Back to discover
Drug

Efavirenz

Regulatory activity · EMA
Emerging researchLate-stage development
Also known as Atripla, Sustiva, Symfi, (S)-6-chloro-4-(Cyclopropylethynyl)-1,4-dihydro-(S)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one+1 more

Atripla, Sustiva, Symfi, (S)-6-chloro-4-(Cyclopropylethynyl)-1,4-dihydro-(S)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one, Efavirenzum.

RxNorm195085ChEMBLCHEMBL223228UNIIJE6H2O27P8
2
Research papers
6
Active clinical trials
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 1, Open-label Drug-drug Interaction Study to Evaluate the Effects of Efavirenz on the Pharmacokinetics of Suzetrigine in Healthy Subjects

Clinical trial2026-07-11Primary completion · ClinicalTrials.gov

A Single-center, Non-randomized, Open-label, Self-controlled, Phase I Clinical Study to Evaluate Drug-Drug Interactions (DDI) of JMKX003142 Tablets in Chinese Healthy Participants.

Clinical trial2026-05-04Results expected Q4 2026 · ClinicalTrials.gov

The Drug-Drug Interaction Study of Clifutinib

Clinical trial2026-04-27Results expected Q2 2027 · ClinicalTrials.gov

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Study to Evaluate the Efficacy and Safety of Efavirenz in Patients With Creutzfeldt-Jakob Disease

Clinical trial2026-03-19Results expected Q4 2028 · ClinicalTrials.gov

Short-term Addition of Efavirenz to Induce CARD8-mediated Reduction of Persistent Nonsuppressible HIV Viremia in People With High Adherence to ART.

Clinical trial2026-03-17Results expected Q4 2027 · ClinicalTrials.gov

Reverse Triple Negative Immune Resistant Breast Cancer

Clinical trial2025-12-03Results expected Q4 2026 · ClinicalTrials.gov

Market withdrawal: Stocrin (EMA)

Regulatory2025-09-30EMA

A Phase II Trial to Assess the Efficacy of Efavirenz as Second-line Monotherapy for the Treatment of Advanced Pancreatic Adenocarcinomas.

Clinical trial2025-08-28Results posted · ClinicalTrials.gov

A Clinical Study to Evaluate the Effect of Multiple Doses of Efavirenz on Single-Dose Pharmacokinetics of MK-7602 in Healthy Participants

Clinical trial2025-08-12Completed · ClinicalTrials.gov

Market withdrawal: Sustiva (EMA)

Regulatory2024-02-01EMA

A phase II trial evaluating the efficacy and safety of efavirenz in metastatic castration-resistant prostate cancer.

Research2014-10-29The oncologist

Combination therapy with efavirenz, nelfinavir, and nucleoside reverse-transcriptase inhibitors in children infected with human immunodeficiency virus type 1. Pediatric AIDS Clinical Trials Group 382 Team.

Research1999-12-01The New England journal of medicine

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Efavirenz
Aliases & brands
AtriplaSustivaSymfi(S)-6-chloro-4-(Cyclopropylethynyl)-1,4-dihydro-(S)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one4-(trifluoromethyl)-2H-3,1-benzoxazin-2-oneEfavirenzum
RxNorm CUI
195085
ChEMBL ID
CHEMBL223228
UNII
JE6H2O27P8
Regulatory jurisdictions
ema

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities
EMA
Total events
2
emaEuropean Medicines Agency· 2 events
2025-09-30Market withdrawalMarket
Market withdrawal: Stocrin (EMA)
Indication: Stocrin is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children three years of age and older. Stocrin… Show full indication

Stocrin is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children three years of age and older. Stocrin has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease-inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing Stocrin.

Evidence ↗
2024-02-01Market withdrawalMarket
Market withdrawal: Sustiva (EMA)
Indication: Sustiva is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children three years of age and older. Sustiva… Show full indication

Sustiva is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children three years of age and older. Sustiva has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease-inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing Sustiva.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

188 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
188
registered trials across all phases
LATEST COMPLETION 2025
6
Active studies
5
Recruiting
107
Late-stage (III+)
158
Completed
24
Discontinued
PHASE DISTRIBUTIONn = 188
Early Phase 11Phase 137Phase 1 / 25Phase 238Phase 2 / 32Phase 346Phase 432Phase N / A27

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Safety, Tolerability, and Efficacy of Efavirenz (EFV) Intensification on HIV-1 Reservoir Reduction

CompletedPH IVWashington University School of Medicinen=72024

Hepatic Safety of Raltegravir-based and Efavirenz-based Antiretroviral Regimens in Antiretroviral-Naïve HIV-infected Subjects Co-Infected With Hepatitis C

CompletedPH IVUniversity of Hawaiin=802021

Optimization of Antiretroviral Therapy

CompletedPH IVShanghai Public Health Clinical Centern=1842019

The Optimization of HAART for Chinese--a RCT Study

CompletedPH IVShanghai Public Health Clinical Centern=1842019

A Phase IV Randomized Trial to Evaluate the Virologic Response and Pharmacokinetics of Two Different Potent Regimens in HIV Infected Women Initiating Triple Antiretroviral Regimens Between 20 and 36 Weeks of Pregnancy for the Prevention of Mother-to-Child Transmission: NICHD P1081

CompletedPH IVWestatn=4082018

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Clinical Study to Evaluate the Effect of Multiple Doses of Efavirenz on Single-Dose Pharmacokinetics of MK-7602 in Healthy Participants

CompletedPH IMerck Sharp & Dohme LLCn=342025

A Phase I, Randomized, Open-label, Drug-drug Interaction Study to Assess the Effect of Multiple Doses of a Moderate and a Strong CYP3A Inducer on the Pharmacokinetics and Safety of Mavorixafor in Healthy Male and Female Participants

CompletedPH IX4 Pharmaceuticalsn=382025

Safety, Tolerability, and Efficacy of Efavirenz (EFV) Intensification on HIV-1 Reservoir Reduction

CompletedPH IVWashington University School of Medicinen=72024

A Phase 1, 3-Part, Open-label, Drug-Drug Interaction Study to Evaluate the Effect of a Moderate CYP3A4 Inhibitor, and of Strong and Moderate CYP3A4 Inducers on the Pharmacokinetics of TAK-279 in Healthy Subjects

CompletedPH ITakedan=1722023

A Study to Evaluate the Effect of Multiple Oral Doses of Efavirenz on the Single-Dose Pharmacokinetics of Nemtabrutinib in Healthy Participants

CompletedPH IMerck Sharp & Dohme LLCn=162023

A Single Sequence, 2-Period, Open-label Crossover Study in Healthy Subjects to Determine the Effect of a Moderate CYP3A4 Inducer on the Pharmacokinetics of Omaveloxolone

CompletedPH IBiogenn=202023

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
19992014
Major research themes1
HIV-11
Journals, researchers & institutions
Top journals
  • The New England journal of medicine1
  • The oncologist1
Leading researchers
  • Becker M1
  • Bellera C1
  • Brundage RC1
  • Dankner WM1
  • Fenton T1
  • Ferrero JM1
  • Fiske W1
  • Fletcher CV1
Leading institutions
free-text, unnormalised
  • Antoine Lacassagne Cancer Center1
  • Centre Hospitalier de Pellegrin1
  • Children's Hospital of Philadelphia1
  • Claudius Régaud Cancer Center1
  • Clinical Research and Clinical Epidemiology Unit1
  • François Baclesse Cancer Center1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.