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Emtricitabine/Tenofovir Disoproxil · Truvada

Small molecule · Inhibitor of HIV-1 reverse transcriptase · developed by Gilead

Approved FDA, Aug 2004

GILD Developer

2 Registered trials

What is Emtricitabine/Tenofovir Disoproxil?

Emtricitabine/tenofovir disoproxil is a fixed-dose combination of two nucleoside analog reverse transcriptase inhibitors, emtricitabine and tenofovir disoproxil fumarate. Both act on HIV-1 reverse transcriptase by competing with natural deoxyribonucleosides and causing early termination of the viral DNA chain. It is studied in HIV-1 infection and pre-exposure prophylaxis of HIV infection.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: Truvada, F/TDF
Drug type: Small molecule
Targets: HIV-1 reverse transcriptase
Mechanism: Inhibitor of HIV-1 reverse transcriptase
Pathways: viral DNA synthesis
Therapy area: Infectious disease
Developer: Gilead (GILD)
FDA status: Approved as Truvada (August 2, 2004), NDA021752 · FDA label

✅ FDA-approved uses

HIV-1 infection
HIV-1 pre-exposure prophylaxis (PrEP)

From the indications section of the FDA label (version of Jul 16, 2025). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT04925752	Phase 3	Pre-Exposure Prophylaxis of HIV Infection	Active not recruiting	GILD
NCT07473778	N/A	HIV Infections	Recruiting	GILD

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

HIV InfectionsPre-Exposure Prophylaxis of HIV Infection

More from Gilead

Axicabtagene Ciloleucel FDA approved Bictegravir FDA approved Brexucabtagene Autoleucel FDA approved Bulevirtide FDA approved Cobicistat FDA approved Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDA approved Emtricitabine And Tenofovir Alafenamide FDA approved Lenacapavir FDA approved Remdesivir FDA approved Sacituzumab Govitecan FDA approved Seladelpar FDA approved Tenofovir Disoproxil FDA approved

Sources

Updated Oct 11, 2026. Something wrong or missing? Report it on the GILD page.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z