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Data updated: May 26, 2026

EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE (emtricitabine)

Infectious Disease Approved 2024-05-17
Jump to: Indications Approvals Trials Competitors Safety Patents
3
Indications
--
Phase 3 Trials
2
Years on Market

Details

Status
Discontinued
First Approved
2024-05-17
Routes
ORAL
Dosage Forms
TABLET

Companies

Lupin Apotex MACLEODS PHARMS LTD
Active Ingredient: EMTRICITABINE , TENOFOVIR ALAFENAMIDE FUMARATE

EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE Approval History

2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2024 to 2026
Apr 2026 ORIGINAL
Update
FDA Letter
Dec 2024 ORIGINAL
Update
May 2024 ORIGINAL
Update
FDA Letter

What EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE Treats

3 FDA approvals

Originally approved for its first indication in 2024 . Covers 3 distinct patient populations.

  • Other (3)
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Clinical Trial Registry

12 trials
Trial Sponsor ID Phase Status Title
NCT05979311 VOGUE 219816 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 AND TENOFOVIR ALAFENAMIDE FUMARATE FDA Label Details

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Data Sources

FDA Approval: ANDA213926 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.