TheraRadar
Data updated: Nov 8, 2026

EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE (emtricitabine) · Apotex

Trial Activity: Declining 1 active trials
Infectious Disease Approved 2026-01-30
FDA label not available. This product's label is not in FDA's label database (openFDA, DailyMed). Search DailyMed → · Drugs@FDA approval documents →
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Development Insights

ViiV Healthcare conducting 2 trials (17%)
10 indications explored (Broad Platform)
→ hiv (3 trials)
→ hiv infections (3 trials)
→ hiv-1 infection (1 trials)
1
Indication
--
Phase 3 Trials
0
Years on Market

Details

Status
Discontinued
First Approved
2026-01-30
Routes
ORAL
Dosage Forms
TABLET

Companies

Apotex
Active Ingredient: EMTRICITABINE , RILPIVIRINE HYDROCHLORIDE , TENOFOVIR ALAFENAMIDE FUMARATE

EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE Approval History

Original
New Indication
New Form
Label Update
1 FDA actions from 2026 to 2026
Jan 2026 ORIGINAL
Update
FDA Letter

What EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE Treats

1 FDA approvals

Originally approved for its first indication in 2026 .

  • Other (1)
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Clinical Trial Registry

12 trials
Trial Sponsor ID Phase Status Title
NCT05979311 VOGUE 219816 2023-504993-40-00, 2023 Ph 3 active not recruiting A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy
NCT01400412 results posted ACTG A5303 1U01AI068636 Ph 2 completed Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen
NCT00799864 results posted CR002677 TMC278-TiDP38-C213, 2008-001696-30 Ph 2 completed A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years
NCT02475915 SEARCH 019 Ph 1, Ph 2 completed Efficacy of VHM After Treatment Interruption in Subjects Initiating ART During Acute HIV Infection
NCT01505114 results posted HPTN 069/A5305 (NEXT Prep) 11789, HPTN 069/A5305 Ph 2 completed Evaluating the Safety and Tolerability of Antiretroviral Drug Regimens Used as Pre-Exposure Prophylaxis to Prevent HIV Infection in At-Risk Men Who Have Sex With Men and in At-Risk Women
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
NCT04477096 HS-10234-108 Ph 1 completed Evaluation of Drug Interaction Between HS-10234 and Emtriccitabine
NCT01803074 results posted 206739 2012-004124-38, AI468-002 Ph 2 completed Study to Evaluate a HIV Drug for the Treatment of HIV Infection
NCT01335620 results posted RTG_60 2010-022907-23 Ph 4 completed The Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age
NCT02116660 RANIA results posted 0518-284 2013-001637-40, MK-0518-284 Ph 2 terminated Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)
NCT02904369 A15-137 Ph 1 completed PK and PD Study of Oral F/TAF for HIV Prevention
NCT00869960 results posted F080428014 1K23AI074390-01A2 Ph 4 completed Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in Healthy Women
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE FDA Label Details

FDA label not available. This product's label is not in FDA's label database (openFDA, DailyMed). Search DailyMed → · Drugs@FDA approval documents →

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Data Sources

FDA Approval: ANDA214095 → Trials: ClinicalTrials.gov →

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