Data updated: May 26, 2026
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE (efavirenz)
Trial Activity: Declining
Infectious Disease
Approved 2024-09-05
Development Insights
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections conducting 2 trials (67%)
3 indications explored (Focused)
→ hiv-1 infection (2 trials)
→ hiv infections (1 trials)
→ kaposi's sarcoma (1 trials)
1
Indication
--
Phase 3 Trials
1
Years on Market
Details
- Status
- None (Tentative Approval)
- First Approved
- 2024-09-05
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
Website: ↗
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE Approval History
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2024 to 2024
Sep 2024 ORIGINAL
Update
What EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE Treats
1 FDA approvalsOriginally approved for its first indication in 2024 .
- Other (1)
Other
(1 approval)- • Approved indication (Sep 2024)
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Clinical Trial Registry
58 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07570069 | VX24-548-018 | Ph 1 | not yet recruiting | Effects of Efavirenz on the Pharmacokinetics of Suzetrigine in Healthy Participants |
| NCT07341672 | HEC73543-AML-105 | Ph 1 | not yet recruiting | A Single-center, Randomized, Open-label, Parallel-design Clinical Study to Evaluate the Pharmacokinetic Effects of Itraconazole, Fluconazole or Efavirenz on a Single Dose of Clifutinib in Healthy Participants |
| NCT07482085 | 临研审[2026]009号-002 | Ph 3 | not yet recruiting | Efavirenz for the Treatment of Creutzfeldt-Jakob Disease |
| NCT05076682 Renaissance | 2107239-9 | Ph 2 | recruiting | Reverse Triple Negative Immune Resistant Breast Cancer |
| NCT06797674 | 7602-005 | Ph 1 | completed | A Study of the Effect Efavirenz on the Plasma Levels of MK-7602 in Healthy Participants (MK-7602-005) |
| NCT06914869 | X4P-001-004 | Ph 1 | completed | Drug-Drug Interaction Potential of Mavorixafor |
| NCT05909644 | 408-C-2202 | Ph 1 | completed | An Open-label DDI Study of Omaveloxolone in Healthy Subjects |
| NCT06698016 | 1026-014 | Ph 1 | completed | A Study of the Effect of Efavirenz on the Plasma Levels of Nemtabrutinib (MK-1026-014) |
| NCT01380080 REMEMBER results posted | ACTG A5274 1U01AI068636 | Ph 4 | completed | REMEMBER: Reducing Early Mortality & Morbidity by Empiric Tuberculosis (TB) Treatment |
| NCT02722421 | 0234-16-FB 1R01HD085887-01A1 | Ph 2 | completed | Pharmacologic Strategies to Use the Levonorgestrel Implant in HIV-infected Women |
| NCT05067439 results posted | B7451092 | Ph 1 | completed | A Study to Estimate the Effect of Multiple Dose Abrocitinib on Caffeine, Efavirenz, and Omeprazole in Healthy Participants |
| NCT05995249 | TAK-279-1002 | Ph 1 | completed | A Study of the Interaction of TAK-279 With Substances That Have an Impact on Metabolism in Healthy Adults |
| NCT01789879 | 0022-14-EP 1R21HD074462-01 | Ph 2 | completed | A Pharmacokinetic Evaluation of Levonorgestrel Implant and Antiretroviral Therapy |
| NCT02475915 | SEARCH 019 | Ph 1, Ph 2 | completed | Efficacy of VHM After Treatment Interruption in Subjects Initiating ART During Acute HIV Infection |
| NCT00775606 results posted | ICE-001 | Ph 4 | terminated | Immune Reconstitution of Lopinavir/Ritonavir-Based vs Efavirenz-based HAART in Advanced HIV Disease |
| NCT05330273 | CKAF156A2107 | Ph 1 | completed | Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Efavirenz |
| NCT04459598 results posted | AC220-A-U106 | Ph 1 | completed | A Study of the Effect of a Moderate CYP3A Inducer Efavirenz on Quizartinib Pharmacokinetics in Healthy Participants |
| NCT04504045 | AKF-395 2020-000162-42 | Ph 1 | terminated | Metformin's Effect on Drug Metabolism in Patients With Type 2 Diabetes |
| NCT00964002 FAVE results posted | CDR0000641767 IB-FAVE, IB 2008-23 | Ph 2 | completed | Efavirenz in Treating Patients With Metastatic Prostate Cancer |
| NCT01147107 results posted | VHARP 001 | Ph 4 | completed | Hepatic Safety of Raltegravir Versus Efavirenz as HIV Therapy for Patients With HIV and HCV Coinfection |
| NCT01709084 SALIF results posted | CR100875 TMC278IFD3002 | Ph 3 | completed | A Clinical Trial Comparing the Efficacy of Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus TDF/FTC/Efavirenz (TDF/FTC/EFV) in Patients With Undetectable Plasma HIV-1 RNA on Current First-line Treatment |
| NCT04390334 | ID-078-120 2020-000653-27 | Ph 1 | completed | A Study in Healthy Male Subjects to Investigate the Effect of Famotidine and Efavirenz on the Way the Body Takes up, Distributes, and Gets Rid of Daridorexant. |
| NCT03983239 | FEDR-CP-002 U1111-1233-7946 | Ph 1 | completed | Effect of Rifampin and Efavirenz on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects |
| NCT01695954 results posted | 11-01787 | Ph 1 | completed | Pharmacokinetic Study of Pitavastatin and Ritonavir-Boosted Darunavir or Efavirenz |
| NCT01075152 COAT results posted | 0810M49622 U01AI089244 | Ph 4 | completed | Cryptococcal Optimal ART Timing Trial |
| NCT02945163 | 2016-M-2 | Ph 4 | completed | Dosing of Tenofovir and Efavirenz in Antiretroviral Therapy |
| NCT02935075 OAT | 2016-M-1 | Ph 4 | completed | Optimization of Antiretroviral Therapy |
| NCT01618305 results posted | P1081 10770, NICHD P1081 | Ph 4 | completed | Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission |
| NCT01632891 results posted | ACTG A5297 1U01AI068636 | Ph 1, Ph 2 | completed | Comparing PI-Based to a nNRTI-based ART for Clearance of Plasmodium Falciparum Parasitemia in HIV-Infected |
| NCT01632345 results posted | 1439-007 MK-1439-007, 2012-001573-93 | Ph 2 | completed | A Dose-Ranging Study to Compare Doravirine (MK-1439) Plus TRUVADA® Versus Efavirenz Plus TRUVADA® in Human Immunodeficiency Virus (HIV)-1 Infected Participants (MK-1439-007) |
| NCT00993031 PROMOTE-PIs results posted | H5741-34342 P01HD059454, 2009-141 | Ph 3 | completed | Protease Inhibitors to Reduce Malaria Morbidity in HIV-Infected Pregnant Women |
| NCT03762928 | B7981017 | Ph 1 | completed | ESTIMATION OF THE EFFECT OF MULTIPLE DOSE PF-06651600 ON THE PHARMACOKINETICS OF SINGLE DOSE MIDAZOLAM AND EFAVIRENZ |
| NCT01989910 results posted | MSD-MISP-39299 TVGH-IRB-2013-07-030B | Ph 4 | completed | Compare the Efficacy and Safety of Raltegravir Versus Efavirenz Combination Therapy in Treatment-naïve HIV-1 Patients |
| NCT02489461 | HIV-VM1500-04 | Ph 2, Ph 3 | completed | Efficacy, Safety and Optimal Dose of VM-1500 in Comparison to Efavirenz Added to Standard-of-care Antiretroviral Therapy |
| NCT01980342 results posted | NA_00087585 | Ph 4 | terminated | Pharmacokinetics and Pharmacodynamics of the Etonogestrel Contraceptive Implant When Co-administered With Efavirenz |
| NCT00951015 ING112276 results posted | 112276 | Ph 2 | completed | A Dose Ranging Trial of GSK1349572 and 2 NRTI in HIV-1 Infected, Therapy Naive Subjects |
| NCT02499874 | SSAT063 | Ph 1 | completed | SSAT063- Pharmacokinetics of Efavirenz 400 mg Once Daily During Pregnancy in HIV-1 Infected Women |
| NCT02401256 results posted | 1205008739 5R01GM078501 | Ph 4 | completed | CYP2B6 Genetics and Drug Interactions in Healthy Volunteers |
| NCT01098526 | 114005 | Ph 1 | completed | GSK1349572 Drug Interaction Study With Efavirenz |
| NCT01194856 results posted | 10-418 5K23AI070078, BMS100MT | Ph 4 | terminated | Switching From Efavirenz to Atazanavir/ Ritonavir in HIV-infected Subjects With Good Virologic Suppression |
| NCT01900015 STERAL | STERAL/50410 | Ph 4 | completed | Changes in Liver Steatosis After Switching to Raltegravir in HIV/HCV Coinfection |
| NCT01516970 PEPDar results posted | CR018349 TMC114IFD3004, 2011-001303-13 | Ph 3 | completed | Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) With Darunavir/Ritonavir (DRV/r) |
| NCT01087814 results posted | 0910M73917 | Ph 4 | completed | Sustiva Levels With Use of a Gel Capsule |
| NCT01588002 | NP28103 | Ph 1 | completed | A Study of Potential Drug-Drug Interaction Between Efavirenz and Danoprevir With Low Dose Ritonavir in Healthy Volunteers |
| NCT01489046 | AI467-003 2011-003329-89 | Ph 2 | terminated | Safety, Efficacy and Dose-response Study of BMS-986001 in Subjects With HIV-1 Infection Who Are Treatment-naive |
| NCT00543725 results posted | CR002704 TMC278-TIDP6-C215 | Ph 3 | completed | TMC278-TiDP6-C215: A Clinical Trial in Treatment Naive HIV-subjects Patients Comparing TMC278 to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors |
| NCT00540449 results posted | CR002689 TMC278-TIDP6-C209 | Ph 3 | completed | TMC278-TiDP6-C209: A Clinical Trial in Treatment Naive HIV-1 Patients Comparing TMC278 to Efavirenz in Combination With Tenofovir + Emtricitabine. |
| NCT02164812 | AI266-959 | Ph 1 | completed | Study to Determine the Effect of Efavirenz on the ECG QTcF Interval in Healthy Subjects |
| NCT01585038 results posted | TMC278HIV4002 | Ph 4 | completed | Efavirenz Versus Rilpivirine on Vascular Function, Inflammation, and Oxidative Stress |
| NCT01254656 results posted | A5271037 | Ph 2 | terminated | A Long Term Safety Study Of Lersivirine For The Treatment Of HIV-1 Infection In Subjects Who Have Completed Treatment With Lersivirine In Studies A5271015 And A5271022 |
Showing 50 of 58 trials
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment