CYP3A4, CYP46A1 via activation
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed HIV infectious disease 1 milestone | |||||
| Filed | US (FDA) | — | HIV infectious disease | 2006-04-27 | “we filed our New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for the co-formulation of Truvada and Sustiva” gilead.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (3) | US (FDA) | SUSTIVA | — | 2000-02-09 – 2013-05-02 | fda.gov ↗ |
| Approved | EU (EMA) | Stocrin | — | 1999-05-28 | europa.eu ↗ |
| Approved | US (FDA) | SUSTIVA | — | 1998-09-17 | fda.gov ↗ |
Trials 207 · started per year
News releases announcing trial results or a regulatory action · 30
| Date | Issuer | Release |
|---|---|---|
| 2020-08-25 | Gilead Sciences | Results Gilead Announces Presentation of More Than 40 Abstracts From Extensive Liver Disease Programs at the Digital International Liver Congress™ 2020 gilead.com ↗
Hepatitis B Data Demonstrate Durable Renal and Bone Safety Benefit of Vemlidy ® |
| 2017-07-25 | Merck Sharp & Dohme LLC | Results Merck’s Investigational NNRTI, Doravirine, Meets Primary Efficacy Endpoint of Non-Inferiority to Efavirenz, Both in Combination with Other Antiretroviral Agents, in Pivotal Phase 3 Trial for Treatment of HIV-1 Infection merck.com ↗
In addition, through 48 weeks, statistically significantly fewer patients taking DOR/3TC/TDF reported pre-specified categories of neuropsychiatric events (dizziness, sleep disorders and disturbances, and inability to think clearly or concentrate) than patients receiving the EFV/FTC/TDF regimen. |
| 2014-11-03 | Merck Sharp & Dohme LLC | Results Merck Announces Data from 48-Week Phase 2b Study of Investigational HIV Therapy Doravirine (MK-1439) in Treatment-Naive Patients merck.com ↗
The results showed a significantly lower incidence of one or more of reported CNS AEs (all causality) among the doravirine-treated group compared to the efavirenz-treated group (22.2 % vs. 43.5 %, respectively; p<0.001). |
| 2014-03-06 | Boehringer Ingelheim | Results Boehringer Ingelheim Announces Phase 3 SVR12 Results in HCV/HIV Co-Infected Patients Treated with Faldaprevir prnewswire.com ↗
In each of these analyses, there was no clinically relevant effect of faldaprevir on the pharmacokinetics of any of the HIV medications studied. |
| 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. |
| 2013-05-03 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb Receives US FDA sNDA Approval for Use of SUSTIVA® (efavirenz) in HIV-1 Infected Pediatric Patients bms.com ↗
This approval offers a once-daily option as part of a regimen for this population and includes a “capsule sprinkle” administration method for patients who cannot swallow capsules or tablets. |
| 2012-11-15 | Gilead Sciences | Results Gilead’s Complera® Non-Inferior to Atripla® Among Treatment-Naïve HIV Patients gilead.com ↗
Complera demonstrated a statistically significant difference in efficacy compared to Atripla among patients with low baseline viral load (≤ 100,000 copies/mL), and was non-inferior to Atripla among patients with high baseline viral load (> 100,000 copies/mL). |
| 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 ↗ |
| 2011-10-13 | Merck Sharp & Dohme LLC | Results Merck’s ISENTRESS® (raltegravir) in Combination Therapy Demonstrated Virological and Immunological Efficacy Versus the Efavirenz Regimen at 192 Weeks of Treatment in Previously Untreated Adults with HIV-1 merck.com ↗
These results offer further insight into the virologic and immunologic response seen with ISENTRESS in combination therapy when compared to efavirenz at 192 weeks in treatment-naïve adult patients with HIV-1,” said Dr. Jürgen Rockstroh, University of Bonn, Bonn-Venusberg, Germany, who presented the data. |
| 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 primary endpoint analysis indicated that 88 percent of patients in the Quad arm compared to 84 percent in the Atripla (95% CI for the difference: -1.6% to 8.8%) achieved HIV RNA (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). |
| 2007-12-17 | Gilead Sciences | Regulatory 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 ↗ |
| 2007-10-29 | Gilead Sciences | Results Gilead Announces 48-Week Data Evaluating Switching from Combivir(R) To Truvada(R) Among Virologically-Suppressed HIV Patients gilead.com ↗
Patients in both study arms maintained virological suppression at 48 weeks. |
| 2007-07-23 | Gilead Sciences | Results 144-Week Data from Gilead's Study 934 Comparing Truvada(R) to Combivir(R) Both in Combination with Sustiva(R) Presented At International AIDS Society Meeting in Sydney gilead.com ↗
today announced the presentation of 144-week data from an ongoing clinical trial, Study 934, comparing a once-daily regimen of Truvada(R) (emtricitabine and tenofovir disoproxil fumarate) and Sustiva(R) (efavirenz) |
| 2006-12-15 | Gilead Sciences | Results 96-Week Data From Gilead's Study 934 Comparing Viread(R) and Emtriva(R) to Combivir(R) Both in Combination With Sustiva(R) Published in Journal of Acquired Immune Deficiency Syndrome gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) today announced the publication of 96-week data from an ongoing clinical trial, Study 934, in the Journal of Acquired Immune Deficiency Syndrome (JAIDS). |
| 2006-10-09 | Gilead Sciences | Regulatory 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 ↗
The MAA for ATRIPLA in the European Union was filed jointly by the three companies through a newly established three-way joint venture based in Ireland, Bristol-Myers Squibb Gilead Sciences And Merck Sharp & Dohme Limited. |
| 2006-08-14 | Gilead Sciences | Results 96-Week Data from Gilead's Study 934 Comparing Viread(R) and Emtriva(R) to Combivir(R) Both in Combination with Sustiva(R) Presented at XVI International AIDS Conference gilead.com ↗ |
| 2006-07-12 | Gilead Sciences | Regulatory 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 ↗
Bristol-Myers Squibb Company (NYSE:BMY) and Gilead Sciences, Inc. (Nasdaq:GILD) today announced the U.S. Food and Drug Administration (FDA) has granted approval of ATRIPLA(TM) (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) for the treatment of HIV-1 infection in adults. |
| 2006-04-27 | Gilead Sciences | Regulatory Bristol-Myers Squibb and Gilead Sciences Submit New Drug Application to U.S. FDA for a Once-Daily Single Tablet Regimen of Sustiva(R) (Efavirenz) and Truvada(R) (Emtricitabine and Tenofovir Disoproxil Fumarate) for HIV Treatment gilead.com ↗ |
| 2006-01-09 | Gilead Sciences | Results Bristol-Myers Squibb and Gilead Announce Data Supporting Bioequivalence for Single-Pill Fixed-Dose Regimen of Sustiva(R) (efavirenz) and Truvada(R) (emtricitabine and tenofovir disoproxil fumarate) gilead.com ↗ |
| 2005-11-17 | Gilead Sciences | Results Preliminary 24-Week Data Evaluating the Impact of Switching from Twice-Daily Combivir(R) to Once-Daily Truvada(R) in Patients with HIV Presented at 10th European AIDS Conference gilead.com ↗
Hemoglobin levels also increased significantly from baseline. |
| 2005-08-09 | Gilead Sciences | Results Gilead Provides Update on Development of Fixed-Dose Regimen of Truvada(R) (Emtricitabine and Tenofovir Disoproxil Fumarate) and Sustiva(R) (Efavirenz) gilead.com ↗
bioequivalence results from its second formulation of the fixed-dose combination of Truvada(R) (emtricitabine and tenofovir disoproxil fumarate) and Bristol-Myers Squibb's Sustiva(R) (efavirenz) for the treatment of HIV did not demonstrate bioequivalence to the individual products dosed separately. |
| 2005-04-26 | Gilead Sciences | Results Gilead Provides Update on Development of Fixed-Dose Regimen of Truvada -emtricitabine and tenofovir disoproxil fumarate- and Sustiva -efavirenz- gilead.com ↗
Preliminary results from the bioequivalence study of the first formulation indicate that efavirenz levels in the blood are lower than those achieved with the recommended 600 mg dose of Sustiva alone and do not meet the definition of bioequivalence. |
| 2005-02-03 | Gilead Sciences | Results Gilead Announces Preliminary 48-Week Data From Study 934 Comparing Viread and Emtriva to Combivir Both in Combination With Sustiva in Patients With HIV gilead.com ↗
Gilead Sciences (Nasdaq:GILD) today announced preliminary 48-week data from the company's Study 934. |
| 2004-10-31 | Gilead Sciences | Results Interim 24-Week Data from Study 934 Comparing a Regimen of Viread and Emtriva Versus Combivir, Both in Combination with Efavirenz, in Patients with HIV Presented at 44th ICAAC gilead.com ↗
Although both triple-drug regimens are relatively convenient, we observed a difference in the two arms, with more patients discontinuing in the Combivir group due to adverse events. |
| 2004-08-26 | Gilead Sciences | Results Gilead Announces Preliminary 24-Week Data from Study 934 Comparing Viread and Emtriva to Combivir Both in Combination With Efavirenz In Patients With HIV gilead.com ↗
Preliminary results show a statistically significant difference favoring Viread/Emtriva in the percentage of patients who achieved and maintained HIV RNA less than 400 copies/mL at 24 weeks, based on the FDA Time to Loss of Virologic Response algorithm (TLOVR). |
| 2003-06-13 | Gilead Sciences | Results 96-Week Data from Gilead's Study 903 Show Low Rate of Virologic Failure among Patients Taking Viread gilead.com ↗
Development of efavirenz resistance either preceded or accompanied development of K65R in all cases. |
| 2003-02-11 | Gilead Sciences | Results Phase III Data Show Emtricitabine Maintains Viral Load Suppression as Part of Once-Daily, Protease-Sparing Anti-HIV Regimen gilead.com ↗
At 48 weeks, 94 percent of patients receiving the once-daily regimen of emtricitabine, didanosine and efavirenz had HIV RNA levels (viral load) less than 400 copies/mL, compared to 92 percent randomized to continue therapy in the PI-based arm (intent to treat population, assays performed at local laboratories at investigational centers). |
| 2003-02-11 | Gilead Sciences | Results 96-Week Data From Phase III Study Show Long-Term Efficacy With Reduced Risk of Lipid and Metabolic Changes for Viread Versus Stavudine in Treatment-Naive HIV Patients gilead.com ↗
The 96-week results presented today show that the Viread and stavudine arms reduced HIV RNA to less than 400 copies/mL in 82 and 78 percent of patients respectively, using the most conservative "missing equals failure" analysis. |
| 1998-09-23 | Gilead Sciences | Results Gilead Sciences Provides Update on PREVEON® Clinical Program for the Treatment of HIV gilead.com ↗
These data suggest that treatment with PREVEON, abacavir and efavirenz, a regimen that does not contain a protease inhibitor, resulted in viral load reductions in patients who have failed treatment with other antiretrovirals. |
All press releases naming this drug 36 releases
Evidence & citations 26 cited values
Every value below carries the sentence it was read from. 378 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | efavirenz | “Generic names: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine,...” NCT00624195 ↗351“It may include one or two nucleoside reverse transcriptase inhibitors, such as zidovudine, didanosine, lamuvidine, zalcitabine, stavudine), a non- nucleoside reverse...” NCT00032669 ↗ “We administered the Basel phenotyping cocktail (caffeine, efavirenz, flurbiprofen, omeprazole, metoprolol, midazolam) to patients with liver cirrhosis (n = 16 Child A, n = 15...” PMID 37328712 ↗ Jun 2023 “Both HIV and HBV can be treated with tenofovir disoproxil fumarate (TDF) and lamivudine (3TC), so we evaluated the safety and efficacy of combination antiretroviral therapy...” PMID 26831232 ↗ Feb 2016 “A Randomised, Multi-Centre, Open-Label Study in Well-Controlled Treatment-Experienced HIV-Infected Patients to Assess Compliance With a Once-Daily Regimen of Lamivudine,...” NCT00214435 ↗ “ART that concurrently contains combinations of non-nucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz, and protease-inhibitors (PIs), such as...” NCT05044962 ↗ “Tenofovir / emtricitabine + efavirenz for all HIV-1-infected men and all HIV-1-infected women who meet the following requirements: on effective contraception and no history of...” NCT00495651 ↗ “Otherwise, patients can be initiated on a preferred regimen of tenofovir (TDF), emtricitabine (FTC), and efavirenz (EFV) according to the US Department of Health and Human...” NCT00799136 ↗ “The study-treatment were lopinavir/r 100/400mg bid or indinavir/r 100/400mg bid for PI-class, for NNRTI-class, efavirenz or nevirapine and all NRTIs except D4T and DDC at usual dosage.” NCT00122668 ↗ “Participants who will be enrolled in this trial would keep their previous combined antiretroviral therapy, such as zidovudine or stavudine plus lamivudine plus nevirapine or efavirenz.” NCT02002286 ↗ “Efficacy and Safety of Tenofovir Disoproxil Fumarate Plus Lamivudine Plus Efavirenz Regimen as First-line Antiretroviral Therapy for ART-naive Chinese Patients With HIV-1 Infection” NCT01844297 ↗ |
| Known as | DMP-266 | “Viracept (Nelfinavir Mesylate) 1250 Mg BID, Crixivan (Indinavir Sulfate) 1200mg q12h, and Sustiva (Efavirenz; DMP-266) 600 Mg q24h” NCT00002235 ↗5“Sustiva (Efavirenz; DMP-266)” NCT00002419 ↗ “Sustiva (Efavirenz; DMP-266)” NCT00002234 ↗ “DMP 266 (Efavirenz, EFV)” NCT00001087 ↗ “Efavirenz (EFV, DMP-266)” NCT00001086 ↗ “DMP 266 (Efavirenz)” NCT00000893 ↗ |
| Known as | Efavirenz component of atripla | ChEMBL registry synonym — accepted as the source's own label CHEMBL223228 ↗ |
| Known as | Efavirenz component of symfi | ChEMBL registry synonym — accepted as the source's own label CHEMBL223228 ↗ |
| Known as | Efavirenz component of telura | ChEMBL registry synonym — accepted as the source's own label CHEMBL223228 ↗ |
| Known as | Efavirenz Stocrin (EFVBMM) | “Efavirenz Stocrin (EFVBMM)” NCT00444379 ↗ |
| Known as | Efavirenz teva | ChEMBL registry synonym — accepted as the source's own label CHEMBL223228 ↗ |
| Known as | efavirenz: Sustiva | “efavirenz (Sustiva)” NCT00884793 ↗1“efavirenz: Sustiva” NCT01318096 ↗ |
| Known as | Efavirenzum | ChEMBL registry synonym — accepted as the source's own label CHEMBL223228 ↗ |
| Known as | EFV | “DESIGN: ICE-001 is a phase IV, randomized, two-arm unblinded study, comparing the effect on immune reconstitution of open-label ritonavir (RTV)-enhanced lopinavir (LPV) to...” NCT00775606 ↗111“The Intensive Pharmacokinetics Sub-study of Encore1: A Randomised, Double-blind, Placebo-controlled, Clinical Trial to Compare the Safety and Efficacy of Reduced Dose Efavirenz...” NCT01271894 ↗ “The purpose of this study is to compare long-term safety and tolerability of stavudine (d4T) extended release (ER) versus conventional (immediate release [IR]) formulations,...” NCT00116298 ↗ “Daily Antiretroviral Therapy (DART-II): An Open-Label, Single-Arm, Prospective, Multicenter Clinical Trial To Evaluate the Efficacy and Safety fo Stavudine Extended Release...” NCT00116116 ↗ “Both HIV and HBV can be treated with tenofovir disoproxil fumarate (TDF) and lamivudine (3TC), so we evaluated the safety and efficacy of combination antiretroviral therapy...” PMID 26831232 ↗ Feb 2016 “In the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) 2010/VESTED study, pregnant women were randomized to initiate dolutegravir (DTG) +...” PMID 38877762 ↗ Nov 2024 “This 96 week, Phase 2b study in 150 HIV-1 infected antiretroviral (ART) naive adult subjects consists of a dose-ranging evaluation of GSK2248761 at blinded doses of 100 mg and...” NCT01231555 ↗ “This will be a two-center, placebo controlled blinded clinical trial to evaluate the safety and tolerability of efavirenz (EFV) in 36 clinically stable subjects with mild...” NCT03706885 ↗ “BACKGROUND: Study 903 is a phase 3 trial with a completed 144-week, double-blind phase comparing tenofovir DF (TDF) with stavudine (d4T), in combination with lamivudine (3TC)...” PMID 18042503 ↗ Nov 2007 “Adult AIDS Clinical Trials Group 5043 examined pharmacokinetic (PK) interactions between amprenavir (APV) and efavirenz (EFV) both by themselves and when nelfinavir (NFV),...” PMID 16048950 ↗ Aug 2005 “The purpose of this study is to see if it is safe and effective to give HIV-positive patients a combination of anti-HIV drugs (abacavir \[ABC\] plus efavirenz \[EFV\] plus...” NCT00005018 ↗ |
| Known as | EFV: Efavirenz | “EFV: Efavirenz” NCT01805258 ↗ |
| Known as | EFV: efavirenz, Sustiva | “EFV: efavirenz, Sustiva” NCT02028676 ↗ |
| Known as | EFZ | “A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Retosiban (GSK221149) When Dosed With Efavirenz (EFZ)” NCT01867996 ↗1“efavirenz (EFZ) and nelfinavir (NFV)” NCT00000893 ↗ |
| Known as | L-743726 | ChEMBL registry synonym — accepted as the source's own label CHEMBL223228 ↗ |
| Known as | NANO-Efavirenz | “a new pharmaceutical formulation of efavirenz (NANO-efavirenz) in HIV negative healthy volunteers after single dose and a steady-state.” NCT02631473 ↗ |
| Known as | NSC-742403 | ChEMBL registry synonym — accepted as the source's own label CHEMBL223228 ↗ |
| Known as | Stocrin | “Truvada (fixed dose combination of tenofovir + emtricitabine) + Stocrin (efavirenz)” NCT00335322 ↗2“plus EFV (Stocrin) 600 mg orally once daily at bedtime” NCT01435018 ↗ “efavirenz (Sustiva/Stocrin) 400 mg once daily” NCT02832778 ↗ |
| Known as | Susitiva | “The purpose of the study is to examine the effect of switching from an antiretroviral combination that includes efavirenz (Susitiva®), in individuals experiencing...” NCT00792324 ↗ |
| Known as | Sustiva | “In this study, we have chosen as BID regimen that containing NNRTI efavirenz (Sustiva®) and Combivir® which is the commercial combination of the NRTI zidovudine + lamivudine,...” NCT00256828 ↗24“A Phase I/II, Open Label Study to Evaluate the Ability of Combination Therapy With ABT-378/Ritonavir (Kaletra), Lamivudine (Epivir), Efavirenz (Sustiva)and Tenofovir DF to...” NCT00038220 ↗ “Canadian Sustiva Oral Liquid Expanded Access Program: An Open-Label, Multicenter Expanded Access Study of the Liquid Formulation of Sustiva (Efavirenz, DMP266)” NCT00162188 ↗ “Viracept (Nelfinavir Mesylate) 1250 Mg BID, Crixivan (Indinavir Sulfate) 1200mg q12h, and Sustiva (Efavirenz; DMP-266) 600 Mg q24h” NCT00002235 ↗ “To assess the bioequivalence of a selected single-dose of NANO-efavirenz to a single dose 600mg of efavirenz as Sustiva®” NCT02631473 ↗ “QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)” NCT00727597 ↗ “administration of 2 capsules Sustiva(R) (2x200 mg efavirenz) on study day 1” NCT00810303 ↗ “Efavirenz 600 mg, (Sustiva, Bristol-Myers Squibb) once daily” NCT00759070 ↗ “600 mg efavirenz (Sustiva tablets, Bristol-Myers Squibb)” NCT00966160 ↗ “most common is Sustiva, which is also called efavirenz.” NCT01087814 ↗ “efavirenz (Sustiva/Stocrin) 400 mg once daily” NCT02832778 ↗ |
| Known as | Sustiva (efavirenz) | “Sustiva (efavirenz)” NCT00523458 ↗ |
| Known as | Sustiva 600 | ChEMBL registry synonym — accepted as the source's own label CHEMBL223228 ↗ |
| Known as | Viraday | ChEMBL registry synonym — accepted as the source's own label CHEMBL223228 ↗ |
| Action | Inhibit | “efavirenz (an NNRTI, non-nucleoside reverse transcriptase inhibitor)” NCT00000918 ↗ |
| Modality | Other / unclassified | “Non-Nucleoside Reverse Transcriptase Inhibitor” NCT00000919 ↗ |
| Route | Oral | “efavirenz 600 mg po QD” NCT00001766 ↗ |
| Target | CYP2B6 | “Efavirenz serves as a model substrate, inhibitor and inducer of CYP2B6 (and other drug disposition proteins).” NCT02401256 ↗ |