Data updated: May 26, 2026
SYMFI LO (efavirenz)
Infectious Disease
Approved 2018-02-05
1
Indication
--
Phase 3 Trials
1
Priority Reviews
8
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2018-02-05
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
Website: ↗
SYMFI LO Approval History
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2018 to 2019
What SYMFI LO Treats
1 FDA approvalsOriginally approved for its first indication in 2018 .
- Other (1)
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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.
SYMFI LO FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.