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Drug

Etravirine

Established medicine
ClassHuman immunodeficiency virus type 1 reverse transcriptase inhibitorResearchOngoing clinical research

Also known as Intelence, Etravirina.

RxNorm475969ChEMBLCHEMBL308954ATCJ05AG04UNII0C50HW4FO1
Reverse transcriptase/RNaseH
Primary target
2
Regulatory events
Latest activity
beta

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

Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Subjects

Clinical trial2026-06-09Results posted · ClinicalTrials.gov

Open-Label, Single-Sequence Study to Evaluate the Effects of Darunavir/Ritonavir and/or Etravirine on the Pharmacokinetics of GSK3640254 and the Effects of GSK3640254 on the Pharmacokinetics of Darunavir/Ritonavir and/or Etravirine in Heathy Adults

Clinical trial2024-08-29Results posted · ClinicalTrials.gov

A Phase 2 Clinical Trial to Test the Safety and Efficacy of Etravirine in Friedreich Ataxia Patients

Clinical trial2023-01-17Completed · ClinicalTrials.gov

The Optimized Treatment That Includes or Omits NRTIs Trial: A Randomized Strategy Study for HIV-1-Infected Treatment-Experienced Subjects Using the cPSS to Select an Effective Regimen

Clinical trial2021-11-04Results posted · ClinicalTrials.gov

A Phase I/II, Open-Label Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Etravirine (ETR) in Antiretroviral (ARV) Treatment-Experienced HIV-1 Infected Infants and Children, Aged ≥ 2 Months to < 6 Years

Clinical trial2021-11-02Results posted · ClinicalTrials.gov

A Phase 1, Open-label, Fixed-sequence, 2-Panel Study to Assess the Effects of Itraconazole and Etravirine on the Single-dose Pharmacokinetics of JNJ-64417184 in Healthy Adult Subjects

Clinical trial2020-03-10Completed · ClinicalTrials.gov

Management Using the Latest Technologies in Resource-limited Settings to Optimize Combination Therapy After Viral Failure (MULTI-OCTAVE)

Clinical trial2019-03-15Results posted · ClinicalTrials.gov

A Single Arm, Open Label Study to Assess the Pharmacokinetics of Darunavir and Ritonavir, Darunavir and Cobicistat, Etravirine, and Rilpivirine in HIV-1 Infected Pregnant Women

Clinical trial2018-07-06Results posted · ClinicalTrials.gov

Clinical Trial to Evaluate Drug-drug Interactions Between Darunavir/Cobicistat and Etravirine in Hiv- Infected Patients

Clinical trial2016-11-23Completed · ClinicalTrials.gov

Antiretroviral Activity and Tolerability of Once Daily Etravirine in Treatment-Naïve Adults With HIV-1 Infection

Clinical trial2016-06-06Results posted · ClinicalTrials.gov

Drug Safety Update: Etravirine: reports of severe hypersensitivity reactions

Regulatory2014-12-11MHRA

Approval: Intelence (EMA)

Regulatory2008-08-28EMA

Profile

Identifiers & mechanism

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

Canonical name
Etravirine
Aliases & brands
IntelenceEtravirina
RxNorm CUI
475969
ChEMBL ID
CHEMBL308954
ATC codes
J05AG04
UNII
0C50HW4FO1
Primary mechanism
Human immunodeficiency virus type 1 reverse transcriptase inhibitor
Regulatory jurisdictions
mhraema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Reverse transcriptase/RNaseH
pol · Q72547
INHIBITORHuman immunodeficiency virus type 1 reverse transcriptase inhibitor

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.

Earliest approval
2008-08-28
Latest approval
2008-08-28
Authorities
EMA · MHRA
Total events
2
emaEuropean Medicines Agency· 1 event
2008-08-28Approval
Approval: Intelence (EMA)
Indication: Intelence, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human-immunodeficiency-virus-type-1… Show full indication

Intelence, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human-immunodeficiency-virus-type-1 (HIV-1) infection in antiretroviral-treatment-experienced adult patients and in antiretroviral-treatment-experienced paediatric patients from six years of age. This indication is based on week-48 analyses from two phase-III trials in highly pretreated patients where Intelence was investigated in combination with an optimised background regimen (OBR) which included darunavir/ritonavir. The indication in paediatric patients is based on 48-week analyses of a single-arm, phase-II trial in antiretroviral-treatment-experienced paediatric patients.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2014-12-11Safety communicationSafety
Drug Safety Update: Etravirine: reports of severe hypersensitivity reactions
Evidence ↗

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

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

31 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
31
registered trials across all phases
LATEST COMPLETION 2026
10
Late-stage (III+)
26
Completed
5
Discontinued
PHASE DISTRIBUTIONn = 31
Phase 19Phase 1 / 21Phase 211Phase 34Phase 45Phase N / A1

Late-stage studies

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

Management Using the Latest Technologies in Resource-limited Settings to Optimize Combination Therapy After Viral Failure (MULTI-OCTAVE)

CompletedPH IVAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infectionsn=5452018

CID 0821 - Pilot Study to Evaluate HIV Viremia and Persistence in Acutely HIV-Infected Antiretroviral Naïve Patients Treated With Darunavir/Ritonavir and Etravirine

TerminatedPH IVUniversity of North Carolina, Chapel Hilln=152013

An Open-Label Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Etravirine (ETR) in Combination With Other Antiretrovirals (ARVs) in Antiretroviral Treatment-Experienced HIV-1 Infected Subjects

CompletedPH IVJanssen R&D Irelandn=2112013

Plasma and Intracellular Concentrations of Raltegravir and Etravirine Administered Once Daily (800 mg and 400 mg, Respectively) Compared With Standard Dosing (400 mg and 200 mg/12 h) in Patients With HIV Infection

CompletedPH IVHospitales Universitarios Virgen del Rocíon=162011

A Multicenter, Randomized, Open, Comparative Trial Of Maraviroc Versus Etravirine Each In Combination With Darunavir/Ritonavir And Raltegravir For The Treatment Of Antiretroviral-Experienced HIV-1 Subjects Co-Infected With Hepatitis C And/Or Hepatitis B

WithdrawnPH IVViiV Healthcare2010

Recent completions

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

Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Subjects

CompletedPH IIIJanssen Sciences Ireland UCn=1802026

A Phase 2 Clinical Trial to Test the Safety and Efficacy of Etravirine in Friedreich Ataxia Patients

CompletedPH IIIRCCS Eugenio Medean=302023

Open-Label, Single-Sequence Study to Evaluate the Effects of Darunavir/Ritonavir and/or Etravirine on the Pharmacokinetics of GSK3640254 and the Effects of GSK3640254 on the Pharmacokinetics of Darunavir/Ritonavir and/or Etravirine in Heathy Adults

CompletedPH IViiV Healthcaren=542021

A Phase I/II, Open-Label Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Etravirine (ETR) in Antiretroviral (ARV) Treatment-Experienced HIV-1 Infected Infants and Children, Aged ≥ 2 Months to < 6 Years

CompletedPH I/IINational Institute of Allergy and Infectious Diseases (NIAID)n=262020

A Phase 1, Open-label, Fixed-sequence, 2-Panel Study to Assess the Effects of Itraconazole and Etravirine on the Single-dose Pharmacokinetics of JNJ-64417184 in Healthy Adult Subjects

CompletedPH IJanssen Research & Development, LLCn=322020

Management Using the Latest Technologies in Resource-limited Settings to Optimize Combination Therapy After Viral Failure (MULTI-OCTAVE)

CompletedPH IVAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infectionsn=5452018
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.