INTELENCE (etravirine)
Intelence (etravirine) is indicated, in combination with other antiretroviral agents, for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in treatment-experienced adult and pediatric patients 2 years of age and older. It is specifically intended for patients who have evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other antiretroviral agents.
How INTELENCE Works
Etravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of HIV-1. It binds directly to the HIV-1 reverse transcriptase (RT) enzyme and blocks RNA-dependent and DNA-dependent DNA polymerase activities by causing a conformational change at the enzyme's catalytic site. Unlike many other NNRTIs, etravirine is designed to maintain activity against many HIV-1 strains with common NNRTI-resistance mutations.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2008-01-18
- Routes
- ORAL
- Dosage Forms
- TABLET
INTELENCE Approval History
What INTELENCE Treats
1 indicationsINTELENCE is approved for 1 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Human Immunodeficiency Virus Infection
INTELENCE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
20 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00980538 results posted | CR016408 TMC125-TIDP35-C239, 2009-013126-16 | Ph 3 | completed | TMC125-TiDP35-C239 - Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Participants |
| NCT04208373 | CR108747 2019-003928-20, 64417184RSV1002 | Ph 1 | completed | A Study to Assess the Effects of Itraconazole and Etravirine on JNJ-64417184 in Healthy Adult Participants |
| NCT00537394 results posted | A5241 10395, ACTG A5241 | Ph 3 | completed | Optimizing Treatment for Treatment-Experienced, HIV-Infected People |
| NCT01641367 MULTI-OCTAVE results posted | ACTG A5288 1U01AI068636 | Ph 4 | completed | A5288/MULTI-OCTAVE: Management Using Latest Technologies to Optimize Combination Therapy After Viral Failure |
| NCT00823979 results posted | A5271022 2007-004392-19 | Ph 2 | terminated | 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 |
| NCT00855335 results posted | CR015442 TMC114HIV3015 | Ph 3 | completed | 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 |
| NCT02818348 | DRV/c-ETR | Ph 1 | completed | Clinical Trial to Evaluate Drug-drug Interactions Between Darunavir/Cobicistat and Etravirine in Hiv- Infected Patients |
| NCT01199731 SONNET results posted | 113399 | Ph 2 | terminated | Dose-finding Study of GSK2248761 in Antiretroviral Therapy-experienced Subjects With NNRTI-resistant HIV Infection |
| NCT00855413 results posted | CID 0821 | Ph 4 | terminated | HIV Viremia and Persistence in Acutely HIV-Infected Patients Treated With Darunavir/Ritonavir and Etravirine |
| NCT01422330 | CR017860 TMC125IFD3002, 2010-023532-16 | Ph 4 | completed | 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 |
| 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 |
| NCT01199939 INROADS results posted | CR017149 TMC125HIV4007 | Ph 2 | completed | A Study of the Once Daily Combination of Etravirine and Darunavir/Ritonavir As Dual Therapy in Early Treatment-Experienced Patients |
| NCT01876966 DDI Coartem | CR018409 2010-023289-31, TMC125VIR1001 | Ph 1 | completed | Interaction Between Etravirine or Darunavir/Ritonavir and Artemether / Lumefantrine |
| NCT01090648 | CR017038 | Ph 1 | completed | TMC125HIV1083 - Swallowability of Uncoated 200 mg Etravirine Tablets in HIV-1 Infected Patients |
| NCT00867152 | 112934 | Ph 1 | completed | GSK1349572 Drug Interaction With Etravirine and Either Darunavir/Ritonavir or Lopinavir/Ritonavir |
| NCT00782301 | A4001080 | Ph 4 | withdrawn | Maraviroc Versus Etravirine In Combination With Antiretroviral Therapy In Drug Experienced HIV And Hepatitis Co-Infected Patients |
| NCT00855088 DESeRT | UNC IRB 08-0419 | Ph 1 | completed | Study in Healthy Males to Measure Darunavir and Etravirine in Blood, Seminal Fluid, and Rectal Tissue |
| NCT01121809 RAET | LLC-RAET-2009-1 2009-014480-39 | Ph 4 | completed | Plasma and Intracellular Concentrations of Raltegravir and Etravirine Administered Once Daily |
| NCT00871234 results posted | 0812-18 (TMC125HIV4003) | Ph 1 | completed | Effects of Etravirine on Endothelial Function in HIV-uninfected Adults: A Pilot Study |
| NCT00792324 | SSAT 029 | Ph 3 | completed | Pilot Study Switching Individuals Receiving EFV With Continuing Central Nervous System Toxicity to TMC125 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
INTELENCE FDA Label Details
Indications & Usage
FDA Label (PDF)INTELENCE is indicated for the treatment of Human Immunodeficiency Virus Infection.
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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