Intelence

(Etravirine)

ApprovedSmall molecule

Intelence is a small molecule that works as a Human Immunodeficiency Virus Type 1 Reverse Transcriptase Inhibitor.[2] It is being used across 8 indications, with its most advanced program in Approved.[1]

Intelence is one of 254 small molecule programs targeting HIV infection. It is currently in Approved.

Indications

Total Trials

Active Trials

253

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

HIV InfectionActive, not recruiting

Viral DiseaseActive, not recruiting

ToxicityActive, not recruiting

Friedreich AtaxiaActive, not recruiting

HIV-1 InfectionActive, not recruiting

AnxietyActive, not recruiting

ImmunodeficiencyActive, not recruiting

Hepatitis CActive, not recruiting

HIV InfectionPhase 2

Active, not recruiting

Viral DiseaseApproved

Active, not recruiting

ToxicityPhase 3

Active, not recruiting

Friedreich AtaxiaPhase 2

Active, not recruiting

HIV-1 InfectionPhase 2

Active, not recruiting

AnxietyPreclinical

Active, not recruiting

ImmunodeficiencyPhase 2

Active, not recruiting

Hepatitis CApproved

Active, not recruiting

Competition

Competitive Landscape

326 competitors in HIV Infection

#DrugCompanyPhaseTrials

Intelence

WWim Janssens

Approved

2 2

Leukine

Sanofi

Phase 3

2 3

Intron a

Merck & Co.

Phase 3

1 4

Sunlenca

Gilead

Phase 3

1 5

Hivid

CConrado Roberto Hoffmann Filho

Phase 3

9 6

Praluent

Regeneron

Phase 3

1 7

Betaseron

PEG-Intron

Megace

TWINRIX™

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Treatment4 trials

Optimizing Treatment for Treatment-Experienced, HIV-Infected People

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00537394·517 enrolled

A Study of the Once Daily Combination of Etravirine and Darunavir/Ritonavir As Dual Therapy in Early Treatment-Experienced Patients

Completed·TTibotec, Inc·Phase 2·NCT01199939·54 enrolled

TMC125-TiDP2-C238: An Exploratory Pharmacokinetics, Safety and Anti-HIV Activity Study of Etravirine (ETR) When Given With Boosted Atazanavir (ATV/Rtv) at Two Different Doses and 1 Nucleoside Reverse Transcriptase Inhibitor (NRTI) in Treatment Experienced HIV Patients

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT00896051·50 enrolled

Show 1 more trial

TMC125-TiDP35-C239 - Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Participants

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00980538·180 enrolled

Interaction3 trials

Interaction Between Etravirine or Darunavir/Ritonavir and Artemether / Lumefantrine

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01876966·33 enrolled

GSK1349572 Drug Interaction With Etravirine and Either Darunavir/Ritonavir or Lopinavir/Ritonavir

Completed· GSK logo

GSK·Phase 1·NCT00867152·17 enrolled

Drug-drug Interaction (DDI) Study of GSK3640254 With Darunavir/Ritonavir (DRV/RTV) and Etravirine (ETR)

Completed· GSK logo

GSK·Phase 1·NCT04630002·54 enrolled

HIV infection2 trials

Evaluating Once Daily Etravirine in Treatment-Naive Adults With HIV Infection

Completed·UUniversity of North Carolina, Chapel Hill·Phase 2·NCT00959894·80 enrolled

Dose-finding Study of GSK2248761 in Antiretroviral Therapy-experienced Subjects With NNRTI-resistant HIV Infection

Terminated· GSK logo

GSK·Phase 2·NCT01199731·30 enrolled

Adolescent2 trials

TMC125-TiDP35-C213: Safety and Antiviral Activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 2·NCT00665847·103 enrolled

IMPAACT P1058A: Pharmacokinetic Effects of New Antiretroviral Drugs on Children, Adolescents and Young Adults

Completed·IInternational Maternal Pediatric Adolescent AIDS Clinical Trials Group··NCT00977756·168 enrolled

Clinical Trial2 trials

A Clinical Trial Comparing the Tolerability of Etravirine to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Treatment-naive HIV-1 Infected Patients

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT00903682·157 enrolled

Clinical Trial to Assess the Efficacy of Darunavir/Ritonavir (DRV/r), Etravirine (ETV) and Raltegravir (MK-0518) in HIV Patients With Resistant Viruses

Completed·FFrench National Agency for Research on AIDS and Viral Hepatitis·Phase 2·NCT00460382·103 enrolled

21 more indications

Drug Interactions1 trial

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

Completed·FFundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia·Phase 1·NCT02818348·30 enrolled

Adult1 trial

A Study to Assess the Effects of Itraconazole and Etravirine on JNJ-64417184 in Healthy Adult Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04208373·32 enrolled

HIV-11 trial

TMC125HIV1083 - Swallowability of Uncoated 200 mg Etravirine Tablets in HIV-1 Infected Patients

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 1·NCT01090648·49 enrolled

HIV-1 infection1 trial

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

Terminated· Pfizer logo

Pfizer·Phase 2·NCT01254656·108 enrolled

Combination Therapy1 trial

A5288/MULTI-OCTAVE: Management Using Latest Technologies to Optimize Combination Therapy After Viral Failure

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 4·NCT01641367·545 enrolled

Antiretroviral Treatment1 trial

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Etravirine Administered in Combination With Other Antiretroviral Agents in Antiretroviral Treatment-Experienced HIV-1 Infected Patients

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT01422330·211 enrolled

Concentration1 trial

Plasma and Intracellular Concentrations of Raltegravir and Etravirine Administered Once Daily

Completed·HHospitales Universitarios Virgen del Rocío·Phase 4·NCT01121809·16 enrolled

Pregnant Women1 trial

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

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00855335·77 enrolled

Viremia1 trial

HIV Viremia and Persistence in Acutely HIV-Infected Patients Treated With Darunavir/Ritonavir and Etravirine

Terminated·UUniversity of North Carolina, Chapel Hill·Phase 4·NCT00855413·15 enrolled

Toxicity1 trial

Pilot Study Switching Individuals Receiving EFV With Continuing Central Nervous System Toxicity to TMC125

Completed·SSt Stephens Aids Trust·Phase 3·NCT00792324·24 enrolled

Hepatitis C1 trial

Maraviroc Versus Etravirine In Combination With Antiretroviral Therapy In Drug Experienced HIV And Hepatitis Co-Infected Patients

Withdrawn· GSK logo

GSK·Phase 4·NCT00782301

Anxiety1 trial

Patient Preference, Sleep Quality, and Anxiety/Depression: A Randomized Comparison of Etravirine and Efavirenz

Completed·UUniversity Hospital, Geneva·N/A·NCT00792584·50 enrolled

ISS1 trial

Study in Healthy Males to Measure Darunavir and Etravirine in Blood, Seminal Fluid, and Rectal Tissue

Completed·UUniversity of North Carolina, Chapel Hill·Phase 1·NCT00855088·13 enrolled

Randomized1 trial

A Phase 2B Multicenter, Randomized, Comparative Trial Of UK-453,061 Versus Etravirine In Combination With Darunavir/Ritonavir And A Nucleos(t)Ide Reverse Transcriptase Inhibitor For The Treatment Of Antiretroviral Experienced HIV-1 Infected Subjects With Evidence Of NNRTI Resistant HIV-1

Terminated· Pfizer logo

Pfizer·Phase 2·NCT00823979·105 enrolled

Friedreich ataxia1 trial

Safety and Efficacy of Etravirine in Friedreich Ataxia Patients

Completed·IIRCCS Eugenio Medea·Phase 2·NCT04273165·30 enrolled

Children1 trial

Evaluating the Safety and Tolerability of Etravirine in HIV-1 Infected Infants and Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT01504841·26 enrolled

Immunodeficiency1 trial

A Study With TMC125 in Human Immunodeficiency Virus (HIV) Type 1 Infected Patients, Who Were Treated With TMC125 Arm in a Sponsor-Selected TMC125 Study

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 2·NCT00128830·211 enrolled

Observational Study1 trial

An Observational Study to Evaluate Tolerability of PREZISTA or INTELENCE in HIV-1 Infected Patients

Completed· Johnson & Johnson logo

Johnson & Johnson··NCT01615601·77 enrolled

Endothelial Function1 trial

Effects of Etravirine on Endothelial Function in HIV-uninfected Adults: A Pilot Study

Completed·IIndiana University·Phase 1·NCT00871234·28 enrolled

Pregnancy1 trial

Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)··NCT00042289·1,578 enrolled

Unspecified1 trial

DDI Study of BMS-663068 With Etravirine (ETR) and/or Darunavir (DVR) + Ritonavir (RTV)

Completed· GSK logo

GSK·Phase 1·NCT02063360·42 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 26, 2012

INTELENCE

NDA NDA022187

Sources

References

[1]
ClinicalTrials.gov — 34 trial records for Etravirine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Etravirine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Etravirine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022187). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Wim Janssens company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Human Immunodeficiency Virus Type 1 Reverse Transcriptase Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: WWim Janssens

Intelence

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Treatment4 trials

Interaction3 trials

HIV infection2 trials

Adolescent2 trials

Clinical Trial2 trials

Drug Interactions1 trial

Adult1 trial

HIV-11 trial

HIV-1 infection1 trial

Combination Therapy1 trial

Antiretroviral Treatment1 trial

Concentration1 trial

Pregnant Women1 trial

Viremia1 trial

Toxicity1 trial

Hepatitis C1 trial

Anxiety1 trial

ISS1 trial

Randomized1 trial

Friedreich ataxia1 trial

Children1 trial

Immunodeficiency1 trial

Observational Study1 trial

Endothelial Function1 trial

Pregnancy1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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