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Data updated: May 26, 2026

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (emtricitabine)

Infectious Disease Approved 2017-06-08
Jump to: Indications Approvals Trials Competitors Safety Patents
14
Indications
--
Phase 3 Trials
8
Years on Market

Details

Status
Discontinued
First Approved
2017-06-08
Routes
ORAL
Dosage Forms
TABLET

Companies

Apotex ZYDUS PHARMS Teva HETERO LABS LTD III CHARTWELL RX Cipla Aurobindo Pharma AMNEAL PHARMS CO STRIDES PHARMA MACLEODS PHARMS LTD PHARMOBEDIENT LAURUS
Active Ingredient: EMTRICITABINE , TENOFOVIR DISOPROXIL FUMARATE

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE Approval History

2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
72 FDA actions from 2017 to 2025
Jul 2025 SUPPL
Label · Labeling
Jun 2025 SUPPL
Label · Labeling
Dec 2024 SUPPL
Label · Labeling

What EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE Treats

14 FDA approvals

Originally approved for its first indication in 2017 . Covers 14 distinct patient populations.

  • Other (14)
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Clinical Trial Registry

13 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
NCT01285050 results posted NA00040361 R01DA013806 Ph 4 completed Interferon Alfa Sensitivity in HIV/HCV Persons Before and After HIV Meds
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 DISOPROXIL FUMARATE FDA Label Details

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Data Sources

FDA Approval: ANDA208740 → Trials: ClinicalTrials.gov →

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